What is Azulfidine?

Azulfidine is used to treat ulcerative colitis (UC), and to decrease the frequency of UC attacks. This medicine will not cure ulcerative colitis, but it can reduce the number of attacks you have.

Azulfidine is also used to treat rheumatoid arthritis in children and adults who have used other arthritis medicines that did not work or have stopped working.

Azulfidine may also be used for purposes not listed in this medication guide.

Azulfidine side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

• fever with headache, rash, and vomiting;
• a skin rash, no matter how mild;
• severe nausea or vomiting when you first start taking Azulfidine;
• little or no urination, urine that looks foamy;
• puffy eyes, swelling in your ankles or feet, weight gain; or
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of Azulfidine may include:

• nausea, vomiting, upset stomach, loss of appetite;
• headache;
• rash; or
• low sperm count in men.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use Azulfidine if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to sulfa drugs, aspirin, or similar medicines called salicylates.

Before taking this medicine

You should not use Azulfidine if you are allergic to it, or if you have:

• a blockage in your bladder or intestines;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• an allergy to sulfa drugs; or
• an allergy to aspirin or other salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• frequent infections;
• asthma;
• low blood cell counts; or
• liver or kidney disease.

Tell your doctor if you are pregnant. Taking Azulfidine can make it harder for your body to absorb folic acid, and folic acid helps prevent major birth defects of the baby’s brain or spine. You may need to take folic acid supplements if you take this medicine during pregnancy. Follow your doctor’s instructions.

Sulfasalazine can pass into breast milk and may cause diarrhea or bloody stools in a nursing baby. Tell your doctor if you are breast-feeding.

Azulfidine is not approved for use by anyone younger than 2 years old.

How should I take Azulfidine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Azulfidine after a meal.

Swallow the tablet whole and do not crush, chew, or break it.

You will need frequent medical tests.

Drink plenty of liquids to keep your kidneys working properly while you are taking Azulfidine.

Azulfidine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Azulfidine may cause your skin or urine to appear orange-yellow in color. Call your doctor if you also have yellowing of your eyes, brown urine, or stomach pain. These may be signs of liver problems.

If you are treating arthritis, do not stop using any of your other arthritis medicines until your doctor tells you to. Azulfidine may not improve your symptoms right away, and you may still need your other medicines for awhile.

Azulfidine is only part of a complete treatment for rheumatoid arthritis that may also include rest and physical therapy. Follow your doctor’s instructions very closely.

What is azithromycin?

Azithromycin is an antibiotic that fights bacteria.

Azithromycin is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, eye infections, and sexually transmitted diseases.

Azithromycin may also be used for purposes not listed in this medication guide.

Warnings

You should not use azithromycin if you have ever had jaundice or liver problems when you have previously taken this medicine.

Before taking this medicine

You should not use azithromycin if you are allergic to it, or if:

• you have ever had jaundice or liver problems caused by taking azithromycin; or
• you are allergic to similar drugs such as clarithromycin, erythromycin, or telithromycin.

To make sure azithromycin is safe for you, tell your doctor if you have ever had:

• liver disease;
• kidney disease;
• myasthenia gravis;
• a heart rhythm disorder;
• low levels of potassium in your blood; or
• long QT syndrome (in you or a family member).

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether azithromycin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take azithromycin?

Take azithromycin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. The dose and length of treatment may not be the same for every type of infection.

You may take most forms of azithromycin with or without food.

Take Zmax extended release liquid (oral suspension) on an empty stomach, at least 1 hour before or 2 hours after a meal.

To use the oral suspension single dose packet: Open the packet and pour the medicine into 2 ounces of water. Stir this mixture and drink all of it right away. Do not save for later use. To make sure you get the entire dose, add 2 more ounces of water to the same glass, swirl gently and drink right away.

Throw away any mixed Zmax oral suspension (extended release formulation) that has not been used within 12 hours. Throw away any immediate-release suspension that has not been used within 10 days.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Azithromycin will not treat a viral infection such as the flu or a common cold.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take azithromycin. This includes Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others. These antacids can make azithromycin less effective when taken at the same time.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Azithromycin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid other drugs that can cause QT prolongation or irregular heart rhythm.

Azithromycin side effects

Get emergency medical help if you have signs of an allergic reaction to azithromycin: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using azithromycin.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or
• liver problems – nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Call your doctor right away if a baby taking azithromycin becomes irritable or vomits while eating or nursing.

Older adults may be more likely to have side effects on heart rhythm, including a life-threatening fast heart rate.

Common azithromycin side effects may include:

• diarrhea;
• nausea, vomiting, stomach pain; or
• headache.

Azilect works by increasing the levels of certain chemicals in the brain.

Azilect is used to treat symptoms of Parkinson’s disease (stiffness, tremors, spasms, poor muscle control).

Azilect is sometimes used with another medicine called levodopa.

Warnings

Do not Azilect if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, selegiline, or tranylcypromine.

Tell your doctor about all medicines you have used in the 2-week period before you start taking Azilect. Many drugs can interact with rasagiline, and some drugs should not be used together.

Before you take this medicine, tell your doctor if you have liver disease.

There are many other drugs that can cause serious medical problems if you take them together with Azilect. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

While you are taking this medicine and for 2 weeks after you stop taking it, you may not be able to eat certain types of cheese. Follow your doctor’s instructions. Rasagiline may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Before taking this medicine

You should not take Azilect if you are allergic to rasagiline.

Do not use Azilect if you have used any other MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, selegiline, tranylcypromine, and others.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Azilect. Your doctor may change your treatment plan if you also use:

• cyclobenzaprine (a muscle relaxer);
• dextromethorphan (contained in many over-the-counter cough medicines);
• meperidine (Demerol);
• methadone;
• St. John’s wort; or
• tramadol (Ultram, Ultracet).

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with rasagiline and cause a serious condition called serotonin syndrome.

To make sure Azilect is safe for you, tell your doctor if you have ever had:

• high or low blood pressure;
• liver or kidney disease; or
• if you take ciprofloxacin (an antibiotic).

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Ask your doctor about skin symptoms to watch for.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

How should I take Azilect?

Take Azilect exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

If you take Azilect alone, your dose may be different than if you take it with other Parkinson’s medications. Follow your doctor’s dosing instructions very carefully.

Azilect may be only part of a complete program of treatment that also includes a special diet. Follow the diet plan created for you by your doctor or nutrition counselor.

Get familiar with the list of foods you should avoid to help prevent certain side effects of rasagiline.

Call your doctor if your Parkinson’s symptoms do not improve, or if they get worse while using Azilect.

Store at room temperature away from moisture and heat.

Do not stop using Azilect suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Dosing information

Usual Adult Dose for Parkinson’s Disease:

Monotherapy:
Recommended dose: 1 mg orally once a day

Adjunct therapy:
Initial dose (in patients on concomitant levodopa): 0.5 mg orally once a day
Initial dose (in patients not on concomitant levodopa): 1 mg orally once a day
Maintenance dose: 0.5 mg to 1 mg orally once a day

Maximum dose: 1 mg orally once a day

Comments: May be used as adjunct therapy in patients on levodopa therapy, with or without other drugs used in the treatment of Parkinson’s disease.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of rasagiline can be fatal.

Overdose symptoms may include drowsiness, dizziness, severe headache, rapid pulse, feeling agitated or irritable, muscle spasms in your neck or jaw, sweating, cold or clammy skin, shallow breathing, fainting, or seizure (convulsions). These symptoms may be delayed for 12 to 24 hours after an overdose.

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid drinking alcohol, especially red wine, vermouth, and tap beers or ale.

Also avoid eating foods that are high in tyramine, such as aged cheeses, fava beans, soy sauce, herring, pickled or processed meats and fish, and meats that are aged, dried, smoked, or fermented. Eating tyramine while you are taking Azilect can raise your blood pressure to dangerous levels which could cause life-threatening side effects.

Azilect side effects

Get emergency medical help if you have signs of an allergic reaction to Azilect: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe headache, blurred vision, pounding in your neck or ears;
• extreme drowsiness or falling asleep suddenly, even after feeling alert;
• unusual changes in mood or behavior;
• hallucinations;
• a light-headed feeling, like you might pass out; or
• worsening symptoms of Parkinson’s disease (especially uncontrolled muscle movements).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Some people taking Azilect with levodopa have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Azilect side effects may include:

• depressed mood;
• sleep problems (insomnia), strange dreams;
• involuntary muscle movements;
• loss of appetite, weight loss;
• indigestion, stomach pain, nausea, vomiting, constipation;
• joint pain or stiffness;
• rash;
• cough or other flu symptoms;
• dry mouth; or
• swelling in your hands or feet.

1. Indications and Usage for Azelastine

Azelastine hydrochloride (HCl) nasal spray, 0.1% is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

2. Azelastine Dosage and Administration

2.1 Seasonal Allergic Rhinitis

The recommended dosage of azelastine HCl nasal spray, 0.1% in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of azelastine HCl nasal spray, 0.1% in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.

2.2 Vasomotor Rhinitis

The recommended dosage of azelastine HCl nasal spray, 0.1% in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily.

2.3 Important Administration Instructions

Administer azelastine HCl nasal spray, 0.1% by the intranasal route only.

Priming: Prime azelastine HCl nasal spray, 0.1% before initial use by releasing 4 sprays or until a fine mist appears. When azelastine HCl nasal spray, 0.1% has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying azelastine HCl nasal spray, 0.1% into the eyes.

3. Dosage Forms and Strengths

Azelastine HCl nasal spray, 0.1% is a nasal spray solution. Each spray of azelastine HCl nasal spray, 0.1% delivers a volume of 0.137 mL solution containing 137 mcg of azelastine HCl, USP.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Somnolence in Activities Requiring Mental Alertness

In clinical trials, the occurrence of somnolence has been reported in some patients taking azelastine HCl nasal spray, 0.1% . Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of azelastine HCl nasal spray, 0.1%. Concurrent use of azelastine HCl nasal spray, 0.1% with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur .

6. Adverse Reactions/Side Effects

Use of azelastine HCl nasal spray, 0.1% has been associated with somnolence.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.

Seasonal Allergic Rhinitis

Azelastine HCl nasal spray, 0.1% Two Sprays Per Nostril Twice Daily

Adverse experience information for azelastine HCl nasal spray, 0.1% is derived from six placebo- and active-controlled, 2-day to 8-week clinical trials which included 391 patients, 12 years of age and older, with seasonal allergic rhinitis who received azelastine HCl nasal spray, 0.1% at a dose of 2 sprays per nostril twice daily. In placebo-controlled efficacy trials, the incidence of discontinuation due to adverse reactions in patients receiving azelastine HCl nasal spray, 0.1% and vehicle placebo was 2.2% and 2.8%, respectively.

Table 1 contains adverse reactions that were reported with frequencies ≥2% in the azelastine HCl nasal spray, 0.1% 2 sprays per nostril twice daily treatment group and more frequently than placebo.

Table 1: Adverse Reactions Reported in ≥2% Incidence in Placebo-Controlled Trials in Patients with Seasonal Allergic Rhinitis [n (%)]

Azelastine HCl Nasal Spray, 0.1% One Spray Per Nostril Twice Daily

Adverse experience information for azelastine HCl nasal spray, 0.1% at a dose of one spray per nostril twice daily is derived from two placebo-controlled 2-week clinical studies which included 276 patients 12 years of age and older with seasonal allergic rhinitis. The incidence of discontinuation due to adverse reactions in patients receiving azelastine HCl nasal spray, 0.1% and vehicle placebo was 0.0% and 0.8%, respectively. Bitter taste was reported in 8.3% of patients compared to none in the placebo group. Somnolence was reported in 0.4% of patients compared to none in the placebo group.

A total of 176 patients 5 to 11 years of age were exposed to azelastine HCl nasal spray, 0.1% at a dose of 1 spray each nostril twice daily in 3 placebo-controlled studies. In these studies, adverse reactions that occurred more frequently in patients treated with azelastine HCl nasal spray, 0.1% than with placebo, and that were not represented in the adult adverse reactions table above include rhinitis/cold symptoms (17.0% vs. 9.5%), cough (11.4% vs. 8.3%), conjunctivitis (5.1% vs. 1.8%), and asthma (4.5% vs. 4.1%).

Adverse Reactions <2% in azelastine HCl nasal spray, 0.1% One or Two Sprays Per Nostril Twice Daily

The following reactions were observed infrequently (<2% and exceeding placebo incidence) in patients who received azelastine HCl nasal spray, 0.1% dosed at 1 or 2 sprays per nostril twice daily in U.S. clinical trials.

Cardiovascular: flushing, hypertension, tachycardia.

Dermatological: contact dermatitis, eczema, hair and follicle infection, furunculosis, skin laceration.

Digestive: constipation, gastroenteritis, glossitis, ulcerative stomatitis, vomiting, increased SGPT, aphthous stomatitis, diarrhea, toothache.

Metabolic and Nutritional: increased appetite.

Musculoskeletal: myalgia, temporomandibular dislocation, rheumatoid arthritis.

Neurological: hyperkinesia, hypoesthesia, vertigo.

Psychological: anxiety, depersonalization, depression, nervousness, sleep disorder, thinking abnormal.

Respiratory: bronchospasm, coughing, throat burning, laryngitis, bronchitis, dry throat, nocturnal dyspnea, nasopharyngitis, nasal congestion, pharyngolaryngeal pain, sinusitis, nasal dryness, paranasal sinus hypersecretion, post nasal drip.

Special Senses: conjunctivitis, eye abnormality, eye pain, watery eyes, taste loss.

Urogenital: albuminuria, amenorrhea, breast pain, hematuria, increased urinary frequency.

Whole Body: allergic reaction, back pain, herpes simplex, viral infection, malaise, pain in extremities, abdominal pain, pyrexia.

Vasomotor Rhinitis

Adverse experience information for azelastine HCl nasal spray, 0.1% is derived from two placebo-controlled clinical studies which included 216 patients 12 years and older with vasomotor rhinitis who received azelastine HCl nasal spray, 0.1% at a dose of 2 sprays per nostril twice daily for up to 28 days. The incidence of discontinuation due to adverse reactions in patients receiving azelastine HCl nasal spray, 0.1% and vehicle placebo was 2.8% and 2.9%, respectively.

The following adverse reactions were reported with frequencies ≥ 2% in the azelastine HCl nasal spray, 0.1% treatment group and more frequently than placebo.

Table 2: Adverse Reactions Reported in ≥2% Incidence in Placebo-Controlled Trials in Patients with Vasomotor Rhinitis [n (%)]

Reactions observed infrequently (<2% and exceeding placebo incidence) in patients who received azelastine HCl nasal spray, 0.1% (2 sprays/nostril twice daily) in U.S. clinical trials in vasomotor rhinitis were similar to those observed in U.S. clinical trials in seasonal allergic rhinitis.

In controlled trials involving nasal and oral azelastine HCl formulations, there were infrequent occurrences of hepatic transaminase elevations.

6.2 Postmarketing Experience

During the post approval use of azelastine HCl nasal spray, 0.1%, the following adverse reactions have been identified. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include: anaphylaxis, application site irritation, atrial fibrillation, chest pain, confusion, dyspnea, facial edema, involuntary muscle contractions, nasal sores, palpitations, paresthesia, parosmia, pruritus, rash, disturbance or loss of sense of smell and/or taste, tolerance, urinary retention, vision abnormal and xerophthalmia.

7. Drug Interactions

7.1 Central Nervous System Depressants

Concurrent use of azelastine HCl nasal spray, 0.1% with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur .

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Limited data from post-marketing experience over decades of use with azelastine HCl nasal spray, 0.1% in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. Oral administration of azelastine HCl to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.096 mg. However, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

In an embryo-fetal development study in mice dosed during the period of organogenesis, azelastine HCl caused embryo-fetal death, structural abnormalities (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 300 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m 2 basis at a maternal oral dose of 68.6 mg/kg/day), which also caused maternal toxicity as evidenced by decreased maternal body weight. Neither fetal nor maternal effects occurred in mice at approximately 15 times the MRHDID in adults (on a mg/m 2 basis at a maternal oral dose of 3 mg/kg/day).

In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, azelastine HCl caused structural abnormalities (oligo-and brachydactylia), delayed ossification, and skeletal variations, in the absence of maternal toxicity, at approximately 270 times the MRHDID in adults (on a mg/m 2 basis at a maternal oral dose of 30 mg/kg/day). Azelastine HCl caused embryo-fetal death and decreased fetal weight and severe maternal toxicity at approximately 610 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 68.6 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 20 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 2 mg/kg/day).

In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, azelastine HCl caused abortion, delayed ossification and decreased fetal weight and severe maternal toxicity at approximately 530 times the MRHDID in adults (on a mg/m 2 basis at a maternal oral dose of 30 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 5 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 0.3 mg/kg/day).

In a prenatal and postnatal development study in pregnant rats dosed from late in the gestation period and through the lactation period from gestation day 17 through lactation day 21, azelastine HCl produced no adverse developmental effects on pups at maternal doses up to approximately 270 times the MRHDID (on mg/m 2 basis at a maternal dose of 30 mg/kg/day).

8.2 Lactation

Risk Summary

There are no data on the presence of azelastine HCl in human milk, the effects on the breastfed infant, or the effects on milk production. Breastfed infants should be monitored for signs of milk rejection during azelastine HCl use by lactating women (see Clinical Considerations).The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for azelastine HCl nasal spray, 0.1% and any potential adverse effects on the breastfed infant from azelastine HCl nasal spray, 0.1% or from the underlying maternal condition.

Clinical Considerations

Monitoring for Adverse Reactions
Breastfed infants of lactating women treated with azelastine HCl nasal spray, 0.1% should be monitored for possible signs of milk rejection related to the bitter taste of azelastine HCl.

8.4 Pediatric Use

The safety and effectiveness of azelastine HCl nasal spray, 0.1% for the treatment of symptoms of seasonal allergic rhinitis have been established for patients 5 years and older [see Adverse Reactions (6.1) and Clinical Studies (14.1)] . The safety and effectiveness of azelastine HCl nasal spray, 0.1% for the treatment of vasomotor rhinitis have been established for patients 12 years and older [see Adverse Reactions (6.1) and Clinical Studies (14.2)] . The safety and effectiveness of azelastine HCl nasal spray, 0.1% in pediatric patients below the age of 5 years with seasonal allergic rhinitis and in pediatric patients below the age of 12 years with vasomotor rhinitis have not been established.

