What is gabapentin?

Gabapentin (Neurontin, Gralise, Horizant) is a medicine used to treat partial seizures, nerve pain from shingles and restless leg syndrome. It works on the chemical messengers in your brain and nerves.  Gabapentin is from a group of medicines called anticonvulsants. 

Different brands of gabapentin are not interchangeable and they are FDA approved for different conditions. Use only the brand and form of gabapentin your doctor has prescribed. Check your medicine each time you get a refill to make sure you receive the correct form. 

Neurontin (gabapentin) is used to treat pain you may have from shingles (postherpetic nerve pain). It is also used with other seizure medicines for partial onset seizures in patients 3 years and older.

Gralise (gabapentin) is only used for pain after having shingles (postherpetic nerve pain). It should not be used for any other medical condition.

Horizant (gabapentin enacarbil) is an extended release tablet used to treat restless legs syndrome and for the pain from having shingles (postherpetic nerve pain).

Generic brands of gabapentin capsules, USP are used for postherpetic nerve pain and for add on therapy for partial onset seizures in patients 3 years and older

Warnings

Gabapentin can cause life-threatening breathing problems, especially if you already have a breathing disorder or if you use other medicines that can make you drowsy or slow your breathing. Seek emergency medical attention if you have very slow breathing.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Seizures may increase if you stop using gabapentin suddenly. Ask your doctor before stopping the medicine.

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

Do not stop using gabapentin suddenly, even if you feel fine.

Before taking this medicine

You should not take gabapentin if you are allergic to it.

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

• breathing problems;
• diabetes;
• depression, a mood disorder, or suicidal thoughts or actions;
• drink alcohol;
• a history of drug addiction;
• a seizure;
• (patients with RLS) if you are a day sleeper or work a night shift; or
• kidney disease (or if you are on dialysis).

Some people have thoughts about suicide while taking seizure medicine. Children taking gabapentin may have behavior changes. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

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

Do not start or stop seizure medication during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor if you become pregnant.

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

Ask a doctor if it is safe to breastfeed while using gabapentin.

How should I take gabapentin?

Take gabapentin 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.

Never take gabapentin in larger amounts, or for longer than prescribed.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

Both Gralise and Horizant should be taken with food.

Neurontin can be taken with or without food.

If you break a tablet and take only half of it, take the other half at your next dose. Any tablet that has been broken should be used as soon as possible or within a few days.

Swallow the tablets of Gralise and Horizant whole. Do not crush, break, or dissolve them. Swallow the capsule whole and do not crush, chew, break, or open the capsule.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Doses are based on weight in children. Your child’s dose may change if the child gains or loses weight.

You should not stop taking gabapentin suddenly. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

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

Your kidney function may need to be checked often and your dose may change based on the results.

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

Store the liquid medicine in the refrigerator, do not freeze.

Follow all storage instructions provided. Your pharmacist can provide more information about how to store this medicine.

Dosing information

Usual Adult Dose for Epilepsy:

Initial dose: 300 mg orally on day one, 300 mg orally 2 times day on day two, then 300 mg orally 3 times a day on day three
Maintenance dose: 300 to 600 mg orally 3 times a day
Maximum dose: 3600 mg orally daily (in 3 divided doses)
-Maximum time between doses in the 3 times a day schedule should not exceed 12 hours

-The safety and effectiveness of gabapentin available under the trade name Gralise or Horizant in patients with epilepsy has not been studied.

Use: Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization

Usual Adult Dose for Postherpetic Neuralgia:

-Initial dose: 300 mg orally on day one, 300 mg orally 2 times day on day two, then 300 mg orally 3 times a day on day three
-Titrate up as needed for pain relief
-Maximum dose: 1800 mg per day (600 mg orally 3 times a day)
Gabapentin available under the trade name Gralise:
-Maintenance dose: Gralise should be titrated to 1800 mg orally once daily with the evening meal.
-Recommended titration schedule:
Day 1: 300 mg orally with the evening meal
Day 2: 600 mg orally with the evening meal
Days 3 through 6: 900 mg orally with the evening meal
Days 7 through 10: 1200 mg orally with the evening meal
Days 11 through 14: 1500 mg orally with the evening meal
Day 15: 1800 mg orally with the evening meal
COMMENT:
-Gralise is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

Gabapentin enacarbil extended release tablets are available under the trade name Horizant:
-The recommended dosage is 600 mg orally 2 times a day. Therapy should be initiated at a dose of 600 mg orally in the morning for 3 days of therapy, then increased to 600 mg 2 times a day (1200 mg/day) on day four.
COMMENT:
Gabapentin enacarbil extended release tablets available under the trade name Horizant and gabapentin are not interchangeable.

Use: Postherpetic neuralgia

Usual Adult Dose for Restless Legs Syndrome:

Gabapentin enacarbil available under the trade name Horizant:
600 mg orally once daily with food at about 5 PM

Use: For the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults

Usual Pediatric Dose for Epilepsy:

Less than 3 years: Not recommended

Greater than or equal to 3 and less than 12 years:
Starting Dose: Ranges from 10 to 15 mg/kg/day in 3 divided doses
Effective Dose: Reached by upward titration over a period of approximately 3 days; the effective dose in patients 5 years of age and older is 25 to 35 mg/kg/day in divided doses (3 times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (3 times a day). Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long term clinical study. The maximum time interval between doses should not exceed 12 hours.

Greater than 12 years:
-Initial dose: 300 mg orally on day one, 300 mg orally 2 times a day on day two, then 300 mg orally 3 times a day on day three
-Maintenance dose: 900 to 1800 mg orally in 3 divided doses; the dose may be increased up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the three times a day schedule should not exceed 12 hours.

Use: Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization in patients 3 years of age and older<

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.

If you take Horizant: skip the missed dose and take 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 can be fatal.

Overdose symptoms may include slow breathing, double vision, tremor, slurred speech, drowsiness, change in your mental state, dizziness, tiredness, or diarrhea.

What should I avoid while taking gabapentin?

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

Avoid taking an antacid within 2 hours before you take gabapentin.

Do not drink alcohol. Dangerous side effects could occur.

Gabapentin side effects

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

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.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Gabapentin 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.

Some side effects are more likely in children taking gabapentin. Call your doctor if the child has any of the following side effects: behavior changes, memory problems, trouble concentrating, or acting restless, hostile, or aggressive.

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

• drowsiness, dizziness, weakness;
• problems with balance or muscle movement; or
• increased seizures.

Common gabapentin side effects may include:

• fever, chills, sore throat, body aches, tiredness;
• headache;
• swelling of your legs and feet;
• trouble speaking;
• vision problems, dizziness, drowsiness;
• tremors, problems with balance or muscle movement; or
• nausea, vomiting.

Uses for gabapentin enacarbil

Gabapentin enacarbil is used to treat moderate-to-severe primary Restless Legs Syndrome (RLS). RLS is a neurologic disorder that makes the legs feel uncomfortable. This results in an irresistible feeling of wanting to move your legs to make them comfortable.

Gabapentin enacarbil is also used to manage a condition called postherpetic neuralgia, which is pain that occurs after shingles.

This medicine is available only with your doctor’s prescription.

Before using gabapentin enacarbil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of gabapentin enacarbil in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gabapentin enacarbil in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving gabapentin enacarbil.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acepromazine
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aripiprazole
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Daridorexant
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Droperidol
• Enflurane
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Levocetirizine
• Levorphanol
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Olanzapine
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Quazepam
• Quetiapine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Ropeginterferon Alfa-2b-njft
• Secobarbital
• Sertindole
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Ginkgo
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or
• Lung or breathing problems (eg, respiratory depression) or
• Mental illness, history of—Use with caution. May make these conditions worse.
• Kidney disease (eg, patients receiving dialysis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
• Patients who need to sleep during daytime and remain awake at night—Use is not recommended.

Proper use of gabapentin enacarbil

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release tablet whole. Do not crush, break, or chew it. It should be taken with food.

For patients with restless legs syndrome: Do not use this medicine if you are required to sleep during the daytime and remain awake at night.

Only use the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):
  • For restless legs syndrome:
    • Adults—600 milligrams (mg) as a single dose at about 5 PM. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For postherpetic neuralgia:
    • Adults—At first, 600 milligrams (mg) once a day taken in the morning for 3 days. Then, your doctor will increase your dose to 600 mg two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 1,200 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using gabapentin enacarbil

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Gabapentin enacarbil may cause dizziness, drowsiness, or sleepiness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. If these side effects are especially bothersome, check with your doctor.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous, restless, or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause respiratory depression, a serious breathing problem that can be life-threatening, when used together with narcotic pain medicines. Check with your doctor right away if you have pale or blue lips, fingernails, or skin, difficult or troubled breathing, or irregular, fast or slow, or shallow breathing.

Check with your doctor right away if you have a fever, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, unusual bleeding or bruising, or yellow eyes or skin. These may be symptoms of a serious and life-threatening allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) or multiorgan hypersensitivity.

Do not stop using this medicine without checking with your doctor. Stopping the medicine suddenly may cause seizures. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Do not drink alcohol while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of gabapentin enacarbil

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• rapid weight gain
• tingling of the hands or feet
• tiredness
• trouble concentrating

Incidence not known

• Black, tarry stools
• bloody or cloudy urine
• changes in behavior
• chest pain or discomfort
• chills or fever
• confusion
• difficulty with breathing
• dizziness or lightheadedness
• fainting
• fast heartbeat
• nausea or vomiting
• painful or difficult urination
• rapid, shallow breathing
• rash
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, feet, or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• thoughts of killing oneself
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Lack or loss of strength
• sleepiness or unusual drowsiness

Less common

• Blurred vision
• decreased interest in sexual intercourse
• dry mouth
• excess air or gas in the stomach or intestines
• inability to have or keep an erection
• sensation of spinning
• weight gain

What is galantamine?

Galantamine improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine (ah see til KO leen). People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning.

Galantamine is used to treat mild to moderate Alzheimer’s type dementia.

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

Galantamine side effects

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

Galantamine can cause serious skin reactions. Stop using galantamine and call your doctor at once if you have the first signs of any skin rash, no matter how mild.

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

• chest pain, slow heart rate;
• little or no urinating;
• blood in your urine;
• 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, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• dehydration symptoms–feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
• a light-headed feeling, like you might pass out; 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 galantamine may include:

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 .

• nausea, vomiting, diarrhea, loss of appetite;
• headache, dizziness; or
• weight loss.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

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

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

• urination problems;
• heart disease or a heart rhythm disorder;
• a history of stomach ulcer or bleeding;
• seizures or epilepsy;
• kidney disease;
• liver disease; or
• a history of asthma or chronic obstructive pulmonary disease (COPD).

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

It is not known whether galantamine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

How should I take galantamine?

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 this medicine in larger or smaller amounts or for longer than recommended.

The galantamine extended-release capsule is usually taken once per day in the morning. Follow your doctor’s instructions.

The galantamine short-acting tablet or the oral solution (liquid) are usually given two times per day, with meals. Follow your doctor’s instructions.

The extended-release capsule works best if you take it with food.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

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.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Take galantamine with a full glass of water. Drink 6 to 8 full glasses of water each day to keep from getting dehydrated while taking this medication.

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

If you have stopped taking galantamine for any reason, talk with your doctor before you start taking it again. You may need to restart the medication at a lower dose.

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

Galantamine dosing information

Usual Adult Dose for Alzheimer’s Disease:

Immediate release tablet and oral solution:
Initial dose: 4 mg orally twice a day, preferably with morning and evening meals
-After a minimum of four weeks, increase to 8 mg twice a day, then after an additional 4 weeks, may increase to 12 mg twice a day
Maintenance dose: 16 to 24 mg per day given in 2 divided doses
Maximum dose: 24 mg/day

Extended release capsule:
Initial dose: 8 mg orally once a day, preferably with the morning meal
-After 4 weeks, dose should be increased to 16 mg once a day, a further increase to 24 mg once a day may be considered after a minimum of 4 weeks of taking 16 mg/day
Maintenance dose: 16 to 24 mg orally once a day based on clinical benefit and tolerability
Maximum dose: 24 mg/day

Conversion from Immediate-Release (IR) Tablets or Oral Solution to Extended-Release (ER) Capsules:
-Take the last dose of IR formulation n in the evening prior to starting ER capsule; start ER capsule following morning at once a day dosing
-Converting from IR to ER should occur at the same total daily dosage

Comments:
-During clinical trials, an immediate-release dose of 32 mg per day was found to be less well tolerated and did not increase clinical benefit; dosing at 24 mg/day was not found to provide statistically significant increased clinical benefit from 16 mg/day; however, it might provide additional benefit for some patients.
-Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
-If therapy is interrupted for more than 3 days, the patient should be restarted at the lowest dosage and the dosage escalated to current dose.

Use: For the treatment of mild to moderate dementia of the Alzheimer’s type.

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 severe nausea, vomiting, stomach cramps, muscle weakness or spasm, watery eyes, drooling, increased urination or bowel movements, sweating, slow heart rate, feeling light-headed or fainting, and seizure (convulsions).

What should I avoid while taking galantamine?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect galantamine?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• atropine;
• cold or allergy medicine that contains an antihistamine (Benadryl and others);
• medicine to treat Parkinson’s disease;
• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
• bladder or urinary medicines–darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
• bronchodilators–aclidinium, ipratropium, or tiotropium;

What is garlic?

Garlic is an herb also known as Ail, Ajo, Allii Sativi Bulbus, Allium, Allium sativum, Camphor of the Poor, Da Suan, Lasun, Lasuna, Nectar of the Gods, Poor Man’s Treacle, Rason, Rust Treacle, or Stinking Rose.

Garlic is a commonly used food and flavoring agent. When used as a food product, garlic is not likely to produce health benefits or side effects. When used as a medicinal product, garlic may produce both desired and unwanted effects on the body.

Garlic products sold as health supplements may vary widely in amount of allicin, the active ingredient in garlic. Allicin is unstable and can be reduced in garlic products that are aged to reduce odor. Odorless garlic may contain little to no allicin. The lower the amount of allicin, the less effective a garlic product might be.

Garlic taken orally (by mouth) has been used in alternative medicine as a possibly effective aid in treating high blood pressure, coronary artery disease (hardened arteries), stomach cancer, colon cancer or rectal cancer, and in preventing tick bites. Garlic applied to the skin may also be possibly effective in treating fungal skin infections such as ringworm, jock itch, or athlete’s foot.

