What is Qalsody?

Qalsody (tofersen) is a prescription medicine used to treat amyotrophic lateral sclerosis (ALS) in adults who have a specific genetic mutation in the superoxide dismutase 1 (SOD1) gene. Qalsody is the first FDA-approved treatment that targets a genetic cause of ALS to slow progression of ALS. Qalsody works by reducing the amount of a toxic protein (SOD1 protein) that causes damage to motor neurons and the symptoms of ALS .

ALS  patients who have a mutation in the SOD1 gene (SOD1-ALS) make a toxic misfolded form of SOD1 protein that damages the motor neurons which causes muscle weakness, loss of function, and in time even death. Qalsody is an antisense oligonucleotide (ASO) that lowers the amount the toxic SOD1 protein made by binding to SOD1 mRNA, which may help slow the progression of ALS.

Warnings

Qalsody can cause serious side effects, contact your doctor immediately if you have:

Inflammation of the spinal cord (myelitis) and/ or irritation of the nerve roots (radiculitis) can occur in patients treated with Qalsody. Discuss with your healthcare provider to learn about the symptoms associated with myelitis or radiculitis. Treatment with Qalsody may need to be interrupted or discontinued.

Swelling of the optic nerve (papilledema) and increased pressure inside the skull (elevated intracranial pressure ) can occur in patients treated with Qalsody.  Discuss with your healthcare provider what the symptoms associated with papilledema or elevated intracranial pressure are.

Inflammation of the brain linings (aseptic meningitis) can occur in patients treated with Qalsody in patients treated with Qalsody. Discuss with your healthcare provider to learn more about symptoms associated with aseptic meningitis.

What should I tell my doctor before taking Qalsody?

Before taking this medicine it is important to tell your healthcare provider if you are pregnant or planning to become pregnant or are breastfeeding or planning to breastfeed.

How is Qalsody administered?

 Qalsody is administered intrathecally using a lumbar puncture, this means that it is given as an injection into the spinal canal.

Dosing information

Loading dose: 100 mg intrathecally every 14 days for 3 doses

Maintenance dose: 100 mg intrathecally every 28 days

Comments:

• Consider utilizing patient sedation and/or imaging techniques to facilitate administration of this drug.
•  Before administering this medicine remove 10 mL from cerebrospinal fluid and then administer Qalsody as an intrathecal bolus injection over 1 to 3 minutes using a lumbar puncture needle.
• If the second loading dose is missed, administer it as soon as possible, and administer the third loading dose 14 days later.
• If the third loading dose or a maintenance dose is missed, administer it as soon as possible, and administer the next dose 28 days later.

Use: For the treatment of amyotrophic lateral sclerosis in adults who have a mutation in the superoxide dismutase 1 gene. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Dosage form: Injection 100 mg/15 mL (6.7 mg/mL) solution in a single-dose vial that is free of preservatives.

What are the side effects of Qalsody?

Common Qalsody side effects may include:

• pain including back pain and pain in arms or legs
• feeling tired
• muscle and joint pain
• increased white blood cell count in the cerebrospinal fluid (CSF).

Less Common but serious side effects include:

• myelitis and radiculitis (see warnings above)
• papilledema and elevated intracranial pressure (see warnings above)
• aseptic meningitis (see warnings above)

What is Qbrelis?

Qbrelis is used alone or in combination with other medications to treat high blood pressure in adults and children at least 6 years old.

Qbrelis is also used in adults to treat congestive heart failure and to improve survival after a heart attack.

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

Qbrelis side effects

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

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

• a light-headed feeling, like you might pass out;
• high blood potassium–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• low white blood cell counts–fever, mouth sores, skin sores, sore throat, cough;
• kidney problems–swelling, urinating less, feeling tired or short of breath; or
• liver problems–loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Qbrelis may include:

• headache, dizziness;
• low blood pressure, cough; or
• chest pain.

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

Warnings

Do not use if you are pregnant. Stop using Qbrelis and tell your doctor right away if you become pregnant.

Tell your doctor about all your other medicines. Some drugs should not be used with Qbrelis.

Before taking this medicine

You should not use Qbrelis if you are allergic to it or to any other ACE (angiotensin converting enzyme) inhibitor such as captopril, fosinopril, enalapril, benazepril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

Do not take Qbrelis within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not take Qbrelis with any medication that contains aliskiren (a blood pressure medicine).

Do not take Qbrelis if you have a history of angioedema (severe allergic reaction).

Tell your doctor if you have ever had:

• heart disease, heart problems such as a recent heart attack;
• low blood pressure;
• low white blood cell count;
• stomach pain;
• if you are on a low-salt diet;
• diabetes;
• liver disease; or
• kidney disease (or if you are on dialysis).

You may also need to avoid taking Qbrelis with aliskiren if you have kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Qbrelis can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Do not breastfeed.

How should I take Qbrelis?

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

You may take Qbrelis with or without food.

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

Your blood pressure will need to be checked often and you may need frequent blood tests.

Tell your doctor if you have a planned surgery.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Qbrelis. This can lead to very low blood pressure, an electrolyte imbalance, or kidney failure.

If you have high blood pressure, keep using Qbrelis even if you feel well. High blood pressure often has no symptoms.

Store tightly closed at room temperature, away from moisture and heat. Do not freeze.

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 Qbrelis?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

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

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Generic name: glycopyrronium tosylate [ glye-koe-pir-OH-nee-um-TOS-i-late ]
Drug class: Miscellaneous topical agents 

Uses for Qbrexza

Glycopyrronium tosylate is used to treat excessive underarm sweating (primary axillary hyperhidrosis).

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

Before using Qbrexza

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 glycopyrronium tosylate in children younger than 9 years of age. 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 glycopyrronium tosylate in the elderly.

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:

• Bladder problems (eg, distended bladder, bladder-neck obstruction) or
• Enlarged prostate or
• Trouble passing urine—Use with caution. May make these conditions worse.

• Blood or vessel disease in acute bleeding, unstable or
• Glaucoma or
• Myasthenia gravis (nerve or muscle disease) or
• Sjogren’s syndrome (immune system disorder) or
• Stomach or bowel problems (eg, paralytic ileus, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis)—Should not be used in patients with these conditions.
• Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper use of Qbrexza

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Apply this medicine to clean, dry skin on your underarm areas only. Do not get it into your eyes, nose, or mouth. Do not swallow the medicine or apply over broken skin.

To use the cloth:

• Wash your hands with soap and water before and after you use this medicine.
• Tear open the pouch and pull out the cloth.
• Unfold the cloth and wipe across one underarm one time. Use the same cloth and wipe across the other underarm one time.
• Do not apply this medicine to broken skin. Do not cover the treated area with a bandage unless your doctor has told you to.

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 topical dosage form (cloth):
  • For excessive sweating of the underarms:
    • Adults and children 9 years of age and older—Apply 1 cloth to both underarm areas once every 24 hours.
    • Children younger than 9 years of age—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

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

Keep this medicine away from heat or flame.

Precautions while using Qbrexza

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

Do not use this medicine to treat a skin problem your doctor has not examined.

This medicine may cause urinary retention (trouble passing urine or not fully emptying the bladder), especially if you have bladder blockage. Check with your doctor right away if you or your child has a decrease in urine volume, a decrease in the frequency of urination, difficulty in passing urine, feeling of full bladder, or painful urination.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. Avoid places that are very hot. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine may cause blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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 Qbrexza

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:

Less common

• Bigger, dilated, or enlarged pupils (black part of the eye)
• blurred vision
• different size pupils of the eyes
• trouble in urinating

Incidence not known

• Decrease in frequency of urination
• decrease in urine volume
• difficulty in emptying your bladder
• difficulty in passing urine (dribbling)
• painful urination

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

• Dry mouth
• fever
• headache
• increased sensitivity of the eyes to light
• muscle aches
• pain in the mouth or throat
• redness, burning, stinging, or itching of the skin
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Less common

• Constipation
• dry eye
• dry skin
• dry throat
• nasal dryness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Commonly used brand name(s)

In the U.S.

• Qbrexza

Available Dosage Forms:

• Pad

Therapeutic Class: Cholinergic Antagonist

Pharmacologic Class: Antimuscarinic

What is Qelbree?

Qelbree is a once-a-day treatment for attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older. Qelbree is a non-stimulant ADHD medicine that may help to improve attention and reduce hyperactivity and impulsiveness.

Qelbree is thought to work by increasing levels of norepinephrine, a chemical messenger found in the brain, by blocking a protein called pre-synaptic norepinephrine transporter. ADHD has been associated with low levels of norepinephrine, leading to symptoms such as hyperactivity, impulsivity, and lack of attention, so increasing norepinephrine levels may reduce ADHD symptoms. Qelbree is classified as a selective norepinephrine reuptake inhibitor (NRI). 