8.5 Geriatric Use

Clinical trials of azelastine HCl nasal spray, 0.1% did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

10. Overdosage

There have been no reported overdosages with azelastine HCl nasal spray, 0.1%. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse reactions, other than increased somnolence, since one bottle of azelastine HCl nasal spray, 0.1% contains 30 mg of azelastine(HCl). Clinical trials in adults with single doses of the oral formulation of azelastine (HCl) (up to 16 mg) have not resulted in increased incidence of serious adverse reactions. General supportive measures should be employed if overdosage occurs. There is no known antidote to azelastine HCl nasal spray, 0.1%. Oral ingestion of antihistamines has the potential to cause serious adverse effects in young children. Accordingly, azelastine HCl nasal spray, 0.1% should be kept out of the reach of children.

11. Azelastine Description

Azelastine HCl nasal spray, 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine HCl, USP occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C 22H 24ClN 3O•HCl with the following chemical structure:

Azelastine HCl nasal spray, 0.1% contains 0.1% azelastine HCl, USP in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride (125 mcg/mL), citric acid, dibasic sodium phosphate, edetate disodium, hypromellose, purified water (pH 6.8) and sodium chloride.

12. Azelastine – Clinical Pharmacology

12.1 Azelastine Mechanism of Action

Azelastine HCl, a phthalazinone derivative, exhibits histamine H 1-receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine HCl nasal spray, 0.1% is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in vitro studies. The major metabolite, desmethylazelastine, also possesses H 1-receptor antagonist activity.

12.2 Pharmacodynamics

Cardiac Electrophysiology:

In a placebo-controlled study (95 subjects with allergic rhinitis), there was no evidence of an effect of azelastine HCl nasal spray, 0.1% (2 sprays per nostril twice daily for 56 days) on cardiac repolarization as represented by the corrected QT interval (QTc) of the electrocardiogram. Following multiple dose oral administration of azelastine 4 mg or 8 mg twice daily, the mean change in QTc was 7.2 msec and 3.6 msec, respectively.

Interaction studies investigating the cardiac repolarization effects of concomitantly administered oral azelastine HCl and erythromycin or ketoconazole were conducted. These drugs had no effect on QTc based on analysis of serial electrocardiograms. At a dose approximately 8 times the maximum recommended dose, azelastine HCl does not prolong the QTc interval to any clinically relevant extent.

12.3 Pharmacokinetics

Absorption: After intranasal administration, the systemic bioavailability of azelastine HCl is approximately 40%. Maximum plasma concentrations (C max) are achieved in 2 to 3 hours.

Azelastine HCl administered intranasally at doses above two sprays per nostril twice daily for 29 days resulted in greater than proportional increases in C max and area under the curve (AUC) for azelastine.

Distribution: Based on intravenous and oral administration, the steady-state volume of distribution is 14.5 L/kg. In vitro studies with human plasma indicate that the plasma protein binding of azelastine and its metabolite, desmethylazelastine, are approximately 88% and 97%, respectively.

Metabolism: Azelastine is oxidatively metabolized to the principal active metabolite, desmethylazelastine, by the cytochrome P450 enzyme system. The specific P450 isoforms responsible for the biotransformation of azelastine have not been identified. After intranasal dosing of azelastine HCl to steady-state, plasma concentrations of desmethylazelastine range from 20% to 50% of azelastine concentrations. Limited data indicate that the metabolite profile is similar when azelastine HCl is administered via the intranasal or oral route.

Elimination: Based on intravenous and oral administration, the elimination half-life and plasma clearance are 22 hours and 0.5 L/h/kg, respectively. Approximately 75% of an oral dose of radiolabeled azelastine HCl was excreted in the feces with less than 10% as unchanged azelastine.

Special Populations:

Hepatic Impairment: Following oral administration, pharmacokinetic parameters were not influenced by hepatic impairment.

Renal Impairment: Based on oral, single-dose studies, renal insufficiency (creatinine clearance <50 mL/min) resulted in a 70% to 75% higher C max and AUC compared to normal subjects. Time to maximum concentration was unchanged.

Age: Following oral administration, pharmacokinetic parameters were not influenced by age.

Gender: Following oral administration, pharmacokinetic parameters were not influenced by gender.

Race: The effect of race has not been evaluated.

Drug-Drug Interactions:

Erythromycin: No significant pharmacokinetic interaction was observed with the co-administration of orally administered azelastine (4 mg twice daily) with erythromycin (500 mg three times daily for 7 days). In this study, co-administration of orally administered azelastine with erythromycin resulted in C max of 5.36 ± 2.6 ng/mL and AUC of 49.7 ± 24 ng•h/mL for azelastine, whereas, administration of azelastine alone resulted in C max of 5.57 ± 2.7 ng/mL and AUC of 48.4 ± 24 ng•h/mL for azelastine.

Cimetidine and Ranitidine: In a multiple-dose, steady-state drug interaction trial in healthy subjects, cimetidine (400 mg twice daily) increased orally administered mean azelastine (4 mg twice daily) concentrations by approximately 65%. No pharmacokinetic interaction was observed with co-administration of orally administered azelastine (4 mg twice daily) with ranitidine hydrochloride (150 mg twice daily). Oral co-administration of azelastine with ranitidine resulted in C max of 8.89 ±3.28 ng/mL and AUC of 88.22 ± 40.43 ng•h/mL for azelastine, whereas, azelastine when administered alone resulted in C max of 7.83 ± 4.06 ng/mL and AUC of 80.09 ± 43.55 ng•h/mL for azelastine.

Theophylline: No significant pharmacokinetic interaction was observed with the co-administration of an oral 4 mg dose of azelastine HCl twice daily and theophylline 300 mg or 400 mg twice daily.

13. Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year carcinogenicity studies in Crl:CD(SD)BR rats and NMRI mice were conducted to assess the carcinogenic potential of azelastine HCl. No evidence of tumorigenicity was observed in rats at doses up to 30 mg/kg (approximately 270 and 240 times the MRHDID for adults and children, respectively, on a mg/m 2 basis). No evidence for tumorigenicity was observed in mice at doses up to 25 mg/kg (approximately 110 and 100 times the MRHDID for adults and children, respectively, on a mg/m 2 basis).

Azelastine HCl showed no genotoxic effects in the Ames test, DNA repair test, mouse lymphoma forward mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow.

There were no effects on male or female fertility and reproductive performance in male and female rats at oral doses up to 30 mg/kg (approximately 270 times the MRHDID in adults on a mg/m 2 basis). At 68.6 mg/kg (approximately 610 times the MRHDID on a mg/m 2 basis), the duration of estrous cycles was prolonged and copulatory activity and the number of pregnancies were decreased. The numbers of corpora lutea and implantations were decreased; however, pre-implantation loss was not increased.

14. Clinical Studies

14.1 Seasonal Allergic Rhinitis

Two Sprays Per Nostril Twice Daily

The efficacy and safety of azelastine HCl nasal spray, 0.1% were evaluated in three placebo-controlled clinical trials of azelastine HCl nasal spray, 0.1% including 322 patients with seasonal allergic rhinitis who received two sprays per nostril twice a day for up to 4 weeks. These trials included 55 pediatric patients ages 12 to 16 years. Assessment of efficacy was based on the 12-hour reflective Total Symptom Complex (TSC) and Major Symptom Complex (MSC). The MSC was calculated as the average of individual symptoms of nose blows, sneezes, runny nose/sniffles, itchy nose, and watery eyes as assessed by patients on a 0 to 5 categorical scale. Azelastine HCl nasal spray, 0.1% two sprays per nostril twice daily demonstrated a greater decrease in the MSC than placebo (Table 3).

Table 3: Mean Change from Baseline in Reflective MSC* in Adults and Adolescents ≥12 Years with Seasonal Allergic Rhinitis Treated with Azelastine HCl Nasal Spray, 0.1% Two Sprays Per Nostril Twice Daily Versus Placebo

In dose-ranging trials, administration of azelastine HCl nasal spray, 0.1% two sprays per nostril twice daily resulted in a statistically significant decrease in symptoms compared to saline placebo within 3 hours after initial dosing and persisted over the 12-hour dosing interval.

One Spray Per Nostril Twice Daily

The efficacy and safety of azelastine HCl nasal spray, 0.1% were evaluated in two placebo-controlled clinical trials of azelastine HCl nasal spray, 0.1% including 275 patients with seasonal allergic rhinitis who received one spray per nostril twice a day for up to 2 weeks. Assessment of efficacy was based on the 12-hour reflective Total Nasal Symptom Score [rTNSS]. rTNSS is calculated as the sum of the patients scoring of four individual nasal symptoms (runny nose, sneezing, itchy nose, and nasal congestion) as assessed by patients on a 0 to 3 categorical scale. The primary efficacy endpoint was the change from Baseline to Day 14 in rTNSS. The mean change from baseline in rTNSS was greater in patients receiving azelastine HCl nasal spray, 0.1% one spray per nostril twice daily than those receiving placebo (Table 4).

Table 4: Mean Change from Baseline in Reflective TNSS* in Adults and Adolescents ≥12 years with Seasonal Allergic Rhinitis Treated with Azelastine HCl Nasal Spray, 0.1% One Spray Per Nostril Twice Daily Versus Placebo

Two-week studies comparing the efficacy (and safety) of azelastine HCl nasal spray, 0.1% two sprays per nostril twice daily versus one spray per nostril twice daily were not conducted.

14.2 Vasomotor Rhinitis

The efficacy and safety of azelastine HCl nasal spray, 0.1% were evaluated in two placebo-controlled clinical trials of azelastine HCl nasal spray, 0.1% including 216 patients with vasomotor rhinitis who received two sprays per nostril twice a day for up to 4 weeks. These patients had vasomotor rhinitis for at least one year, negative skin tests to indoor and outdoor aeroallergens, negative nasal smears for eosinophils, and negative sinus X-rays. Azelastine HCl nasal spray, 0.1% demonstrated a significantly greater decrease in a symptom complex comprised of rhinorrhea, post nasal drip, nasal congestion, and sneezing compared to placebo.

16. How is Azelastine supplied

Azelastine HCl nasal spray 0.1%, 137 mcg, is supplied as a 30-mL package (NDC 42291-094-30) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit.

The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white or clear plastic dust cover. The net content of the bottle is 30 mL (net weight 30 g of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine HCl, USP. After priming [see Dosage and Administration (2.3)] , each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine HCl, USP. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty.

The bottle should be discarded after 200 sprays have been used. Azelastine HCl nasal spray, 0.1% should not be used after the expiration date “EXP” printed on the medicine label and carton.

Storage:

Store upright at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

17. Patient Counseling Information

See FDA-approved patient labeling ( Patient Information and Instructions for Use).

Activities Requiring Mental Alertness

Somnolence has been reported in some patients taking azelastine HCl nasal spray, 0.1%. Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of azelastine HCl nasal spray, 0.1%.

Concurrent Use of Alcohol and other Central Nervous System Depressants

Instruct patients to avoid concurrent use of azelastine HCl nasal spray, 0.1% with alcohol or other central nervous system depressants because additional reductions in alertness and additional impairment of central nervous system performance may occur .

Common Adverse Reactions

Inform patients that the treatment with azelastine HCl nasal spray, 0.1% may lead to adverse reactions, which include bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase  .

Priming

Instruct patients to prime the pump before initial use and when azelastine HCl nasal spray, 0.1% has not been used for 3 or more days .

Keep Spray Out of Eyes

Instruct patients to avoid spraying azelastine HCl nasal spray, 0.1% into their eyes.

Keep Out of Children’s Reach

Instruct patients to keep azelastine HCl nasal spray, 0.1% out of the reach of children. If a child accidentally ingests azelastine HCl nasal spray, 0.1%, seek medical help or call a poison control center immediately.

Manufactured for:

AvKARE

Pulaski, TN 38478

Manufactured by:

Amneal Pharmaceuticals LLC

Branchburg, NJ 08876

Mfg. Rev. 10-2018-02 AV 02/21

PATIENT INFORMATION

Azelastine Hydrochloride (ay” ze las’ teen hye” droe klor’ ide) Nasal Spray, 0.1%

What is azelastine HCl nasal spray, 0.1%?

• Azelastine HCl nasal spray, 0.1% is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people age 5 and older and vasomotor rhinitis in people age 12 and older.
• Azelastine HCl nasal spray, 0.1% may help to reduce your nasal symptoms including stuffy nose, runny nose, itching and sneezing.

It is not known if azelastine HCl nasal spray, 0.1% is safe and effective in children with seasonal allergic rhinitis under 5 years of age or in children with vasomotor rhinitis under 12 years of age.

What should I tell my healthcare provider before using azelastine HCl nasal spray, 0.1%?

Before using azelastine HCl nasal spray, 0.1%, tell your healthcare provider if you are:

• allergic to any of the ingredients in azelastine HCl nasal spray, 0.1%. See the end of this leaflet for a complete list of ingredients in azelastine HCl nasal spray, 0.1%.
• pregnant, or plan to become pregnant.
• breastfeeding, or plan to breastfeed. It is not known if azelastine HCl passes into your breast milk. You and your healthcare provider should decide if you will use azelastine HCl nasal spray, 0.1% if you plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Azelastine HCl nasal spray, 0.1% and other medicines may affect each other, causing side effects.

How should I use azelastine HCl nasal spray, 0.1%?

• Read the Instructions for Use at the end of this leaflet for information about the right way to use azelastine HCl nasal spray, 0.1%.
• Spray azelastine HCl nasal spray, 0.1% in your nose only. Do not spray it into your eyes or mouth.
• Use azelastine HCl nasal spray, 0.1% exactly as your healthcare provider tells you to use it.
• Do not use more than your healthcare provider tells you.
• Throw away your azelastine HCl nasal spray, 0.1% bottle after using 200 sprays. Even though the bottle may not be completely empty, you may not get the correct dose of medicine.
• If you use too much or a child accidentally swallows azelastine HCl nasal spray, 0.1%, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while using azelastine HCl nasal spray, 0.1%?

Azelastine HCl nasal spray, 0.1% can cause sleepiness:

• Do not drive, operate machinery, or do other dangerous activities until you know how azelastine HCl nasal spray, 0.1% affects you.
• Do not drink alcohol or take other medicines that may cause you to feel sleepy while using azelastine HCl nasal spray, 0.1%. It may make your sleepiness worse.

What are the possible side effects of azelastine HCl nasal spray, 0.1%?

The most common side effects of azelastine HCl nasal spray, 0.1% include:

• unusual bitter taste
• headache
• sleepiness
• nose burning, pain or discomfort
• runny nose
• scratchy or sore throat
• nosebleeds
• inflammation or swelling of the sinuses
• sneezing
• nausea
• dry mouth
• fatigue
• dizziness
• weight increase

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of azelastine HCl nasal spray, 0.1%. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store azelastine HCl nasal spray, 0.1%?

• Keep azelastine HCl nasal spray, 0.1% upright at 68° to 77°F (20° to 25°C).
• Do not freeze azelastine HCl nasal spray, 0.1%.
• Do not use azelastine HCl nasal spray, 0.1% after the expiration date “EXP” on the medicine label and box.

Keep azelastine HCl nasal spray, 0.1% and all medicines out of reach of children.

General information about the safe and effective use of azelastine HCl nasal spray, 0.1%.

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use azelastine HCl nasal spray, 0.1% for a condition for which it was not prescribed. Do not give azelastine HCl nasal spray, 0.1% to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about azelastine HCl nasal spray, 0.1%. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about azelastine HCl nasal spray, 0.1% that is written for health professionals.

For more information call 1-855-361-3993.

What are the ingredients in azelastine HCl nasal spray, 0.1%?

Active ingredient: Azelastine HCl, USP

Inactive ingredients: Benzalkonium chloride, citric acid, dibasic sodium phosphate, edetate disodium, hypromellose, purified water (pH 6.8) and sodium chloride.

* Trademarks are the property of their respective owners.

Manufactured for:

AvKARE

Pulaski, TN 38478

Manufactured by:

Amneal Pharmaceuticals LLC

Branchburg, NJ 08876

Mfg. Rev. 10-2018-02 AV 02/21

Instructions for Use

Azelastine Hydrochloride (ay” ze las’ teen hye” droe klor’ ide) Nasal Spray, 0.1%

For the correct dose of medicine:

• Keep your head tilted downward when spraying into your nostril.
• Change nostrils each time you use the spray.
• Breathe gently and do not tip your head back after using the spray. This will keep the medicine from running down into your throat. You may get a bitter taste in your mouth.

Figure A identifies the parts of your azelastine HCl nasal spray, 0.1% pump

Before you use azelastine HCl nasal spray, 0.1% for the first time, you will need to prime the bottle.

Priming your azelastine HCl nasal spray, 0.1%

Remove the dust cover over the tip of the pump and the white safety clip just under the “shoulders” of the pump (See Figure B).

Hold the bottle upright with 2 fingers on the shoulders of the spray pump unit and

• put your thumb on the bottom of the bottle. Press upward with your thumb and release for the pumping action. Repeat this until you see a fine mist (See Figure C).
• To get a fine mist you must pump the spray fast and use firm pressure against the bottom of the bottle. If you see a stream of liquid, the pump is not working correctly and you may have nasal discomfort.
• This should happen in 4 sprays or less.

Now your pump is primed and ready to use.

• Do not use azelastine HCl nasal spray, 0.1% unless you see a fine mist after you do the priming sprays. If you do not see a fine mist, clean the tip of the spray nozzle. See the “Cleaning the Spray Tip of your azelastine HCl nasal spray, 0.1%” section below.
• If you do not use azelastine HCl nasal spray, 0.1% for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist.Using your azelastine HCl nasal spray, 0.1%

Step 1. Blow your nose to clear your nostrils.

Step 2. Keep your head tilted downward toward your toes.

Step 3. Place the spray tip about ¼ inch to ½ inch into 1 nostril. Hold bottle upright and aim the

spray tip toward the back of your nose (See Figure D).

Step 4. Close your other nostril with a finger. Press the pump 1 time and sniff gently at the same time, keeping your head tilted forward and down (See Figure E).

Step 5. Repeat Step 3 and Step 4 in your other nostril.

Step 6. If your healthcare provider tells you to use 2 sprays in each nostril, repeat Steps 2 through 4 above for the second spray in each nostril.

Step 7. Breathe in gently, and do not tilt your head back after using azelastine HCl nasal spray, 0.1%. This will help to keep the medicine from going into your throat.

Step 8. When you finish using your azelastine HCl nasal spray, 0.1%, wipe the spray tip with a clean tissue or cloth. Put the safety clip and dust cover back on the bottle.