Garlic has also been used to treat high cholesterol, stomach ulcers caused by H. pylori, cancer, or circulation problems in the legs. However, research has shown that garlic may not be effective in treating these conditions.

Other uses not proven with research have included preventing the common cold, and improving urination problems caused by an enlarged prostate.

It is not certain whether garlic is effective in treating any medical condition. Medicinal use of this product has not been approved by the FDA. Garlic should not be used in place of medication prescribed for you by your doctor.

Garlic is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Garlic may also be used for purposes not listed in this product guide.

Garlic side effects

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

Although not all side effects are known, garlic is thought to be possibly safe when taken for a short period of time.

Stop using garlic and call your healthcare provider at once if you have:

• redness, swelling, or blistering (when applied to the skin); or
• easy bruising or bleeding (nosebleeds, bleeding gums).

Common side effects (especially when eating raw garlic) may include:

• unpleasant breath or body odor;
• heartburn, burning in your mouth or throat;
• nausea, vomiting, gas or
• diarrhea.

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

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

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

Ask a doctor, pharmacist, or other healthcare provider if it is safe for you to use this product if you have:

• a stomach ulcer;
• problems with digestion; or
• a bleeding or blood clotting disorder such as hemophilia.

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

The use of garlic as a flavoring agent in foods is considered safe during pregnancy.

Do not give any herbal/health supplement to a child without medical advice. Garlic taken by mouth in large doses may be harmful to children.

How should I take garlic?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use garlic, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Do not use different forms (cloves, tablets, oil, etc) of garlic at the same time without medical advice. Using different formulations together increases the risk of an overdose.

Do not crush, chew, or break an enteric coated pill. Swallow it whole. The pill has a special coating to protect your stomach. Breaking the pill will damage this coating.

Call your doctor if the condition you are treating with garlic does not improve, or if it gets worse while using this product.

Garlic can affect blood-clotting and may increase your risk of bleeding. If you need surgery, dental work, or a medical procedure, stop taking garlic at least 2 weeks ahead of time.

Store at room temperature away from moisture, heat, and light, or as directed on the package.

What happens if I miss a dose?

Skip the missed dose and take the next regularly scheduled dose. Do not use 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 garlic?

Avoid taking fish oil or vitamin E while you are taking garlic.

Also avoid using garlic together with other herbal/health supplements that can also affect blood-clotting. This includes angelica (dong quai), capsicum, clove, danshen, ginger, ginkgo, horse chestnut, panax ginseng, poplar, red clover, turmeric, and willow.

What other drugs will affect garlic?

Do not take garlic without medical advice if you are using any of the following medications:

• acetaminophen (Tylenol);
• birth control pills;
• chlorzoxazone;
• cyclosporine;
• theophylline;
• warfarin (Coumadin, Jantoven);
• HIV or AIDS medicines–delavirdine, efavirenz, nevirapine, saquinavir;
• medicine used to prevent blood clots, such as alteplase, clopidogrel, dipyridamole, ticlopidine, and urokinase; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Do not take garlic without medical advice if you are using a medication to treat any of the following conditions:

• any type of infection (including HIV, malaria, or tuberculosis);
• anxiety or depression;
• asthma or allergies;
• cancer;
• erectile dysfunction;
• heartburn or gastroesophageal reflux disease (GERD);
• high blood pressure, high cholesterol, or a heart condition;
• migraine headaches;
• psoriasis, rheumatoid arthritis, or other autoimmune disorders;
• a psychiatric disorder; or
• seizures.

What is Gattex?

Gattex is used to treat short bowel syndrome (SBS) in adults and children at least 1 year old who depend on intravenous (parenteral) feeding to receive nutrition.

Gattex’s mechanism of action involves boosting levels of a peptide called human glucagon-like peptide-2 (GLP-2), which is needed for the proper functioning and growth of cells in the stomach and intestines. GLP-2 is found in low concentrations in people with SBS and Gattex is a man-made form of GLP-2.

Gattex first gained FDA approval on December 21, 2012. Approval of Gattex was extended on May 17, 2019, to include children aged 1 year and older with SBS. A Gattex generic has not yet been approved but there is speculation that one may be introduced soon.

Warnings

You should not use Gattex if you are allergic to teduglutide, or if you have cancer of the stomach, intestines, liver, gallbladder, or pancreas.

Before using Gattex, tell your doctor if you have heart disease, kidney disease, intestinal polyps, a blockage in your stomach or intestines, a colostomy or ileostomy, or a history of gallbladder or pancreas problems.

Teduglutide can make it easier for your body to absorb any medicines you take by mouth. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using.

Gattex may increase your risk of colon polyps (in your large intestine). You will need a colonoscopy before and during treatment with Gattex. Teduglutide may also increase your risk of certain types of cancer. Talk with your doctor about the risks and benefits of this medicine.

Call your doctor at once if you have severe constipation, stomach cramps, fever, chills, nausea, vomiting, dark urine, or yellowing of your skin or eyes.

While using Gattex, you may need frequent blood tests (every 6 months), and then a colonoscopy after 1 year of treatment. If you use this medication long-term, you may need a colonoscopy every 5 years.

Before taking this medicine

Gattex can cause any abnormal cells in your body to grow faster. Some abnormal cells could become cancerous, increasing your risk of cancer of the liver, gallbladder, pancreas, or intestines. Ask your doctor about your specific risk.

Gattex may also increase your risk of polyps in your colon (large intestine). You will need a colonoscopy before and during treatment with teduglutide.

Talk with your doctor about the risks and benefits of this medicine.

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

• cancer;
• polyps in your intestines or rectum;
• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;
• heart problems, high blood pressure;
• kidney disease; or
• problems with your gallbladder or pancreas.

Short bowel syndrome can increase your risk of malnutrition during pregnancy. This could lead to premature delivery, low birth weight, birth defects, or other complications in both mother and baby. Follow your doctor’s instructions about using this medicine if you are pregnant.

You should not breastfeed while using this medicine.

How is Gattex given?

Use Gattex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Use the medicine at the same time each day.

Gattex is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself or how to give an injection to a child using teduglutide. Do not inject into a vein or muscle.

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

Gattex 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. Mixed medicine must be used within 3 hours.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You may need blood tests every 6 months while using Gattex. Your stools may need to be checked for blood every 12 months. You may also need a colonoscopy after 1 year of treatment, and then once every 5 years if you use Gattex long-term.

Do not change your dose or dosing schedule without your doctor’s advice.

Store unmixed powder at room temperature. Do not freeze and do not shake the vial. Throw away any Gattex not used before the expiration date on the medicine label.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe 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.

Dosing information

Usual Adult and Child Dose of Gattex for Short Bowel Syndrome (SBS):

Gattex 0.05 mg/kg via subcutaneous injection 1 time a day.

Comments:
-Injection sites should be alternated, and may include the thighs, arms, and abdominal quadrants.
-IV and IM administration should be avoided.
-Missed doses should be taken as soon as possible on that day; patients should not take 2 doses on the same day.

Use: Treatment of patients with short bowel syndrome who are dependent on parenteral support

What happens if I miss a dose?

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use 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 using Gattex?

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

Gattex side effects

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

Call your doctor at once if you have:

• severe constipation or stomach cramps, nausea, vomiting;
• swelling in your hands and feet, rapid weight gain, feeling short of breath;
• a change in your stools (bowel movements);
• severe pain in your upper stomach spreading to your back;
• fever, chills; or
• dark urine or yellowing of your skin or eyes.

Common Gattex side effects may include:

• an allergic reaction;
• stomach pain or swelling;
• nausea, vomiting;
• cold or flu symptoms;
• swelling in your hands or feet; or
• pain, swelling, redness, or other irritation where the medicine was injected.

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

What other drugs will affect Gattex?

Teduglutide can make it easier for your body to absorb any medicines you take by mouth, which could increase your blood levels of those medicines or cause unwanted effects. 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.

Gattex storage

If you have Gattex at home for self-administration, store the Gattex powder at room temperature up to 77°F (25°C).

Do not freeze Gattex. Use the Gattex powder by the expiration date on the “Use By” sticker on the kit.

Use Gattex within 3 hours after mixing it. Throw away any unused Gattex that has been mixed, even if there is medicine left in the vial. Do not store any Gattex you have mixed.

Keep out of the reach of children.

Gattex ingredients

Active ingredient: teduglutide

Inactive ingredients: dibasic sodium phosphate heptahydrate, L-histidine, mannitol, and monobasic sodium phosphate monohydrate. Sterile Water for Injection is provided as a diluent.

What is Gaviscon?

Gaviscon are antacids that can lower the acidity of stomach acid.

Gaviscon is a combination medicine that is used to treat heartburn, acid indigestion, sour stomach, or upset stomach.

.Gaviscon is also used to provide temporary relief from heartburn and acid indigestion caused by acid reflux.

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

Gaviscon 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.

Common side effects may include diarrhea.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Ask a doctor or pharmacist if Gaviscon is safe to use if:

• you have a peptic ulcer;
• you have trouble swallowing;
• you have kidney disease; or
• you are on a low-salt diet.

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

How should I take Gaviscon?

Use exactly as directed on the label, or as prescribed by your doctor.

You must chew the chewable tablet before you swallow it. Then drink about 4 ounces of water or other liquid.

Do not take more than 16 tablets in 24 hours.

Call your doctor if your symptoms do not improve, or if you have acid indigestion more than 2 times per week.

Do not take this medicine for longer than 2 weeks unless your doctor tells you to.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Gaviscon 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 .

What should I avoid while taking Gaviscon?

Ask a doctor or pharmacist before taking Gaviscon if you take other medicines regularly. Gaviscon can make it harder for your body to absorb other medicines you take by mouth.

What other drugs will affect Gaviscon?

Other drugs may affect Gaviscon, 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.

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What is Gavreto?

Gavreto (pralsetinib) is an oral prescription medicine that may be used to treat the following cancers caused by abnormal RET (rearranged during transfection) genes that have spread (metastasized):

• non-small cell lung cancer (NSCLC) in adults
• advanced thyroid cancer or thyroid cancer in adults and children 12 years of age and older who require a medicine by mouth or injection (systemic therapy) and who have received radioactive iodine and it did not work or is no longer working.

Your healthcare provider will perform a test to make sure that Gavreto is right for you.

Gavreto is a targeted cancer treatment that works by blocking the activity of a specific protein called RET, which is involved in the growth and development of certain cancers. Gavreto’s mechanism of action means it effectively targets RET-driven cancers, including those with specific mutations or fusions.

Gavreto gained FDA approval initially under the accelerated designation for metastatic RET fusion-positive NSCLC on September 4, 2020, which was upgraded to full approval on August 9, 2023.

• FDA approval for metastatic RET fusion-positive thyroid cancer for Gavreto is still under the accelerated approval designation. Continued approval may be dependent on favorable clinical trials.

Gavreto side effects

The most common side effects of Gavreto are:

• muscle or joint pain
• constipation or diarrhea
• high blood pressure
• low blood cell counts or other abnormal laboratory tests
• feeling tired
• swelling of your face, arms, legs, hands, and feet (edema)
• fever
• cough
• low sodium levels and other electrolyte changes.

The most common severe abnormal blood test results with Gavreto include:

• decreased white blood cell, red blood cell, and platelet counts
• decreased levels of phosphate, body salt (sodium), calcium, and potassium in the blood
• abnormal liver function blood tests
• increased levels of an enzyme called alkaline phosphatase in the blood (this is a test for liver or bone problems)
• increased levels of potassium in the blood.

Serious side effects and warnings

Gavreto may cause the following serious side effects.

Lung problems. Gavreto may cause severe or life-threatening inflammation of the lungs during treatment,
which can lead to death. Tell your healthcare provider right away if you have any new or worsening
symptoms, including:

• shortness of breath
• cough
• fever.

High blood pressure (hypertension). High blood pressure is common with Gavreto and may sometimes
be severe. You should check your blood pressure regularly during treatment. Tell your healthcare provider if you have increased blood pressure readings or get any symptoms of high blood pressure, including:

• confusion
• headaches
• shortness of breath
• dizziness
• chest pain.

Liver problems. Liver problems (showing as increased liver function blood test results) can happen during treatment with Gavreto and may sometimes be serious. Your healthcare provider will do blood tests before and
during treatment to check you for liver problems. Tell your healthcare provider right away if you get any signs or symptoms of liver problems during treatment, including:

• yellowing of your skin or the white part of your eyes (jaundice)
• dark “tea-colored” urine
• sleepiness
• bleeding or bruising
• loss of appetite
• nausea or vomiting
• pain on the upper right side of your stomach area.

Bleeding problems. Gavreto can cause bleeding which can be serious and cause death. Tell your
healthcare provider if you have any signs or symptoms of bleeding during treatment, including:

• vomiting blood or if your vomit looks like coffee grounds
• pink or brown urine
• red or black (looks like tar) stools
• coughing up blood or blood clots
• unusual bleeding or bruising of your skin
• menstrual bleeding that is heavier than normal
• unusual vaginal bleeding
• nose bleeds that happen often
• drowsiness or difficulty being awakened
• confusion
• headache
• change in speech.

Tumor lysis syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause you to
have kidney failure and the need for dialysis treatment, an abnormal heartbeat, and may sometimes lead
to hospitalization. Your healthcare provider may do blood tests to check you for TLS. You should stay well
hydrated during treatment with Gavreto. Call your healthcare provider or get emergency medical help
right away if you develop any of these symptoms during treatment:

• nausea
• vomiting
• weakness
• swelling
• shortness of breath
• muscle cramps
• seizures.

Risk of wound healing problems. Wounds may not heal properly during treatment with Gavreto. Tell your
healthcare provider if you plan to have any surgery before or during treatment.

• You should not take Gavreto for at least 5 days before surgery.
• Your healthcare provider should tell you when you may start taking Gavreto again after surgery

Gavreto may affect fertility in males and females, which may affect your ability to have children. Talk to your
healthcare provider if this is a concern for you.

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

Gavreto may affect the growth plates of growing children.

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 .

Before taking

Before taking Gavreto, tell your healthcare provider about all of your medical conditions, including if you:

• have lung or breathing problems other than lung cancer
• have high blood pressure
• have bleeding problems
• have liver problems
• plan to have surgery. You should stop taking Gavreto at least 5 days before your planned surgery
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Gavreto may impair fertility. Talk to your healthcare provider if this is a concern for you.