Qelbree’s FDA approval was received on April 2, 2021, and it is now indicated for the treatment of ADHD in adults and pediatric patients 6 years and older. Qelbree contains the active ingredient (which is sometimes referred to as the generic name) viloxazine.

Qelbree side effects

Common Qelbree side effects

Common Qelbree side effects in adults are trouble sleeping, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. 

Common Qelbree side effects in pediatric patients are sleepiness, decreased appetite, tiredness, nausea, vomiting, trouble sleeping, and irritability.

These common side effects occurred in 5% or more of patients, at least twice the rate of patients taking a placebo.

Serious Qelbree side effects

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

Report any new or worsening symptoms to your doctor, such as mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have symptoms of a manic episode. Manic symptoms include racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, or being agitated or talkative.

This medicine can affect weight in children. Tell your doctor if your child loses weight or is not gaining weight at a normal rate.

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

Warnings

Some people have thoughts about suicide while taking  this medicine, especially within the first few months of treatment or when the dose is changed. Stay alert to changes in your or your child’s mood or symptoms. Report to your healthcare provider right away if there are any sudden changes in mood, behavior, thoughts, or feelings or if you or your child develops suicidal thoughts or actions.

See the Side Effects section for more information about side effects.

Before taking this medicine

Some drugs should not be used with Qelbree. Your treatment plan may change if you also use:

• alosetron;
• duloxetine;
• ramelteon;
• tasimelteon;
• tizanidine; or
• theophylline.

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

Tell your doctor if you or anyone in your family has ever had:

• depression;
• bipolar disorder (manic depression);
• psychosis; or
• suicidal thoughts or actions.

Tell your doctor if you have ever had:

• heart problems;
• high blood pressure;
• liver disease; or
• severe kidney disease.

Pregnancy

Qelbree may be harmful when taken during pregnancy. Tell your doctor right away if a pregnancy occurs.

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

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed, as it is not known if Qelbree passes into breastmilk. Ask to your healthcare provider about the best way to feed the baby during treatment with this medicine.

How should I take Qelbree?

Qelbree directions: Qelbree capsules are taken once a day, with or without food. Swallow the capsule whole, and do not crush, chew, break, or open it. If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

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.

Your heart rate and blood pressure will need to be checked often.

Qelbree dosing information

Usual Pediatric Qelbree Dose for Attention Deficit Disorder:

6 to 11 years
Initial dose: 100 mg orally once a day
Dose increases: May titrate in increments of 100 mg per week based on response and tolerability
Maximum dose: 400 mg/day

12 to 17 years
Initial dose: 200 mg orally once a day
Dose increases: After 1 week, may titrate to 400 mg once a day based on response and tolerability
Maximum dose: 400 mg/day

Usual Adult Qelbree Dose for Attention Deficit Disorder:

Adult patients: 
Initial dose: Recommended starting dosage is 200 mg once daily. 
Dose increases: May titrate in increments of 200 mg weekly to maximum recommended dosage of 600 mg once daily
Maximum dose: 600 mg/day

Comments:

• Assess heart rate and blood pressure prior to initiating treatment.
• Screen patients for a personal or family history of suicide, bipolar disorder, and depression prior to initiating treatment.
• Pharmacologic treatment for Attention-Deficit Hyperactivity Disorder (ADHD) may be needed for extended periods; periodically reevaluate and adjust dosage as needed.

Qelbree is available in Extended-release capsules: 100 mg, 150 mg, and 200 mg.

What should I avoid while taking Qelbree?

Do not drive or operate heavy machinery until you know how this medicine will affect you. Qelbree may cause you to feel sleepy or tired.

What other drugs will affect Qelbree?

Tell your healthcare provider about all the medicines you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Qelbree and other medicines may affect each other, causing possible serious side effects.

Your healthcare provider will decide if Qelbree can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

• MAOIs
• alosetron
• duloxetine
• ramelteon
• tasimelteon
• tizanidine
• theophylline

What is Qfitlia?

Qfitlia is used in adults and children at least 12 years old with hemophilia A or B to help prevent bleeding episodes or make them occur less often.

Your doctor will make sure you can be treated with Qfitlia.

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

Qfitlia 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.

Seek medical help right away if you show signs of a blood clot such as sudden numbness or weakness (especially on one side of the body), severe headache, confusion, vision changes, slurred speech, chest pain, shortness of breath, fast heart rate, dizziness, coughing up blood, or pain, swelling, or warmth in arms or legs.

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

• liver problems–loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• gallbladder problems–stomach pain after eating, nausea, vomiting, heartburn, bloating, and severe upper stomach pain that may spread to your back.

Common side effects of Qfitlia may include:

• bacterial or viral infections; 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.

Warnings

Using Qfitlia can increase your risk of blood clots especially if you have certain medical conditions or you also use other medicines to help treat blood clots.

Qfitlia can increase your risk of gallbladder disease. Call your doctor right away if you have unexplained stomach pain, nausea, vomiting, or heartburn.

Before taking this medicine

Tell your doctor if you have or have ever had:

• blood clots or any other blood clotting disorder;
• gallbladder disease; or
• liver disease.

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

Using Qfitlia with certain hormonal birth controls can increase your risk of blood clots. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge. Ask your doctor if you have any questions.

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

Do not allow a child to use Qfitlia without help from an adult.

How should I use Qfitlia?

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.

Tell your doctor if you are using other treatments to help protect against bleeding. Your healthcare provider will provide instructions for stopping your current treatment when switching to Qfitlia.

Qfitlia is injected under the skin. Your healthcare provider will show you or your caregiver where to inject this medicine. Your doctor will determine your treatment schedule.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not inject within 2 inches of your navel, or areas where the skin is tender, damaged, scaly, has bruises, scars, or visible veins. Do not inject into the same place two times in a row.

Throw away after one use, even if there is still medicine left inside.

Your blood may need to be tested often before and during treatment. Your doctor will need to check your progress on a regular basis.

You may be given other medicines to treat unexpected bleeding during treatment with Qfitlia. Follow your doctor’s instructions very carefully.

Your condition may get worse if you stop using Qfitlia suddenly. Ask your doctor before stopping the medicine.

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

Store Qfitlia in the original container in the refrigerator. Protect from light and do not freeze or shake the medicine.

Take the medicine out of the refrigerator and let it reach room temperature before using. Do not warm the medicine with hot water, sunlight, or a microwave.

You may store Qfitlia at room temperature. Certain formulations may only be stable for a limited number of months after being removed from the refrigerator. Throw away any medicine not used within that time. Talk to your pharmacist if you have any questions.

What happens if I miss a dose?

Use the medicine as soon as you remember, and then go back to your regular 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 taking Qfitlia?

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

What other drugs will affect Qfitlia?

Other drugs may affect Qfitlia, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What is Qinlock?

Qinlock is an enzyme inhibitor that blocks the action of protein kinases.

Qinlock is a prescription medicine used to treat tumors of the stomach and intestines, specifically adults with advanced gastrointestinal stromal tumor (GIST).

Qinlock is for use in adults who have already been treated with at least 3 other cancer medicines.

Warnings

Qinlock may affect fertility in males which may affect the ability to have children. Talk to your healthcare provider if this is a concern for you.

Qinlock and certain other medicines can affect each other causing side effects or affect how ripretinib works. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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 may not be able to use Qinlock if you have untreated or uncontrolled hypertension (high blood pressure).

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

• skin problem called palmar-plantar erythrodysesthesia syndrome;
• high blood pressure;
• heart problems; or
• if you have recently had surgery or plan to have surgery.

Using Qinlock may increase your risk of developing skin cancer. Your skin may need to be checked while you are using this medicine. Ask your doctor about skin symptoms to watch for.

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

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

Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Qinlock.

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

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

How should I take Qinlock?

Take Qinlock 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.

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

Take the medicine at the same time each day, with or without food.

If you vomit shortly after taking Qinlock, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Your blood pressure will need to be checked often. Your heart function may also need to be checked.

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

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

Do not change your dose or stop taking Qinlock without your doctor’s advice.

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

Dosing information

Usual Adult Dose for Gastrointestinal Stromal Tumor:

150 mg orally once daily until disease progression or unacceptable toxicity

Use: For adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 8 hours late for the dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

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

Qinlock side effects

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

Call your doctor at once if you have:

• severe stomach pain, nausea, or vomiting;
• severe headache, blurred vision, pounding in your neck or ears;
• pain, blisters, bleeding, or severe rash in the palms of your hands or the soles of your feet;
• heart problems – tiredness, feeling short of breath, swollen veins in the sides of your neck, swelling in your stomach or lower legs;
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• skin changes – a new wart, a skin sore or red bump that bleeds or does not heal, or any change in the size or color of a mole.