Cleaning the Spray Tip of your azelastine HCl nasal spray, 0.1%

• The spray tip opening is clogged, do not use a pin or pointed object to unclog the tip. Unscrew the spray pump unit from the bottle by turning it to the left (counter-clockwise) (See Figure F).
• Soak only the spray pump unit in warm water. Squirt the spray unit several times while holding it under water. Use the pumping action to clear the opening in the tip (See Figure G).

• Let the spray pump unit air dry. Make sure it is dry before you put it back onto the bottle.
• Put the spray pump unit back into the open bottle and tighten it by turning clockwise (to the right).
• To keep the medicine from leaking out, use firm pressure when you put the pump back onto the bottle.
• After cleaning, follow the instructions for priming.

This Patient Information and Instructio

What is azathioprine?

Azathioprine weakens your body’s immune system, to help keep it from “rejecting” a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Azathioprine is used to prevent your body from rejecting a transplanted kidney. Azathioprine is also used to treat symptoms of rheumatoid arthritis.

Azathioprine may also be used for purposes not listed in this medication guide.

Azathioprine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Azathioprine may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Stop using azathioprine and call your doctor right away if you have any of these symptoms of lymphoma:

• fever, swollen glands, body aches, night sweats, not feeling well;
• pale skin, rash, easy bruising or bleeding;
• cold hands and feet, feeling light-headed or short of breath;
• pain in your upper stomach that may spread to your shoulder; or
• feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• signs of infection (fever, chills, weakness, flu symptoms, sore throat, cough, pain or burning when you urinate);
• severe nausea, vomiting, or diarrhea;
• easy bruising, unusual bleeding;
• rapid heartbeats, shortness of breath;
• pale skin, cold hands and feet; or
• dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of azathioprine may include:

• nausea, diarrhea, stomach pain;
• hair loss; or
• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Azathioprine may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis.

Before taking this medicine

You should not take azathioprine if you are allergic to azathioprine.

You should not use azathioprine to treat rheumatoid arthritis if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine.

Azathioprine may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

While taking azathioprine, you may have a higher risk of developing skin cancer. Ask your doctor about skin symptoms to watch for.

Tell your doctor if you have ever had:

• kidney disease, or a kidney transplant (if you are using azathioprine for rheumatoid arthritis);
• any type of viral, bacterial, or fungal infection;
• liver disease; or
• chemotherapy with medications like cyclophosphamide, chlorambucil, melphalan, busulfan, and others.

You should not breast-feed while you are using azathioprine.

How should I take azathioprine?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using azathioprine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

When given for kidney transplant, azathioprine is usually given right before or on the day of transplant. For rheumatoid arthritis, azathioprine is taken on a daily basis.

It may take up to 8 weeks before your symptoms improve. Keep using azathioprine as directed and tell your doctor if your symptoms have not improved after 12 weeks of use.

Take with food if azathioprine upsets your stomach.

You may not be able to continue taking other arthritis medications together with azathioprine. Do not change your dose or dosing schedule without your doctor’s advice.

Azathioprine affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking azathioprine?

Avoid sunlight or tanning beds. Azathioprine can increase your risk of developing skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avonex is a disease-modifying therapy (DMT) used to treat relapsing multiple sclerosis (MS) in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). Avonex injection (interferon beta-1a injection) is given intramuscularly (into a muscle), usually once weekly at bedtime.

For people living with MS, Avonex helps manage the disease by resembling the mechanism of action of interferons, which are proteins naturally produced by our immune system that help regulate the body’s immune response and fight viral infections.

• Avonex contains interferon beta 1-a, which is a man-made form of interferon that works in the same way, binding to specific receptors on cell surfaces and decreasing the activity of immune cells that attack the myelin sheath, reducing inflammation in the central nervous system, and helping to suppress the autoimmune response that characterizes MS.
• Avonex belongs to the drug class called interferons. It may also be called an immunomodulator.

Important: Avonex injection will not cure MS; it will only decrease the frequency of relapse symptoms.

Avonex (interferon beta-1a) gained FDA approval on May 17, 1996. There is no Avonex generic (more correctly called a biosimilar).

• Another form of interferon beta-1a, called Rebif, also used for MS, is given 3 times a week by subcutaneous (under the skin) injection.

Avonex and MS

Multiple sclerosis (MS) is an autoimmune disease that occurs when the immune system attacks the myelin sheath protecting nerve fibers, disrupting brain-body communication and causing MS symptoms like vision problems, muscle weakness, and coordination difficulties.

Avonex for MS addresses this disease process by modulating the immune response. The interferon beta-1a reduces immune attacks on myelin, decreases central nervous system inflammation, and prevents new MS lesions. For MS patients, this means fewer relapses, reduced disease activity, and slower disability progression.

Warnings

Liver Damage: Avonex injection can harm your liver. Call your doctor if you have symptoms such as nausea, loss of appetite, tiredness, confusion, easy bruising or bleeding, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Mental Health: Some MS patients using interferon beta-1a have thoughts about suicide. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before using Avonex injection, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, heart disease, chest pain (angina), congestive heart failure, a heart rhythm disorder, or a history of depression or suicidal behavior.

Before taking this medicine

Do not use Avonex injection if you are allergic to natural or recombinant interferon beta or albumin.

To make sure Avonex injection is safe for you, tell your doctor if you have:

• depression, mental illness, or suicidal thoughts or actions;
• liver disease;
• bleeding problems or a blood clot;
• low blood cell counts;
• heart disease;
• a thyroid disorder;
• a latex allergy;
• an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;
• a seizure; or
• if you drink alcohol.

Plasma-derived products: Some brands of interferon beta-1a contain donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding.

Interferon beta-1a is not approved for use by anyone younger than 18 years old.

How to Give an Avonex Injection

Use Avonex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Avonex Injection Guidelines:

• Frequency: Once weekly at bedtime, on the same day each week (such as every Monday)
• Method: Intramuscular injection into a muscle
• Injection devices: Available as a prefilled syringe or a prefilled autoinjector pen
• Site rotation: Use a different place each time you give an injection.

Avonex Injection Site Safety:

• Injection site reactions can occur with Avonex injections, including injection site necrosis
• About 2 hours after the Avonex injection, check for skin redness, swelling, or pain
• Report immediately: Any break in skin with blue-black discoloration, swelling, or drainage
• Call your doctor if the injection site reaction doesn’t go away within a few days.

Storage Instructions:

• Store in refrigerator, protect from light, do not freeze
• Prefilled syringe/autoinjector: Remove 30 minutes before injection to reach room temperature
• Do not leave the prefilled syringe/autoinjector out of the refrigerator for longer than 7 days.

Avonex Side Effects

Get emergency medical help if you have signs of an allergic reaction to Avonex (hives, itching, anxiety, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Life-threatening blood clots: Interferon beta-1a can cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Call your doctor at once if you have:

• pain, swelling, bruising, redness, oozing, or skin changes where the injection was given;
• a light-headed feeling, like you might pass out;
• unusual changes in mood or behavior (feeling hopeless, anxious, nervous, irritable, or depressed);
• thoughts about suicide or hurting yourself;
• easy bruising, unusual bleeding;
• a seizure;
• heart problems – swelling, rapid weight gain, feeling short of breath, rapid heartbeats, chest pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – nausea, loss of appetite, tiredness, confusion, easy bruising or bleeding, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes);
• signs of infection – fever, chills, cough with mucus, bloody diarrhea, pain or burning when you urinate; or
• thyroid problems – mood swings, trouble sleeping, tiredness, hunger, diarrhea, pounding heartbeats, muscle weakness, sweating, dry skin, thinning hair, menstrual changes, weight changes, puffiness in your face, feeling more sensitive to hot or cold temperatures
• breathing difficulties. Pulmonary arterial hypertension can occur with interferon beta products,
  including Avonex. Symptoms may include new or increasing fatigue or shortness of breath.

Common Avonex side effects may include:

• low blood cell counts;
• skin changes where the injection was given;
• depression;
• abnormal liver function tests;
• stomach pain; or
• flu symptoms – headache, fever, chills, chest pain, back pain, tiredness, weakness, muscle aches.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Dosing Information

Usual Adult Maintenance Dose of Avonex for MS

• 30 mcg intramuscularly once a week.

Titrate the dose as follows to reduce the incidence and severity of influenza-like symptoms:

• Week 1: 7.5 mcg intramuscularly once weekly
• Week 2: 15 mcg intramuscularly once weekly
• Week 3: 22.5 mcg intramuscularly once weekly
• Week 4+: 30 mcg intramuscularly once weekly.

Available forms: Avonex injection is available as a single-dose prefilled syringe and single-dose prefilled autoinjector.

Missed Dose

Use the medicine as soon as you can, but do not inject Avonex two days in a row. Do not use two doses at one time.

Overdose

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Avonex?

Other drugs may interact with interferon beta-1a, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Avonex Injection Ingredients

Active ingredient: interferon beta-1a
Inactive ingredients: Avonex Single-Dose Prefilled Syringe: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for injection.

Inactive ingredients: Avonex Single-Dose Prefilled Autoinjector Pen: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for injection. 

Who makes Avonex?

Biogen Inc. makes Avonex.

Frequently Asked Questions

How long does it take for Avonex to work?

Avonex typically takes 3-6 months to show its full effect in reducing MS relapses. Some patients may notice improvements in fatigue and overall well-being within the first few weeks, but the medication’s primary benefit of reducing relapse frequency and slowing disability progression becomes more apparent over time. It’s important to continue treatment even if you don’t immediately notice changes, as the medication works to prevent future MS activity.

Can I travel with Avonex injections?

Yes, you can travel with Avonex, but it requires careful planning. Keep medication in its original packaging with prescription labels. For air travel, pack Avonex in carry-on luggage with a cooling pack (but not frozen). Bring a doctor’s letter explaining your medical need for the injection.

For international travel, research medication regulations in your destination country. Consider bringing extra supplies in case of delays. Avonex can be stored at room temperature for up to 7 days (prefilled syringe) or 30 days (vial) if refrigeration isn’t available.

What’s the difference between Avonex and Rebif?

Both Avonex and Rebif contain interferon beta-1a, but they differ in dosing and administration. Avonex is given once weekly by intramuscular injection (into the muscle), while Rebif is given three times weekly by subcutaneous injection (under the skin). Rebif typically has a higher cumulative weekly dose.

Both medications have similar effectiveness for MS treatment, but some patients may prefer the less frequent Avonex injections, while others may tolerate the smaller, more frequent Rebif doses better. Your neurologist can help determine which is best for your situation.

How can I manage flu-like symptoms from Avonex?

Flu-like symptoms are common, especially when starting Avonex, but usually improve over time. To minimize symptoms: take Avonex at bedtime so you sleep through the worst effects, pre-treat with over-the-counter pain relievers like acetaminophen or ibuprofen 30 minutes before injection and continue for 24 hours after, stay well-hydrated, use a heating pad for muscle aches, and ensure adequate rest.

The dose titration schedule (starting with lower doses) also helps reduce these symptoms. Most patients find flu-like effects diminish significantly after 2-3 months of treatment.

Can I drink alcohol while taking Avonex?

While there’s no absolute prohibition on alcohol with Avonex, you should use caution. Both Avonex and alcohol can affect liver function, so combining them may increase the risk of liver problems. Additionally, alcohol can worsen some MS symptoms like fatigue, balance problems, and depression. If you choose to drink, do so in moderation and discuss your alcohol consumption with your healthcare provider, especially if you have any liver function abnormalities or are taking other medications.

How to administer the Avonex injection?

Avonex is given by intramuscular injection, typically in the thigh (vastus lateralis muscle) or upper arm (deltoid muscle). Rotate between different sites to prevent tissue damage and injection site reactions.

For thigh injections, alternate between left and right thighs, and vary the exact location within each thigh. If using the upper arm, you may need assistance from someone else for proper injection technique.

Keep a record of injection sites to ensure proper rotation. Never inject into areas that are red, bruised, infected, or have scar tissue.

What blood tests do I need while taking Avonex?

Regular monitoring is essential while taking Avonex. Typical tests include: complete blood count (CBC) to check for low white blood cells, red blood cells, or platelets; liver function tests to monitor for hepatotoxicity; and thyroid function tests since Avonex can affect thyroid function. Initially, these tests may be done monthly for the first few months, then every 3-6 months once you’re stable. Your neurologist will determine the appropriate testing schedule based on your individual situation and any side effects you experience.

Can I get pregnant while taking Avonex?

If you’re planning to become pregnant or become pregnant while taking Avonex, discuss this immediately with your healthcare provider. Avonex is pregnancy category C, meaning effects on pregnancy aren’t fully known. Some studies suggest interferons may increase risk of miscarriage.

Your neurologist will weigh the benefits of continued MS treatment against potential risks to pregnancy. There are alternative MS treatments that may be safer during pregnancy. Don’t stop Avonex abruptly without medical supervision, as this could lead to MS relapses.

Is there financial assistance available for Avonex?

Yes, several options exist to help with Avonex costs. Biogen, the manufacturer, offers the Avonex Patient Support Program which may provide co-pay assistance for eligible patients with commercial insurance. The program may cover up to a certain amount per prescription.

Additionally, patient assistance programs are available for uninsured or underinsured patients who meet income requirements. The National MS Society also provides information about financial assistance programs. Contact Biogen’s patient support services or speak with your healthcare provider’s financial counselor to explore available options.

What should I do if I experience injection site reactions?

Mild injection site reactions (redness, swelling, pain) are common and usually resolve within a few days. Apply ice before injection and heat afterward to minimize discomfort. However, watch for signs of serious reactions: persistent pain, increasing redness or swelling after 2-3 days, skin breakdown or ulceration, blue-black discoloration, or drainage from the injection site. These could indicate injection site necrosis, which requires immediate medical attention.

Always rotate injection sites and never inject into irritated or damaged skin. If reactions persist or worsen, contact your healthcare provider.

Can I receive vaccines while taking Avonex?

Generally, inactivated (killed) vaccines are safe while taking Avonex, but live vaccines should typically be avoided as they may pose risks for people on immunomodulatory therapy. Common safe vaccines include the flu shot (inactivated), the pneumonia vaccine, and the hepatitis B vaccine.

However, timing and specific recommendations can vary. Always inform healthcare providers that you’re taking Avonex before receiving any vaccine. Your neurologist and primary care provider should coordinate your vaccination schedule to ensure optimal protection while maintaining MS treatment safety.

Avonex Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Avonex.Avonex (interferon beta-1a) – Biogen Inc.

What is Auvi-Q?

Auvi-Q injection contains epinephrine, a chemical that narrows blood vessels and opens airways in the lungs. These effects can reverse severe low blood pressure, wheezing, severe skin itching, hives, and other symptoms of an allergic reaction.

Auvi-Q injection is used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens. Epinephrine is also used to treat exercise-induced anaphylaxis.

Auvi-Q auto-injectors may be kept on hand for self-injection by a person with a history of an severe allergic reaction. This medicine is for use in adults and children who weigh at least 16.5 pounds (7.5 kilograms).

Warnings

Seek emergency medical attention after any use of Auvi-Q to treat a severe allergic reaction. After the injection you will need to receive further treatment and observation.

Before using this medicine

Before using Auvi-Q, tell your doctor if any past use of this medicine caused an allergic reaction to get worse.

To make sure Auvi-Q is safe for you, tell your doctor if you have ever had:

• heart disease or high blood pressure;
• asthma;
• Parkinson’s disease;
• depression or mental illness;
• a thyroid disorder; or
• diabetes.

Having an allergic reaction while pregnant or nursing could harm both mother and baby. You may need to use epinephrine during pregnancy or while you are breastfeeding. Seek emergency medical attention right away after using the injection.

If possible during an emergency, tell your medical caregivers if you are pregnant or breastfeeding.

How should I use Auvi-Q?

The Auvi-Q auto-injector device is a disposable single-use system. Follow all directions on your prescription label and read all medication guides or instruction sheets. Do not inject this medicine if you do not understand these instructions. Use the medicine exactly as directed. Ask your doctor or pharmacist if you do not understand these instructions.

Use an auto-injector only one time. Do not try to reinsert an auto-injector a second time. If the needle is bent from the first use, it may cause serious injury to your skin.

Do not give this medicine to a child without medical advice.

Auvi-Q is injected into the skin (subcutaneously) or muscle (intramuscularly) of your outer thigh. In an emergency, this injection can be given through your clothing.

Your medicine may also come with a “trainer pen.” The trainer pen contains no medicine and no needle. It is only for non-emergency use to practice giving yourself an Auvi-Q injection.

Do not remove the safety cap until you are ready to use the auto-injector. Never put your fingers over the injector tip when removing the safety cap or after the safety cap has been removed.

To use an Auvi-Q auto-injector:

Auvi-Q contains an electronic voice instruction system to help guide you through each step of your injection. If the voice instructions do not work for any reason, use Auvi-Q as directed in the steps below. It will still work during an allergic reaction emergency.

1. Pull Auvi-Q up from the outer case.
2. Pull Red safety guard down and off of Auvi-Q. To reduce the chance of an accidental injection, do not touch the black base of the auto-injector, which is where the needle comes out. If an accidental injection happens, get medical help right away. Note that the red safety guard is made to fit tight. Pull firmly to remove.
3. Place black end of Auvi-Q against the middle of the outer thigh (through clothing, if needed), then push firmly until you hear a click and hiss sound, and hold in place for 2 seconds. Only inject into the middle of the outer thigh. Do not inject into any other part of the body. If you are administering Auvi-Q to a young child or infant, hold the leg firmly in place while administering an injection.The needle automatically retracts after the injection is complete, so the needle will not be visible after the injection. Auvi-Q includes a 2-second countdown after it is activated, then the voice instruction will indicate the injection is complete.
4. Seek emergency medical attention after any use of epinephrine to treat a severe allergic reaction.The effects of epinephrine may wear off after 10 or 20 minutes. You will need to receive further treatment and observation.

Do not use Auvi-Q if it has changed colors or has particles in it, or if the expiration date on the label has passed. Call your pharmacist for a new prescription.

Store at room temperature away from moisture, heat, and light. Do not refrigerate or freeze this medication, and do not store it in a car.

Do not reuse a needle or syringe. Use only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Since epinephrine is used when needed, it does not have a daily dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include numbness or weakness, severe headache, blurred vision, pounding in your neck or ears, sweating, chills, chest pain, fast or slow heartbeats, severe shortness of breath, or cough with foamy mucus.

What should I avoid while using Auvi-Q?

Do not inject epinephrine into a vein or into the muscles of your buttocks, or it may not work as well. Inject it only into the fleshy outer portion of the thigh.

Accidentally injecting epinephrine into your hands or feet may result in a loss of blood flow to those areas, and resulting numbness.