It is not known if Gavreto is safe and effective when used to treat cancers caused by abnormal RET genes:

• in children for the treatment of NSCLC
• in children younger than 12 years of age for the treatment of thyroid cancer.

Pregnancy

Gavreto can harm an unborn baby. If you are a female who can become pregnant your healthcare provider will do a pregnancy test before you start treatment with Gavreto. You should use an effective form of non-hormonal birth control (contraception) during treatment and for 2 weeks after your last dose of Gavreto.

Birth control methods that contain hormones (such as birth control pills, injections, or transdermal system
patches) may not work as well during treatment with Gavreto. To prevent pregnancy while using Gavreto, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Talk to your healthcare provider about birth control methods that may be right for you during this time.

Tell your healthcare provider right away if you become pregnant or think you might be pregnant during
treatment with Gavreto.

Males with female partners who can become pregnant should use effective birth control (contraception) during treatment with Gavreto and for 1 week after their last dose.

Breastfeeding

It is not known if Gavreto passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of Gavreto.

How should I take Gavreto?

Take Gavreto exactly as your healthcare provider tells you to take it. Do not change your dose or stop using the medicine without your doctor’s advice.

• Take Gavreto 1 time each day.
• Gavreto should be taken on an empty stomach at least 1 hour before or 2 hours after a meal.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Gavreto if you develop side effects.

• If you vomit after taking a dose of Gavreto, do not take an extra dose. Take your next dose of Gavreto at your regular time the next day.
• Your blood pressure will need to be checked often and you will need frequent blood tests.
• Your doctor will monitor your liver function (specifically ALT and AST enzymes) before initiating Gavreto, then every 2 weeks for the first 3 weeks, then monthly thereafter.
• If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Gavreto dosing information

Gavreto dosage for adults and children 12 and over: Gavreto 400 mg orally 1 time a day.

• Each Gavreto capsule is 100 mg, which means you will take 4 capsules of Gavreto.
• Gavreto should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
• If you vomit shortly after taking Gavreto, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

What happens if I miss a dose?

If you miss a dose of Gavreto, take it as soon as possible on the same day. Then take your next dose of
Gavreto at your regular time the next day. 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

Gavreto can delay wound healing. Do not take Gavreto for at least 5 days before surgery. Your healthcare provider should tell you when you may start taking Gavreto again after surgery

What other drugs will affect Gavreto?

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. Tell your doctor about all your current medicines including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Many drugs can interact with Gavreto, especially:

• some antibiotic or antifungal medicines
• antiviral medications used to treat HIV or hepatitis C
• some cancer medications
• certain cholesterol medications
• seizure medications.

Avoid administering Gavreto with strong or moderate CYP3A inhibitors and/or P-gp inhibitors such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit. Your doctor may reduce the dosage of Gavreto if coadministration is unavoidable.

Avoid administering Gavreto with strong or moderate CYP3A inducers such as phenobarbital, phenytoin, rifampicin, St. John’s Wort, and glucocorticoids. Your doctor may increase the dosage of Gavreto if coadministration is unavoidable.

This list is not complete and many other drugs may interact with pralsetinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. See the Gavreto Prescribing Information for a complete list.

Storage

Store Gavreto 100 mg capsules at room temperature between 68°F to 77°F (20°C to 25°C) away from moisture and heat.

Keep out of the reach of children.

Gavreto ingredients

Active ingredient: pralsetinib 100 mg.

Inactive ingredients: citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch, and sodium bicarbonate.

Capsule shell: FD&C Blue #1 (Brilliant Blue FCF), hypromellose, and titanium dioxide.

White printing ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution, and titanium dioxide.

Gavreto 100 mg capsules are available in bottles of 60, 90, and 120 capsules.

What Is Gazyva?

Gazyva (obinutuzumab) is targeted immunotherapy treatment that works with your immune system to treat specific types of blood cancers. Gazyva is a prescription medicine administered intravenously by a healthcare professional, typically alongside other cancer treatments. Currently, no generic version is available.

FDA-Approved Uses for Gazyva

Gazyva is specifically approved for adults with:

• Chronic lymphocytic leukemia (CLL): For first-time treatment in combination with chlorambucil
• Follicular lymphoma (FL): For patients whose cancer has relapsed or not responded to rituximab-containing regimens, used with bendamustine followed by Gazyva maintenance therapy
• Stage II bulky, III, or IV follicular lymphoma: For first-time treatment, used with chemotherapy first, then as monotherapy if treatment is successful

How Gazyva Works

Gazyva targets a protein called CD20 that appears on both normal and cancerous B-lymphocytes (a type of white blood cell). By binding to this protein, Gazyva:

• Helps your immune system identify and destroy marked cells
• Directly attacks cancer cells
• Preserves stem cells in bone marrow, allowing your body to keep producing healthy blood cells.

Clinical Effectiveness

Clinical trials have demonstrated that CLL patients receiving Gazyva plus chlorambucil experienced:

• Nearly 80% partial or complete response rate (versus 66.3% with rituximab plus chlorambucil)
• Approximately one additional year without cancer progression (26.7 months versus 14.9 months with rituximab plus chlorambucil).

Common Side Effects

The most common side effects of Gazyva are:

• Infusion-related reactions
• Low white blood cell counts (neutropenia)
• Fatigue
• Nausea
• Fever
• Cough.

Serious Side Effects and Warnings

Boxed Warnings

Gazyva carries FDA Boxed Warnings for:

• Hepatitis B Virus (HBV) Reactivation: Can cause liver failure or death in patients with previous HBV infection
• Progressive Multifocal Leukoencephalopathy (PML): A rare, serious brain infection that can be fatal

Additional Serious Risks

• Infusion-Related Reactions (IRRs): May occur during or within 24 hours of infusion
• Severe Allergic Reactions: Including anaphylaxis and serum sickness
• Tumor Lysis Syndrome (TLS): Rapid breakdown of cancer cells causing metabolic complications
• Infections: May be severe or fatal
• Low Blood Cell Counts: Including neutropenia (white cells) and thrombocytopenia (platelets)
• Disseminated Intravascular Coagulation (DIC): A rare but potentially fatal blood clotting disorder.

These are not all the possible side effects of Gazyva. For more information, ask your doctor or pharmacist.

Tell your doctor right away about any side effects you experience. You may report side effects to the FDA at (800) FDA-1088, or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Before receiving Gazyva

Contraindications

Do NOT receive Gazyva if you’ve had an allergic reaction to obinutuzumab or any ingredients in the injection.

Important Disclosures to Your Doctor

Tell your healthcare provider if you:

• Have heart disease
• Have any infection, particularly hepatitis B
• Have lung or breathing problems
• Recently received or plan to receive vaccines
• Take blood-thinning medications
• Are pregnant, planning pregnancy, or breastfeeding.

Pregnancy and Breastfeeding

• Pregnancy: Gazyva may harm unborn babies. Use effective contraception during treatment and for 6 months afterward.
• Breastfeeding: Not recommended during treatment and for 6 months after the last dose due to potential risks to infants.
• Vaccinations: Discuss timing of live virus vaccines for infants if you received Gazyva during pregnancy.

Gazyva Administration and Dosing Schedule

Gazyva is administered as an intravenous infusion in a clinic or infusion center. Most people will complete their Gazyva treatment in about 6 months.

Treatment Format

• 6 treatment cycles of 28 days each (6 months total).
• Gradual dose increases during Cycle 1 to minimize side effects
• For CLL patients: Chlorambucil on Day 1 and Day 15 of each cycle.

Dosing Schedule

Cycle 1:

• Day 1: 100 mg
• Day 2: 900 mg
• Day 8: 1000 mg
• Day 15: 1000 mg

Cycles 2-6:

Day 1: 1000 mg

Preparing for Infusions

One Week Before:

• Review all medications with your doctor
• Discuss blood pressure medications that might need adjustment.

Day of the Infusion:

• Arrange transportation home
• Wear comfortable clothing
• Bring snacks, entertainment, and activities
• Expect to spend most of the day at the facility.

Pre-Medications:

Your doctor may prescribe medications one hour before infusion to reduce side effects:

• Acetaminophen
• Antihistamines
• Steroids.

Ongoing Monitoring

During treatment, your doctor will regularly assess:

• Symptoms
• Lymph node, liver, and spleen size
• Blood counts
• Side effects.

What to Avoid During Treatment

Live vaccines: Do not receive BCG, MMR, MMRV, rotavirus, or varicella vaccines during Gazyva treatment

Manufacturer Information

Gazyva is manufactured by Genentech, a subsidiary of Roche. Genentech is headquartered in South San Francisco, California, while Roche’s global headquarters is in Basel, Switzerland. Other Notable Medications from Genentech/Roche include:

• Avastin (bevacizumab)
• Herceptin (trastuzumab)
• Rituxan (rituximab)
• Tecentriq (atezolizumab)
• Perjeta (pertuzumab)
• Actemra (tocilizumab) for rheumatoid arthritis
• Ocrevus (ocrelizumab) for multiple sclerosis
• Lucentis (ranibizumab) for eye conditions
• Xolair (omalizumab) for asthma and allergies
• Hemlibra (emicizumab) for hemophilia A.

Gazyva 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 is 1 for Gazyva.Gazyva (obinutuzumab) – Genentech, Inc.

What is gemcitabine?

Gemcitabine is used to treat cancers of the pancreas, lung, ovary, and breast.

Gemcitabine is sometimes given with other cancer medicines, or when other cancer treatments did not work or have stopped working.

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

Gemcitabine 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.

Also call your doctor at once if you have:

• headache, confusion, change in mental status, vision loss, seizure (convulsions);
• blisters or ulcers in your mouth, trouble eating or swallowing;
• severe skin redness, swelling, oozing, or peeling during or after radiation treatment;
• liver problems–loss of appetite, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood cell counts–fever, chills, tiredness, skin sores, cold hands and feet, feeling light-headed;
• fluid build-up in or around the lungs–pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold, clammy skin, anxiety, rapid heartbeats; or
• signs of damaged red blood cells–unusual bruising or bleeding, pale skin, bloody diarrhea, red or pink urine, swelling, rapid weight gain, and little or no urination.

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

Common side effects of gemcitabine may include:

• fever;
• nausea, vomiting;
• low blood cell counts;
• abnormal blood or urine tests;
• shortness of breath;
• swelling in your hands or feet;
• rash; or
• red or pink urine.

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

Gemcitabine can increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, tiredness, bruising or bleeding, pale skin).

Gemcitabine can also affect your liver, kidneys, or lungs. Tell your doctor if you have stomach pain, dark urine, yellow skin or eyes, little or no urinating, swelling, rapid weight gain, severe shortness of breath, wheezing, or cough with foamy mucus.

If you receive gemcitabine during or after radiation treatment, tell your doctor right away if you have severe skin redness, swelling, oozing, or peeling.

Before taking this medicine

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

Tell your doctor if you have ever had:

• kidney disease;
• liver disease (especially cirrhosis);
• alcoholism; or
• radiation treatment.

Both men and women using gemcitabine should use effective birth control to prevent pregnancy. Gemcitabine can harm an unborn baby if the mother or father is using this medicine.

• If you are a woman, do not use gemcitabine if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months 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 gemcitabine.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because gemcitabine can harm an unborn baby.

You should not breastfeed while you are using gemcitabine, and for at least 1 week after your last dose.

How is gemcitabine used?

Gemcitabine is given as an infusion into a vein. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when gemcitabine is injected.

If any of this medicine accidentally gets on your skin, wash the area thoroughly with soap and warm water.

Gemcitabine can increase your risk of bleeding or infection. You will need frequent medical tests.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using gemcitabine?

Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury.

Do not receive a “live” vaccine while using gemcitabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect gemcitabine?

Other drugs may affect gemcitabine, 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.

What is gemfibrozil?

Gemfibrozil helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

Gemfibrozil is used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis.

Gemfibrozil is also used to lower the risk of stroke, heart attack, or other heart complications in certain people with high cholesterol and triglycerides who have not been helped by other treatment methods.

Warnings

You should not take gemfibrozil if you have severe liver or kidney disease, gallbladder disease, or if you are also taking repaglinide, dasabuvir, or simvastatin.

Before taking this medicine

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

• severe liver disease;
• severe kidney disease;
• gallbladder disease; or
• if you are also taking repaglinide, dasabuvir, or simvastatin.

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

• gallstones; or
• if you also take warfarin (Coumadin, Jantoven).

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

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

How should I take gemfibrozil?

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

Gemfibrozil is usually taken 30 minutes before breakfast and dinner. Follow your doctor’s dosing instructions very carefully.

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

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

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

Dosing information

Usual Adult Dose of Gemfibrozil for Hyperlipidemia:

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose of Gemfibrozil for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL):

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose of Gemfibrozil for Hyperlipoproteinemia Type IV (Elevated VLDL):

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL):

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Hypertriglyceridemia:

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Prevention of Cardiovascular Disease:

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

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 gemfibrozil?

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

Avoid drinking alcohol. It may interfere with your treatment.

Gemfibrozil side effects

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

In rare cases, gemfibrozil can cause a condition that results in the breakdown of skeletal muscle tissue, leading 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, and dark colored urine.

Also call your doctor at once if you have:

• sharp pain in your upper stomach (especially after eating);
• jaundice (yellowing of your skin or eyes);
• pain or burning when you urinate;
• blurred vision, eye pain, or seeing halos around lights; or
• low blood cell counts – pale skin, easy bruising, unusual bleeding, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common gemfibrozil side effects may include:

• stomach pain, indigestion, diarrhea;
• numbness or tingly feeling;
• dizziness, drowsiness;
• blurred vision;
• muscle or joint pain; or
• loss of interest in sex, impotence.

What is Gemzar?

Gemzar is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Gemzar is used to treat cancers of the pancreas, lung, ovary, and breast.

Gemzar is sometimes given with other cancer medicines, or when other cancer treatments did not work or have stopped working.

Warnings

Gemzar can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, tiredness, bruising or bleeding, pale skin).

Gemzar can also affect your liver, kidneys, or lungs. Tell your doctor if you have stomach pain, dark urine, yellow skin or eyes, little or no urinating, swelling, rapid weight gain, severe shortness of breath, wheezing, or cough with foamy mucus.

If you receive gemcitabine during or after radiation treatment, tell your doctor right away if you have severe skin redness, swelling, oozing, or peeling.

Before receiving Gemzar

You should not use Gemzar if you are allergic to gemcitabine.