Common Qinlock side effects may include:

• nausea, vomiting, stomach pain, loss of appetite;
• diarrhea, constipation;
• tiredness;
• muscle pain; or
• thinning hair, hair loss.

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

What other drugs will affect Qinlock?

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 blood pressure medicine.

Other drugs may interact with ripretinib, 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 Qlosi?

Qlosi is a cholinergic agonist eye drop used to improve near vision in adults with presbyopia (age-related, blurry near vision). Qlosi eye drops work by contracting eye muscles, which makes the pupil smaller, so it is easier to focus on near objects. 

Qlosi is a new option for people with presbyopia to improve their vision instead of using reading glasses or contact lenses. Qlosi can be used daily, or as needed, up to twice per day and starts to improve near vision after 20 minutes and may last up to 8 hours. Qlosi is a preservative-free eye drop that is available in single-use vials.

Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% received FDA approval on October 18, 2023, to treat adults with presbyopia. This was based on positive results from phase 3 clinical trials NEAR-1 and NEAR-2. Qlosi showed a statistically significant 3-lines or more improvement in near vision, after 8 days, without the loss of 1-line or more in distance vision.

What is presbyopia?

Presbyopia is when your eyes gradually lose the ability to clearly see objects that are up close or near. This is a normal part of aging and usually begins after the age of 40. This happens because the eye’s lens becomes less flexible and harder as we get older, making it difficult to focus on near objects.

How does Qlosi work?

Qlosi contains a low dose of pilocarpine, a cholinergic compound. It functions by stimulating muscarinic receptors in the iris sphincter muscle, causing the pupil to contract. This results in a smaller pupil size, making it easier to focus on nearby objects.

Qlosi side effects

Common Qlosi side effects are painful or sore eyes and headaches, which affect 5% to 8% of patients. Blurred vision occurred in 2-5% of patients. Most side effects were mild, short-lasting, and resolved without further action.

What is the cost of Qlosi?

The cost for Qlosi is $79 for a 30-vial supply or $99 for a 60-vial supply but will vary depending on which pharmacy you use. Refer to our Qlosi price guide page for more information about Qlosi costs.

Warnings 

Blurred Vision: If vision you have blurred vision do not drive or operate machinery. When using these eye drops, be cautious with night driving and other hazardous occupations in poor light.

Risk of Retinal Detachment: There have been rare cases of retinal detachment when using miotics (eye drops that constrict the pupil).  Examination of the retina is advised in all patients before starting therapy. Seek immediate medical care if you have a sudden onset of flashes of light, floaters, or vision loss.

Inflammation of the iris (Iritis): Caution is advised in patients who have iritis.

Who should not use Qlosi?

You should not use Qlosi if you have hypersensitivity to the active ingredient pilocarpine hydrochloride, or any of the inactive ingredients. 

Before taking this medicine

Contact Lens Wear Remove contact lens before instillation of of these drops and wait 10 minutes after dosing before reinserting contact lenses. 

Potential for Eye Injury or Contamination To prevent eye injury or contamination, avoid touching the tip of the single-patient-use vial to the eye or to any other surface.

Use of Qlosi with other eye drops, gels or ointments. If you are using more than one topical eye medication, the medicines must be administered at least 5 minutes apart.

Pregnancy

Talk to your healthcare provider if you are pregnant or plan to become pregnant, as there are no adequate and well-controlled studies of Qlosi use in pregnant women to be able to inform a drug-associated risk.

Breastfeeding

Talk to your healthcare provider if you are breastfeeding or plan to breastfeed while using these eye drops, as there is no data on the presence Qlosi in human milk, the effects on breastfed infants, or the effects on milk production to be able to inform the risk of these eye drops to an infant during breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this medicine and any potential adverse effects on the breastfed child from this medication.

Qlosi dosing information

• Instill one drop of Qlosi in each eye this may be repeated a second time after 2 to 3 hours with a resulting effect for up to 8 hours. Qlosi can be administered on a daily basis or as needed, up to twice each day.
• If more than one eye medication is used in the eyes, the medicines must be used at least 5 minutes apart. 
• Discard single-patient-use vial after use

Qlosi is available in a single-patient-use vial containing 0.4 mL of pilocarpine hydrochloride 0.4% (4 mg/mL).

• There are 5 single-patient-use vials are packaged in a foil pouch.
• Box of 10 single-patient-use vials (2 pouches containing 5 vials) 
• Box of 20 single-patient-use vials (4 pouches containing 5 vials)

What is QNASL?

QNASL contains beclomethasone, a corticosteroid. It prevents the release of substances in the body that cause inflammation.

QNASL Nasal Aerosol (80 mcg) is a prescription medicine that treats seasonal nasal and year-round nasal allergy symptoms, such as congestion, sneezing, and runny nose in adults and children 12 years of age and older.

QNASL Nasal Aerosol (40 mcg) is used for the treatment of nasal allergy symptoms in children 4-11 years of age.

Warnings

Before using QNASL nasal spray, tell your doctor if you have been sick or have had an infection of any kind. Also tell your doctor if you have glaucoma or cataracts, herpes simplex infection of your eyes, tuberculosis, sores or ulcers in your nose, or if you have recently had injury of or surgery on your nose.

It may take up to 2 weeks before your symptoms improve. Keep using QNASL nasal spray as directed and tell your doctor if your symptoms do not improve after 1 week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Beclomethasone can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using QNASL. Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Steroid medicines such as beclomethasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using QNASL.

Before taking this medicine

You should not use QNASL if you are allergic to beclomethasone.

Before using QNASL, tell your doctor if you have been sick or have had any infections. You may not be able to use the nasal spray until you are well.

QNASL should not be given to a child younger than 4 years old.

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

• asthma;
• glaucoma or cataracts;
• herpes simplex virus of your eyes;
• tuberculosis or any other infection or illness;
• sores or ulcers your nose; or
• an injury or surgery affecting your nose.

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

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

How should I use QNASL?

Use QNASL nasal spray exactly as prescribed by your doctor. The usual dose is 1 to 2 sprays into each nostril once per day. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medicine comes with patient instructions for safe use, and directions for priming and disposal of the nasal spray. Ask your doctor or pharmacist if you have any questions.

Steroid medicine can weaken (suppress) your immune system, and you may get an infection more easily. If you use this medicine long-term, you may need frequent medical tests.

It may take several days before your symptoms improve. Call your doctor if your symptoms do not improve, or if they get worse while using QNASL nasal spray.

Your doctor will need to check your progress while you are using QNASL nasal spray, to make sure this medicine is not causing harm to your nose or sinuses.

Store in an upright position at room temperature, away from moisture and heat.

Throw away the QNASL nasal spray after you have used 120 sprays, or if the dose indicator shows a zero.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose of beclomethasone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using QNASL?

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Using steroid medicine can lower blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using QNASL nasal spray.

QNASL side effects

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

Call your doctor at once if you have:

• severe or ongoing nosebleed;
• sores in the nose that won’t heal;
• blurred vision, eye pain, or seeing halos around lights;
• signs of a hormonal disorder – worsening tiredness or muscle weakness, anxiety, feeling irritable, feeling light-headed, nausea, vomiting, loss of appetite, diarrhea, weight loss, or weight gain (especially in your face or your upper back and torso); or
• signs of infection – fever, chills, sores or white patches in or around your nose, flu symptoms, redness or swelling.

Beclomethasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Common QNASL side effects may include:

• discomfort or irritation inside your nose;
• sneezing, runny or stuffy nose;
• nosebleed;
• fever, sore throat;
• headache, nausea; or
• unpleasant taste or smell.

What is Qsymia?

Qsymia contains a combination of phentermine and topiramate in an extended-release capsule. Phentermine is an appetite suppressant similar to an amphetamine. Topiramate is typically used as a seizure medication, also called an anticonvulsant.

Qsymia is used together with diet and exercise to help some adults and children 12 years and older with obesity, or some overweight adults who also have weight-related medical problems such as diabetes, high cholesterol, or high blood pressure, to lose weight and keep the weight off.

Qsymia will not treat any of these underlying conditions. Keep using any other medicines your doctor has prescribed to treat these conditions.

Warnings

Do not use Qsymia if you are pregnant or if you become pregnant. This medicine may increase the risk of a birth defect called cleft lip and palate in a newborn.

You should not take Qsymia if you are allergic to phentermine (Adipex-P, Oby-Cap, Suprenza, T-Diet, Zantryl) or topiramate (Topamax), or if you have glaucoma or overactive thyroid.