Auvelity is a combination antidepressant medicine used to treat major depressive disorder (MDD) in adults. Auvelity contains dextromethorphan, an NMDA receptor antagonist, and bupropion, a norepinephrine-dopamine reuptake inhibitor (NDRI). 

Auvelity works by targeting multiple brain pathways involved in depression. Dextromethorphan works by blocking NMDA receptors, increasing the levels of glutamate, a chemical messenger (neurotransmitter),  to improve mood and brain connectivity. While bupropion helps dextromethorphan last longer in the body and increases dopamine and norepinephrine levels to improve depression symptoms.

Auvelity’s usual dose is 1 tablet taken once daily for 3 days, followed by 1 tablet twice daily, separated by at least 8 hours.  Tablets should be swallowed whole and not crushed or chewed.

Auvelity is a rapid-acting antidepressant that started working as early as 1 week, and patients’ depression symptoms continued to improve over time when compared to placebo in a 6-week clinical study for MDD (Study 1, NCT04019704).

Auvelity became an FDA-approved medicine on August 18, 2022, for adults with major depressive disorder (MDD).

How does Auvelity work?

Auvelity’s active ingredient, dextromethorphan, works as a N-methyl D-aspartate (NMDA) receptor antagonist and is also an agonist at the sigma-1 receptors. This helps to improve depressive symptoms by increasing glutamate levels, changing glutamate signalling, and regulating other neurotransmitters.

The second active ingredient, bupropion, helps dextromethorphan work more effectively by slowing how quickly it’s broken down in the body. It does this by blocking an enzyme called CYP2D6, allowing dextromethorphan to stay active longer. As a norepinephrine-dopamine reuptake inhibitor, bupropion also helps improve mood by increasing levels of dopamine and norepinephrine in the brain.

What is the cost of Auvelity?

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about the cost of Auvelity.

You may also be eligible for an Auvelity savings card or an Auvelity coupon. Ask your doctor or pharmacist if you qualify.

Auvelity side effects

Common Auvelity side effects

The most common Auvelity side effects include:

• dizziness
• diarrhea
• dry mouth
• excessive sweating
• headache
• feeling sleepy
• sexual function problems

Serious Auvelity side effects

Also, see Warnings.

Auvelity may cause serious side effects, including:

Seizures. There is a risk of seizures during treatment with this medicine. The risk is higher in people who:

• take higher doses of this medicine
• have certain medical problems
• take it with certain other medicines

Do not take Auvelity with other medicines unless your healthcare provider tells you to.
If you have a seizure during treatment, stop taking this medicine and call your healthcare provider right away. Do not take this medicine again if you have a seizure.

Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment. Your healthcare provider should check your blood pressure before you start taking and during treatment.

Manic episodes. Manic episodes may happen in people with bipolar disorder who take Auvelity. Symptoms may include:

• greatly increased energy
• racing thoughts
• unusually grand ideas
• talking more or faster than usual
• severe trouble sleeping
• reckless behavior
• excessive happiness or irritability

Unusual thoughts or behaviors. One of the ingredients in Auvelity (bupropion), can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.

Eye problems (angle-closure glaucoma). Auvelity may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.

Dizziness. this medicine may cause dizziness, increasing your fall risk.

Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take Auvelity with certain other medicines. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:

• agitation
• seeing or hearing things that are not there (hallucinations)
• confusion
• coma
• fast heartbeat
• changes in blood pressure
• dizziness
• sweating
• flushing
• high body temperature (hyperthermia)
• shaking (tremors), stiff muscles, or muscle twitching
• loss of coordination
• seizures
• nausea, vomiting, diarrhea

Austedo (deutetrabenazine) is a prescription medicine used to treat chorea associated with Huntington’s disease and tardive dyskinesia (TD), which are involuntary movement disorders. Austedo helps reduce uncontrolled movements and improve the quality of life for patients; however, it does not cure the underlying condition causing the movement disorder. 

Austedo works by regulating the storage and release of natural chemical messengers (neurotransmitters) from nerves, to help control symptoms such as twitching, jerking, or facial tics. It does this by targeting and blocking a protein in the brain called VMAT2, which is responsible for moving neurotransmitters (chemical messengers) into nerve cell storage areas.

Austedo’s drug class is a VMAT2 inhibitor (vesicular monoamine transporter 2 inhibitor).

Austedo tablets are taken twice daily, and the Austedo XR (extended-release) tablets are taken once daily.

What is Tardive dyskinesia (TD) and chorea associated with Huntington’s disease 

Tardive dyskinesia (TD) is a nervous system disorder that causes repetitive, uncontrolled muscle movements, usually in the face (chewing, lip smacking, frowning, tongue movement, blinking, or eye movement). Tardive dyskinesia can develop due to using certain medicines.

Chorea associated with Huntington’s disease is sudden, involuntary movements usually of the arms, legs, face, and tongue. It is an inherited disease that causes the progressive breakdown of nerve cells in the brain. Austedo is not a cure for Huntington’s disease and will only treat the symptom of chorea; it does not treat other symptoms of this condition.

Austedo side effects

Common Austedo side effects may include:

• drowsiness;
• tiredness;
• dry mouth;
• runny or stuffy nose, sore throat;
• sleep problems (insomnia); or
• diarrhea.

Serious Austedo side effects

Get emergency medical help if you have signs of an allergic reaction to Austedo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people have thoughts about suicide while taking Austedo for Huntington’s disease. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Some side effects may actually be signs that your Huntington’s disease is progressing. Your doctor will need to check your progress on a regular basis.

Deutetrabenazine may cause other serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• severe restlessness or agitation;
• tremors, shaking;
• muscle stiffness;
• problems with balance or coordination; or
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What is the cost of Austedo tablets?

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our Austedo price guide or Austedo XR price guide pages for more information about the cost of this medicine.

Who is eligible for the Austedo Coupon or Copay Card?

You are eligible for the Austedo Copay Card if you have commercial or private insurance, a valid prescription, and are a resident of the United States or the United States territories. 

You are not eligible for an Austedo Copay Card if you are enrolled in Medicare, Medigap, Medicaid, VA, DOD, TRICARE, Puerto Rico Government Health Insurance Plan, and Medicare-eligible patient enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.

How can I apply for the AustedoCopay Card?

You can apply for the Austedo Copay Card or Coupon online; there is a link on the Austedo Price Guide page. 

Check the terms and conditions for the Austedo Savings Card online.

Warnings 

QTc Prolongation. This medicine may prolong the QT interval, but the degree of QT prolongation is not clinically significant when administered within the recommended dosage range.  Austedo tablets and XR tablets should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias associated with a prolonged QT interval. 

Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including: 

• slow heart rate (bradycardia),
• low potassium levels (hypokalemia), 
• low magnesium blood levels (hypomagnesemia), 
• having a congenital prolongation of the QT interval, and
• concomitant use of other drugs that prolong the QTc interval.

Depression and Suicide. Some people have thoughts about suicide while taking Austedo tablets and extended-release tablets; stay alert to changes in your mood, feelings, thoughts, or behaviors. Tell your doctor right away if you have any sudden changes in mood or behavior or thoughts about suicide.

You should not use this medicine if you have Huntington’s disease and you have untreated or uncontrolled depression, or if you have thoughts about suicide.

Other medicines. Do not use this medicine if you have taken reserpine (Serpalan, Renese-R) in the past 20 days, or if you have used an MAO inhibitor (isocarboxazid, linezolid, rasagiline, selegiline, and others) in the past 14 days. See the Interactions section for more interactions with this medicine.

Before taking this medicine

You should not use Austedo if you are allergic to the active ingredient, deutetrabenazine, inactive ingredients, or if you have:

• untreated or uncontrolled depression;
• thoughts about suicide or hurting yourself;
• if you have recently taken tetrabenazine or valbenazine; or
• liver impairment.

Do not use this medicine if you have taken reserpine in the past 20 days, or if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• depression, anxiety, nervousness, or agitation;
• mental illness or psychosis;
• suicidal thoughts or actions;
• breast cancer;
• a heart rhythm disorder;
• long QT syndrome (in you or a family member);
• an electrolyte imbalance (such as low blood levels of potassium or magnesium); or
• liver disease.

People with Huntington’s disease may have a higher risk of depression and suicidal thoughts or behaviors. Taking this medicine may further increase this risk. However, the benefits of taking this medicine (improvement in daily living) may outweigh any suicidal risks.

Taking this medicine may cause symptoms similar to Parkinson’s disease (resting tremor, stiff muscles, slow movements, difficulty maintaining balance, and walking). Ask your doctor about your risk.

Your doctor will need to check your progress on a regular basis. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you are pregnant or breastfeeding.

How should I take this medicine?

Take Austedo as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

If you are switching from a similar medicine called tetrabenazine, take your first dose of Austedo one day after your last dose of tetrabenazine.

Austedo tablets are usually taken twice daily with food and a whole glass of water. Swallow the tablet whole and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the tablet whole.

You may need medical tests to check your heart function using an electrocardiograph or ECG (sometimes called an EKG).

Do not stop the medicine without your doctor’s advice. If you stop taking Austedo for longer than 1 week, do not start taking it again without your doctor’s advice.

Store at room temperature away from moisture and heat. Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative.

Austedo dose information

Austedo dose

Initial dose: 6 mg twice daily (12 mg per day).
Dose titration: May increase dose in increments of 6 mg/day at weekly intervals, based on reduction of chorea or tardive dyskinesia, and tolerability up to a maximum of 48 mg/day in divided doses.
Maximum Dose: 48 mg/day in divided doses.
Important Administration Instructions: 

• Take Austedo tablets with food
• Swallow whole. Do not chew, crush, or break tablets
• Take total daily dosages of 12 mg or above in two divided doses.

Austedo XR dose

Initial Dose: 12 mg once daily (12 mg per day).
Dose titration: May increase dose in increments of 6 mg/day at weekly intervals, based on reduction of chorea or tardive dyskinesia, and tolerability up to a maximum of 48 mg/day.
Maximum Dose:  48 mg/day
Important Administration Instructions:

• Take XR tablets with or without food 
• Swallow whole. Do not chew, crush, or break tablets.
• Take Austedo XR once daily. 

General dosing information

Switching Between Austedo and Austedo XR When switching between Austedo tablets (twice daily) and Austedo XR extended-release tablets (once daily), switch to the same total daily dosage.

Dose modifications: Dose modifications may be required when taking other medications due to drug interactions.

Discontinuation and Interruption of Treatment: Treatment with this medicine can be discontinued without tapering. Following treatment interruption of greater than one week, this therapy should be re-titrated when resumed. For treatment interruption of less than one week, treatment can be resumed at the previous maintenance dose without titration.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line ,

Overdose symptoms may include involuntary muscle movements, tremors, rapid eye movements, nausea, vomiting, diarrhea, flushing, sweating, severe drowsiness, confusion, hallucinations, or feeling light-headed.

What should I avoid while taking this medicine?

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Drinking alcohol with this medicine can cause side effects.

What other drugs will affect this medicine?

Austedo can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using Austedo with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with the active ingredient deutetrabenazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Augmentin contains a combination of amoxicillin and clavulanate potassium. Amoxicillin is a penicillin antibiotic that fights bacteria in the body. Clavulanate potassium is a beta-lactamase inhibitor that helps prevent certain bacteria from becoming resistant to amoxicillin.

Augmentin is prescription antibiotic used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.

Warnings

You should not use Augmentin if you have severe kidney disease, if you have had liver problems or jaundice while taking amoxicillin and clavulanate potassium, or if you are allergic to any penicillin or cephalosporin antibiotic, such as Amoxil, Ceftin, Cefzil, Moxatag, Omnicef, and others.

If you switch from one tablet form to another (regular or extended-release tablet), take only the new tablet form and strength prescribed for you. Amoxicillin and clavulanate may not be as effective or could be harmful if you do not use the exact tablet form your doctor has prescribed.

Amoxicillin and clavulanate potassium can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Augmentin can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking amoxicillin and clavulanate potassium.

Warnings

You should not use Augmentin if you have severe kidney disease, if you have had liver problems or jaundice while taking amoxicillin and clavulanate potassium, or if you are allergic to any penicillin or cephalosporin antibiotic,

Before taking this medicine

You should not use Augmentin if you are allergic to amoxicillin and clavulanate or if:

• you have severe kidney disease (or if you are on dialysis);
• you have had liver problems or jaundice while taking amoxicillin and clavulanate potassium; or
• you are allergic to any penicillin or cephalosporin antibiotic, such as Amoxil, Ceftin, Cefzil, Moxatag, Omnicef, and others.

To make sure Augmentin is safe for you, tell your doctor if you have:

• liver disease (hepatitis or jaundice);
• kidney disease; or
• mononucleosis.

The liquid may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Tell your doctor if you are pregnant or breastfeeding.

Augmentin can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy.

Do not give this medicine to a child without medical advice.

How should I take Augmentin?

Take Augmentin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Augmentin may work best if you take it at the start of a meal.

Take the medicine every 12 hours.

Do not crush or chew the extended-release tablet. Swallow the pill whole, or break the pill in half and take both halves one at a time. Tell your doctor if you have trouble swallowing a whole or half pill.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Augmentin.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Augmentin will not treat a viral infection such as the flu or a common cold.

Store the tablets at room temperature away from moisture and heat.

Store the liquid in the refrigerator. Throw away any unused liquid after 10 days.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose can cause nausea, vomiting, stomach pain, diarrhea, skin rash, drowsiness, hyperactivity, and decreased urination.

What to avoid

Avoid taking this medicine together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Augmentin side effects

Get emergency medical help if you have signs of an allergic reaction to Augmentin (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Augmentin and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• pale or yellowed skin, dark colored urine, fever, confusion or weakness;
• loss of appetite, upper stomach pain;
• little or no urination; or
• easy bruising or bleeding.

Common Augmentin side effects may include:

• nausea, vomiting; diarrhea;
• rash, itching;
• vaginal itching or discharge; or
• diaper rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Augmentin?

Tell your doctor about all your other medicines, especially:

• allopurinol;
• probenecid; or
• a blood thinner – warfarin, Coumadin, Jantoven.

What is Aubagio?

Aubagio is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). Aubagio may help reduce the relapse rate, slow disability progression, and also slow lesion size growth, compared to placebo treatment. Aubagio tablets are taken once daily with or without food.

Aubagio affects the immune system and reduces swelling and inflammation in the nervous system. Aubagio works by lowering the number of lymphocytes that cause inflammation and damage to the nerves. This helps to slow the progression of RRMS and reduce the relapse rate.

In RRMS, a type of white blood cell called lymphocytes mistakenly attacks the protective coating (myelin) that surrounds your neurons, which causes inflammation of the neurons and loss of myelin. The neurons are unable to work properly, causing the symptoms of RRMS.

Aubagio is not a cure for MS; it helps slow disease progression and reduces relapse rate.

Aubagio received FDA approval on September 12, 2012. The generic for Aubagio is called teriflunomide and is also now available.

Aubagio side effects

Common Aubagio side effects may include:

• headache;
• nausea, diarrhea;
• thinning hair; or
• abnormal liver function tests.

Serious Abagio side effects

Get emergency medical help if you have signs of an allergic reaction to Aubagio (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using this medicine and call your doctor at once if you have:

• numbness or tingling in your hands or feet that feels different from your MS symptoms;
• trouble breathing, new or worsening cough with or without fever;
• signs of infection – fever, chills, body aches, nausea, vomiting, feeling tired, or
• liver problems – upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

Do not use Aubagio if you are pregnant or may become pregnant. You will need to have a negative pregnancy test before starting this treatment. Tell your doctor right away if you become pregnant during treatment or within 2 years after your treatment ends.

Teriflunomide can cause severe liver problems. You should not use this medicine if you have severe liver disease or if you are also taking leflunomide (Arava). Tell your doctor if you have a history of liver disease.

Call your doctor at once if you have signs of liver problems: upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Your doctor may need to test your liver function up to 6 months before you start taking Aubagio and then every month when you first start taking this medicine.

Teriflunomide can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. While using Aubagio, you may need blood tests every 6 months. Your blood pressure will also need to be checked often.

After you stop taking Aubagio, the drug could stay in your body for up to 2 years. You may need to be treated with other medications to help your body eliminate teriflunomide quickly. Follow your doctor’s instructions.

Before taking this medicine

You should not use Aubagio if you are allergic to teriflunomide or leflunomide, or if:

• you have severe liver disease or
• you are also taking leflunomide (Arava).

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• high blood sugar;
• high blood pressure;
• skin problems when taking medicines;
• a fever, or uncontrolled infections;
• breathing problems;
• tuberculosis; or
• nerve problems, such as neuropathy.

Pregnancy

Do not use Aubagio if you are pregnant or may become pregnant You will need to have a negative pregnancy test before starting this treatment. Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking Aubagio, continue using birth control until you have received blood tests to make sure the drug has been eliminated from your body.

Avoid getting pregnant until after you stop taking this medicine and undergo a “drug elimination” procedure to help rid your body of this medicine. Stop taking Aubagio and call your doctor right away if you miss a period or think you might be pregnant. If you inadvertently become pregnant while receiving Aubagio or within 2 years of stopping it, there is a pregnancy surveillance program for Aubagio. You or your healthcare provider can report the pregnancy by calling 1-800-745- 4447. This is to track the outcome of the pregnancy and to evaluate any effects of teriflunomide on the baby.

If you are a man, use effective birth control to prevent pregnancy if your sex partner is able to get pregnant. After your treatment ends, keep using birth control until you have received the medications to help your body eliminate teriflunomide.

Breastfeeding

You should not breastfeed while using this medicine.

How should I take Aubagio?

Before you start treatment with Aubagio, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Aubagio with or without food.

Your blood pressure will need to be checked often.

Teriflunomide can lower your blood cell counts. Your blood will need to be tested often. Your treatment may be delayed based on the results.

After you stop taking Aubagio, you may need to be treated with other medicines to help your body eliminate teriflunomide quickly. If you do not undergo this drug elimination procedure, teriflunomide could stay in your body for up to 2 years. Follow your doctor’s instructions.

You will also need to go through this drug elimination procedure if you plan to become pregnant after you stop taking this medicine.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Multiple Sclerosis:

7 mg or 14 mg orally once a day

Use: Treatment of patients with relapsing forms of multiple sclerosis.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using Aubagio, and for at least 6 months after you stop taking it. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Aubagio?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can interact with teriflunomide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is atorvastatin?

Atorvastatin is a prescription medicine used to treat high cholesterol and to reduce the risk of heart attack, stroke, angina, and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

Atorvastatin helps lower LDL cholesterol (‘bad cholesterol’) and triglyceride levels, and increases HDL cholesterol (‘good cholesterol’) levels, to improve your overall lipid profile.