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

• kidney disease;
• liver disease (especially cirrhosis);
• alcoholism; or
• radiation treatment.

Both men and women using Gemzar should use effective birth control to prevent pregnancy. Gemcitabine can harm an unborn baby if the mother or father is using this medicine.

• If you are a woman, do not use Gemzar if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months 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 gemcitabine.

Gemzar may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because gemcitabine can harm an unborn baby.

You should not breastfeed while you are using gemcitabine, and for at least 1 week after your last dose.

How is Gemzar used?

Gemzar is injected into a vein as an IV infusion. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Gemzar is injected.

If any Gemzar injection accidentally gets on your skin, wash the area thoroughly with soap and warm water.

Gemcitabine can increase your risk of bleeding or infection by changing the way your immune system works. You will need frequent medical tests.

What happens if I miss a dose?

Contact your doctor if you miss a miss an appointment to receive your Gemzar infusion.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid?

Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury.

Do not receive a “live” vaccine while using Gemzar, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Gemcitabine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient’s body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Gemzar side effects

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

If you receive Gemzar during or after radiation treatment, tell your doctor right away if you have severe skin redness, swelling, oozing, or peeling.

Also call your doctor at once if you have:

• headache, confusion, change in mental status, vision loss, seizure (convulsions);
• blisters or ulcers in your mouth, red or swollen gums, trouble eating or swallowing;
• severe skin redness, swelling, oozing, or peeling during or after radiation treatment;
• liver problems – loss of appetite, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood cell counts – fever, chills, tiredness, skin sores, cold mhands and feet, feeling light-headed;
• fluid build-up in or around the lungs – pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold, clammy skin, anxiety, rapid heartbeats; or
• signs of damaged red blood cells – unusual bruising or bleeding, pale skin, bloody diarrhea, red or pink urine, swelling, rapid weight gain, and little or no urination.

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

Common Gemzar side effects may include:

• fever;
• nausea, vomiting;
• low blood cell counts;
• abnormal blood or urine tests;
• shortness of breath;
• swelling in your hands or feet;
• mild rash; or
• red or pink urine.

What is Gemtesa?

Gemtesa is used to treat overactive bladder (OAB) symptoms, including urinary urgency, urinary frequency, and urge incontinence, which is when you have a strong need to urinate with leaking or wetting accidents. Gemtesa is used to relieve these symptoms in adults with overactive bladder or men taking medicine for benign prostatic hyperplasia (BPH).

Gemtesa works by relaxing the bladder muscle so the bladder can hold more urine and this may reduce the urgency to use the bathroom and decrease the frequency of urinary leaks. 

 Gemtesa generic name is vibegron.

Gemtesa is a once-daily tablet that is swallowed whole with water or may be crushed, mixed with a tablespoon (~15 mL) of applesauce and taken immediately with a glass of water. The tablet can be taken with or without food. 

Gemtesa FDA approval

Gemtesa’s FDA approval is to treat adults with: 

• Overactive bladder symptoms of urge urinary incontinence, urgency, and urinary frequency 
• Overactive bladder symptoms of urge urinary incontinence, urgency, and urinary frequency in men taking medicines for benign prostatic hyperplasia (BPH). 

How does Gemtesa work?

Gemtesa’s mechanism of action (MOA) is a selective human beta-3 adrenergic receptor agonist (β3-AR agonist). Gemtesa works by binding and activating β3-adrenergic receptor, which relaxes the muscles in the wall of the bladder (detrusor muscle), which increases bladder volume. Gemtesa is from a class of medications called beta-3 agonists.

Gemtesa Clinical trial results 

In the 12-week clinical trial called Study 3003 (NCT03492281) used for overactive bladder symptoms, Gemesa patients had:

• 2 fewer daily leakage episodes (compared with 1.4 fewer episodes for placebo)
• 1.8 fewer bathroom visits per day (compared to 1.3 fewer episodes for placebo)
• 2.7 fewer “need to urinate immediately” episodes (compared to 2 fewer episodes for placebo

Gemtesa side effects

Common Gemtesa side effects

The most common Gemtesa side effects for OAB include: 

• headache (22%)
• cold symptoms -nasopharyngitis (15%)
• diarrhea (12%)
• nausea (12%) 

These common side effects occurred in 2% or more of the Gemtesa patients in the 12-week clinical trial for OAB called Study 3003. 

The long-term 52-week study had the same side effects as above and also included urinary tract infection (6.6%) and bronchitis (2.9%).

The most common Gemtesa side effects for OAB with BPH include: 

In a 12-week clinical trial (Study 3005) evaluating Gemtesa in males with overactive bladder (OAB) who were also taking medication for benign prostatic hyperplasia (BPH), the most common side effects occurring in more than 2% of patients were:

• Hypertension: 9% (compared to 8.3% with placebo)
• Urinary tract infection: 2.5% (compared to 2.2% with placebo)

Serious Gemtesa side effects

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

Call your doctor at once if:

• you are unable to completely empty your bladder; or
• you have pain or burning when you urinate.

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

Gemtesa should not be taken if you have hypersensitivity to the active ingredient vibegron or any of the inactive ingredients in this medicine.

Urinary Retention: It is important to monitor for urinary retention, especially in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for OAB, as the risk of urinary retention may be greater. If urinary retention develops, discontinue Gemtesa. 

Angioedema: Angioedema of the face and/or larynx has been reported with this medicine.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not take Gemtesa if you are allergic to the active ingredient vibegron, or any inactive ingredients.

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

• trouble emptying your bladder;
• a weak stream of urine;
• liver disease; or
• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Gemtesa?

The normal dose of Gemtesa 75mg is one tablet, taken by mouth, once daily. Take this medicine with a full glass of water. You may take Gemtesa with or without food.

If you cannot swallow a tablet whole, you may crush the tablet and mix it with 1 tablespoon of applesauce. Swallow the mixture right away with a glass of water. Do not save the mixture for later use.

Use Gemtesa exactly as prescribed by your doctor. Follow all directions on your prescription label and use the medicines exactly as directed. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Gemtesa Dosing information 

Dosing Information for Gemtesa

• Usual Adult Gemtesa Dose: One Gemtesa 75 mg tablet orally once a day.
• How to take: Take Gemtesa tablet with a glass of water with or without food.
• Crushing Option: If you cannot swallow a tablet whole, you may crush the tablet and mix it with 1 tablespoon of applesauce. Swallow the mixture right away with a glass of water. Do not save the mixture for later use.

Missed 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.

Overdose

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Gemtesa?

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

What other drugs will affect Gemtesa?

Tell your doctor about all your other medicines, especially:

• digoxin or digitalis.

What is Genotropin?

Genotropin (somatropin) is a human growth hormone (HGH, hGH) important for the growth of bones and muscles.

Genotropin is used to treat growth failure in children and adults who lack natural growth hormone. This includes people with short stature due to Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. 

Genotropin mechanism of action (MOA) is it behaves like a natural human growth hormone by binding to the GH receptor on target cells which signals skeletal growth, muscle growth, and protein synthesis.  Genotropin is a hormone produced in the pituitary gland at the base of the brain. If the pituitary gland doesn’t make enough, or any, human growth hormone it causes a condition called growth-related disorder. 

Genotropin is given as a subcutaneous injection using the Genotropin pen device or the Genotropin Miniquick.

Genotropin Pfizer Inc, a Division – Pharmacia & Upjohn Co.

Who can use Genotropin?

Genotropin injection is FDA-approved to be used for growth failure in:

Pediatric patients who have:

• growth failure due to an inadequate secretion of endogenous growth hormone
• Prader-Willi syndrome (PWS) which has been confirmed by appropriate genetic testing
• Turner syndrome
• idiopathic short stature (ISS), also called non-growth hormone-deficient short stature in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. 

Adult patients as replacement of endogenous growth hormone in adults with growth hormone deficiency who have:

• Adult Onset (AO) Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
• Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. 

Genotropin side effects

Common side effects of Genotropin may include:

• pain, itching, or skin changes where the medicine was injected;
• swelling, rapid weight gain;
• muscle or joint pain;
• numbness or tingling;
• stomach pain, gas;
• headache, back pain; or
• cold or flu symptoms, stuffy nose, sneezing, sore throat, ear pain.

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

Serious Genotropin side effects

Serious breathing problems may occur in patients with Prader-Willi syndrome who use Genotropin injection. If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Also, call your doctor at once if you have:

• pain in your knees or hips, walking with a limp;
• ear pain, swelling, warmth, or drainage;
• numbness or tingling in your wrist, hand, or fingers;
• severe swelling or puffiness in your hands and feet;
• changes in behavior;
• vision problems, unusual headaches;
• changes in the shape or size of a mole;
• pain or swelling in your joints;
• pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;
• increased pressure inside the skull – severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• signs of an adrenal gland problem – extreme weakness, severe dizziness, weight loss, changes in skin color, feeling very weak or tired.

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 Genotropin injection if you have cancer, diabetic retinopathy, or if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems. You should not use this medicine if you have a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma.

Before taking this medicine

You should not use Genotropin injection if you are allergic to the active ingredient somatropin,  benzyl alcohol, or if you have:

• a serious illness due to lung failure, or complications from recent surgery, injury, or medical trauma;
• closed epiphyses;
• active cancer;
• eye problems caused by diabetes (diabetic retinopathy); or
• you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems (including sleep apnea).

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

• cancer (especially during childhood);
• diabetes;
• breathing problems, sleep apnea (breathing stops during sleep);
• a pituitary gland disorder;
• abnormal curvature of the spine (scoliosis);
• underactive thyroid;
• a head injury or brain tumor; or
• childhood brain cancer and radiation treatment.

In some cases, Genotropin should not be used in a child. Certain brands of somatropin contain an ingredient that can cause serious side effects or death in very young infants or premature babies. Do not give this medicine to a child without medical advice.

Tell your doctor if you are pregnant or breastfeeding.

How should I use Genotropin?

The weekly dose should be divided into 6 or 7 subcutaneous (under the skin) injections. Genotropin must not be injected intravenously.

A healthcare provider will teach you how to properly use the medication by yourself.

Do not inject the subcutaneous injection (under the skin) into the same place two times in a row.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Do not use Genotropin if you don’t understand all the instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not shake the medicine. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Genotropin is available as Genotropin Pen Device and Genotropin Miniquick. Read the full directions for your device or read the full Instructions for Use.

Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before.

Avoid areas that are bony, bruised, red, sore, or hard. You should also avoid areas of the skin that have scars or skin problems.

Clean the injection site with the alcohol swab.

Genotropin Pen device instructions

• Firmly pinch a fold of skin at the injection area. Use the Genotropin Pen device to push the needle fully into the skin fold at a 90° angle.
• Push the pen device injection button until it clicks. Wait while counting slowly for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected.

Genotropin Miniquick instructions

• Remove the outer needle cover and the inner needle cover from the needle of the Genotrophin Miniquick. Save the outer needle cover.
• Pinch a fold of skin at the injection site firmly, and push the needle straight into the skin at a 90°angle. 
• Push the plunger rod in as far as it will go, to inject all of the medicine in the Genotropin Miniquick into the fold of skin. 
• Wait a few seconds to be sure that all of the growth hormone solution has been injected. Pull out the needle.
• Replace the outer needle cover on the needle.

Genotropin Pen Device and Genotropin Miniquick Strengths

Genotropin Miniquick: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg in a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge (without preservative)

Genotropin 12 mg Pen, Genotropin Pen Device 5mg in a single-patient-use two-chamber cartridge (with preservative).

Genotropin pen replacement​. The pen has a use period of 2 years starting from the first use by the patient.

Genotropin Dosing Information

Genotropin is given as a subcutaneous injection

• Pediatric GHD: 0.16 to 0.24 mg/kg/week
• Prader-Willi Syndrome: 0.24 mg/kg/week
• Small for Gestational Age: Up to 0.48 mg/kg/week
• Turner Syndrome: 0.33 mg/kg/week
• Idiopathic Short Stature: up to 0.47 mg/kg/week.

Adult GHD: Either a non-weight-based or a weight-based dosing regimen may be followed, with doses adjusted based on treatment response and IGF-I concentrations 

• Non-weight-based dosing: A starting dose of approximately 0.2 mg/day (range, 0.15–0.30 mg/day) may be used without consideration of body weight, and increased gradually every 1–2 months by increments of approximately 0.1–0.2 mg/day. 
• Weight-based dosing: The recommended initial dose is not more than 0.04 mg/kg/week; the dose may be increased as tolerated to not more than 0.08 mg/kg/week at 4–8 week intervals. 

What happens if I miss a dose?

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

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

Who should not use Genotropin?

Genotropin injection should not be used in

• Acute Critical Illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure 
• Prader-Willi Syndrome in Children who are severely obese, have a history of upper airway obstruction or sleep apnea, or have a severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients.
• Active Malignancy. Any preexisting malignancy should be inactive and its treatment complete before starting therapy with somatropin. Since growth hormone deficiency may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.
• Hypersensitivity to somatropin or any of its excipients. The 5 mg and 12 mg presentations of lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins.
• Diabetic Retinopathy in patients with active proliferative or severe non-proliferative diabetic retinopathy.
• Closed Epiphyses this medicine should not be used for growth promotion in pediatric patients with closed epiphyses.

What other drugs will affect Genotropin?

Tell your doctor about all your other medicines, especially:

• birth control pills or hormone replacement therapy;
• insulin or oral diabetes medicine; or
• a steroid (prednisone, dexamethasone, methylprednisolone, and others).

What is gentamicin?

Gentamicin is an antibiotic that fights bacteria.

Gentamicin is used to treat severe or serious bacterial infections.

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

Gentamicin 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.

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

• hearing loss, or a roaring sound in your ears;
• severe or ongoing dizziness;
• weak or shallow breathing;
• numbness or tingly feeling;
• twitching, muscle tightness or contraction;
• seizure (convulsions);
• severe stomach pain, diarrhea that is watery or bloody;
• fever, blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• kidney problems–little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
• signs of an electrolyte imbalance–confusion, weakness, bone pain, increased urination; or
• increased pressure inside the skull–severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Side effects may be more likely in older adults.

Common side effects of gentamicin may include:

• vision problems;
• nausea, vomiting, loss of appetite, weight loss;
• a light-headed feeling, like you might pass out;
• itching or rash;
• pain where the medicine was injected;
• headache, mood changes; or
• joint 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 .