Before you take Qsymia, tell your doctor if you have high blood pressure, heart disease, diabetes, liver or kidney disease, low blood levels of potassium, or if you have had a heart attack or stroke in the past 6 months.

Phentermine may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it. Do not stop taking Qsymia suddenly, or you could have a seizure (convulsions). You may need to use less and less before you stop the medication completely. Ask your doctor how to avoid seizures when you stop using Qsymia

Topiramate may cause vision problems that can be permanent if not treated quickly. Call your doctor right away if you have a sudden decrease in vision.

Some people have thoughts about suicide while taking topiramate. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Qsymia can increase your resting heart rate. Tell your doctor if you have fast or pounding heartbeats while you are resting.

Before taking this medicine

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

You should not use Qsymia if you are allergic to phentermine or topiramate, or if you have:

• glaucoma;
• overactive thyroid; or
• if you are pregnant or may become pregnant.

You may need to have a negative pregnancy test before starting this treatment. Do not use Qsymia if you are pregnant. Stop taking this medicine and call your doctor right away if you become pregnant.

Topiramate may increase the risk of cleft lip and palate in a newborn. This birth defect occurs early in pregnancy, and can develop even before you know you are pregnant. Weight loss during pregnancy also can harm an unborn baby, even if you are overweight. Use effective birth control to prevent pregnancy while you are using Qsymia.

Qsymia is not FDA-approved for use by anyone younger than 12 years old.

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

• heart problems, high blood pressure;
• a heart attack or stroke;
• diabetes (weight loss may cause low blood sugar);
• metabolic acidosis (too much acid in your blood);
• soft or brittle bones (osteomalacia, osteopenia, osteoporosis);
• kidney disease, kidney stones, or dialysis;
• liver disease;
• mood problems, depression, or suicidal thoughts or actions;
• an allergy to aspirin or yellow dye (tartrazine):
• a seizure; or
• chronic diarrhea.

Topiramate can increase the level of acid in your blood (metabolic acidosis). This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. You may need blood tests to make sure you do not have metabolic acidosis.

Some people have thoughts about suicide while taking topiramate. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

You should not breast-feed while using Qsymia.

How should I take Qsymia?

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

Your healthcare provider should start you on a diet and exercise program when you start taking Qsymia. Stay on this program during your treatment. 

Take this medicine each morning, with or without food.

Drink plenty of water each day to prevent dehydration or kidney stones while you are taking Qsymia.

To start treatment with Qsymia:

• Take one Qsymia 3.75 mg/23 mg capsule one time each morning for the first 14 days.
• After taking 3.75 mg/23 mg capsule for 14 days, then take one 7.5 mg/46 mg capsule one time each morning.

After taking Qsymia for 12 weeks:

• Your healthcare provider may tell you to increase your dose if you do not lose a certain amount of weight or do not have a certain decrease in BMI for children 12 years and older, within the first 12 weeks of treatment at the recommended dose.

If your healthcare provider increases the dose of Qsymia:

• Take one 11.25 mg/69 mg capsule one time each morning for 14 days.
• After taking 14 days of the 11.25 mg/69 mg capsule, then take one 15 mg/92 mg capsule one time each morning.

Stopping Qsymia treatment:

Your healthcare provider should tell you to stop taking Qsymia if you have not lost a certain amount of weight or do not have a certain decrease in BMI for children 12 years and older, after an additional 12 weeks of treatment on the higher dose.

Do not stop taking Qsymia without talking to your healthcare provider. Stopping Qsymia suddenly can cause serious problems, such as seizures. Your healthcare provider will tell you how to stop taking Qsymia slowly.

Store at room temperature away from moisture and heat.

Phentermine may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Dosing information

Usual Adult Dose of Qsymia for Weight Loss:

-Initial dose: Take one capsule of the lowest dose (phentermine 3.75 mg/topiramate 23 mg extended-release) orally once a day in the morning for the first 14 days.

-Maintenance dose: After 14 days, take one capsule of the recommended dose (phentermine 7.5 mg/topiramate 46 mg extended-release) orally once a day in the morning.

Comments:
-Weight loss should be evaluated after 12 weeks with phentermine 7.5 mg/topiramate 46 mg extended-release. If a patient has not lost at least 3% of baseline body weight increase the dosage to phentermine 11.25 mg/topiramate 69 mg) orally once daily for 14 days; followed by an increase in the dosage to phentermine 15 mg/topiramate 92 mg orally once daily. Weight loss should be evaluated after 12 weeks with phentermine 15 mg/topiramate 92 mg. If a patient has not lost at least 5% of baseline body weight, discontinue treatment, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss at this dose. Discontinue phentermine 15 mg/topiramate 92 mg dose gradually by taking once daily every other day for at least one week prior to stopping treatment altogether.

Use: Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients with an initial body mass index (BMI) of 30 kg/m² or greater (obese) OR 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia.

Usual Pediatric Dose of Qsymia for Weight Loss:

-Initial dose: Take one capsule of the lowest dose (phentermine 3.75 mg/topiramate 23 mg extended-release) orally once a day in the morning for the first 14 days.

-Maintenance dose: After 14 days, take one capsule of the recommended dose (phentermine 7.5 mg/topiramate 46 mg extended-release) orally once a day in the morning.

Comments:
-Weight loss should be evaluated after 12 weeks with phentermine 7.5 mg/topiramate 46 mg extended-release. If a pediatric patient has not lost at least 3% of baseline BMI, increase the dosage to phentermine 11.25 mg/topiramate 69 mg) orally once daily for 14 days; followed by an increase in the dosage to phentermine 15 mg/topiramate 92 mg orally once daily. Weight loss should be evaluated after 12 weeks with phentermine 15 mg/topiramate 92 mg. If a pediatric patient has not lost at least 5% of baseline BMI, discontinue treatment, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss at this dose. Discontinue phentermine 15 mg/topiramate 92 mg dose gradually by taking once daily every other day for at least one week prior to stopping treatment altogether.

Use: Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and older with BMI in the 95th percentile or greater standardized for age and sex.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include confusion, hallucinations, panic, personality changes, tremors, a restless feeling followed by severe tiredness, nausea, vomiting, diarrhea, stomach cramps, irregular heartbeat, rapid breathing, seizure, or coma.

What to avoid

Do not take other weight-loss products without your doctor’s advice.

Ketogenic or “ketosis” diets that are high in fat and low in carbohydrates can increase the risk of metabolic acidosis. Avoid the use of such diets while you are taking this medicine.

Drinking alcohol with this medicine can cause side effects.

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

Avoid becoming overheated or dehydrated in hot weather. Topiramate can decrease sweating and increase body temperature, leading to life-threatening dehydration.

Qsymia side effects

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

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• unusual changes in mood or behavior;
• confusion, trouble concentrating, problems with speech or memory;
• fast or pounding heartbeats while you are resting;
• a seizure;
• signs of a kidney stone – severe pain in your side or lower back, painful or difficult urination; or
• signs of too much acid in your blood – loss of appetite, tiredness, thinking problems, irregular heartbeats.

Common Qsymia side effects may include:

• joint pain, ankle sprain;
• flu-like symptoms;
• dizziness;
• constipation;
• numbness or tingly feeling;
• sleep problems (insomnia);
• dry mouth, changes in your sense of taste; or
• mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, thoughts about hurting yourself.

Clinical Overview

Use

Quassia has a variety of suggested uses, including treatment for measles, diarrhea, fever, and lice. Quassia has antibacterial, antifungal, antifertility, antitumor, antileukemic, and insecticidal actions as well. However, efficacy in clinical trials has not been proven.

Dosing

Quassia wood has been used as a bitter tonic, with a typical oral dose of 500 mg. No studies have been performed to support this dose. Several recent studies of topical quassia tincture for head lice have been reported.

Contraindications

Contraindications have not yet been identified.

Pregnancy/Lactation

Documented adverse reactions. Avoid use.

Interactions

None well documented.

Adverse Reactions

Quassia is used in a number of food products and is considered safe by the FDA. If taken in large doses, this product can irritate the GI tract and cause vomiting. It is not recommended for pregnant women.

Toxicology

Quassia is listed as generally regarded as safe (GRAS) by the FDA. Parenteral administration of quassin is toxic, leading to cardiac irregularities, tremors, and paralysis.

Scientific Family

• Simaroubaceae

Botany

Surinam quassia is a 2 to 5 m tall shrub or small tree native to Argentina, Colombia, Guyana, and Panama. Jamaican quassia is a taller tree that reaches 25 m and is native to the Caribbean Islands, Jamaica, West Indies, and northern Venezuela. The leaves and pale yellow wood are used medicinally.