Atorvastatin calcium belongs to a class of medications called HMG-CoA reductase inhibitors, commonly referred to as statins.

Atrovastatin tablets are taken once daily with or without food. 

How does atorvastatin work?

Atorvastatin works by selectively blocking HMG-CoA reductase, the key enzyme the liver uses to produce cholesterol. By slowing this process, it reduces cholesterol production in the liver and increases the number of LDL receptors on liver cells, which helps remove more LDL (“bad”) cholesterol from the bloodstream. 

As a result, it lowers overall LDL levels, decreases the number of LDL particles, and improves the body’s ability to clear cholesterol.

What is atrovastatin used for?

Atorvastatin FDA-approved uses:

To reduce the risk of cardiovascular events in adults with:

• Multiple risk factors for coronary heart disease (CHD), but without established CHD.
  Use: to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina.
• Type 2 diabetes and multiple risk factors for CHD, without established CHD
  Use: to help reduce the risk of MI and stroke.
• Adults with clinically evident CHD:
  Use: To reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina.

As an adjunct to diet to lower LDL-C:

• Adults with primary hyperlipidemia.
• Adults and pediatric patients (10 years and older) with heterozygous familial hypercholesterolemia (HeFH).

As an adjunct to other LDL-lowering therapies:

• For adults and pediatric patients (10 years and older) with homozygous familial hypercholesterolemia.

As an adjunct to diet for additional lipid disorders in adults:

• Primary dysbetalipoproteinemia.
• Hypertriglyceridemia.

How atorvastatin improves cholesterol and heart health

When cholesterol and fats build up along your artery walls, in a process called atherosclerosis, they narrow the blood vessels and reduce blood and oxygen flow to your heart, brain, and other parts of your body. By slowing cholesterol production, atorvastatin helps prevent this buildup to keep blood flowing more freely to vital organs.

Lowering your blood level of cholesterol and fats with atorvastatin may help prevent heart disease, angina (chest pain), strokes, and heart attacks.

Your healthcare provider will check your blood lipid levels regularly to assess how well your treatment is working. These measurements include:

• LDL-C: Low-density lipoprotein (“bad” cholesterol)
• HDL-C: High-density lipoprotein (“good” cholesterol)
• TG: Triglycerides (a type of blood fat)
• Total-C: Total cholesterol

Warnings

You should not take atrovastatin calcium if you have liver disease or cirrhosis.

Atorvastatin calcium can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have fever, unusual tiredness, or dark urine.

Serious drug interactions can occur when certain medicines are used together with atrovastatin calcium. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Avoid drinking more than 1.2 liters of grapefruit juice each day.

Avoid eating foods that are high in fat or cholesterol. Atrovastatin is often used in conjunction with a cholesterol-lowering diet.

Atorvastatin side effects

Common atorvastatin side effects

Common atorvastatin side effects may include pain in your bones, spine, joints, or muscles, muscle spasms, upset stomach, trouble sleeping, stuffy nose, runny nose, sore throat, diarrhea, nausea, or pain in your arms or legs, urinary tract infection with pain and burning when you urinate, painful urination. 

Serious atorvastatin side effects

Allergic reactions: Get emergency medical help if you have signs of an allergic reaction to atorvastatin (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Myopathy and Rhabdomyolysis: Atorvastatin calcium can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have fever, unusual tiredness, or dark urine. This serious side effect is more likely in older adults and those who have kidney problems, thyroid problems, or take certain other medicines.

Other serious side effects may occur. Call your doctor at once if you have:

• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing, or standing;
• liver problems – loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems – swelling, urinating less, feeling tired or short of breath; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not take atorvastatin if you have liver disease or cirrhosis.

Atorvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have fever, unusual tiredness, or dark urine.

Serious drug interactions can occur when certain medicines are used together with atorvastatin. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Avoid eating foods that are high in fat or cholesterol. Atorvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Atorvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Before taking this medicine

You should not use atorvastatin if you are allergic to it, or if you have liver failure or cirrhosis.

To make sure atorvastatin is safe for you, tell your doctor if you have ever had:

• muscle pain or weakness;
• diabetes;
• stroke;
• a thyroid disorder;
• a habit of drinking more than 2 alcoholic beverages per day; or
• kidney disease.

Atorvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, or people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Pregnancy

Tell your healthcare professional if you are pregnant, or plan to become pregnant, or become pregnant. Atorvastatin may harm your unborn baby. If you become pregnant, stop taking atorvastatin and call your healthcare provider right away.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take this medicine or breastfeed. You should not take atorvastatin if you breastfeed. Talk to your healthcare provider about the best way to feed your baby if you take LIPITOR.

How should I take atorvastatin?

Take atorvastatin tablet once daily with or without food. Many people ask when to take atorvastatin morning or night? It can be taken any time of the day, but try and take it at the same time each day. 

Take the liquid medicine on an empty stomach, at least 1 hour before a meal or 2 hours after a meal. Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Take atorvastatin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not change your dose or stop taking any of your medications without your doctor’s advice.

It may take up to 2 weeks before your cholesterol levels improve, and you may need frequent blood tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

Your treatment may also include diet, exercise, weight control, and blood tests.

Store at room temperature away from moisture, heat, and light.

Throw away in the trash any unused liquid 60 days after opening the bottle.

Atorvastatin Dosing Information

Recommended Dosage in Adult Patients The recommended starting dosage of Lipitor is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. Patients who require a reduction in LDL-C greater than 45% may be started at 40 mg once daily.

Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HeFH The recommended starting dosage of Lipitor is 10 mg once daily. The dosage range is 10 mg to 20 mg once daily. 

Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HoFH The recommended starting dosage of Lipitor is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. 

Comments: Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating Lipitor, and adjust the dosage if necessary.

This medicine is available as: atorvastatin 10 mg tablets, atorvastatin 20 mg tablets, atorvastatin 40 mg tablet, 80 mg tablets. 

The original brand name of atorvastatin was Lipitor, and now it is also available as a generic.
Atorvastatin calcium oral suspension is also available as the brand Aorvaliq 20mg/5ml.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking atorvastatin?

Avoid eating foods high in fat or cholesterol, or atorvastatin will not be as effective.

Drinking alcohol may increase your risk of liver damage.

Grapefruit may interact with atorvastatin and cause side effects. Avoid consuming grapefruit products and drinking more than 1.2 liters of grapefruit juice each day.

What other drugs will affect atorvastatin?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which can increase the risk of serious muscle problems or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can interact with atorvastatin, especially:

• other cholesterol-lowering medicines – gemfibrozil, niacin, fenofibrate, fenofibric acid, and others;
• colchicine;
• antibiotic or antifungal medicine – rifampin, erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole;
• birth control pills;
• medicine to prevent organ transplant rejection; or
• antiviral medicine to treat hepatitis C or HIV.

Ativan (lorazepam) belongs to a class of medications called benzodiazepines. It is thought that benzodiazepines work by enhancing the activity of certain neurotransmitters in the brain.

Ativan is used in adults and children at least 12 years old to treat anxiety disorders.

Ativan is also used to treat insomnia caused by anxiety or temporary situational stress.

Ativan is sometimes used to treat nausea and vomiting from cancer treatment and to control agitation caused by alcohol withdrawal.

Warnings

Ativan can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. These effects can be fatal.

MISUSE OF ATIVAN CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep this medicine where others cannot get to it.

Lorazepam may be habit-forming and should be used only by the person it was prescribed for. Ativan should never be shared with another person, especially someone who has a history of drug abuse or addiction.

Do not stop using Ativan without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Get medical help right away if you stop using Ativan and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Do not use Ativan if you are pregnant. Lorazepam can cause birth defects or life-threatening withdrawal symptoms in a newborn.

You should not use this medicine if you have narrow-angle glaucoma, severe respiratory insufficiency, myasthenia gravis, or if you are allergic to Valium or a similar medicine.

Before taking this medicine

You should not use Ativan if you have:

• narrow-angle glaucoma; or
• a history of allergic reaction to any benzodiazepine (lorazepam, alprazolam, diazepam, Valium, Xanax, Versed, Klonopin, and others).

To make sure Ativan is safe for you, tell your doctor if you have ever had:

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• drug or alcohol addiction;
• depression, mental illness or psychosis, mood changes, or suicidal thoughts or actions;
• seizures;
• an allergy to aspirin or yellow food dye; or
• kidney or liver disease.

Tell your doctor if you are pregnant or plan to become pregnant. If you use Ativan during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lorazepam on the baby.

You should not breastfeed.

If you do breastfeed, tell your doctor if you notice drowsiness, feeding problems, or slow weight gain in the nursing baby.

How should I take Ativan?

Take Ativan exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Ativan in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share Ativan with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Do not stop using Ativan without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Store Ativan tablets tightly closed at room temperature, away from moisture and heat.

Keep your medicine in a place where no one can use it improperly.

Dosing information

Usual Adult Dose for Anxiety:

Initial dose: 2 to 3 mg orally per day, given 2 to 3 times per day
Maintenance dose: 1 to 2 mg orally 2 to 3 times a day

Uses:
-Management of anxiety disorders
-Short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms

Usual Adult Dose for Insomnia:

2 to 4 mg orally once a day at bedtime

Comments:
-The dosage should be increased gradually when needed to help avoid adverse effects.
-Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

Use: Management of insomnia due to anxiety of transient situational stress

Usual Geriatric Dose for Anxiety:

Older or debilitated patients:
-Initial dose: 1 to 2 mg orally per day, given in divided doses

-Management of anxiety disorders
-Short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms

Usual Pediatric Dose for Anxiety:

12 years or older:
-Initial dose: 2 to 3 mg orally per day, given 2 to 3 times per day
-Maintenance dose: 1 to 2 mg orally 2 to 3 times a day

-The daily dosage may vary from 1 to 10 mg/day.
-The dosage should be increased gradually when needed to help avoid adverse effects.
-When higher dosage is indicated, the evening dose should be increased before the daytime doses.
-Use of anxiolytic agents is typically not needed to treat anxiety/tension associated with the stress of everyday life.
-Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

Uses:
-Management of anxiety disorders
-Short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms

Usual Pediatric Dose for Insomnia:

12 years or older: 2 to 4 mg orally once a day at bedtime

Comments:
-For debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended.
-The dosage should be increased gradually when needed to help avoid adverse effects.
-Clinical studies have not evaluated this drug for efficacy in long-term treatment (e.g., greater than 4 months).

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of lorazepam can be fatal if you also drink alcohol or use other drugs that cause drowsiness or slow breathing.

Overdose symptoms may include severe drowsiness, confusion, slurred speech, feeling restless, muscle weakness, loss of balance or coordination, feeling light-headed, slow heartbeats, weak or shallow breathing, or coma.

What should I avoid while taking Ativan?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how Ativan will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Ativan side effects

Get emergency medical help if you have signs of an allergic reaction to Ativan: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Lorazepam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Ativan may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness;
• unusual changes in mood or behavior, being agitated or talkative;
• sudden restless feeling or excitement;
• seizures, depression, thinking problems, thoughts of suicide or hurting yourself;
• confusion, aggression, hallucinations;
• sleep problems (insomnia);
• vision changes; or
• dark urine, or jaundice (yellowing of the skin or eyes).

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common Ativan side effects may include:

• dizziness, sedation, drowsiness;
• weakness; or
• feeling unsteady.

You will need frequent blood tests to check your blood counts and liver function.

After you stop using Ativan, seek medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.

Some withdrawal symptoms may last up to 12 months or longer after stopping Ativan suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.

What is atenolol?

Atenolol is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins).

Atenolol is used to treat angina (chest pain) and hypertension (high blood pressure).

Atenolol is also used to lower the risk of death after a heart attack.

Warnings

You should not use this atenolol if you have a serious heart condition such as “AV block,” very slow heartbeats, or heart failure.

Do not stop taking atenolol without first talking to your doctor. Stopping suddenly may make your condition worse.

If you are having any type of surgery, be sure the surgeon knows ahead of time that you are using this medicine.

Atenolol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which could increase drowsiness and dizziness while you are taking this medicine.

Atenolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Before taking this medicine

You should not use atenolol if you are allergic to it, or if you have:

• a serious heart condition such as “AV block” (second or third degree);
• slow heartbeats;
• heart failure; or
• if your heart cannot pump blood properly.

To make sure atenolol is safe for you, tell your doctor if you have:

• congestive heart failure;
• coronary artery disease (hardened arteries);
• asthma, bronchitis, emphysema;
• diabetes;
• overactive thyroid;
• liver or kidney disease;
• pheochromocytoma (tumor of the adrenal gland);
• peripheral vascular disease such as Raynaud’s syndrome; or
• allergies (or if you are undergoing allergy treatments or skin-testing).

Atenolol may harm an unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.

Atenolol can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Atenolol is not approved for use by anyone younger than 18 years old.

How should I take atenolol?

Take atenolol exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your blood pressure will need to be checked often.

If you need surgery, tell the surgeon ahead of time that you are using atenolol. You may need to stop using the medicine for a short time.

Keep using the medication as directed and tell your doctor if your symptoms do not improve.

You should not stop taking atenolol suddenly. Stopping suddenly may make your condition worse.

If you are being treated for high blood pressure: Keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Your condition may need to be treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Atenolol dosing information

Usual Adult Dose of Atenolol for Hypertension:

Initial dose: 50 mg orally once a day
Maintenance dose: 50 to 100 mg orally once a day
Maximum dose: 100 mg per day

Comments:
-If desired response not achieved after 1 to 2 weeks, increase to 100 mg may be beneficial.
-Doses greater than 100 mg once a day did not result in significant additional antihypertensive effects.

Use: For the treatment of hypertension alone or in combination with other antihypertensive agents.

Usual Adult Dose of Atenolol for Angina Pectoris Prophylaxis:

Initial dose: 50 mg orally once a day
-Increase to 100 mg orally once a day after 1 week if optimal response not achieved
Maintenance dose: 50 to 200 mg orally once a day
Maximum dose: 200 mg per day

Comments:
-Some patients may require 200 mg per day to attain optimal effect.

Use: For the long-term management of angina pectoris due to coronary atherosclerosis.

Usual Adult Dose of Atenolol for Angina Pectoris:

Initial dose: 50 mg orally once a day
-Increase to 100 mg orally once a day after 1 week if optimal response not achieved
Maintenance dose: 50 to 200 mg orally once a day
Maximum dose: 200 mg per day

Comments:
-Some patients may require 200 mg per day to attain optimal effect.

Use: For the long-term management of angina pectoris due to coronary atherosclerosis.

Usual Adult Dose of Atenolol for Myocardial Infarction:

50 mg orally twice a day or 100 mg orally once a day

Comments:
-If IV beta blockers are contraindicated or inappropriate, oral therapy should continue for at least 7 days post-myocardial infarction (MI).
-Treatment with beta blockers post MI should generally continue for 1 to 3 years if there are no contraindications.

Use: For the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality.

Usual Geriatric Dose of Atenolol for Hypertension:

Initial dose: Consider reducing the starting dose to 25 mg orally once a day

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include extreme weakness or lack of energy, very slow heart rate, shortness of breath, or fainting.

What should I avoid while taking atenolol?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Atenolol side effects

Get emergency medical help if you have signs of an allergic reaction to atenolol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or worsening chest pain;
• slow or uneven heartbeats;
• a light-headed feeling, like you might pass out;
• shortness of breath (even with mild exertion), swelling, rapid weight gain; or
• a cold feeling in your hands and feet.

Common atenolol side effects may include include:

• cold hands or feet;
• dizziness;
• tiredness; or
• depressed mood.

What is Alprolix?

Alprolix is used to help control and prevent bleeding in people with hemophilia B (congenital Factor IX deficiency). Alprolix is a coagulation Factor IX concentrate that replaces the missing or low levels of Factor IX; this helps control bleeding episodes, manage bleeding in surgery, and can be used regularly to prevent bleeding episodes. Coagulation Factor IX is sometimes written as coagulation Factor 9.

Alprolix is a recombinant Factor product, which means it is developed in a laboratory and is not human plasma derived from donor-sourced plasma.

Hemophilia B is a genetic disorder that causes low levels of a clotting protein called Factor IX, this causes individuals to bleed for a longer time than other people.  External bleeding can be due to dental procedures, minor cuts, or trauma and can also involve internal bleeding into joints and muscles.

Alprolix FDA approval was received on March 28, 2014, for the company Biogen Idec. It is now manufactured for Bioverativ Therapeutics Inc. which is a Sanofi Company.

Alprolix side effects

Common side effects of Alprolix 

Common Alprolix side effects may include nausea, headache, dizziness, altered sense of taste, mild skin rash, or pain, redness, itching, stinging, or other irritation where the medicine was injected.

Serious side effects of Alprolix 

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, tightness in your chest, difficult breathing, fast heartbeats, blue lips, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Alprolix may cause other serious side effects. Call your doctor at once if you have:

• weight gain, swelling in your waist, hands, or lower legs;
• loss of appetite;
• fever or chills;
• continued bleeding after treatment;
• new or worsened bleeding; or
• signs of excessive blood clotting–sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance, chest pain, coughing up blood, or pain, swelling, warmth, and redness in one or both legs.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use Alprolix if you are allergic to Alprolix or any of the other ingredients. Tell your healthcare provider if you have had an allergic reaction to any Factor IX product prior to using Alprolix.

Before using this medicine

Tell your doctor about all of your medical conditions, including if you:

• have been told that you have inhibitors to Factor IX (because Alprolix may not work for you).

Pregnancy

Tell you healthcare provider if you are pregnant or planning to become pregnant. It is not known if Alprolix may harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. It is not known if Alprolix passes into breast milk or if it can harm your baby.

How should I use Alprolix?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Alprolix is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Alprolix Administration

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Alprolix must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

The mixture should appear clear, yellow, or colorless. Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Gently swirl but do not shake the medicine while mixing or you may ruin the medicine. Use the injection within 3 hours after mixing your dose.

You may need frequent blood tests.

In case of emergency, wear or carry medical identification to let others know you have a bleeding disorder.

Alprolix Dosing information

On-demand treatment and control of bleeding episodes:

Perioperative management:

• Minor surgery: a single infusion to reach FIX level of 50–80 IU/dL may be sufficient. Repeat as needed after 24–48 hours until bleeding stops and healing is achieved.
• Major surgery: initial infusion to reach FIX level of 60–100 IU/dL. Consider a repeat dose after 6–10 hours and then every 24 hours for the first 3 days, then every 48 hours until bleeding stops and healing is achieved.