Warnings

Gentamicin can harm your kidneys, and may also cause nerve damage or hearing loss, especially if you have kidney disease or use certain other medicines.

Tell your doctor about all your medical conditions and all the medicines you are using. If you need surgery, tell the surgeon ahead of time that you are using gentamicin.

Before taking this medicine

You should not use gentamicin if you are allergic to gentamicin or similar antibiotics such as amikacin, kanamycin, neomycin, paromomycin, streptomycin, or tobramycin.

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

• kidney disease;
• asthma or sulfite allergy;
• myasthenia gravis;
• a nerve-muscle disorder;
• a nervous system disorder such as Parkinson’s disease;
• an electrolyte imbalance (low levels of calcium, potassium, or magnesium in your blood); or
• if you are dehydrated.

Do not use gentamicin if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy during treatment.

It is not known whether gentamicin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take gentamicin?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Gentamicin is usually given for 7 to 10 days.

Gentamicin is injected into a muscle, or into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Do not use gentamicin if it has changed colors or has particles in it. Call your pharmacist for new medication.

Do not mix gentamicin with other medicines in a syringe or IV bag.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

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. Gentamicin will not treat a viral infection such as the flu or a common cold.

Drink plenty of liquids while you are taking gentamicin. This will help keep your kidneys working properly.

While using gentamicin, you may need frequent blood or urine tests. Your hearing, kidney function, and nerve function may also need to be checked.

If you need surgery, tell the surgeon ahead of time that you are using gentamicin.

Store this medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of gentamicin.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking gentamicin?

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.

What other drugs will affect gentamicin?

Gentamicin can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Tell your doctor about all your current medicines and any you start or stop using, especially:

• a diuretic or “water pill”; or
• any other antibiotic.

What is Geodon?

Geodon is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Geodon is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old. It is available as an oral (by mouth) treatment as an injection.

Geodon injection is used to quickly treat agitation in people with schizophrenia.

Warnings

You should not use Geodon if you have a heart rhythm disorder, a history of long QT syndrome, uncontrolled heart failure, if you have recently had a heart attack, or if you are allergic to ziprasidone.

Some medicines can cause unwanted or dangerous effects when used with ziprasidone, and should not be used at the same time. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Stop taking Geodon and call your doctor right away if you have a chest pain, severe dizziness, and a fast or pounding heartbeat. These could be signs of a serious heart rhythm problem.

This medicine is not approved for use in older adults with dementia-related psychosis.

Stop taking Geodon and call your doctor right away if you have severe muscle pains, muscle spasms, fevers, sweating, or confusion.

Stop using this medicine and call your doctor right away if you have a new or worsening skin rash with fever or swollen glands.

Tell your doctor if you experience prolonged diarrhea or loose stools while taking Geodon.

Before taking this medicine

You should not use Geodon if you are allergic to ziprasidone, or if you have:

• a heart rhythm disorder;
• a personal or family history of long QT syndrome;
• uncontrolled or untreated heart failure; or
• if you have recently had a heart attack.

Geodon is not approved for use in psychotic conditions related to dementia. Ziprasidone may increase the risk of death in older adults with dementia-related psychosis.

Geodon should never be taken together with any of the following drugs, or a life-threatening heart rhythm disorder could occur:

• anagrelide;
• methadone;
• tacrolimus;
• certain anti-nausea medicines including dolasetron, droperidol, or ondansetron;
• the antibiotics azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, and pentamidine;
• certain cancer medicines such as arsenic trioxide and vandetanib;
• the antidepressants citalopram, escitalopram;
• anti-malaria medications including chloroquine, halofantrine, mefloquine;
• the following heart rhythm medicines – amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or
• certain anti-psychotics such as chlorpromazine, haloperidol, mesoridazine, pimozide, and thioridazine.

This list is not complete and there may be other drugs that should not be taken at the same time as Geodon. Tell your doctor about all medicines you use.

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

• any heart problems;
• a heart attack or stroke;
• a bone marrow or blood cell disorder;
• breast cancer;
• low blood levels of potassium or magnesium;
• diabetes (ziprasidone may raise your blood sugar);
• seizures or epilepsy;
• suicidal thoughts;
• Alzheimer’s disease;
• trouble swallowing;
• liver disease; or
• kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking Geodon, do not stop taking it without your doctor’s advice.

It is not known whether ziprasidone passes into breast milk or if it could harm a nursing baby. Talk to your doctor about Geodon if you are planning to breastfeed.

Older adults may be more sensitive to the effects of this medicine.

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

How should I take Geodon?

Use Geodon 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.

Geodon capsules are taken by mouth.

Geodon injection is injected into a muscle. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Take this medicine with food. Swallow the capsule whole.

While using Geodon, you may need frequent blood tests to check your kidney or liver function may.

If you are diabetic, check your blood sugar levels on a regular basis while you are taking Geodon.

Use Geodon regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

It may take several weeks before your symptoms improve. Do not stop using this medicine suddenly, even if you feel fine. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

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

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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 cause excessive sleepiness, slurred speech, high blood pressure, shaking, tremors, or anxiety.

While you are taking Geodon, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medicine.

Geodon may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

Geodon side effects

Get emergency medical help if you have signs of an allergic reaction to Geodon: (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, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using ziprasidone.

Also call your doctor at once if you have:

• dizziness or a light-headed feeling, like you might pass out;
• chest pain, fast or pounding heartbeats;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, pain when swallowing;
• increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
• very stiff (rigid) muscles, high fever, sweating, confusion, agitation.

Common Geodon side effects may include:

• dizziness, drowsiness, weakness;
• headache;
• nausea, vomiting;
• trouble swallowing;
• weight gain;
• feeling restless or being unable to sit still;
• tremors, involuntary muscle movements;
• vision problems; or
• runny nose, new or worsening cough.

What is Giazo?

The Colazal brand of balsalazide is used to treat mild to moderate active ulcerative colitis in adults and children who are at least 5 years old.

The Giazo brand of balsalazide is used to treat mild to moderate active ulcerative colitis in men who are at least 18 years old.

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

Giazo 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.

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

• pain or burning when you urinate;
• worsening colitis symptoms–fever, stomach pain, cramps, or bloody diarrhea;
• kidney problems–little or no urinating, swelling, rapid weight gain;
• liver problems–upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of Giazo may include:

• headache;
• mild or occasional nausea, vomiting, stomach pain, diarrhea;
• joint pain;
• fever; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Giazo if you are allergic to Giazo or mesalamine, or to aspirin or other salicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• kidney disease;
• liver disease; or
• a stomach condition called pyloric stenosis.

Giazo tablets contain sodium. Talk to your doctor before using this form of balsalazide if you are on a low salt diet.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether Giazo will harm an unborn baby. However, having active ulcerative colitis during pregnancy may cause premature delivery or low birth weight. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

Giazo capsules should not be given to a child younger than 5 years old. This medicine tablets should not be given to anyone under 18 years old.

How should I take Giazo?

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

Giazo can be taken with or without food.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away. Medicine from the capsule may stain your teeth or tongue yellow/orange when mixed with food. Do not save the mixture for later use.

Call your doctor if your symptoms do not improve, or if they get worse.

Giazo is usually taken only for a short time (8 to 12 weeks). Follow your doctor’s dosing instructions very carefully.

Store at room temperature away from moisture and heat.

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.

What should I avoid while taking Giazo?

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

What is  Ginkgo Biloba?

Ginkgo Biloba is a plant also known as Maidenhair tree, Ginkgo Biloba  biloba, Abricot Argente Japonais, Adiantifolia, Arbre aux Ecus, Arbre du Ciel, Arbre Fossile, Bai Guo Ye, Baiguo,  Extrait de Ginkgo Biloba, Fossil Tree, Graine de Ginkgo Biloba, Herba Ginkgo Biloba Biloba, Japanese Silver Apricot, Kew Tree, Noyer du Japon, Pei Go Su Ye, Salisburia Adiantifolia, Yen Xing, Yinhsing, Arbe aux Quarante Ecus, Extrait de Feuille de Ginkgo Biloba, Ginkgo Biloba Folium and other names.

Ginkgo Biloba has been used in alternative medicine as a possibly effective aid in treating anxiety, certain types of dementia, premenstrual symptoms, vertigo (dizziness), stroke, schizophrenia, or a movement disorder (tardive dyskinesia) caused by taking certain antipsychotic drugs.

Ginkgo Biloba has also been used to treat memory problems, tinnitus (ringing in the ears), high blood pressure, multiple sclerosis, heart disease, and sexual problems caused by taking antidepressants. However, research has shown that Ginkgo Biloba may not be effective in treating these conditions.

Other uses not proven with research have included altitude sickness, macular degeneration (age-related vision loss), attention deficit disorder, dyslexia, vitiligo (discolored skin), migraine, lung disease, high cholesterol, Raynaud’s syndrome, Lyme disease, fibromyalgia, chronic fatigue syndrome, blood clots, seasonal allergy, leg pain caused by blood circulation problems, cough, depression, sexual dysfunction in females, asthma, autism spectrum disorder, chronic kidney disease, cocaine dependence, vision problems, hemorrhoids, intestinal parasite infection, wound healing, and certain type of cancers.

It is not certain whether Ginkgo Biloba is effective in treating any medical condition. Medicinal use of this product has not been approved by the FDA. Ginkgo Biloba should not be used in place of medication prescribed for you by your doctor.

Ginkgo Biloba is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Ginkgo Biloba may also be used for purposes not listed in this product guide.

Ginkgo Biloba 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).

Stop using Ginkgo Biloba and call your healthcare provider at once if you have:

• fast, slow, or uneven heart rate, a light-headed feeling, like you might pass out;
• stroke;
• ringing in your ears;
• a seizure (convulsions);
• headache, dizziness or drowsiness, sleep problems (insomnia);
• weak pulse, weak or shallow breathing, loss of consciousness; or
• unusual bleeding–nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop.

Common side effects of Ginkgo Biloba may include:

• stomach pain, nausea, vomiting, dry mouth;
• diarrhea, constipation; or
• headache, dizziness.

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 .

Creatine is a quickly available source of energy for muscle contractions and is used to enhance …

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Warnings

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Before using Ginkgo Biloba, talk to your healthcare provider. You may not be able to use this product if you have certain medical conditions.

Ask a doctor, pharmacist, or other healthcare provider if it is safe for you to use this product if you have ever had:

• diabetes;
• seizures or epilepsy;
• a bleeding or blood clotting disorder;
• an allergy to plants such as poison ivy, poison oak, poison sumac;
• food allergies; or
• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

 Ginkgo Biloba may affect fertility in men or women. Pregnancy could be harder to achieve if either parent is using this product.

Ginkgo Biloba is considered likely unsafe to use during pregnancy. Taking Ginkgo Biloba during pregnancy could cause bleeding or premature labor.

Ginkgo Biloba is considered likely unsafe to use if you are nursing a baby. Ask a doctor before using this product.

Do not give any herbal/health  supplement to a child without medical advice.

How should I take Ginkgo Biloba?

When considering the use of Ginkgo Biloba, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use Ginkgo Biloba, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Ginkgo Biloba leaf extract is thought to be likely safe when taken in recommended doses. Roasted Ginkgo Biloba seeds are possibly unsafe when taken by mouth.

Fresh Ginkgo Biloba seeds in raw form are poisonous and are considered likely unsafe to eat.

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

Call your doctor if your symptoms do not improve, or if they get worse.

If you need surgery, dental work, or a medical procedure, stop taking Ginkgo Biloba at least 2 weeks ahead of time. Tell your healthcare provider if you have a planned surgery.

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

What happens if I miss a dose?

Skip the missed dose and take the next regularly scheduled dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Ginkgo Biloba?

Do not use different forms of Ginkgo Biloba (pills, liquids, and others) at the same time or you could have an overdose.

Avoid using Ginkgo Biloba together with other herbal/health supplements that can also affect blood-clotting. This includes angelica (dong quai), capsicum, clove, dandelion, danshen, evening primrose, garlic, ginger, horse chestnut, Panax ginseng, poplar, red clover, saw palmetto, turmeric, and willow.

Avoid using Ginkgo Biloba together with other herbal/health supplements that can increase your risk of seizures. This includes EDTA, folic acid, GBL (gamma butyrolactone), GHB (gamma hydroxybutyrate), glutamine, hyssop oil, juniper, L-carnitine (levocarnitine), melatonin, rosemary, sage, wormwood, and others.

What other drugs will affect Ginkgo Biloba?

Do not take Ginkgo Biloba without medical advice if you are using a medication to treat any of the following conditions:

• any type of infection (including HIV, malaria, tuberculosis, or hepatitis C);
• anxiety, depression, or a mental illness;
• asthma or allergies;
• cancer;
• erectile dysfunction;
• heartburn or gastroesophageal reflux disease (GERD);
• high blood pressure, high cholesterol, or a heart condition;
• migraine headaches;
• psoriasis, rheumatoid arthritis, or other autoimmune disorders; or
• seizures.

Do not take Ginkgo Biloba without medical advice if you are using any of the following medications:

• insulin or oral diabetes medicine;
• a blood thinner–warfarin, Coumadin, Jantoven; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

• Panax ginseng
• Panax quinquefolius
• Panax schinseng
• American Ginseng
• Anchi Ginseng
• Asian Ginseng
• Asiatic Ginseng
• Baie Rouge
• Canadian Ginseng
• Chinese Ginseng
• Chinese Red Ginseng
• Ginseng a Cinq Folioles
• Ginseng Occidental
• Ginseng Oriental
• Ginseng Root
• Ginseng, Panax
• Japanese Ginseng
• Korean Ginseng
• Korean Ginseng Root
• Korean Panax
• Korean Panax Ginseng
• Korean Red Ginseng
• Korean White Ginseng
• North American Ginseng
• Oriental Ginseng
• Panax Quinquefolia
• Panax Quinquefolium
• Racine de Ginseng
• Radix Ginseng
• Red Berry
• Red Chinese Ginseng
• Red Ginseng
• Red Kirin Ginseng
• Red Korean Ginseng
• Red Panax Ginseng
• Ren Shen
• Sang
• Shang
• Shi Yang Seng
• Tibetan Ginseng
• White Ginseng
• White Panax Ginseng
• Wisconsin Ginseng
• Xi Yang Shen

What is this product used for?

Ginseng is used by some people as medicine. Science does not support the use of this product for any health problem.

What are the precautions when taking this product?