History

Quassia has been used for malaria in the Amazon region. It has been used topically for measles and orally or rectally for intestinal parasites, diarrhea, and fever. The plants have been used as anthelmintics and insecticides. Central Americans have been known to build boxes out of quassia wood, which acts as a natural insect repellent, to store clothing

Quassia has been used as an insecticide. Traditional use includes remedies for infestations of lice or worms, anorexia, and dyspepsia.Duke 1985 Certain tribes have used the plants to treat measles and fever, and as a mouthwash.

The extracts and purified mixtures of bitter principles (“quassin”) have been used to give a bitter taste to various food products, especially alcoholic (eg, bitters, liqueurs) and nonalcoholic beverages, desserts, candy, baked goods, and puddings.Garcia Gonzalez 1997

Chemistry

Both quassia species have similar constituents. These include alkaloids (0.25%), such as canthin-6-one, 5-methoxycanthin-6-one, and carboline alkaloids. Terpenoids in 1 or both plants include isoquassin and mixtures of bitter principles (said to be 50 times more bitter than quinine), including quassin, neo-quassin, and 18-hydroxyquassin. Dihydronorneoquassin and simalikalactone D are also present. Other constituents include coumarins (Q. amara), thiamine (P. excelsa), beta-sitosterol, and beta-sitostenone.Duke 1985, Kupchan 1976, Newall 1996, Schulz 1998 From Q. amara, the quassinoid quassimarin has been reportedCasinovi 1966 and amarid 18-oxyquaxine has been isolated.Fernando 1993 The molecular phylogenetics of Q. amara have been studied using the chloroplast gene rbcl.Rutter 1990

Uses and Pharmacology

Chemotherapeutic effects

Animal data

Quassimarin has been reported to have antileukemic properties when tested in animals. Antitumor activity in mice has been demonstrated, as well as in vitro activity of quassin against human nasopharynx carcinoma.(Duke 1985)

Head lice

Clinical data

Quassia, as a tincture, has reportedly been used successfully to treat head lice. Canthin-6-one possesses antibacterial and antifungal activity.(Duke 1985, Mac-Mary 2012)

Other uses

Research is ongoing, with evaluations for potential applications in malaria, diabetes, and ulcer healing.(Cosmetic 2008, Mishra 2010)

The beta-carboline alkaloids exhibit positive inotropic activity in animals.(Duke 1985)

A 4% hydroglycolic extract of Q. amara gel was reportedly effective in reducing the severity of symptoms in facial seborrheic dermatitis(Diehl 2013) and rosacea.(Ferrari 2012)

Quassin has demonstrated antilarval activity and was effective at concentrations of 6 ppm.(Evans 1992)

In a hepatotoxic mouse model, administration of Q. amara stem bark extract not only improved lipid parameters (ie, total cholesterol, low-density lipoprotein, high-density lipoprotein) but also improved oxidative stress markers (ie, melondialdehyde, superoxide dismutase).(Obembe 2021)

Dosing

Quassia wood has been used as a bitter tonic, with a typical oral dose of 500 mg. No studies have been performed to support this dosage. Several recent studies of topical quassia tincture for head lice have been reported.

Pregnancy / Lactation

Documented adverse reactions. Avoid use.Bisset 1994

Interactions

None well documented.

Adverse Reactions

No adverse reactions were reported upon topical application of the scalp preparation in the 454 patients in the head lice study.(Duke 1985) However, large amounts given orally have been known to irritate the mucus membrane in the stomach and may lead to vomiting.(Schulz 1998) Excessive use may also interfere with existing cardiac and anticoagulant regimens. Because of the plant’s cytotoxic and emetic properties, its use during pregnancy should be avoided.(Duke 1985)

Histopathological and morphological deformities were observed in mouse spermatozoa induced by administration of Q. amara extract as well as its biologically active secondary metabolite, quassin.(Faisal 2021) A mechanism of this activity may be due to inhibition of cuticle development, as suggested in 1 report.(Njar 1995)

Toxicology

Quassia is listed as generally regarded as safe (GRAS) by the FDA. Parenteral administration of quassin is toxic, leading to cardiac irregularities, tremors, and paralysis.Schulz 1998

Mean weights of testes, seminal vesicles, and epididymides were significantly reduced, and weights of the anterior pituitary glands were significantly increased in rats given quassin at doses up to 2 g/kg in drinking water. Furthermore, lowered sperm counts, levels of LH, follicle-stimulating hormone (FSH) and of testosterone were observed.Garcia Gonzalez 1997, Mac-Mary 2012, Raji 1997

References

Disclaimer

This information relates to an herbal, vitamin, mineral or other dietary supplement. This product has not been reviewed by the FDA to determine whether it is safe or effective and is not subject to the quality standards and safety information collection standards that are applicable to most prescription drugs. This information should not be used to decide whether or not to take this product. This information does not endorse this product as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this product. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This information is not specific medical advice and does not replace information you receive from your health care provider. You should talk with your health care provider for complete information about the risks and benefits of using this product.

This product may adversely interact with certain health and medical conditions, other prescription and over-the-counter drugs, foods, or other dietary supplements. This product may be unsafe when used before surgery or other medical procedures. It is important to fully inform your doctor about the herbal, vitamins, mineral or any other supplements you are taking before any kind of surgery or medical procedure. With the exception of certain products that are generally recognized as safe in normal quantities, including use of folic acid and prenatal vitamins during pregnancy, this product has not been sufficiently studied to determine whether it is safe to use during pregnancy or nursing or by persons younger than 2 years of age.

Cosmetic Ingredient Review Expert Panel. Final report of the safety assessment of Alcohol Denat., including SD Alcohol 3-A, SD Alcohol 30, SD Alcohol 39, SD Alcohol 39-B, SD Alcohol 39-C, SD Alcohol 40, SD Alcohol 40-B, and SD Alcohol 40-C, and the denaturants, Quassin, Brucine Sulfate/Brucine, and Denatonium Benzoate. Int J Toxicol. 2008;27 Suppl 1:1-43. PMID: 18569160.

Diehl C, Ferrari A. Efficacy of topical 4% Quassia amara gel in facial seborrheic dermatitis:a randomized, double-blind, comparative study. J Drugs Dermatol. 2013 Mar;12(3):312-5. PMID: 23545914.23545914

Duke JA. CRC Handbook of Medicinal Herbs. Boca Raton, FL: CRC Press; 1985:399.

Duke JA, Vasquez R. Amazonian Ethnobotanical Dictionary. Boca Raton, FL: CRC Press, Inc.; 1994.

Evans DA, Kaleysa RR. Effect of quassin on the metabolism of catecholamines in different life cycle stages of Culex quinquefasciatus. Indian J Biochem Biosphys. 1992;29:360–363.1427964

Evans DA, Raj RK. Larvicidal efficacy of Quassin against Culex quinquefasciatus. Indian J Med Res. 1991;93:324-327.1778621

Faisal K, Akbarsha MA. Observations on Dag-like defect of spermatozoa induced by treatment of the phytotherapeutic Quassia amara/quassin in the mouse model. Andrologia. 2021;53(6):e14046.33756011

Fernando ES, Gadek PA, Crayn DM, Quinn CJ. Rosid affinities of Surianaceae: molecular evidence. Mol Phylogenet Evol. 1993;2:344-350.8049783

Ferrari A, Diehl C. Evaluation of the efficacy and tolerance of a topical gel with 4% quassia extract in the treatment of rosacea. J Clin Pharmacol. 2012 Jan;52(1):84-8. PMID: 21343346.21343346

Garcia Gonzalez M, Gonzalez Camacho SM, Pazos Sanou L. Pharmacologic activity of the aqueous wood extract from Quassia amara (Simarubaceae) on albino rats and mice [in Spanish]. Rev Biol Trop. 1997;44-45:47-50.9404515

Kupchan SM, Streelman DR. Quassimarin, a new antileukemic quassinoid from Quassia amara. J Org Chem. 1976;41:3481-3482.978297

Mac-Mary S, Messikh R, Jeudy A, et al. Assessment of the efficacy and safety of a new treatment for head lice. ISRN Dermatol. 2012;2012:460467. PMID: 2320992823209928

Mishra K, Chakraborty D, Pal A, Dey N. Plasmodium falciparum: in vitro interaction of quassin and neo-quassin with artesunate, a hemisuccinate derivative of artemisinin. Exp Parasitol. 2010 Apr;124(4):421-7. PMID: 2003665720036657

Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A Guide for Health-Care Professionals. London: Pharmaceutical Press; 1996:223-234.