Routine prophylaxis:

For adults and adolescents ≥12 years of age, start at 50 IU/kg once weekly or 100 IU/kg once every 10 days.
For children <12 years of age, start at 60 IU/kg once weekly.
Adjust dosing regimen based on individual response. More frequent or higher doses may be needed in children <12 years of age.

Use: adults and children with hemophilia B for:

• On-demand treatment and control of bleeding episodes,
• Perioperative management of bleeding,
• Routine prophylaxis to reduce the frequency of bleeding episodes.

What other drugs will affect Alprolix?

Tell your healthcare provider about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal medicines.

There are no known drugs interactions with Alprolix.

Storage

Store Alprolix vials at 2°C to 8°C (36°F to 46°F). Do not freeze.

Alprolix vials may also be stored at room temperature up to 30°C (86°F) for a single 6-month period.

If you choose to store Alprolix at room temperature:

• Note on the carton the date on which the product was removed from refrigeration.
• Use the product before the end of this 6-month period or discard it.
• Do not return the product to the refrigerator.

Do not use product or diluent after the expiration date printed on the carton, vial, or syringe.

After Reconstitution:

• Use the reconstituted product as soon as possible; however, you may store the reconstituted product at room temperature up to 30°C (86°F) for up to 3 hours. Protect the reconstituted product from direct sunlight. Discard any product not used within 3 hours after reconstitution.
• Do not use Alprolix if the reconstituted solution is cloudy, contains particles or is not colorless.

What else should I know about Alprolix?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use Alprolix for a condition for which it was not prescribed. Do not share it with other people, even if they have the same symptoms that you have.

Alprolix Instructions for Use

Read the Instructions for Use before you start using Alprolix and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Your healthcare provider should show you or your caregiver how to reconstitute and administer Alprolix the first time Alprolix is used.

Check the expiration date on the Alprolix kit.

Do not use the product if past the expiration date.

Allow the Alprolix vial and the diluent to come to room temperature.

Do not use external heat sources such as putting the vial and/or diluent in hot water.

Find a clean, flat work surface and collect all the supplies you will need to reconstitute and administer Alprolix.

Wash your hands with soap and water. Aseptic technique (clean and germ free) should be used.

Alprolix Reconstitution

Step 1:  Remove the plastic cap from the Alprolix vial. Wipe the rubber stopper of the vial with an alcohol wipe and allow it to dry.
After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.

Step 2:  Completely remove the backing from the vial adapter package by peeling back the lid.
Do not remove the vial adapter from the package or touch the inside of the vial adapter.

Step 3:  Keep the vial on a flat surface. Hold the vial adapter package with one hand and using the other hand, place the vial adapter over the vial.
The spike should be placed directly above the center of the rubber stopper.
Push the vial adapter straight down until the adapter spike punctures the center of the vial stopper and is fully inserted.

Step 4:  Lift the package cover away from the vial adapter and discard the cover.

Step 5: Only use the diluent syringe provided to reconstitute the drug product.
Hold the plunger rod at the circular disk.
Place the tip of the plunger rod into the end of the syringe.
Turn in a clockwise motion until it is securely attached.

Step 6:  With one hand, hold the diluent syringe right under the cap, and with the cap pointing up.
Make sure you are holding the diluent syringe by the ridged part directly under the cap.
Do not use if the cap has been removed or is not securely attached.

Step 7:  With your other hand, grasp the cap and bend it at a 90° angle until it snaps off.
After the cap snaps off, you will see the glass tip of the syringe.
Do not touch the glass tip of the syringe or inside of the cap.

Step 8: Be sure the vial is sitting on a flat surface.
Insert the tip of the syringe into the adapter opening.
Turn the syringe in a clockwise motion until it is securely attached to the adapter.

Step 9: Slowly depress the plunger rod to inject all of the diluent into the vial.
The plunger rod may rise slightly after this process. This is normal.

Step 10:  With the syringe still connected to the adapter, gently swirl the vial until the product is completely dissolved.
The appearance of the solution should be clear to slightly opalescent and colorless.
Do not shake.
Do not use the reconstituted Alprolix if it contains visible particles or is cloudy.

If you are using more than one vial, stop here and proceed to the Pooling Instructions on the back.

Step 11:  Make sure the plunger rod is completely depressed.
Turn the vial upside-down.
Slowly pull on the plunger rod to draw the solution into the syringe.
Be careful not to pull the plunger rod completely out of the syringe.

Step 12:  Gently unscrew the syringe from the vial adapter and dispose of the vial with the adapter still attached.
Do not touch the syringe tip or the inside of the cap.
Reconstituted Alprolix should be administered as soon as possible. Figure

Alprolix Pooling

Pooling is the process of combining two or more reconstituted vials into a larger syringe (not into the diluent syringe) prior to intravenous administration.

If you are using two or more vials, follow these pooling steps.

Be sure to leave the vial adapter attached to the vial as you will need it for attaching a large luer lock syringe.

Do not detach the diluent syringe or the large luer syringe until you are ready to attach the large luer lock syringe to the next vial (with vial adapter attached).

Step 1:  Remove the diluent syringe from the vial adapter by turning it counterclockwise until it is completely detached.

Step 2:  Attach a separate large luer lock syringe by turning clockwise until it is securely attached.

Step 3:  Slowly pull on the plunger rod to draw the solution into the syringe.
Repeat this pooling procedure with each vial you will be using.
Once you have pooled the required dose, proceed to administration using the large luer lock syringe.

Alprolix Administration (Intravenous Injection)

Alprolix is administered by intravenous infusion after reconstitution of the drug powder with the diluent.

Your healthcare provider should teach you how to infuse Alprolix. Once you have been taught to self-infuse, you can follow these instructions.

Do not administer reconstituted Alprolix if it contains particulate matter, is discolored, or is cloudy.

Step 1: Attach the syringe to the connector end of the infusion set tubing by turning clockwise until it is securely attached.
Do not administer reconstituted Alprolix in the same tubing or container with other medicinal products.

Step 2:  Apply a tourniquet and clean the skin area where you will perform the infusion using an alcohol wipe.

Step 3: Depress the plunger until all air is removed from the syringe and Alprolix has reached the end of the infusion set tubing.
Do not push Alprolix through the needle.

Step 4:  Remove the protective needle cover from the infusion set tubing.
Insert the needle on the infusion set tubing into the vein.
Remove the tourniquet.
Always verify proper needle placement when performing intravenous administration.

Step 5: Slowly depress the plunger on the syringe to administer Alprolix.
Alprolix should be injected intravenously over several minutes.
The rate of administration should be determined by your comfort level.
The small amount of drug product left in the infusion set will not affect treatment.

Step 6: After infusing Alprolix, remove the infusion set and use a sterile gauze to put pressure on the infusion site for several minutes.
Apply an adhesive bandage if necessary.

What is allopurinol?

Allopurinol belongs to a class of medications called xanthine oxidase inhibitors. It works by reducing the production of uric acid in the body. High levels of uric acid may cause gout attacks or kidney stones.

Allopurinol is used to treat gout (a type of arthritis in which uric acid, a naturally occurring substance in the body, builds up in the joints and causes sudden attacks of redness, swelling, pain, and heat in one or more joints). Allopurinol is used to prevent gout attacks, not to treat them once they occur. Allopurinol does not need to be stopped during an acute flare.

Allopurinol is also used to treat high levels of uric acid that builds up in the blood as tumors break down in people with certain types of cancer who are being treated with chemotherapy medications. It is also used to treat kidney stones that have come back in people who have high levels of uric acid in their urine.

Warnings

You should not use this medicine if you have ever had an allergic reaction to allopurinol.

Allopurinol can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

In rare cases, allopurinol may cause a severe allergic reaction. Stop taking this medicine and call your doctor right away if you have painful urination, blood in your urine, burning in your eyes, swelling in your face or throat, skin redness or a rash that spreads and causes blistering and peeling.

Avoid drinking alcohol. It can make your condition worse. Allopurinol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Before taking this medicine

You should not use allopurinol if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• diabetes;
• congestive heart failure;
• high blood pressure;
• if you are receiving chemotherapy;
• if you have a gene variation called HLA-B*58:01 allele (your doctor can test you for this);
• liver disease; or
• kidney disease.

Allopurinol may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

How should I use allopurinol?

Take allopurinol exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take the tablets with a full glass of water. To reduce your risk of kidney stones, drink 8 to 10 full glasses of fluid every day, unless your doctor tells you otherwise.

Take with food if allopurinol tablets upsets your stomach.

Allopurinol injection is injected into a vein by a healthcare provider. The injection is usually only used if you are unable to take medicine by mouth.

You may need frequent medical tests while using this medicine, even if you have no symptoms.

Your kidney and liver function may also need to be tested. Your doctor may change your dose if your kidney function changes.

You may have gout attacks when you first start taking allopurinol tablets. Your doctor may recommend another gout medication to take with allopurinol. Keep taking the medicine as directed.

Your symptoms may not improve for up to 2 to 6 weeks. Call your doctor if your symptoms do not improve after 6 weeks.

You may need to follow a special diet to help prevent kidney stones. Follow all instructions of your doctor or dietitian. Learn about the foods you should eat or avoid.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take allopurinol as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if you miss an appointment for your allopurinol injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using allopurinol?

Avoid driving or hazardous activity until you know how allopurinol will affect you. Your reactions could be impaired.

Avoid drinking alcohol.

Allopurinol side effects

Get emergency medical help if you have signs of an allergic reaction to allopurinol (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Allopurinol may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

• any skin rash, no matter how mild;
• painful urination, blood in the urine;
• inflammation of your blood vessels – numbness or tingling, skin rash, fever, headache, body aches, night sweats, weight loss, feeling or weak or tired;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• liver problems – loss of appetite, weight loss, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common allopurinol side effects may include:

• an increase in gout attacks when you first start taking this medicine;
• rash;
• drowsiness;
• abnormal liver function tests;
• nausea, vomiting, diarrhea; or
• kidney problems – swelling, urinating less, feeling tired or short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect allopurinol?

Tell your doctor about all your other medicines, especially:

• azathioprine or mercaptopurine;
• chlorpropamide;
• cyclosporine;
• cancer medicine;
• other gout medications;
• an antibiotic such as ampicillin or amoxicillin;
• a blood thinner such as warfarin, Coumadin, Jantoven; or
• a diuretic or “water pill”.

What is Alecensa?

Alecensa (alectinib) is an oral kinase inhibitor that may be used to treat certain types of non-small cell lung cancer (NSCLC) in adults that have been caused by an abnormal anaplastic lymphoma kinase (ALK) gene, specifically:

• to help prevent your lung cancer from coming back after your tumor has been removed by surgery (adjuvant), or
• as treatment when your lung cancer has spread to other parts of your body (metastatic).

Alecensa is used only if your cancer has a specific genetic marker (an abnormal “ALK” gene). Your doctor will test you for this gene.

Alecensa works by targeting ALK and RET — these are 2 tyrosine kinases present in 5% to 7% of people with NSCLC. By preventing the activity of these kinases, Alecensa reduces the viability of cancer cells.

Alecensa was FDA approved on December 11, 2015.

Alecensa side effects

Common Alecensa side effects may include:

• anemia;
• constipation;
• swelling in your face, eyelids, hands, or lower legs;
• tired feeling; or
• muscle pain.

Serious side effects and warnings

Alecensa can cause serious or life-threatening side effects.

Get emergency medical help if you have signs of an allergic reaction to Alecensa, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Serious side effects of Alecensa include the following:

Liver problems (hepatotoxicity). These are common with Alecensa and can be severe. Your healthcare provider will do blood tests at least every 2 weeks for the first 3 months, and then 1 time each month and
as needed during treatment to check your liver function. Tell your healthcare provider right away if you get any of the following signs and symptoms:

• feeling tired
• feeling less hungry than usual
• yellowing of your skin or the whites of your eyes
• dark urine
• itchy skin
• nausea or vomiting
• pain on the right side of your stomach area
• bleeding or bruising more easily than normal.

Lung problems, which may be severe or life-threatening and similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.

Kidney problems, which may be fatal. Tell your healthcare provider right away if you have a change in the amount or color of your urine, or if you get new or worsening swelling in your legs or feet.

Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe. Your healthcare
provider will check your heart rate and blood pressure during treatment. Tell your healthcare
provider right away if you feel dizzy, lightheaded, or if you faint during treatment. Tell your
healthcare provider if you take any heart or blood pressure medicines.

Severe muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. Your healthcare provider will do blood tests at least every 2 weeks for the first month and as needed during treatment. Tell your healthcare provider right away if you get new or worsening signs and
symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away,
tenderness, or weakness.

Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take Alecensa. If this happens, you may not have enough healthy red blood cells. Your
healthcare provider may temporarily stop treatment and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your healthcare provider may either restart you at a lower dose when the
hemolytic anemia goes away or may stop your treatment. Tell your healthcare provider right away
if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.

Call your doctor at once if you have:

• heart problems–severe dizziness, very slow heartbeats;
• a light-headed feeling, like you might pass out;
• unexplained muscle pain, tenderness, or weakness;
• lung problems – sudden chest pain or discomfort, wheezing, dry cough or cough with mucus, feeling short of breath;
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed, cold hands and feet;
• kidney problems – a change in your urine color, little or no urination, swelling in your feet or ankles; or
• liver problems – stomach pain (upper right side), loss of appetite, easy bruising or bleeding, feeling tired, dark urine, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use Alecensa if you are allergic to alectinib or any of the inactive ingredients in Alecensa.

Tell your doctor if you have ever had:

• lung or breathing problems other than lung cancer;
• liver disease; or
• slow heartbeats.

Tell your healthcare provider if you are pregnant, intending to become pregnant, or breastfeeding.

Pregnancy

Alecensa can harm an unborn baby or cause birth defects if the mother or the father is taking this medicine.

• If you are a woman, do not use Alecensa if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 week after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Alecensa.

Breastfeeding

It is not known whether Alecensa passes into breast milk or if it could harm a nursing baby. You should not breastfeed while you are using alectinib and for at least 1 week after your last dose.

How should I take Alecensa?

Before you start treatment with Alecensa, your doctor will perform a special test to make sure Alecensa is the best treatment for your type of lung cancer. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

The usual dosage of Alecensa is 600 mg twice daily.

• Alecensa works best if you take it with food.
• Swallow the capsule whole and do not crush, chew, dissolve, or open it.
• If you vomit shortly after taking Alecensa, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Store at room temperature away from moisture, heat, and light.

Alecensa dosing

Usual Alecensa Adult Dose for Non-Small Cell Lung Cancer:

• 600 mg orally 2 times a day
  • Available as Alecensa 150 mg capsules.
  • Four capsules (4 x 150 mg) make up one dose of Alecensa to be taken twice a day.

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments: This drug should be taken with food.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time. If you vomit shortly after taking Alecensa, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

What to avoid

Alectinib could make you sunburn more easily. Avoid sunlight or tanning beds during treatment and for at least 7 days after your last dose of Alecensa. Wear protective clothing and use sunscreen (SPF 50 or higher) when you are outdoors.

What is Aldactone?

Aldactone is a potassium-sparing diuretic (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

Aldactone is used to treat heart failure, high blood pressure (hypertension), or hypokalemia (low potassium levels in the blood).

Aldactone also treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic syndrome.

Aldactone is also used to diagnose or treat a condition in which you have too much aldosterone in your body. Aldosterone is a hormone produced by your adrenal glands to help regulate the salt and water balance in your body.

Warnings

You should use Aldactone with caution if you have kidney problems, high levels of potassium in your blood, Addison’s disease, if you are unable to urinate, or if you are also taking eplerenone.

Aldactone has caused tumors in animals but it is not known whether this could occur in people. Do not use this medicine for any condition that has not been checked by your doctor.

Before taking this medicine

You should not use Aldactone if you are allergic to spironolactone, or if you have:

• Addison’s disease (an adrenal gland disorder);
• high levels of potassium in your blood (hyperkalemia);
• if you are unable to urinate; or
• if you are also taking eplerenone.

To make sure Aldactone is safe for you, tell your doctor if you have:

• an electrolyte imbalance (such as low levels of calcium, magnesium, or sodium in your blood);
• kidney disease;
• liver disease; or
• heart disease.

Tell your doctor if you are pregnant or plan to become pregnant. Having congestive heart failure, cirrhosis, or uncontrolled high blood pressure during pregnancy may lead to medical problems in the mother or the baby. Your doctor should decide whether you take Aldactone if you are pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I take Aldactone?

Take Aldactone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not share this medicine with another person, even if they have the same symptoms you have.

You may take Aldactone with or without food, but take it the same way each time.

You will need frequent medical tests.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Aldactone.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from heat, light, and moisture.

Dosing information

Usual Adult Dose of Aldactone for Edema:

25 to 200 mg orally per day in single or divided doses

Duration of therapy: When given as the sole diuretic, continue the initial dose for at least 5 days, after which the initial dose may be adjusted to an optimal maintenance dose.

Comments:

-A second diuretic that acts more proximally at the renal tubule may be added if adequate diuresis has not been achieved after 5 days. The dose of this drug should remain unchanged if a second diuretic is added.

Uses:

-Treatment of edematous conditions in patients with congestive heart failure who are only partially responsive to or intolerant of other therapeutic measures or who are taking digitalis when other therapies are considered inappropriate.

-Treatment of edematous conditions in patients with liver cirrhosis accompanied by edema and/or ascites.

-Treatment of edematous conditions in patients with nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.

Usual Adult Dose of Aldactone for Hypertension:

Initial dose: 50 to 100 mg orally per day in single or divided doses

Duration of therapy: Treatment should be continued for at least 2 weeks to achieve a maximum response. Subsequently, the dose may be adjusted according to patient response.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 25 mg orally once a day assuming serum potassium is less than or equal to 5 mEq/L and serum creatinine is less than or equal to 2.5 mg/dL

Maintenance dose:

-Patients tolerant of initial dose: May increase to 50 mg orally once a day as clinically indicated

-Patients intolerant of initial dose: May decrease to 25 mg orally every other day

Use: To increase survival and reduce the need for hospitalization of severe heart failure patients (New York Heart Association [NYHA] class III to IV) when used in addition to standard therapy.

Usual Adult Dose for Primary Hyperaldosteronism:

Diagnostic dose:

-Long test: 400 mg orally per day for 3 to 4 weeks

-Short test: 400 mg orally per day for 4 days

Maintenance dose: 100 to 400 mg orally per day until surgery; may be used long-term at the lowest effective dose in patients deemed unsuitable for surgery.

Comments:

-For the long test, correction of hypokalemia and hypertension provides presumptive evidence of primary hyperaldosteronism.