• Always check with your doctor before you use a natural product. Some products may not mix well with drugs or other natural products.
• Do not use this product if you are pregnant or plan to become pregnant soon. Use birth control you can trust while taking this product.
• Do not use this product if you are breastfeeding.
• This product may interfere with some lab tests. Be sure to talk with your doctor about this and all drugs you are taking.
• Be sure to tell your doctor that you take this product if you are scheduled for surgery or tests.
• Do not use this product in infants or children.
• Take extra care if you are taking drugs to thin your blood. These are drugs like warfarin, heparin, or enoxaparin.
• Take extra care if you are taking drugs to dissolve blood clots. These are drugs like alteplase, reteplase, or streptokinase.
• Take extra care if you are taking drugs to help with swelling or inflammation. These are drugs like nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, ibuprofen, or naproxen.
• Do not use this product if you are taking drugs called MAO inhibitors. These are drugs like isocarboxazid, phenelzine, and tranylcypromine.
• Take extra care if you are taking drugs called “water pills.” These are drugs like furosemide, hydrochlorothiazide, or chlorothiazide. This product may make them not work as well.
• Do not use this product if you have health problems that are sensitive to hormones. These are problems like breast cancer, prostate cancer, or endometriosis.
• Take extra care if you are at a high risk for infection. This includes people who have had a transplant, are on chemo, or have an autoimmune disease.
• If you have blood sugar problems, keep hard candies, glucose tablets, liquid glucose, or juice on hand for low blood sugar.
• Take extra care and check with your doctor if you have:
  • Liver problems
  • Heart problems, especially heart failure
  • Bleeding problems
  • Stomach or bowel problems
  • Blood pressure problems
  • Diabetes
  • Cancer
  • Mental health problems

What should I watch for?

• Upset stomach
• Loss of appetite
• Rash

When do I need to call the doctor?

• Signs of a very bad reaction. These include wheezing; chest tightness; trouble breathing, swallowing, or talking; fever; rash; hives; itching, discolored, swollen, blistered, or peeling skin; or swelling of face, lips, tongue, or throat. Go to the ER right away.
• Signs of overdose. These include high blood pressure, very loose stools, trouble sleeping, breast pain, skin rash, confusion, and very low mood.
• Signs of low blood sugar. These include hunger, dizziness, shaking, a fast heartbeat, confusion, or sweating.
• Signs of high blood pressure like very bad headaches, nervousness, problems breathing, or nosebleeds.
• Signs of low blood pressure like feeling dizzy, weak, or tired; fainting; more thirst; or skin that is pale, cool, and clammy
• Very bad throwing up
• Very bad loose stools
• Trouble sleeping
• Breast pain
• Bruising or bleeding that is not normal
• Changes in menstrual periods like lots of bleeding, spotting, or bleeding between cycles
• Changes in thinking, unusual behavior, low mood, confusion, or restlessness
• Fast heart beat

Last Reviewed Date

2023-06-12

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof.

Uses for glatiramer

Glatiramer injection is used to treat relapsing-forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure multiple sclerosis, but may extend the time between relapses.

This medicine is available only with your doctor’s prescription.

Before using glatiramer

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of glatiramer injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of glatiramer injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to mannitol—Should not be used in patients with this condition.
• Infection—May decrease your body’s ability to fight infections.
• Liver disease—Use with caution. May make this condition worse.

Proper use of glatiramer

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the hips, stomach, thighs, or upper arms. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that have scars or dents.

This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine comes in a prefilled syringe. It may also be given using an autoinjector that is compatible with glatiramer. Make sure your doctor, nurse, or pharmacist instructs you on how to prepare and administer this medicine. Also, read all instructions carefully to make sure you know how to use your device.

To use the injection:

• First, gather the items you will need on a clean cloth or towel in a well-lighted area.
• Wash your hands with soap and water. Do not touch your hair or skin afterwards.
• Remove one prefilled syringe from the carton in the refrigerator. Take the syringe out of the protective wrapper. Allow 20 minutes for the syringe to warm up to room temperature before injecting the medicine.
• Check the liquid in the prefilled syringe. It should be clear or colorless to slightly yellow. If the liquid is cloudy or has particles in it, do not use the syringe. Take out another syringe and follow the same steps for warming.
• Choose an injection site on your body. Clean the injection site with a fresh alcohol wipe, and let it dry.
• Pick up the 1-milliliter prefilled syringe and hold it as you would a pencil, using the hand you write with. Remove the plastic cover from the needle, but do not touch the needle itself.
• Pinch about a 2-inch fold of skin between your thumb and index finger.
• Insert the needle into the 2-inch fold of skin. It may help to steady your hand by resting the heel of your hand against your body.
• When the needle is all the way in, release the fold of skin.
• Inject the medicine by holding the syringe steady while pushing down on the plunger. The injection should take just a few seconds.
• Pull the needle straight out.
• Press a dry clean cotton ball on the injection site for a few seconds, but do not massage it.
• Put the plastic cover back on the needle.
• Throw away any unused medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • For multiple sclerosis (MS):
    • Adults—20 milligrams (mg) injected under the skin once a day, or 40 mg injected under the skin 3 times per week (at least 48 hours apart).
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may also store glatiramer injection at room temperature for up to 1 month. Avoid exposing this medicine to higher temperatures or bright or intense light.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions while using glatiramer

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Some patients have a reaction to this medicine a few minutes after receiving a shot. The symptoms might include: chest pain, flushing, fast, irregular, or pounding heartbeat, anxiety, trouble breathing, a tight feeling in the throat, or hives. These symptoms will usually go away without treatment in a short time. Call your doctor right away if these symptoms become worse or do not go away. This reaction can happen even if you have used the medicine regularly for several months. Also, chest pain can occur by itself, but should not last more than a few minutes.

This medicine may cause serious skin problems, including a permanent depression (dent) under the skin at the injection site. Contact your doctor right away if you have depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin at the injection site.

Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem (eg, liver failure, hepatitis with jaundice).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of glatiramer

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety
• bleeding, hard lump, hives or welts, itching, pain, redness, or swelling at the injection site
• chest pain
• cough or hoarseness
• excessive muscle tone
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• fever or chills
• joint pain
• lower back or side pain
• neck pain
• painful or difficult urination
• redness of the face, neck, arms, and occasionally, upper chest
• skin rash
• swelling or puffiness of the face
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• trouble breathing

Less common

• Agitation
• bloating or swelling
• chest tightness
• confusion
• difficulty with swallowing
• feeling faint, dizzy, or lightheaded
• headache, severe and throbbing
• itching of the vagina or outside genitals
• muscle aches or pain
• pain during sexual intercourse
• purple spots under the skin
• red streaks on the skin
• shakiness in the legs, arms, hands, or feet
• small lumps under the skin
• spasm of the throat
• strong urge to urinate
• sweating
• swelling of the fingers, arms, feet, or legs
• thick, white curd-like vaginal discharge without odor or with mild odor
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• unusual weight gain or loss

Rare

• Blood in the urine
• burning or stinging of the skin
• continuous, uncontrolled back-and-forth or rolling eye movements
• decreased sexual ability
• diarrhea
• difficulty with moving
• ear pain
• fast breathing
• irritation of the mouth and tongue (thrush)
• loss of appetite
• menstrual pain or changes
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• sensation of motion, usually whirling, either of oneself or of one’s surroundings
• speech problems
• vision problems

Incidence not known

• Abnormal vaginal bleeding or discharge
• back pain, sudden and severe
• bleeding gums
• blindness
• blurred or decreased vision
• chest discomfort or heaviness
• clear or bloody discharge from the nipple
• cloudy urine
• coughing up blood
• dark urine
• decreased urine output
• difficult or frequent urination
• dilated neck veins
• dimpling of the breast skin
• drowsiness
• extreme tiredness or weakness
• eye pain
• gaseous stomach pain
• general feeling of discomfort or illness
• general tiredness and weakness
• hair loss
• headache
• heartburn
• increased menstrual flow or vaginal bleeding
• indigestion
• inverted nipple
• joint swelling
• large amount of cholesterol in the blood
• light-colored stools
• lump in the breast or under the arm
• lump or swelling in the stomach
• muscle weakness, sudden and progressing
• nausea
• nerve pain
• nosebleed
• pain or discomfort the in arms or jaw
• paralysis
• persistent crusting or scaling of the nipple
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, lips, or tongue
• rapid, shallow breathing
• recurrent fever
• red or black, tarry stools
• redness or swelling of the breast
• seizures
• sore on the skin of the breast that does not heal
• sore throat
• stiff neck or back
• stomach bloating, burning, cramping, or pain
• tearing
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vomiting
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Lack or loss of strength
• stuffy or runny nose

What is Gleevec?

Gleevec is a targeted therapy cancer treatment used to treat specific types of leukemia (blood cancer), bone marrow disorders, skin cancers and certain tumors of the stomach and digestive system.

Gleevec (imatinib) is an oral tablet that is taken once or twice a day.

Gleevec works by interfering with specific proteins that help tumors grow and spread through the body; they come from the family of medicines called BCR-ABL tyrosine kinase inhibitors. Gleevec was a groundbreaking cancer treatment when it was first FDA approved on May 10, 2001.

Gleevec is used to treat specific types of these cancers:

• Chronic Myeloid (myelogenous) Leukemia (Ph+ CML)
• Acute Lymphoblastic Leukemia (ALL)
• Myelodysplastic / Myeloproliferative Diseases  (MDS/MPD)
• Aggressive Systemic Mastocytosis (ASM)
• Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)
• Dermatofibrosarcoma Protuberans (DFSP)
• Gastrointestinal Stromal Tumors (GIST)

Gleevec (imatinib) is now available as a generic.

Warnings

Gleevec can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Gleevec may increase the risk of liver problems. Tell your doctor if you have upper stomach pain, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Gleevec may increase the risk of fluid retention or heart problems. Tell your doctor if you have swelling or rapid weight gain, shortness of breath, fast or slow heart rate, weak pulse, or fainting.

Before taking this medicine

You should not use Gleevec if you are allergic to imatinib.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B);
• kidney disease;
• underactive thyroid, recent or upcoming thyroid surgery;
• heart disease, high blood pressure, congestive heart failure;
• a stomach ulcer or bleeding;
• diabetes; or
• chemotherapy.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Gleevec if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 14 days after your last dose.

Do not breast-feed a baby while you are using Gleevec and for at least 1 month after your last dose.

How should I take Gleevec?

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

Take Gleevec with a meal and a large glass of water. Do not take Gleevec on an empty stomach.

If you cannot swallow a tablet whole, you may dissolve it in a glass of water or apple juice to make the pill easier to swallow. Use about 2 ounces of liquid for each 100-milligram tablet, or 7 ounces of liquid for each 400-milligram tablet. Stir the mixture and drink all of it right away.

Do not use a broken tablet. The medicine from a broken pill can be dangerous if it gets in your mouth, eyes, or nose, or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water. Ask your pharmacist how to safely dispose of a broken pill.

Gleevec can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

You will also need frequent tests to check your liver function.

Do not stop using Gleevec without your doctor’s advice.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Gleevec Dose for Chronic Myelogenous Leukemia:

Chronic phase: 400 mg orally once a day
Accelerated phase or blast crisis: 600 mg orally once a day

A dose increase may be considered in the absence of a severe adverse drug reaction and severe non-leukemia related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time), failure to achieve a satisfactory hematologic response after at least 3 months of treatment, failure to achieve a cytogenetic response after 6 to 12 months of treatment, or loss of a previously achieved hematologic or cytogenetic response:
-Disease progression chronic phase: 600 mg orally once a day
-Disease progression accelerated phase or blast crisis: 400 mg orally 2 times a day

Uses:
-Newly diagnosed patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase
-Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy

Usual Adult Dose of Gleevec for Acute Lymphoblastic Leukemia:

600 mg orally daily

Use: For relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)

Usual Adult Dose of Gleevec for Myeloproliferative Disorder:

400 mg orally once a day

Comments:
-Determine PDGFRb gene rearrangements status prior to initiating therapy.

Use: For patients with myelodysplastic/myeloproliferative (MDS/MPD) diseases associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements

Usual Adult Dose of Gleevec for Myelodysplastic Disease:

400 mg orally once a day

Comments:
-Determine PDGFRb gene rearrangements status prior to initiating therapy.

Use: For patients with myelodysplastic/myeloproliferative (MDS/MPD) diseases associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements

Usual Adult Dose of Gleevec for Systemic Mastocytosis:

-For patients with ASM without the D816V c-Kit mutation: 400 mg orally daily
-If c-Kit mutational status is not known or unavailable: 400 mg orally daily may be considered for patients with ASM not responding satisfactorily to other therapies.
-For patients with ASM associated with eosinophilia, a clonal hematological disease related to the fusion kinase FIP1L1-PDGFR alpha, a starting dose of 100 mg/day is recommended. Dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
-For patients with ASM associated with eosinophilia (a clonal hematological disease related to the fusion kinase FIP1L1-PDGFR alpha: 100 mg orally daily; a dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy

Comments:
-Determine D816V c-Kit mutation status prior to initiating treatment.

Use: For patients with aggressive systemic mastocytosis without the D816V c-Kit mutation

Usual Adult Dose of Gleevec for Hypereosinophilic Syndrome:

-For patients with HES/CEL: 400 mg orally daily
-For patients with HES/CEL with demonstrated FIP1L1-PDGFR alpha fusion kinase: 100 mg orally daily; dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy

Use: For patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR alpha fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR alpha fusion kinase negative or unknown

Usual Adult Dose of Gleevec for Chronic Eosinophilic Leukemia:

-For patients with HES/CEL: 400 mg orally daily
-For patients with HES/CEL with demonstrated FIP1L1-PDGFR alpha fusion kinase: 100 mg orally daily; dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy

Use: For patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR alpha fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR alpha fusion kinase negative or unknown

Usual Adult Dose of Gleevec for Dermatofibrosarcoma Protuberans:

100 mg orally daily

Use: For patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)

Usual Pediatric Dose of Gleevec for Chronic Myelogenous Leukemia:

1 year and older:
340 mg/m2 orally once a day or 170 mg/m2 orally 2 times a day
Maximum Dose: 600 mg daily
Comments:
-Therapy can be given as a once daily dose or the daily dose may be split into 2 doses, with one portion dosed in the morning and one portion in the evening.
-There is no experience with this drug in children under 1 year of age.

Use:
-Newly diagnosed patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase.

What happens if I miss a dose?