Njar VC, Alao TO, Okogun JI, Raji Y, Bolarinwa AF, Nduka EU. Antifertility activity of Quassia amara: quassin inhibits the steroidogenesis in rat Leydig cells in vitro. Planta Med. 1995;61:180-182.7753928

Obembe OO, Usman TO, Raji Y. Hepatoprotective effects of Quassia amara stem bark against cadmium-induced toxicity in male Wistar rats [published online ahead of print, 2021 Feb 5]. J Basic Clin Physiol Pharmacol. 2021;10.1515/jbcpp-2020-0128.33544994

Quassia amara and Picrasma excelsa. USDA, NRCS. 2017. The PLANTS Database (http://plants.usda.gov, December 2017). National Plant Data Team, Greensboro, NC 27401-4901 USA. Accessed December 2017.

Raji Y, Bolarinwa AF. Antifertility activity of Quassia amara in male rats—in vivo study. Life Sci. 1997;61:1067-1074.9307052

Rutter R. Catalogo de Plantas Utiles de la Amazonia Peruana. Lima, Peru: Instituto Linguistico de Verano; 1990.

What is quazepam?

Quazepam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used to treat insomnia (trouble falling or staying asleep).

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

Quazepam side effects

Quazepam may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea, vomiting; swelling of your face, lips, tongue, or throat.

Quazepam 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.

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

• confusion, agitation, hallucinations;
• unusual thoughts or behavior;
• suicidal thoughts; or
• worsening depression.

Some people using quazepam have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.

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

Common side effects of quazepam may include:

• drowsiness, dizziness;
• headache;
• feeling tired;
• dry mouth; or
• upset stomach.

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

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

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

Warnings

Quazepam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

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

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

Do not use if you are pregnant.

Before taking this medicine

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

• a chronic breathing disorder;
• sleep apnea (breathing stops during sleep); or
• an allergy to sleep medicine or to other benzodiazepines (such as alprazolam, diazepam, lorazepam, midazolam, Ativan, Valium, Tranxene, Versed, Xanax, and others).

May cause birth defects. Do not use if you are pregnant. If you use quazepam during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks. Use effective birth control while using quazepam. Tell your doctor if you become pregnant.

Tell your doctor if you have ever had:

• breathing problems;
• drug or alcohol addiction;
• suicidal thoughts or actions;
• depression or mental illness; or
• liver or kidney disease.

Do not breastfeed.

Not approved for use by anyone younger than 18 years old.

How should I take quazepam?

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

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

When you first start taking quazepam, you may need to cut the tablet in half to get the correct dose. Follow your doctor’s dosing instructions carefully.

Take this medicine only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Call your doctor if your insomnia does not improve after taking quazepam for 7 to 10 nights, or if you have any mood or behavior changes. Insomnia can be a symptom of depression, mental illness, or certain medical conditions. Do not take quazepam for longer than 10 nights in a row, unless your doctor has told you to.

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

Store at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.

• Your insomnia symptoms may return when you stop using quazepam after using it over a long period of time.

Quazepam dosing information

Usual Adult Dose for Insomnia:

Initial dose: 7.5 mg orally once a day at bedtime
Maintenance dose: 7.5 to 15 mg orally once a day at bedtime

Comments:
-Prolonged administration is not recommended.
-The dose may be increased to 15 mg orally at bedtime if necessary for efficacy.
-The lowest effective dose should be used as adverse effects are dose related.

Use: Treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings

What happens if I miss a dose?

Quazepam is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of quazepam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

• Overdose symptoms may include extreme drowsiness, confusion, or coma.

Overdose symptoms may include drowsiness, confusion, slurred speech, weak or shallow breathing, or coma.

What should I avoid while taking quazepam?

Do not drink alcohol while taking quazepam or for several days after you stop taking quazepam.

You may still feel sleepy the morning after taking this medicine. Wait until you are fully awake before you drive, operate machinery, or do anything that requires you to be awake and alert. Your reactions may be impaired.

What other drugs will affect quazepam?

Using quazepam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect quazepam, including prescription and over-the-counter medicines, vitamins, and herbal products.

Uses for Qudexy XR

Topiramate is used alone or together with other medicines to help treat certain types of seizures (eg, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome). This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it. It is also used to help prevent migraine headaches.

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

Before using Qudexy XR

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 topiramate capsules, oral solution, or tablets, or Qudexy® extended-release capsules to treat seizures in children younger than 2 years of age (when used alone or together with other medicines). However, children are more likely to have unwanted effects (eg, rickets, slow growth, and increased risk of kidney stones) to this medicine. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Trokendi extended-release capsules for the treatment of seizures in children younger than 6 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of topiramate capsules, extended-release capsules, tablets, or oral solution for the prevention of migraine headaches in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of topiramate have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of topiramate 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 topiramate.

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
• Acetazolamide
• Alfentanil
• Alprazolam
• Amitriptyline
• Amobarbital
• Anileridine
• Apixaban
• Aripiprazole
• Aripiprazole Lauroxil
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Brinzolamide
• Bromazepam
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Citalopram
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Daridorexant
• Desogestrel
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Dichlorphenamide
• Dienogest
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Dorzolamide
• Doxylamine
• Droperidol
• Drospirenone
• Enflurane
• Esketamine
• Estazolam
• Estetrol
• Estradiol
• Eszopiclone
• Ethchlorvynol
• Ethinyl Estradiol
• Ethopropazine
• Ethylmorphine
• Ethynodiol
• Etonogestrel
• Fentanyl
• Flibanserin
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fosphenytoin
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Gestodene
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrochlorothiazide
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lemborexant
• Levocetirizine
• Levonorgestrel
• Levorphanol
• Lithium
• Lofexidine
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Medroxyprogesterone
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Mestranol
• Metaxalone
• Metformin
• Methadone
• Methazolamide
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nifedipine
• Nitrazepam
• Nitrous Oxide
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Olanzapine
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenytoin
• Pimozide
• Pioglitazone
• Piperacetazine
• Piperaquine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Quazepam
• Quetiapine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Rivaroxaban
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Segesterone
• Sertindole
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Tramadol
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Ulipristal
• Valproic Acid
• Venlafaxine
• 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.

• Ginkgo
• Phenobarbital
• Posaconazole

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.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

• Bone problems (eg, osteoporosis, osteomalacia, osteopenia) or
• Depression, history of or
• Eye or vision problems (eg, glaucoma) or
• Mood disorder, history of or
• Metabolic acidosis (too much acid in the blood), or history of—Use with caution. May make these conditions worse.

• Diarrhea or
• Lung or breathing problems or
• Patients on ketogenic diet or
• Status epilepticus (prolonged seizure)—May increase risk for metabolic acidosis.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Patients with metabolic acidosis who are also taking metformin—Should not be used in patients with this condition.
• Patients undergoing hemodialysis—Use with caution. The effects of Topamax® or Eprontia may be lessened because of its faster removal from the body.

Proper use of Qudexy XR

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

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

Topiramate may be taken with or without food.

Swallow the Trokendi XR extended-release capsule whole. Do not open, crush, or chew the capsule.

Measure the Eprontia oral solution with a marked measuring spoon, oral syringe, or medicine cup.

Avoid drinking alcohol with Eprontia, Qudexy® XR, or Topamax®, or avoid for 6 hours before and 6 hours after taking the Trokendi XR capsule.

Swallow the tablet whole. Do not break, crush, or chew it. The tablet may taste bitter if it is held in the mouth or chewed.

The Topamax® sprinkle capsule or Qudexy® XR extended-release capsule may be swallowed whole or opened and sprinkled on a small amount (1 teaspoon) of soft food (eg, applesauce). Swallow the food mixture right away without chewing. Do not save for later use.

Drink extra water with this medicine to help prevent kidney stones.