-For the short test, increased serum potassium with this drug and a decrease upon discontinuation provide presumptive evidence of primary hyperaldosteronism.

Uses:

-Initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.

-Short-term preoperative treatment of patients with primary hyperaldosteronism.

-Long-term maintenance therapy for patients deemed unsuitable for surgery or those with idiopathic hyperaldosteronism.

Usual Adult Dose for Hypokalemia:

25 to 100 mg orally per day

Uses:

-Treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate.

-Prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

What to avoid

Drinking alcohol can increase certain side effects.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Aldactone side effects

Get emergency medical help if you have signs of an allergic reaction to Aldactone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• little or no urination;
• high potassium level – nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; o
• signs of other electrolyte imbalances – increased thirst or urination, confusion, vomiting, muscle pain, slurred speech, severe weakness, numbness, loss of coordination, feeling unsteady.

Common Aldactone side effects may include:

• breast swelling or tenderness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Aldactone?

Using Aldactone with other drugs that make you dizzy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your other medicines, especially:

• colchicine;
• digoxin;
• lithium;
• loperamide;
• trimethoprim;
• heart or blood pressure medicine (especially another diuretic);
• medicine to prevent a blood clot; or

What is Advil?

Advil is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

Advil is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury.

Advil is used in adults and children who are at least 2 years old. For children under 2 years check with a doctor.

Warnings

Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or intestines. Use only the smallest amount of medication needed to get relief from your pain, swelling, or fever.

Before taking this medicine

Advil can increase your risk of fatal heart attack or stroke, even if you don’t have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Advil may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use Advil if you are allergic to ibuprofen, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• liver or kidney disease;
• asthma; or
• if you take aspirin to prevent heart attack or stroke.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

If you are pregnant, you should not take ibuprofen unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Do not give Advil to a child younger than 2 years old without the advice of a doctor.

How should I take Advil?

Use Advil exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that is effective in treating your condition.

An ibuprofen overdose can damage your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses).

A child’s dose of ibuprofen is based on the age and weight of the child. Carefully follow the dosing instructions provided with Junior Strength Advil for the age and weight of your child. Ask a doctor or pharmacist if you have questions.

Take Advil with food or milk to lessen stomach upset.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You must chew the chewable tablet before you swallow it.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?

Since Advil is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What to avoid

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ibuprofen (such as aspirin, ketoprofen, or naproxen).

Avoid taking aspirin unless your doctor tells you to.

If you also take aspirin to prevent stroke or heart attack, taking ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you take both medicines, take ibuprofen at least 8 hours before or 30 minutes after you take aspirin (non-enteric coated form).

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Advil side effects

Get emergency medical help if you have signs of an allergic reaction to Advil (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using Advil and call your doctor at once if you have:

• changes in your vision;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• a skin rash, no matter how mild;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia) – pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common Advil side effects may include:

• nausea, vomiting, gas;
• bleeding; or
• dizziness, headache.

What is acetazolamide?

Acetazolamide reduces the activity of a protein in your body called carbonic anhydrase. Blocking this protein can help reduce the build-up of certain fluids in the body.

Acetazolamide is used in people with certain types of glaucoma to reduce the amount of fluid in the eye, which decreases pressure inside the eye.

Acetazolamide is also used as a diuretic (“water pill”) in people with congestive heart failure, to reduce the build-up of fluid in the body. This build-up is called edema.

Acetazolamide is also used to treat certain types of seizures, and to treat or prevent altitude sickness.

Acetazolamide may also be used for purposes not listed in this medication guide.

Acetazolamide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Acetazolamide may cause serious side effects. Call your doctor at once if you have:

• blood in urine or stools;
• a seizure (convulsions);
• loss of movement in any part of your body;
• a blood cell disorder–sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, pale skin, feeling tired or short of breath, rapid heart rate, nosebleeds, bleeding gums;
• liver problems–nausea, upper stomach pain or swelling, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of metabolic acidosis–confusion, vomiting, lack of energy, irregular heartbeats;
• signs of a kidney stone–pain in your side or lower back, blood in your urine, painful or difficult urination; or
• severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of acetazolamide may include:

• nausea, vomiting, loss of appetite, diarrhea;
• numbness or tingling, especially in your arms and legs;
• drowsiness, confusion;
• hearing problems, ringing in your ears;
• increased urination; or
• altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use acetazolamide if you have cirrhosis, severe liver or kidney disease, an electrolyte imbalance, adrenal gland failure, or an allergy to acetazolamide or sulfa drugs.

Before taking this medicine

You should not use acetazolamide if you are allergic to it, or if you have:

• severe liver disease, or cirrhosis;
• severe kidney disease;
• an electrolyte imbalance (such as acidosis or low levels of potassium or sodium in your blood);
• adrenal gland failure; or
• an allergy to sulfa drugs.

To make sure acetazolamide is safe for you, tell your doctor if you have:

• severe breathing problems;
• angle closure glaucoma; or
• if you also take aspirin in high doses.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Acetazolamide can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Acetazolamide is not approved for use by anyone younger than 18 years old.

How should I take acetazolamide?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use acetazolamide in larger or smaller amounts or for longer than recommended.

Your dose of this medicine will depend on the condition you are treating. If you take acetazolamide for congestive heart failure, your doctor may tell you to skip your medication for a day. Follow your doctor’s dosing instructions very carefully.

Take this medicine with a full glass of water.

While using acetazolamide, you may need frequent blood tests.

Acetazolamide may be only part of a complete treatment program that may also include other medications. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking acetazolamide?

acetazolamide may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid exposure to sunlight or tanning beds. Acetazolamide can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What is Atarax?

Atarax reduces activity in the central nervous system. It also acts as an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing and runny nose, or hives on the skin.

Atarax is used as a sedative to treat anxiety and tension. It is also used together with other medications given for anesthesia.

Atarax is also used to treat allergic skin reactions such as hives or contact dermatitis.

Atarax may also be used for purposes not listed in this medication guide.

Warnings

You should not use Atarax if you are allergic to hydroxyzine, or if you are pregnant.

Before you take Atarax, tell your doctor if you have a seizure disorder, liver disease, or kidney disease.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Stop using Atarax and call your doctor at once if you have a serious side effect such as tremors, confusion, seizures, or restless muscle movements in your eyes, tongue, jaw, or neck.

Drinking alcohol can increase certain side effects of hydroxyzine.

Before taking this medicine

You should not use Atarax if you are allergic to hydroxyzine, or if you are pregnant.

To make sure you can safely take Atarax, tell your doctor if you have any of these other conditions:

• epilepsy or other seizure disorder;
• asthma, emphysema, or other breathing problem;
• glaucoma;
• heart disease or high blood pressure;
• stomach ulcer, blockage in your stomach or intestines;
• thyroid disorder;
• enlarged prostate or problems with urination;
• liver disease; or
• kidney disease.

Do not use Atarax without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether hydroxyzine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medication.

How should I take Atarax?

Take Atarax exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Measure Atarax syrup with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include extreme drowsiness, nausea, vomiting, feeling like you might pass out.

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of Atarax.

Atarax side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Atarax: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Atarax and call your doctor at once if you have a serious side effect such as:

• restless muscle movements in your eyes, tongue, jaw, or neck;
• tremor (uncontrolled shaking);
• confusion; or
• seizure (convulsions).

Less serious Atarax side effects may include:

• dizziness, drowsiness;
• blurred vision, dry mouth; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Atarax?

Before using Atarax, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Atarax.

This list is not complete and other drugs may interact with hydroxyzine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What is Aromasin?

Aromasin ) lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Aromasin is used to treat early and advanced breast cancer in postmenopausal women. Early breast cancer is cancer that has not spread outside the breast. Advanced breast cancer is cancer that has spread to other parts of the body.

Aromasin is sometimes given after you have taken tamoxifen for 2 or 3 years, or if tamoxifen did not work or has stopped working.

Warnings

You should not use Aromasin if you are allergic to exemestane, if you have not started menopause, or if you are pregnant or able to become pregnant.

Do not use Aromasin if you are pregnant. It could harm the unborn baby.

Before using this medicine, tell your doctor if you have liver or kidney disease, or if you have not yet completed menopause and are still having menstrual periods.

Use Aromasin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep taking take this medicine for up to 5 years. Follow your doctor’s instructions. This medicine may not work as well if you take it together with hormone replacement medication.

Before taking this medicine

You should not use Aromasin if you are allergic to exemestane, or if:

• you are pregnant or able to become pregnant; or
• you have not yet completed menopause, and are still having menstrual periods.

Some drugs should not be used together with Aromasin. Your doctor may change your treatment plan if you also use medicines that contain estrogen, such as:

• birth control pills, patches, injections, or implants; or
• hormone replacement therapy.

To make sure Aromasin is safe for you, tell your doctor if you have ever had:

• liver or kidney disease; or
• if you are still having menstrual periods.

Exemestane can decrease bone mineral density, which may increase your risk of developing osteoporosis. Talk to your doctor about your individual risk of bone loss.

This medicine is for use only in women who can no longer get pregnant. Exemestane can harm an unborn baby. Do not take this medicine if you are pregnant or may become pregnant. You may need to have a negative pregnancy test before starting this treatment.

If you are not past menopause, use effective birth control to prevent pregnancy while you are taking Aromasin and for at least 1 month after your last dose. Tell your doctor right away if you become pregnant.

This medicine may affect fertility (your ability to have children). However, if you are not past menopause you should still use birth control to prevent pregnancy because exemestane can harm an unborn baby.

You should not breastfeed while using this medicine and for 1 month after your last dose.

How should I take Aromasin?

Take Aromasin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Aromasin is usually taken once per day, after a meal. Try to take the medicine at the same time each day.

You will need frequent medical tests.

Your doctor may have you take extra vitamin D while you are taking Aromasin. Take only the amount of vitamin D that your doctor has prescribed.

Use Aromasin regularly to get the most benefit. You may need to keep taking take this medication for up to 5 years.

Store in the original container at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Breast Cancer:

25 mg orally once a day

Comment:
-This drug should be administered after a meal.

Uses:
-Adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy.
-Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Aromasin side effects

Get emergency medical help if you have signs of an allergic reaction to Aromasin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain or pressure;
• new or unusual bone pain;
• swelling in your hands or feet;
• feeling short of breath, even with mild exertion; or
• signs of a blood clot – sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common Aromasin side effects may include:

• hot flashes;
• headache, feeling tired;
• joint pain;
• nausea;
• increased appetite;
• sleep problems (insomnia); or
• increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Aromasin?

When you start or stop taking Aromasin, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs may interact with exemestane, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. 

What is Arimidex?

Arimidex lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Arimidex is used to treat breast cancer in postmenopausal women.

Arimidex is often given to women whose cancer has progressed even after taking tamoxifen (Nolvadex, Soltamox).

Warnings

Arimidex may decrease blood flow to your heart, especially if you have ever had coronary artery disease (clogged arteries). Seek medical attention if you have new or worsening chest pain, or if you feel short of breath.

Do not use anastrozole if you are pregnant. It could harm the unborn baby.

Arimidex may not work as well if you take it together with estrogen medication (such as hormone replacement therapy, estrogen creams, or birth control pills, injections, implants, skin patches, and vaginal rings).

Arimidex may increase your risk of a stroke or blood clot. Call your doctor at once if you have sudden numbness or weakness, (especially on one side of the body), sudden severe headache, slurred speech, or problems with vision or balance.

Before taking this medicine

You should not use Arimidex if you are allergic to anastrozole, or if you have not yet completed menopause.

Arimidex is not approved for use in men or children.

You should not take anastrozole if you also take tamoxifen.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart problems;
• coronary artery disease (clogged artery disease);
• high cholesterol; or
• osteoporosis or low bone mineral density.

Hormonal cancer treatment can weaken your bones. You may be more likely to have a broken bone while using Arimidex. Talk with your doctor about ways to keep your bones healthy.

Although it is not likely that a postmenopausal woman would be pregnant, anastrozole may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control if you are not past menopause. Keep using birth control for at least 3 weeks after your last dose of Arimidex. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

How should I take Arimidex?

Take Arimidex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Arimidex is usually taken once per day. Follow your doctor’s dosing instructions very carefully.

You may take Arimidex with or without food.

You may need to keep taking this medication for up to 5 years. Follow your doctor’s instructions.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Breast Cancer:

Initial dose: 1 mg orally taken once a day
Duration of therapy: Until tumor progression (treatment of advanced breast cancer); unknown (adjuvant treatment of early breast cancer)

Uses:
-Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer;
-First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer;
-Second-line treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Arimidex side effects

Get emergency medical help if you have signs of an allergic reaction to Arimidex (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Anastrozole may decrease blood flow to your heart, especially if you have ever had coronary artery disease (clogged arteries). Seek medical attention if you have new or worsening chest pain, or if you feel short of breath.

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• numbness, prickly feeling, pain, or weakness in your hands or wrists;
• symptoms of bone fracture – bruising, swelling, tenderness, pain that worsens with movement;
• liver problems – right-sided upper stomach pain, yellowing of your skin or eyes, and not feeling well; or
• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common Arimidex side effects may include:

• numbness, tingling, or tickling feeling in your skin;
• hot flashes;
• weakness;
• joint pain or stiffness;
• bone pain, risk of fracture;
• swelling in your arms, legs, or feet;
• sore throat, cough, shortness of breath;
• headache, back pain;
• depression, sleep problems (insomnia);
• high blood pressure;
• nausea, vomiting; or
• rash.

What is Aptiom?

Aptiom is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and pain.

Aptiom is used alone or with other medications to treat partial-onset seizures in adults and children who are at least 4 years old.

Aptiom may also be used for purposes not listed in this medication guide.

Warnings

Do not stop using Aptiom suddenly.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using Aptiom.

Call your doctor right away if you have symptoms of low sodium levels in your body such as nausea, confusion, severe weakness, muscle pain, or increased seizures.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before taking this medicine

You should not use Aptiom if you are allergic to eslicarbazepine or oxcarbazepine.

To make sure Aptiom is safe for you, tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• a blood cell disorder; or
• mood problems or suicidal thoughts.

Some people have thoughts about suicide while taking an anticonvulsant. Your doctor will need to check your progress at regular visits while you are taking Aptiom. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking Aptiom during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking Aptiom for seizures.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of eslicarbazepine on the baby.

Aptiom can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Aptiom.

Eslicarbazepine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Aptiom not approved for use by anyone younger than 18 years old.

How should I take Aptiom?

Aptiom is usually given once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Aptiom with or without food. The Aptiom tablet may be crushed or swallowed whole.

Do not stop using Aptiom suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Get your prescription refilled before you run out of medicine completely.

Eslicarbazepine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Aptiom.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of Aptiom for Epilepsy:

Monotherapy and Adjunctive Therapy:
-Initial dose: 400 mg orally once a day; some patients may be initiated at 800 mg orally once a day if the need for seizure reduction outweighs an increased risk of adverse reactions
-Dose titration: Increase dosage by 400 to 600 mg weekly, based on response and tolerability
-Maintenance dose: 800 to 1600 mg orally once a day; for patients on monotherapy, the 800 mg once daily maintenance dose should be considered in patients who are unable to tolerate a 1200 mg daily dose; for patients on adjunctive therapy, the 1600 mg daily dose should be considered in patients who did not achieve a satisfactory response with a 1200 mg daily dose

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures as monotherapy or adjunctive therapy

Usual Adult Dose of Aptiom for Seizures:

Monotherapy and Adjunctive Therapy:
-Initial dose: 400 mg orally once a day; some patients may be initiated at 800 mg orally once a day if the need for seizure reduction outweighs an increased risk of adverse reactions
-Dose titration: Increase dosage by 400 to 600 mg weekly, based on response and tolerability
-Maintenance dose: 800 to 1600 mg orally once a day; for patients on monotherapy, the 800 mg once daily maintenance dose should be considered in patients who are unable to tolerate a 1200 mg daily dose; for patients on adjunctive therapy, the 1600 mg daily dose should be considered in patients who did not achieve a satisfactory response with a 1200 mg daily dose

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures as monotherapy or adjunctive therapy

Usual Pediatric Dose of Aptiom for Epilepsy:

4 to less than 18 years:
Monotherapy and Adjunctive Therapy:
11 to 21 kg:
-Initial dose: 200 mg orally once a day; increase once a week in increments of no more than 200 mg, based on tolerability and response
-Maintenance dose: 400 to 600 mg orally once a day
-Maximum dose: 600 mg orally once a day
22 to 31 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 500 to 800 mg orally once a day
-Maximum dose: 800 mg orally once a day
32 to 38 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 600 to 900 mg orally once a day
-Maximum dose: 900 mg orally once a day
Greater than 38 kg:
-Initial dose: 400 mg orally once a day; increase once a week in increments of no more than 400 mg, based on tolerability and response
-Maintenance dose: 800 to 1200 mg orally once a day
-Maximum dose: 1200 mg orally once a day

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures in patients 4 years of age and older

Usual Pediatric Dose of Aptiom for Seizures:

4 to less than 18 years:
Monotherapy and Adjunctive Therapy:
11 to 21 kg:
-Initial dose: 200 mg orally once a day; increase once a week in increments of no more than 200 mg, based on tolerability and response
-Maintenance dose: 400 to 600 mg orally once a day
-Maximum dose: 600 mg orally once a day
22 to 31 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 500 to 800 mg orally once a day
-Maximum dose: 800 mg orally once a day
32 to 38 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 600 to 900 mg orally once a day
-Maximum dose: 900 mg orally once a day
Greater than 38 kg:
-Initial dose: 400 mg orally once a day; increase once a week in increments of no more than 400 mg, based on tolerability and response
-Maintenance dose: 800 to 1200 mg orally once a day
-Maximum dose: 1200 mg orally once a day

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures in patients 4 years of age and older

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What to avoid

Aptiom may impair your thinking or reactions. Avoid driving or operating machinery until you know how Aptiom will affect you.

Aptiom side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using eslicarbazepine.

Eslicarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Call your doctor right away if you have nausea, lack of energy, confusion, feeling tired or irritable, severe weakness, muscle pain, or increased seizures.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Also call your doctor at once if you have:

• severe dizziness or drowsiness, vision changes, thinking problems, trouble with walking or coordination;
• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores; or
• liver problems – nausea, loss of appetite, upper stomach pain, dark urine, jaundice (yellowing of the skin or eyes).

Common Aptiom side effects may include:

• dizziness, drowsiness, headache;
• feeling tired;
• nausea, vomiting;
• coordination problems, feeling shaky; or
• double vision.

What is apixaban?

Apixaban is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation.