Take your dose as soon as you can, making sure you also eat a meal and drink a large glass of water. 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

Gleevec may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Grapefruit may interact with Gleevec and lead to unwanted side effects. Avoid the use of grapefruit products.

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

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Gleevec side effects

Get emergency medical help if you have signs of an allergic reaction to Gleevec (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).

Call your doctor at once if you have:

• fluid retention–shortness of breath (even while lying down), swelling, rapid weight gain;
• kidney problems–little or no urination, swelling in your feet or ankles;
• fluid build-up in the lungs–pain when you breathe, wheezing, gasping for breath, cough with foamy mucus;
• liver problems–upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• low blood cell counts–fever, cold or flu symptoms, easy bruising, unusual bleeding, mouth sores, pale skin, unusual tiredness, feeling light-headed, cold hands and feet;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• signs of tumor cell breakdown–confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth; or
• thyroid symptoms–tiredness, dry skin, hair loss, constipation, depression, slow heart rate, weight gain, feeling more sensitive to cold temperatures.

Imatinib can affect growth in children and teenagers. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common Gleevec side effects may include:

• fluid retention;
• nausea, vomiting, stomach pain, diarrhea;
• joint or muscle pain;
• skin rash; 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. You may report side effects to FDA .

What other drugs will affect Gleevec?

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.

Tell your doctor about all your current medicines. Many drugs can have interactions with Gleevec, especially:

• an antibiotic, antifungal, or antiviral medicine;
• seizure medicine;
• a blood thinner such as warfarin (Coumadin, Jantoven); or
• a  vitamin or mineral  supplement that contains iron.

What is glimepiride?

Glimepiride is an oral diabetes medicine that is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. glimepiride is not for treating type 1 diabetes.

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

Glimepiride 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).

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

• pale or yellowed skin, dark colored urine;
• confusion, weakness; or
• fever.

Common side effects of glimepiride may include:

• headache;
• dizziness, weakness;
• nausea; or
• low blood sugar.

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

You should not use glimepiride if you have diabetic ketoacidosis, or if you are allergic to sulfa drugs.

Before taking this medicine

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

• an allergy to sulfa drugs; or
• diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• heart disease;
• liver or kidney disease; or
• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

Glimepiride may increase your risk of serious heart problems, but not treating your diabetes can also damage your heart and other organs. Talk to your doctor about the risks and benefits of glimepiride.

Follow your doctor’s instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby. However, you may need to stop taking glimepiride for a short time just before your due date.

Medications similar to glimepiride have caused severe hypoglycemia in newborn babies whose mothers used the medicine near the time of delivery. If you take glimepiride during pregnancy, stop taking this medicine at least 2 weeks before your due date.

If you breastfeed while taking glimepiride, call your doctor if your baby shows signs of hypoglycemia (extreme drowsiness, feeding problems, mottled skin, blue lips, feeling cold or jittery, or having a seizure).

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

How should I take glimepiride?

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.

Glimepiride is usually taken once a day with breakfast or the first main meal of the day. Follow your doctor’s instructions. Take glimepiride with a full glass of water.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor’s office.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Glimepiride is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

Glimepiride dosing information

Usual Adult Dose for Diabetes Type 2:

Initial dose: 1 to 2 mg orally once a day
Maintenance dose: Increase in 1 or 2 mg increments no more frequently than every 1 to 2 weeks based on glycemic response
Maximum dose: 8 mg per day

Comments:
-Administer with breakfast or first main meal of the day.
-In patients who are at increased risk for hypoglycemia, start with 1 mg orally once a day and titrate slowly.
-When patients are being transferred to this drug from a longer half-life sulfonylurea, monitor 1 to 2 weeks for overlapping drug effect.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Usual Geriatric Dose for Diabetes Type 2:

Initial dose: 1 mg orally once a day; titrate slowly and monitor closely

Usual Pediatric Dose for Diabetes Type 2:

Not recommended because of adverse effects on body weight and hypoglycemia.

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 . A glimepiride overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

What should I avoid while taking glimepiride?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

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

What other drugs will affect glimepiride?

Glimepiride may not work as well when you use other medicines 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.

If you also take colesevelam, take your glimepiride dose at least 4 hours before you take colesevelam.

Other drugs may affect glimepiride, 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.

What is glipizide?

Glipizide is an oral diabetes medicine that helps control blood sugar levels by helping your pancreas produce insulin.

Glipizide is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Glipizide is not for treating type 1 diabetes.

Warnings

You should not use glipizide if you have diabetic ketoacidosis (call your doctor for treatment).

Before taking this medicine

You should not use this medicine if you are allergic to glipizide, or if you have diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• liver or kidney disease;
• chronic diarrhea, or a blockage in your intestines; or
• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

Follow your doctor’s instructions about using glipizide if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby. You should not take glipizide during the last 2 weeks of pregnancy. Agents other than glipizide are currently recommended to treat diabetes in pregnant women.

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

How should I take glipizide?

Take glipizide exactly as prescribed by your doctor. 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.

Take the regular tablet 30 minutes before your first meal of the day.

Take the glipizide extended-release tablet with your first meal of the day.

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

Your blood sugar may need to be checked often, and you may need other blood tests at your doctor’s office.

Low blood sugar (hypoglycemia) can happen to anyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Some forms of glipizide are made with a shell that is not absorbed or melted in the body. Part of the tablet shell may appear in your stool. This is a normal side effect and will not make the medication less effective.

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

What happens if I miss a dose?

Take your dose as soon as you can, but only if you are getting ready to eat a meal. If you skip a meal, skip the missed dose and wait until your next meal. 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 . A glipizide overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What to avoid

Avoid drinking alcohol. It lowers blood sugar and can cause side effects.

Avoid driving or operating machinery until you know how this medicine will affect you.

Glipizide side effects

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

Call your doctor at once if you have symptoms of low blood sugar:

• headache, irritability
• sweating, fast heart rate;
• dizziness, nausea; or
• hunger, feeling anxious or shaky.

Common glipizide side effects may include:

• diarrhea, constipation, gas;
• dizziness, drowsiness;
• tremors; or
• skin rash, redness, or itching.

What is glucagon?

Glucagon is a hormone that increases blood sugar levels. It also slows involuntary muscle movements of the stomach and intestines that aid in digestion.

Glucagon injection is a prescription medicine used to treat very low blood sugar (hypoglycemia).

Glucagon is also used to stop stomach movement during radiologic (x-ray) examinations undertaken to diagnose certain disorders of the stomach or intestines.

Glucagon is available as an auto-injector, prefilled syringe, or injection vial.

Warnings

Glucagon should be used to treat hypoglycemia only if the person cannot eat, passes out, or is having a seizure. Be sure you know how to give a glucagon injection before you need to use it. Hypoglycemia should be treated as quickly as possible. Having low blood sugar for too long can cause seizure, coma, or death.

You should not use glucagon injection if you are allergic to glucagon or lactose, or if you have a tumor of the pancreas (insulinoma) or adrenal gland (pheochromocytoma).

Avoid driving and doing other tasks or actions that call for you to be alert until you have eaten sugar or a product that has sugar in it like a regular soft drink or fruit juice. Avoid these tasks or actions until you feel fully alert.

Low blood sugar can happen with this medicine (glucagon auto-injectors and prefilled syringes) in people who have certain types of pancreas tumors (glucagonoma, insulinoma). Very low blood sugar can lead to seizures, confusion, passing out, and sometimes death. If signs of low blood sugar happen after using this glucagon, get medical help right away.

Before taking this medicine

You should not use this medicine if you are allergic to glucagon or lactose, or if you have:

• a tumor of the pancreas (insulinoma); or
• a tumor of the adrenal gland (pheochromocytoma).

Glucagon should be used to treat hypoglycemia only if the person is unable to eat, or is unconscious or having a seizure.

Tell your doctor if:

• you have any tumor of the pancreas;
• you have not recently eaten on a regular basis; or
• you have chronic low blood sugar.

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

Glucagon is not expected to harm an unborn baby, but quickly treating hypoglycemia would outweigh any risks posed by using glucagon.

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

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medicine.

How should I use glucagon?

Use glucagon exactly as prescribed by your doctor. Hypoglycemia should be treated as quickly as possible. Having low blood sugar for too long can cause seizure, coma, or death.

Glucagon is injected under the skin, into a muscle, or into a vein. You will be shown how to use the emergency injections for severe hypoglycemia. Call your doctor after each time you use a glucagon injection.

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

Be sure you know how to give a glucagon injection before you need to use it. The correct dose for a child is lower than an adult dose. A child’s dose may also be based on how much the child weighs. Follow your doctor’s dosing instructions very carefully.

You may need to mix glucagon with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

After the injection, you should eat a fast-acting source of sugar (fruit juice, glucose gel, hard candy, raisins, or non-diet soda) and then eat a snack or small meal such as cheese and crackers or a meat sandwich.

If you are a caregiver, get emergency medical help after giving a glucagon injection. If the patient does not improve within 15 minutes, you may need to mix a new dose and give a second injection.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

To keep from having severe hypoglycemia, follow your diet, medication, and exercise routines very closely.

Store glucagon and any diluent at room temperature, away from moisture, heat, and light. Do not refrigerate or freeze. Throw away any mixed medicine you have not used right away. Do not use this medicine after the expiration date on the label has passed.

Store the auto-injector or prefilled syringe in the foil pouch and use the medicine right away after opening.

What happens if I miss a dose?

Since glucagon is used as needed, it does not have a daily dosing schedule.

Call your doctor promptly if symptoms do not improve after using glucagon.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include nausea, vomiting, diarrhea, rapid pulse, or high blood pressure (severe headache, blurred vision, pounding in your neck or ears).

What should I avoid after using glucagon?

Avoid drinking alcohol. It can lower your blood sugar.

Glucagon side effects

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

Call your doctor at once if you have any of the following skin changes on your face, legs, groin, or genital area:

• redness;
• itching;
• blistering;
• crusting, scaling; or
• other skin sores or lesions.

Common glucagon side effects may include:

• nausea, vomiting; or
• swelling where an injection was given.

What is Glucophage?

Glucophage is an oral diabetes medicine that helps control blood sugar levels.

Glucophage is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Glucophage is sometimes used together with insulin or other medications, but metformin is not for treating type 1 diabetes.

Warnings

You should not use Glucophage if you have severe kidney disease, metabolic acidosis, or diabetic ketoacidosis (call your doctor for treatment).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Glucophage.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Before taking this medicine

You should not use Glucophage if you are allergic to metformin, or if you have:

• severe kidney disease; or
• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Glucophage. Be sure your caregivers know ahead of time that you are using this medication.

Tell your doctor if you have ever had:

• kidney disease (your kidney function may need to be checked before you take this medicine);
• high ketone levels in your blood or urine;
• heart disease, congestive heart failure;
• liver disease; or
• if you also use insulin, or other oral diabetes medications.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

Follow your doctor’s instructions about using Glucophage if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby. Tell your doctor if you become pregnant while taking Glucophage.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while using this medicine.

Glucophage should not be given to a child younger than 10 years old. Glucophage XR is not approved for use by anyone younger than 18 years old.

How should I take Glucophage?

Take Glucophage 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. Use the medicine exactly as directed.

Take Glucophage with a meal, unless your doctor tells you otherwise. Glucophage XR is taken only once daily with the evening meal. Follow your doctor’s instructions.

Do not crush, chew, or break an extended-release tablet. Swallow the tablet whole.

Glucophage XR tablet are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Glucophage is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

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

Your doctor may have you take extra  vitamin B12 while you are taking metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

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 can cause severe hypoglycemia or lactic acidosis.

What to avoid

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Glucophage side effects

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

Some people using metformin develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:

• unusual muscle pain;
• feeling cold;
• trouble breathing;
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, vomiting; or
• slow or irregular heart rate.

Common Glucophage side effects may include:

• low blood sugar;
• nausea, upset stomach; or
• diarrhea.

What is glycopyrrolate?

Glycopyrrolate helps to control conditions such as peptic ulcers that involve excessive stomach acid production.

Glycopyrrolate is also used to reduce drooling in children ages 3 to 16 who have certain medical conditions, such as cerebral palsy.

Glycopyrrolate injection is also used during surgery to reduce secretions in your stomach or airway, and to help protect your heart and nervous system while you are under general anesthesia.

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

Glycopyrrolate 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.

Glycopyrrolate may cause serious side effects. Stop using glycopyrrolate and call your doctor at once if you have:

• severe constipation, severe stomach pain and bloating;
• diarrhea (especially if you have a colostomy or ileostomy);
• painful or difficult urination;
• fast or pounding heartbeats, fluttering in your chest;
• confusion, severe drowsiness;
• eye pain, seeing halos around lights;
• fever, shallow breathing, weak pulse, hot and red skin; or
• (in a child taking glycopyrrolate) dry diapers, fussiness, or excessive crying.

Common side effects of glycopyrrolate may include:

• constipation, nausea, vomiting, bloating;
• drowsiness, dizziness, weakness, feeling nervous;
• slow or fast heartbeats;
• sleep problems (insomnia);
• flushing (sudden warmth, redness, or tingly feeling);
• blurred vision, sensitivity to light;
• dry mouth, decreased sense of taste;
• decreased sweating, decreased urination;
• impotence, sexual problems;
• headache; or
• 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 .

Warnings

You should not use glycopyrrolate if you have urination problems, a blockage in your stomach or intestines, severe constipation, severe ulcerative colitis or toxic megacolon, glaucoma, myasthenia gravis, or active bleeding with heart and blood circulation problems.

Before taking this medicine

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

• a bladder obstruction or other urination problems;
• a stomach or bowel obstruction (including paralytic ileus);
• severe constipation;
• severe ulcerative colitis or toxic megacolon;
• glaucoma;
• myasthenia gravis; or
• active bleeding with fast heartbeats, low blood pressure, shortness of breath, and cold hands or feet.

Tell your doctor if you have ever had:

• an enlarged prostate;
• liver or kidney disease;
• heart problems or a heart rhythm disorder;
• high blood pressure;
• a stomach disorder such as ulcerative colitis, hiatal hernia, reflux disease, or slow digestion;
• a colostomy or ileostomy;
• a thyroid disorder; or
• a nerve disorder.

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

You should not breastfeed while using glycopyrrolate. Glycopyrrolate may slow breast milk production.

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

How should I use glycopyrrolate?