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 capsules):
  • For seizures (taken with other medicines):
    • Adults—At first, 25 to 50 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children—
      • Qudexy®:
        • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 25 milligrams (mg) once a day in the evening. Your doctor may adjust the dose as needed. However, the dose is usually not more than 5 to 9 mg per kilogram (kg) of body weight per day.
        • Children younger than 2 years of age—Use is not recommended.
      • Trokendi:
        • Children 6 years of age and older—At first, 25 milligrams (mg) once a day in the evening. Your doctor may adjust the dose as needed. However, the dose is usually not more than 5 to 9 mg per kilogram (kg) of body weight per day.
        • Children younger than 6 years of age—Use is not recommended.
  • For seizures (taken alone):
    • Qudexy®:
      • Adults and children 10 years of age and older—At first, 50 milligrams (mg) once a day. Your doctor may increase the dose as needed. However, the dose is usually not more than 400 mg per day.
      • Children 2 to 10 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 25 mg once a day, in the evening. Your doctor may increase the dose as needed and tolerated. However, the dose is usually not more than 400 mg per day.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • Trokendi:
      • Adults and children 10 years of age and older—At first, 50 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day.
      • Children younger than 10 years of age—Use and dose must be determined by your doctor.
  • For migraine headaches:
    • Adults and children 12 years of age and older—At first, 25 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 100 mg per day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For oral dosage forms (capsules or tablets):
  • For seizures (taken with other medicines):
    • Adults and children 17 years of age and older—At first, 25 or 50 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children 2 to 16 years of age—Dose is based on body weight and must be determined by your child’s doctor. The starting dose is usually 25 milligrams (mg) once a day in the evening. The doctor may adjust the dose as needed.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For seizures (taken alone):
    • Adults and children 10 years of age and older—At first, 50 milligrams (mg) per day, taken in 2 divided doses. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children 2 to 9 years of age—Dose is based on body weight and must be determined by your child’s doctor. The starting dose is usually 25 mg once a day in the evening. The doctor may adjust the dose as needed. However, the dose is usually not more than 250 to 400 mg per day.
      • Weighing more than 38 kilograms (kg)—250 to 400 mg per day taken in 2 divided doses.
      • Weighing 32 to 38 kg—250 to 350 mg per day taken in 2 divided doses.
      • Weighing 23 to 31 kg—200 to 350 mg per day taken in 2 divided doses.
      • Weighing 12 to 22 kg—200 to 300 mg per day taken in 2 divided doses.
      • Weighing 11 kg or less—150 to 250 mg per day taken in 2 divided doses.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For migraine headaches:
    • Adults and children 12 years of age and older—At first, 25 milligrams (mg) once a day in the evening. Your doctor may adjust the dose as needed. However, the dose is usually not more than 100 mg per day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For oral dosage forms (solution):
  • For seizures (taken with other medicines):
    • Adults and children 17 years of age and older—At first, 25 or 50 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children 2 to 16 years of age—Dose is based on body weight and must be determined by your child’s doctor. The starting dose is usually 25 milligrams (mg) once a day in the evening. The doctor may adjust the dose as needed.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For seizures (taken alone):
    • Adults and children 10 years of age and older—At first, 50 milligrams (mg) per day, taken in 2 divided doses. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children 2 to 9 years of age—Dose is based on body weight and must be determined by your child’s doctor. The starting dose is usually 25 mg once a day in the evening. The doctor may adjust the dose as needed. However, the dose is usually not more than 250 to 400 mg per day.
      • Weighing more than 38 kilograms (kg)—250 to 400 mg per day taken in 2 divided doses.
      • Weighing 32 to 38 kg—250 to 350 mg per day taken in 2 divided doses.
      • Weighing 23 to 31 kg—200 to 350 mg per day taken in 2 divided doses.
      • Weighing 12 to 22 kg—200 to 300 mg per day taken in 2 divided doses.
      • Weighing 11 kg or less—150 to 250 mg per day taken in 2 divided doses.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For migraine headaches:
    • Adults and children 12 years of age and older—At first, 25 milligrams (mg) once a day in the evening. Your doctor may adjust the dose as needed. However, the dose is usually not more than 100 mg per day.
    • Children younger than 12 years of age—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.

If your next regular dose of Topamax® capsule or tablet or Eprontia oral solution is within 6 hours away, wait until then to use the medicine and skip the missed dose.

If you miss more than 1 dose of Topamax® capsule or tablet orEprontia oral solution, contact your doctor for instructions about how to restart it.

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.

Throw away any unused Eprontia oral solution 60 days after first opening.

Precautions while using Qudexy XR

It is very important that your doctor check your or your child’s progress at regular visits to see if the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Birth control pills containing estrogen may not work properly if you take them with topiramate. To keep from getting pregnant, use an additional form of birth control (eg, condoms, spermicide) together with your birth control pill. If you have any questions about this, check with your doctor or pharmacist.

This medicine may cause vision changes, clumsiness or unsteadiness, dizziness, drowsiness, or trouble with thinking or speaking. Make sure you know how you or your child react to this medicine before you drive, use machines, climb in high places, swim, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system. The use of alcohol or other medicines that affect the CNS with topiramate may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Check with your doctor right away if you or your child have changes in vision or pain around the eyes during and after treatment with this medicine. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

This medicine may make you sweat less which will cause your body temperature to increase. Use extra care not to become overheated during exercise or hot weather with this medicine. Overheating may result in heat stroke and hot baths or saunas may make you dizzy or feel faint.

Topiramate may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause nausea, muscle tremors, breathing problems, eating problems, a fast heartbeat, restlessness, and stomach pain. Tell your doctor right away if you or your child have any of these symptoms. You might have a serious condition called metabolic acidosis (too much acid in the blood).

This medicine may decrease the density of bones, which can make your bones weak. Talk with your doctor if you have any concerns about this.

This medicine may cause slow growth. For children, the doctor will need to keep track of height and weight to make sure that the child is growing properly.

Do not suddenly stop using this medicine without checking first with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur with Topamax® and Eprontia. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness with this medicine.

Check with your doctor right away if you or your child are having unusual drowsiness, dullness, tiredness, weakness, feelings of sluggishness, mental depression or anxiety, nightmares or unusually vivid dreams, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.

Check with your doctor right away if you or your child have sudden back pain, stomach pain, pain while urinating, or bloody or dark urine. These may be symptoms of kidney stones.

Tell your doctor if your or your child’s skin feels like it is burning, crawling, itching, or if you have numbness, prickling, “pins and needles”, or tingling feeling after using topiramate.

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 Qudexy XR

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

• Blurred vision
• burning, prickling, or tingling sensations
• clumsiness or unsteadiness
• confusion
• continuous, uncontrolled back-and-forth or rolling eye movements
• dizziness
• double vision
• drowsiness
• eye redness or pain
• generalized slowing of mental and physical activity
• increased eye pressure
• memory problems
• menstrual changes or pain
• nervousness
• speech or language problems
• trouble in concentrating or paying attention
• unusual tiredness or weakness

Less common

• Aggression
• agitation
• chest pain
• chills
• discouragement
• feeling sad or empty
• fever
• irritability
• lack of feeling or emotion
• lessening of sensations or perception
• loss of appetite
• loss of interest or pleasure
• red, irritated, or bleeding gums
• sore throat
• stomach pain
• trouble sleeping
• weight loss

Rare

• Blood in the urine
• difficult or painful urination
• frequent urination
• hearing loss
• itching, skin rash
• loss of bladder control
• lower back or side pain
• nosebleeds
• pale skin
• ringing or buzzing in the ears
• swelling
• trouble breathing

Incidence not known

• Blistering, peeling, or loosening of the skin
• bloating
• bone fractures, especially of the thigh bone
• bone pain, tenderness, or aching
• clay-colored stools
• constipation
• cough
• decrease in height
• diarrhea
• increased rate of breathing
• joint or muscle pain
• muscle weakness
• pain in the back, ribs, arms, or legs
• pain or tenderness in the upper stomach
• red skin lesions, often with a purple center
• sores, ulcers, or white spots in the mouth or on the lips
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Decreased awareness or responsiveness
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• severe sleepiness
• unusual drowsiness, dullness, or feeling of sluggishness

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

• Breast pain in women
• tremors

Less common

• Constipation
• feeling of warmth
• heartburn
• increased sweating
• redness of the face, neck, arms, and occasionally, upper chest

Rare

• Decrease in sexual performance or desire

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects.

Commonly used brand name(s)

In the U.S.

• Eprontia
• Qudexy XR
• Topamax
• Topiragen
• Trokendi XR

Available Dosage Forms:

• Tablet
• Capsule, Extended Release
• Solution
• Capsule

• 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one
• 3, 3′, 4′, 5, 7-pentahydroxy-2-phenylchromen-4-one
• 3,3′,4’5,7-Penthydroxyflavone
• Bioflavonoid
• Bioflavonoid Complex
• Bioflavonoid Concentrate
• Bioflavonoid Extract
• Bioflavonoids
• Bioflavonoïde
• Bioflavonoïde de Citron
• Bioflavonoïdes de Citron
• Citrus Bioflavones
• Citrus Bioflavonoid
• Citrus Bioflavonoid Extract
• Citrus Bioflavonoids
• Citrus Flavones
• Citrus Flavonoids
• Complexe de Bioflavonoïde
• Concentré de Bioflavonoïde
• Extrait de Bioflavonoïde
• Extrait de Bioflavonoïdes de Citron
• Flavones de Citron
• Flavonoid
• Flavonoids
• Flavonol
• Flavonoïde
• Meletin
• Mélétine
• Pentahydroxyflavone
• Quercetin Dihydrate
• Quercetina
• Quercetine
• Quercétine
• Sophretin
• Sophrétine
• Vitamin P

What is this product used for?

Quercetin may help to lower blood pressure. It may also help protect against heart problems. Quercetin may improve the ability of some people to exercise longer.