Apixaban is also used after hip or knee replacement surgery to prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism).

Apixaban is also used to treat DVT or pulmonary embolism (PE), and to lower your risk of having a repeat DVT or PE.

Apixaban may also be used for purposes not listed in this medication guide.

Apixaban side effects

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, wheezing, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot such as tingling, numbness, or muscle weakness especially in your legs and feet.

Apixaban may cause serious side effects. Call your doctor at once if you have:

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;
• heavy menstrual bleeding;
• headache, dizziness, weakness, feeling like you might pass out;
• urine that looks red, pink, or brown; or
• black or bloody stools, coughing up blood or vomit that looks like coffee grounds.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Apixaban increases your risk of severe or fatal bleeding, especially if you take certain medicines at the same time (including some over-the-counter medicines). Tell your doctor about all medicines you have recently used.

Call your doctor at once if you have signs of bleeding such as: easy bruising, unusual bleeding, unexpected pain or swelling, feeling very weak or dizzy, bleeding gums, nosebleeds, heavy menstrual bleeding, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds, or any bleeding that will not stop.

Apixaban can cause a very serious blood clot around your spinal cord that can lead to long-term or permanent paralysis. This type of blood clot can occur during a spinal tap or spinal anesthesia (epidural), especially if you have a genetic spinal defect, if you use a spinal catheter, if you’ve had spinal surgery or repeated spinal taps, or if you use other drugs that can affect blood clotting.

Get emergency medical help if you have symptoms of a spinal cord blood clot such as tingling, numbness, or muscle weakness especially in your legs and feet.

Do not stop taking apixaban unless your doctor tells you to. Stopping suddenly can increase your risk of blood clot or stroke.

Before taking this medicine

You should not take apixaban if you are allergic to it, or if you have active bleeding from a surgery, injury, or other cause.

Apixaban may cause you to bleed more easily, especially if you have a bleeding disorder that is inherited or caused by disease.

Tell your doctor if you have an artificial heart valve, or if you have ever had:

• bleeding problems;
• antiphospholipid syndrome, especially if you have a triple positive antibody test; or
• liver or kidney disease.

Apixaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:

• you have a spinal catheter in place or if a catheter has been recently removed;
• you have a history of spinal surgery or repeated spinal taps;
• you have recently had a spinal tap or epidural anesthesia;
• you take aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs)–ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or
• you are using other medicines to treat or prevent blood clots.

Taking apixaban may increase the risk of bleeding while you are pregnant or during your delivery. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

How should I take apixaban?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take apixaban with or without food.

If you cannot swallow a tablet whole, crush it and mix with water, apple juice, or applesauce. Swallow the mixture right away without chewing.

A crushed tablet mixture may also be given through a nasogastric (NG) feeding tube. Read and carefully follow any Instructions for Use provided with your medicine.

Apixaban can make it easier for you to bleed, even from a minor injury. Seek medical attention if you have bleeding that will not stop.

Tell your doctor if you have a planned surgery or dental work. You may need to stop taking apixaban for a short time.

Do not stop taking apixaban unless your doctor tells you to.

If you stop taking apixaban for any reason, your doctor may prescribe another medicine to prevent blood clots.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your twice-daily schedule. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What should I avoid while taking apixaban?

Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

What other drugs will affect apixaban?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many other drugs (including some over-the-counter medicines) can increase your risk of bleeding or blood clots. Tell your doctor about all medicines you have recently used, especially:

• any other medicines to treat or prevent blood clots;
• a blood thinner such as heparin or warfarin (Coumadin, Jantoven);
• an antidepressant; or
• aspirin or other NSAID (nonsteroidal anti-inflammatory drug) used long term.

What is AndroGel?

AndroGel contains testosterone, a naturally occurring male hormone necessary for many processes in the body. It works by replacing or supplementing the testosterone that is naturally made in the body.

AndroGel is used to treat conditions in men that result from a lack of natural testosterone.

AndroGel will not enhance athletic performance and should not be used for this purpose.

Warnings

You should not use AndroGel if you have prostate cancer, male breast cancer, are pregnant, or are breastfeeding.

Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with this medicine, or with a man’s skin where the medicine has been applied.

Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with this medicine. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Misuse of AndroGel can cause dangerous or irreversible effects. Never use more than your prescribed dose. Do not share this medicine with another person.

Before taking this medicine

You should not use AndroGel if you are allergic to testosterone patches or gels, or if you have;

• prostate cancer; or
• male breast cancer.

To make sure AndroGel is safe for you, tell your doctor if you have ever had:

• cancer;
• enlarged prostate, urination problems;
• sleep apnea (breathing stops during sleep);
• high blood pressure, heart disease, heart attack, or stroke;
• a blood clot;
• diabetes; or
• liver disease or kidney disease.

Older men who use AndroGel may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk.

AndroGel should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone gel, or with a man’s skin areas where the gel has been applied. If contact does occur, wash with soap and water right away.

Do not use AndroGel on anyone younger than 18 years old.

How should I use AndroGel?

Use AndroGel exactly as it was prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than prescribed.

Misuse of AndroGel can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Do not share this medicine with another person.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Apply AndroGel only to your shoulders, upper arms, and/or abdomen that will be covered by a short sleeve t-shirt. Wash your hands with soap and water before and after applying the gel. Keep the area covered until you have washed the application area well or have showered. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.

Do not apply AndroGel to your penis or scrotum.

Apply AndroGel to dry skin after showering or bathing. Allow the medicine to dry for at least 5 minutes before you dress. Avoid showering, swimming or bathing for at least 2 hours after you application.

AndroGel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Cover treated skin areas with clothing to keep from getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.

While using AndroGel, you may need frequent blood tests.

Use AndroGel regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the gel as soon as you remember. Skip the missed dose if it is almost time to apply your next dose. Do not use extra gel to make up the missed dose.

What should I avoid while using AndroGel?

Do not apply this medicine to your penis or your scrotum.

Avoid swimming, bathing, or showering for at least 5 hours after applying AndroFel.

AndroGel side effects

Get emergency medical help if you have any signs of an allergic reaction to AndroGel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using AndroGel and call your doctor at once if you have:

• increased urination (many times per day), loss of bladder control;
• painful or difficult urination;
• breast pain or swelling;
• painful or bothersome erections;
• swelling, rapid weight gain, shortness of breath during sleep;
• chest pain or pressure, pain spreading to your jaw or shoulder;
• liver problems – nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of a blood clot in the lung – chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg – pain, swelling, warmth, or redness in one or both legs.

Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.

Common AndroGel side effects may include:

• redness, itching, burning, hardened skin or other irritation where the medicine was applied or where the skin patch was worn;
• increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);
• increased prostate-specific antigen;
• increased blood pressure;
• headache;
• mood changes, strange dreams;
• frequent or prolonged erections;
• nausea, vomiting; or
• swelling in your lower legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect AndroGel?

Tell your doctor about all your current medicines and any you start or stop using during your treatment with AndroGel, especially:

• insulin;
• a blood thinner; (warfarin, Coumadin, Jantoven); or
• a steroid medicine; methylprednisolone (Medrol), prednisone (Sterapred), and others.

This list is not complete. Other drugs may interact with testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is amoxicillin and clavulanate potassium?

Amoxicillin and clavulanate potassium is a combination prescription antibiotic. Amoxicillin is a penicillin antibiotic that fights bacteria in the body. Clavulanate potassium is a beta-lactamase inhibitor that helps prevent certain bacteria from becoming resistant to amoxicillin.

Amoxicillin and clavulanate potassium is used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.

Warnings

You should not use amoxicillin and clavulanate potassium if you have severe kidney disease, if you have had liver problems or jaundice while taking this medicine previously, or if you are allergic to any penicillin or cephalosporin antibiotic, such as Amoxil, Ceftin, Cefzil, Levaquin, Moxatag, Omnicef, and others.

If you switch from one tablet form to another (regular, chewable, or extended-release tablet), take only the new tablet form and strength prescribed for you. Amoxicillin and clavulanate may not be as effective or could be harmful if you do not use the exact tablet form your doctor has prescribed.

Amoxicillin and clavulanate potassium can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Amoxicillin and clavulanate potassium can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking this medicine.

Before taking this medicine

You should not use this medicine if you are allergic to amoxicillin and clavulanate, or if:

• you have severe kidney disease (or if you are on dialysis);
• you have had liver problems or jaundice while taking amoxicillin and clavulanate potassium; or
• you are allergic to any penicillin or cephalosporin antibiotic, such as Amoxil, Ceftin, Cefzil, Moxatag, Omnicef, and others. Discuss your personal risk with your prescriber.

To make sure this medicine is safe for you, tell your doctor if you have:

• liver disease (hepatitis or jaundice);
• kidney disease; or
• mononucleosis.

The liquid or chewable tablet may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Tell your doctor if you are pregnant or breastfeeding.

Amoxicillin and clavulanate potassium can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy.

Do not give this medicine to a child without medical advice.

How should I take amoxicillin and clavulanate potassium?

Take amoxicillin and clavulanate exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Amoxicillin and clavulanate potassium may work best if you take it at the start of a meal.

Take the medicine every 12 hours.

Do not crush or chew the extended-release tablet. Swallow the pill whole, or break the pill in half and take both halves one at a time. Tell your doctor if you have trouble swallowing a whole or half pill.

You must chew the chewable tablet before you swallow it.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

amoxicillin and clavulanate potassium can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Amoxicillin and clavulanate potassium will not treat a viral infection such as the flu or a common cold.

Store the tablets at room temperature away from moisture and heat.

Store the liquid in the refrigerator. Throw away any unused liquid after 10 days.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose can cause nausea, vomiting, stomach pain, diarrhea, skin rash, drowsiness, hyperactivity, and decreased urination.

What to avoid

Avoid taking amoxicillin and clavulanate potassium together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Amoxicillin and clavulanate potassium side effects

Get emergency medical help if you have signs of an allergic reaction to amoxicillin and clavulanate (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• pale or yellowed skin, dark colored urine, fever, confusion or weakness;
• loss of appetite, upper stomach pain;
• little or no urination; or
• easy bruising or bleeding.

Common amoxicillin and clavulanate side effects may include:

• nausea, vomiting; diarrhea;
• rash, itching;
• vaginal itching or discharge; or
• diaper rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect amoxicillin and clavulanate potassium?

Tell your doctor about all your other medicines, especially:

• allopurinol;
• probenecid; or
• a blood thinner – warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may interact with amoxicillin and clavulanate potassium, including prescription and over-the-counter medicines, vitamins, and herbal products.

What is amitriptyline?

Amitriptyline is a tricyclic antidepressant used to treat symptoms of depression (FDA approved), and amitriptyline is used off-label for insomnia, migraine prevention, ADHD, eating disorders, bipolar disorder, anxiety, psychotic disorders, and some types of pain. Amitriptyline may work by increasing chemical messengers (neurotransmitters) serotonin and norepinephrine that communicate between brain cells and help regulate mood.

The first amitriptyline brand was Elavil, which was FDA-approved on April 7, 1961, and has since been discontinued. Other amitriptyline brand names include Vanatrip and Endep, which have also been discontinued. Amitriptyline is now available as a generic medication. Amitriptyline is from the drug class tricyclic antidepressants (TCA).

Amitriptyline is available in combination with chlordiazepoxide for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. Amitriptyline, in combination with perphenazine, is FDA-approved for types of severe anxiety and/or agitation.

Amitriptyline side effects

Common amitriptyline side effects

Common amitriptyline side effects may include dry mouth, vision changes, sleepiness (sedation), tiredness, appetite or weight changes, constipation, diarrhea, nausea, vomiting, upset stomach, mouth pain, unusual taste, black tongue, urinating less than usual, breast swelling (in men or women), lower sex drive, impotence, or difficulty having an orgasm.

Serious amitriptyline side effects

Allergic reactions: Get emergency medical help if you have signs of an allergic reaction to amitriptyline, including difficulty breathing, hives, or swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• signs of a blood clot – sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg;
• unusual thoughts or behavior;
• a light-headed feeling, like you might pass out;
• chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• pounding heartbeats or fluttering in your chest;
• confusion, hallucinations;
• a seizure (convulsions);
• painful or difficult urination;
• severe constipation;
• easy bruising, unusual bleeding, or
• fever, chills, sore throat, mouth sores.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Warnings

You should not use amitriptyline if you have recently had a heart attack.

Do not use amitriptyline if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

You may have thoughts about suicide when you first start taking an antidepressant such as amitriptyline, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Amitriptyline may trigger an angle closure glaucoma attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Before taking this medicine

You should not use this medicine if you are allergic to amitriptyline or any of the inactive ingredients or:

• if you have recently had a heart attack.

Do not use amitriptyline if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have used an “SSRI” antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.

To make sure amitriptyline is safe for you, tell your doctor if you have ever had:

• bipolar disorder (manic-depression) or schizophrenia;
• mental illness or psychosis;
• liver disease;
• heart disease;
• a heart attack, stroke, or seizures;
• diabetes (amitriptyline may raise or lower blood sugar);
• glaucoma; or
• problems with urination.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

What is Ambien?

Ambien is a sedative, also called a hypnotic. Ambien (zolpidem) affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).

Ambien is used to treat insomnia. The immediate-release tablet is used to help you fall asleep when you first go to bed. The extended-release form, Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

Your doctor will determine which form of Ambien is best for you.

Warnings

Ambien may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Do not share Ambien with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Ambien may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.

Never take Ambien in larger amounts or for longer than prescribed.

Do not take zolpidem if you have consumed alcohol during the day or just before bed.

Before taking this medicine

Some people using Ambien have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking this medicine and talk with your doctor about another treatment for your sleep disorder.

You should not use Ambien if you are allergic to zolpidem. The tablets may contain lactose. Use caution if you are sensitive to lactose.

Ambien is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• depression, mental illness, or suicidal thoughts;
• drug or alcohol addiction;
• lung disease or breathing problems;
• sleep apnea (breathing stops during sleep); or
• liver or kidney disease.

Taking Ambien in the last 3 months of pregnancy may cause drowsiness or breathing problems in your newborn.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

How should I take Ambien?

Take Ambien exactly as prescribed by your doctor. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed.

The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Zolpidem may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of Ambien are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Never take this medicine if you do not have a full 7 to 8 hours to sleep before being active again.

Ambien is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take this medicine for longer than 4 or 5 weeks without your doctor’s advice.

Do not stop using Ambien suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.

Insomnia symptoms may also return after you stop taking Ambien, and may be even worse than before. Call your doctor if you still have worsened insomnia for the first few nights after you stop taking this medicine.

Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since Ambien is taken only at bedtime if needed, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of zolpidem can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What to avoid

Avoid taking Ambien during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Ambien.

Avoid driving or hazardous activity until you know how zolpidem will affect you. You may still feel sleepy the morning after taking Ambien, and your reactions could be impaired. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Ambien side effects

Zolpidem may cause a severe allergic reaction. Stop taking Ambien and get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using this medicine and call your doctor at once if you have:

• chest pain, fast or irregular heartbeat, feeling short of breath;
• trouble breathing or swallowing; or
• feeling like you might pass out.

The sedative effect of Ambien may be stronger in older adults.

Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Common Ambien side effects may include:

• daytime drowsiness, dizziness, weakness, feeling “drugged” or light-headed;
• tired feeling, loss of coordination;
• stuffy nose, dry mouth, nose or throat irritation;
• nausea, constipation, diarrhea, upset stomach; or
• headache, muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ambien?

Using Ambien with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is Alunbrig?

Alunbrig is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Alunbrig is used to treat non-small cell lung cancer that has spread to other parts of the body (metastatic).

Alunbrig is used only if your cancer has a specific genetic marker (an abnormal “ALK” gene). Your doctor will test you for this gene.

Warnings

Alunbrig can cause serious side effects such as lung problems, vision problems, high blood pressure, high blood sugar, very slow heartbeats, muscle damage, or pancreatitis.

Call your doctor at once if you have side effects, such as: severe headache, confusion, feeling light-headed, blurred vision, seeing flashes of light or “floaters” in your vision, increased thirst or urination, hunger, nausea, upper stomach pain spreading to your back, unexplained muscle pain or weakness, fever, cough, chest pain, trouble breathing, very slow heartbeats, or feeling like you might pass out.

Before taking this medicine

You should not use Alunbrig if you are allergic to brigatinib.

To make sure Alunbrig is safe for you, tell your doctor if you have ever had:

• lung disease or breathing problems;
• slow heartbeats;
• high blood pressure;
• vision problems;
• diabetes or glucose intolerance;
• pancreas problems;
• liver disease; or
• kidney disease (or if you are on dialysis).

You may need to have a negative pregnancy test before starting this treatment.

Brigatinib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use this medicine if you are pregnant. Alunbrig can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Alunbrig, use an effective non-hormonal form of birth control such as an intrauterine device (IUD). Avoid getting pregnant for at least 4 months after your last dose.
• If you are a man, use condoms or other barrier birth control if your sex partner is able to get pregnant. Keep using condoms for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using brigatinib.

Alunbrig may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because brigatinib can harm an unborn baby.

You should not breastfeed while using this medicine, and for at least 1 week after your last dose.

How should I take Alunbrig?

Take Alunbrig exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Alunbrig is usually taken once per day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking Alunbrig, do not take another dose. Stay on your regular schedule.

Your blood pressure will need to be checked often.

You should not stop using this medicine unless your doctor tells you to.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

-Initial Dose: 90 mg orally once a day for the first 7 days
-Maintenance Dose: If initial dose is tolerated during the first 7 days, increase to 180 mg orally once a day.
-Duration of Therapy: Until disease progression or unacceptable toxicity

Use: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Grapefruit may interact with brigatinib and lead to unwanted side effects. Avoid the use of grapefruit products.

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Alunbrig side effects

Get emergency medical help if you have signs of an allergic reaction to Alunbrig: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• lung problems – cough, trouble breathing, chest pain, fever;
• vision problems – blurred vision, double vision, increased sensitivity to light, seeing flashes of light or “floaters” in your vision;
• high blood pressure – severe headache, pounding in your neck or ears, dizziness;
• high blood sugar – increased thirst, increased urination, hunger, nausea, fruity breath odor, weakness, confusion;
• heart problems – very slow heartbeats, feeling like you might pass out;
• muscle problems – unexplained muscle pain or weakness; or
• pancreatitis – upper stomach pain (worse with eating and may spread to your back), nausea, weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Alunbrig side effects may include:

• nausea, vomiting, diarrhea;
• increased blood pressure;
• trouble breathing;
• cough;
• rash;
• muscle pain;
• headache; or
• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Alunbrig?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with brigatinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.