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 need to take glycopyrrolate on an empty stomach, at least 1 hour before or 2 hours after a meal. Follow the instructions provided with your medicine.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Allow the orally disintegrating tablet to dissolve in your mouth without chewing. Swallow the tablet without water.

Glycopyrrolate doses are based on weight in children. Your child’s dose needs may change if the child gains or loses weight.

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

Glycopyrrolate injection is given as an infusion into a vein or injected into a muscle. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

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 severe muscle weakness, loss of movement, dilated pupils, jerky muscle movements, or seizure (convulsions).

What should I avoid while using glycopyrrolate?

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

Avoid becoming overheated or dehydrated during exercise and in hot weather. Glycopyrrolate can decrease sweating and you may be more prone to heat stroke.

Drinking alcohol with this medicine can cause side effects.

What other drugs will affect glycopyrrolate?

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.

Tell your doctor about all your other medicines, especially:

• medicine to treat depression, anxiety, mood disorders, or mental illness;
• opioid medication;
• sleep medicine, cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson’s disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder;
• bronchodilator asthma medication; or
• seizure medication.

Uses for glycerin

Glycerin , when taken by mouth, is used to treat certain conditions in which there is increased eye pressure, such as glaucoma. It may also be used before eye surgery to reduce pressure in the eye.

Glycerin may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor’s prescription.

Before using glycerin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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Pediatric

Although there is no specific information comparing use of glycerin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Glycerin reduces water in the body, and there may be an increased risk that elderly patients taking it could become dehydrated.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Arsenic Trioxide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus—Use of glycerin may increase the chance of dehydration (loss of too much body water)

• Confused mental states or
• Heart disease or
• Kidney disease—Glycerin may make these conditions worse

Proper use of glycerin

It is very important that you take this medicine only as directed. Do not take more of it and do not take it more often than your doctor ordered.

To improve the taste of this medicine, mix it with a small amount of unsweetened lemon, lime, or orange juice, pour over cracked ice, and sip through a straw.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (oral solution):
  • To lower pressure in the eye:
    • Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 2 grams per kilogram (kg) (0.45 to 0.91 grams per pound) of body weight taken one time. Then, additional doses of 500 milligrams (mg) per kg (227 mg per pound) of body weight every six hours may be taken if needed.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 1.5 grams per kg (0.45 to 0.68 grams per pound) of body weight taken one time. The dose may be repeated in four to eight hours if needed.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions while using glycerin

Your doctor should check your progress at regular visits to make sure that this medicine is working properly.

In some patients, headaches may occur when this medicine is taken. To help prevent or relieve the headache, lie down while you are taking this medicine and for a short time after taking it. If headaches become severe or continue, check with your doctor.

Side Effects of glycerin

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Confusion

Rare

• Irregular heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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More common

• Headache
• nausea or vomiting

Less common

• Diarrhea
• dizziness
• dryness of mouth or increased thirst

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

What is Glyxambi?

Glyxambi contains a combination of empagliflozin and linagliptin. Empagliflozin and linagliptin are oral diabetes medicines that help control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Linagliptin works by regulating the levels of insulin your body produces after eating.

Glyxambi is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Glyxambi is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

This medicine is not for treating type 1 diabetes.

Warnings

You should not use Glyxambi if you have severe kidney disease (or if you are on dialysis) or diabetic ketoacidosis, or if you have ever had a severe allergic reaction to empagliflozin or linagliptin.

Call your doctor at once if you have signs of a serious side effect, such as severe pain in your upper stomach spreading to your back, vomiting, fast heart rate, dizziness, feeling very thirsty or hot, decreased urination, heavy sweating, or hot and dry skin.

In rare cases, Glyxambi can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don’t feel well.

Before taking this medicine

You should not use Glyxambi if you are allergic to empagliflozin or linagliptin, or if you have:

• severe kidney disease (or if you are on dialysis);
• a history of severe allergic or skin reaction after taking empagliflozin or linagliptin; or
• diabetic ketoacidosis (call your doctor for treatment).

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

• liver or kidney disease;
• a bladder infection or urination problems;
• a pancreas disorder;
• heart failure;
• gallstones;
• a genital infection (penis or vagina);
• alcoholism, or if you currently drink large amounts of alcohol;
• if you are on a low salt diet;
• if you are 65 or older.
• if you have a planned surgery; or
• if you have high cholesterol or triglycerides.

Follow your doctor’s instructions about using Glyxambi if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

You should not use Glyxambi during the second or third trimester of pregnancy.

You should not breastfeed while using Glyxambi.

How should I take Glyxambi?

Take Glyxambi 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..

Glyxambi is usually taken in the morning, with or without food.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Empagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Glyxambi can affect the results of certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Glyxambi.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store Glyxambi.at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of Glyxambi for Diabetes Type 2:

Initial dose: Empagliflozin 10 mg-linagliptin 5 mg orally once a day in the morning
-For patients tolerating therapy, may increase to empagliflozin 25 mg-linagliptin 5 mg once a day
Maximum dose: Empagliflozin 25 mg-linagliptin 5 mg per day

Comments:
-Not recommended in patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis in these patients.
-Has not been studied in patients with a history of pancreatitis and it is not know whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis during therapy.
-When used in combination with insulin or insulin secretagogues, a lower dose of the insulin secretagogues or insulin may be necessary to reduce the risk of hypoglycemia.

Uses:
-As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
-Empagliflozin is indicated to reduce the risk of cardiovascular death in patients with diabetes mellitus and established cardiovascular disease.

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 Glyxambi?

Avoid drinking alcohol.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Glyxambi side effects

Get emergency medical help if you have signs of an allergic reaction to Glyxambi: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Stop taking Glyxambi and call your doctor at once if you have:

• pain and burning when you urinate, painful urination;
• a light-headed feeling, like you might pass out;
• low blood sugar – headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky;
• heart problems – swelling, rapid weight gain, feeling short of breath; or
• dehydration – dizziness, confusion, feeling very thirsty, less urination.

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

• severe or ongoing pain in your joints;
• serious skin reaction – itching, blisters, breakdown of the outer layer of skin;
• ketoacidosis (too much acid in the blood) – nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
• pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting.

Common Glyxambi side effects may include:

• a bladder infection; or
• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

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 Glyxambi?

Other drugs may increase or decrease the effects of Glyxambi on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin, or other oral diabetes medicine;
• rifampin (to treat tuberculosis); or
• a diuretic or “water pill.”

What is glucosamine?

Glucosamine is sugar protein that helps your body build cartilage (the hard connective tissue located mainly on the bones near your joints).

Glucosamine is a naturally occurring substance found in bones, bone marrow, shellfish and fungus.

Glucosamine has been used in alternative medicine as an aid to relieving joint pain, swelling, and stiffness caused by arthritis.

Not all uses for glucosamine have been approved by the FDA. Glucosamine should not be used in place of medication prescribed for you by your doctor.

Glucosamine is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Glucosamine may also be used for purposes not listed in this product guide.

Glucosamine side effects

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

Common side effects of glucosamine may include:

• nausea, vomiting;
• diarrhea, constipation; or
• heartburn.

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

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use this product if you are allergic to glucosamine.

Ask a doctor, pharmacist, or other healthcare provider if it is safe for you to use this product if you have:

• diabetes;
• high cholesterol or triglycerides (a type of fat in the blood);
• cancer;
• liver disease;
• asthma or other breathing disorder;
• if you are allergic to shellfish; or
• if you take a blood thinner (warfarin, Coumadin, Jantoven).

It is not known whether glucosamine will harm an unborn baby. Do not use this product without medical advice if you are pregnant.

Glucosamine may pass into breast milk and may harm a nursing baby. Do not use this product without medical advice if you are breast-feeding a baby.

Do not give any herbal/health supplement to a child without medical advice.

How should I take glucosamine?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use glucosamine, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Do not use different formulations of glucosamine at the same time without medical advice. Using different formulations together increases the risk of an overdose of glucosamine.

glucosamine can cause unusual results with a blood glucose (sugar) test. Do not use this product without a doctor’s advice if you are diabetic.

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

It may take up to 8 weeks before your symptoms improve. For best results, keep using glucosamine as directed.

Call your doctor if your symptoms do not improve, or if they get worse while using glucosamine.

Store at room temperature away from moisture and heat.

Glucosamine dosing information

Usual Adult Dose for Dietary Supplement:

This product is a dietary supplement with no official approved dosing. Consult product labeling.

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra glucosamine 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 glucosamine?

Some glucosamine products also contain manganese. Taking too much of this combination can cause a manganese overdose. Do not take more than directed on the medicine label.

What other drugs will affect glucosamine?

Other drugs may interact with glucosamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What is Glucotrol?

Glucotrol is an oral diabetes medicine that helps control blood sugar levels by helping your pancreas produce insulin.

Glucotrol is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Glucotrol is not for treating type 1 diabetes.

Warnings

You should not use Glucotrol if you have diabetic ketoacidosis (call your doctor for treatment).

Before taking Glucotrol, tell your doctor if you have kidney or liver disease, chronic diarrhea or a blockage in your intestines, glucose-6-phosphate dehydrogenase deficiency (G6PD), a disorder of your pituitary or adrenal glands, a history of heart disease, or if you are malnourished.

Before taking this medicine

You should not use Glucotrol if you are allergic to glipizide, or if you have diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• liver or kidney disease;
• chronic diarrhea, or a blockage in your intestines; or
• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

Follow your doctor’s instructions about using Glucotrol if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby. However, you may need to stop taking Glucotrol for a short time just before your due date.

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

How should I take Glucotrol?

Take Glucotrol exactly as prescribed by your doctor. 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.

Take the regular tablet 30 minutes before your first meal of the day.

Take the Glucotrol XL extended-release tablet with your first meal of the day. Swallow the tablet whole and do not crush, chew, or break it.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor’s office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

When you take Glucotrol XL you may see something in your stool that looks like a tablet. This is the empty shell from the tablet. It is normal for the empty shell to pass with your bowel movement after medicine has been absorbed by your body.

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

Dosing information

Usual Adult Dose of Glucotrol for Diabetes Type 2:

Immediate release:
Initial dose: 5 mg orally once a day, 30 minutes before breakfast
Maintenance dose: Up to 40 mg in divided doses 30 minutes before a meal of adequate caloric content. Doses may be increased in intervals of 2.5 to 5 mg a day according to blood glucose response.
Maximum single dose: 15 mg
Maximum daily dose: 40 mg
Comments:
-At least several days should elapse between titration steps.
-If response to a single dose is not satisfactory, dividing that dose may prove effective.

Extended Release:
Initial dose: 5 mg orally once a day, 30 minutes before breakfast
Maintenance dose: 5 to 10 mg orally once a day
Maximum daily dose: 20 mg
Patients receiving immediate release may be switched safely to extended release tablets once-a-day at the nearest equivalent total daily dose, or titrate to the appropriate extended release dose starting with 5 mg once daily.
Combination use:
-When adding other blood-glucose-lowering agents to the extended release tablets, the agent should be initiated at the lowest recommended dose. Observe for hypoglycemia.
-When adding extended release tablets to other blood-glucose-lowering agents, Glucotrol XL extended release can be initiated at 5 mg. Start at a lower dose in patients that are more sensitive to hypoglycemia.

When transferring patients from insulin to glipizide, the following general guidelines should be considered:
-For patients with daily insulin doses of 20 units or less: Discontinue insulin and begin glipizide at usual dosages.
-For patients with daily insulin doses greater than 20 units: Insulin dose should be reduced by 50% and glipizide therapy may begin at usual dosages.
Comments:
-Several days should elapse between titration steps.
-Subsequent reductions in insulin dosage should depend on individual patient response.
-During the insulin withdrawal period, the patient should test urine samples for sugar and ketone bodies at least three times daily.
-Some patients receiving greater than 40 units of insulin daily may need to consider hospitalization during the transition period.

Patients Receiving Other Oral Hypoglycemic Agents:
-When transferring from longer half-life sulfonylureas: Observe for 1 to 2 weeks for hypoglycemia.
-Glucotrol XL extended release coadministered with colesevelam: Glipizide should be administered at least 4 hours prior to colesevelam.

Use: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Usual Geriatric Dose of Glucotrol for Diabetes Type 2:

Initial dose: 2.5 mg orally once a day 30 minutes before breakfast

Comments:
-Maintenance dosing should be conservative to avoid hypoglycemic reactions.
-Doses can be adjusted with caution taking into account the degree of hepatic, renal, or cardiac function, and the concomitant disease or other drug therapy.

Use: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

What happens if I miss a dose?

Take your dose as soon as you can, but only if you are getting ready to eat a meal. If you skip a meal, skip the missed dose and wait until your next meal. 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 . A glipizide overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What to avoid

Avoid drinking alcohol. It lowers blood sugar and can cause side effects.

Avoid driving or operating machinery until you know how glipizide will affect you.

Glucotrol side effects

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

Call your doctor at once if you have symptoms of low blood sugar:

• headache, irritability
• sweating, fast heart rate;
• dizziness, nausea; or
• hunger, feeling anxious or shaky.

Common Glucotrol side effects may include:

• diarrhea, constipation, gas;
• dizziness, drowsiness;
• tremors; or
• skin rash, redness, or itching.

• Gamma-Glutamylcysteinylglycine
• Gamma-L-Glutamyl-L-Cysteinylglycine
• Glutathion
• GSH
• L-Glutathion
• L-Glutathione

What is this product used for?

Glutathione is used by some people as medicine. Science does not support the use of this product for any health problem.

What are the precautions when taking this product?

• Always check with your doctor before you use a natural product. Some products may not mix well with drugs or other natural products.
• Be sure to tell your doctor if you are pregnant, plan on getting pregnant, or are breastfeeding. You will need to talk about the benefits and risks of using this natural product.
• Take extra care if you are taking the drug acetaminophen.
• Take extra care and check with your doctor if you have:
  • Liver problems
  • Cancer
  • Asthma (if inhaling glutathione mist)

What should I watch for?

• Increased gas
• Skin becomes red and hot, or flushed
• Weight gain

When do I need to call the doctor?

• Signs of a very bad reaction. These include wheezing; chest tightness; trouble breathing, swallowing, or talking; fever; rash; hives; itching, discolored, swollen, blistered, or peeling skin; or swelling of face, lips, tongue, or throat. Go to the ER right away.
• Very bad loose stools
• Cough, constricted airway, and difficulty breathing after inhaling the mist of liquid glutathione through a nebulizer

Last Reviewed Date

2023-06-12

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