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.
• Avoid the use of quercetin while taking digoxin.
• Take extra care if you are taking drugs to thin your blood. These are drugs like warfarin.
• 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.
• Do not use this product if you are breastfeeding.
• Take extra care and check with your doctor if you have:
  • Heart problems
  • High blood pressure

What should I watch for?

• Upset stomach

When do I need to call the doctor?

• Signs of a very bad reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat. Go to the ER right away.

Last Reviewed Date

2024-05-29

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. 

What is Questran?

Questran is used to lower high levels of cholesterol in the blood, especially low-density lipoprotein (LDL) (“bad” cholesterol).

Questran is also used to treat itching caused by a blockage in the bile ducts of the gallbladder.

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

Questran 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.

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

• ongoing or worsening constipation;
• severe stomach pain;
• blood in your urine;
• black, bloody, or tarry stools; or
• easy bruising, unusual bleeding.

Side effects such as constipation may be more likely in older adults.

Common side effects of Questran may include:

• mild constipation, diarrhea;
• stomach pain, nausea, loss of appetite;
• bloating or gas;
• irritation of your tongue; or
• itching or irritation around your rectal area.

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

Warnings

You should not use Questran if you have a blockage in your stomach or intestines.

Before taking this medicine

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

• a blockage in your biliary tract.

Tell your doctor if you have ever had:

• chronic constipation;
• a thyroid disorder;
• diabetes;
• kidney disease;
• liver disease; or
• coronary artery disease (clogged arteries).

This medicine may contain phenylalanine. Talk to your doctor before using Questran if you have phenylketonuria (PKU).

Taking Questran can make it harder for your body to absorb certain vitamins. Your doctor may recommend you take a vitamin supplement.

Tell your doctor if you are pregnant or breastfeeding.

You may have an even greater need for vitamin supplements during pregnancy or while you are breast-feeding a baby. Follow your doctor’s instructions about taking vitamin supplements during treatment with Questran.

How should I take Questran?

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.

Although Questran is usually taken once or twice per day, Questran may be taken up to 6 times per day. Carefully follow your doctor’s dosing instructions.

Mix the Questran powder with at least 2 to 6 ounces of water or other non-carbonated beverage. You may also mix the powder with a brothy soup, crushed pineapple, or applesauce. Measure the powder using the scoop provided with your medication. Do not use any other scoop or measuring cup to measure your this medicine dose.

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

Questran can affect the surfaces of your teeth. Sipping the this medicine/liquid mixture slowly or holding the liquid in your mouth for too long may result in tooth discoloration, enamel erosion, or tooth decay. Be sure to brush your teeth regularly while you are using this medicine.

Drink extra fluids to prevent constipation while you are taking Questran.

While using Questran, you may need frequent blood tests.

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

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 line

Overdose symptoms may include severe stomach pain or constipation.

What should I avoid while taking Questran?

Avoid taking other medications at the same time you take Questran. Wait at least 1 hour before or 4 to 6 hours after taking this medicine before you take any other medications.

What is Questran Light?

Questran Light is used to lower high levels of cholesterol in the blood, especially low-density lipoprotein (LDL) (“bad” cholesterol).

Questran Light is also used to treat itching caused by a blockage in the bile ducts of the gallbladder.

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

Questran Light 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.

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

• ongoing or worsening constipation;
• severe stomach pain;
• blood in your urine;
• black, bloody, or tarry stools; or
• easy bruising, unusual bleeding.

Side effects such as constipation may be more likely in older adults.

Common side effects of Questran Light may include:

• mild constipation, diarrhea;
• stomach pain, nausea, loss of appetite;
• bloating or gas;
• irritation of your tongue; or
• itching or irritation around your rectal area.

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

Warnings

You should not use Questran Light if you have a blockage in your stomach or intestines.

Before taking this medicine

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

• a blockage in your biliary tract.

Tell your doctor if you have ever had:

• chronic constipation;
• a thyroid disorder;
• diabetes;
• kidney disease;
• liver disease; or
• coronary artery disease (clogged arteries).

This medicine may contain phenylalanine. Talk to your doctor before using Questran

Taking Questran Light can make it harder for your body to absorb certain vitamins. Your doctor may recommend you take a vitamin supplement.

Tell your doctor if you are pregnant or breastfeeding.

You may have an even greater need for vitamin supplements during pregnancy or while you are breast-feeding a baby. Follow your doctor’s instructions about taking vitamin supplements during treatment with Questran Light.

How should I take Questran Light?

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.

Although Questran Light is usually taken once or twice per day, Questran Light may be taken up to 6 times per day. Carefully follow your doctor’s dosing instructions.

Mix the Questran Light powder with at least 2 to 6 ounces of water or other non-carbonated beverage. You may also mix the powder with a brothy soup, crushed pineapple, or applesauce. Measure the powder using the scoop provided with your medication. Do not use any other scoop or measuring cup to measure your this medicine dose.

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

Questran Light can affect the surfaces of your teeth. Sipping the this medicine/liquid mixture slowly or holding the liquid in your mouth for too long may result in tooth discoloration, enamel erosion, or tooth decay. Be sure to brush your teeth regularly while you are using this medicine.

Drink extra fluids to prevent constipation while you are taking Questran Light.

While using Questran Light, you may need frequent blood tests.

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

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 line

What should I avoid while taking Questran Light?

Avoid taking other medications at the same time you take Questran Light. Wait at least 1 hour before or 4 to 6 hours after taking this medicine before you take any other medications.

What is quetiapine?

Quetiapine is used to treat schizophrenia in adults and children who are at least 13 years old. It is also used alone or with with divalproex or lithium to treat episodes of mania (frenzied, abnormally excited or irritated mood) or depression in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods).

In addition, quetiapine is used with other medications to prevent episodes of depression in patients with bipolar disorder.

Quetiapine extended release is also used alone to treat manic episodes in children at least 10 years old with bipolar disorder.

Quetiapine extended release is used in combination with antidepressant medications to treat major depressive disorder in adults.

Quetiapine tablets may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children and teenagers.

Quetiapine belongs to class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Quetiapine side effects

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

High doses or long-term use of quetiapine can cause a serious movement disorder that may not be reversible. The longer you use this medicine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

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.

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

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• breast swelling and tenderness, nipple discharge, impotence, missed menstrual periods;
• trouble swallowing, severe constipation;
• painful or difficult urination;
• high blood pressure, fast, slow or uneven heart rate;
• a light-headed feeling, sudden numbness or weakness, severe headache;
• blurred vision, eye pain or redness, seeing halos around lights;
• a seizure, feeling unusually hot or cold;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• underactive thyroid – tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor; or
• low white blood cell counts – fever, mouth sores, skin sores, sore throat, cough.

Common quetiapine side effects may include:

• speech problems;
• dizziness, drowsiness, tiredness;
• feeling like you might pass out;
• lack of energy;
• fast heartbeats;
• increased appetite, weight gain;
• upset stomach, vomiting, constipation;
• stomach pain, nausea;
• abnormal liver function tests, sore throat;
• stuffy nose, dry mouth; or
• difficulty moving.

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

Before taking this medicine

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

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

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

• a nervous system reaction associated with antipsychotic medication use;
• heart disease, a heart attack or stroke;
• long QT syndrome (in you or a family member);
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• high or low blood pressure;
• low white blood cell (WBC) counts;
• abnormal thyroid tests or prolactin levels;
• an enlarged prostate, constipation or urination problems;
• a seizure;
• glaucoma or cataracts;
• diabetes (in you or a family member);
• high cholesterol or triglycerides; or
• liver disease.

Quetiapine may increase the risk of death in older adults with mental health problems related to dementia.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

It may be harder for you to get pregnant while you are using quetiapine.

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

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

How should I take quetiapine?

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

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

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

Your blood may need to be checked on a regular basis, and you may need other medical tests.

Your blood pressure may need to be checked often.

Do not stop using quetiapine suddenly, your condition may get worse, or you could have unpleasant symptoms (such as trouble sleeping, nausea and vomiting). Ask your doctor before stopping the medicine.

This medicine may cause false results on a drug-screening urine test. Tell the laboratory staff that you use quetiapine.

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 line .

What should I avoid while taking quetiapine?

Do not drink alcohol. Dangerous side effects could occur.

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

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of liquids while you are taking quetiapine.

Warnings

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting quetiapine. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

What is QuilliChew ER?

QuilliChew ER is a chewable extended-release tablet used to treat attention deficit hyperactivity disorder (ADHD). The tablet is cherry flavored and is taken each morning. It contains methylphenidate hydrochloride, a central nervous system (CNS) stimulant.

It’s not known exactly how QuilliChew ER and other methylphenidate-containing medications work in people with ADHD, but it does increase activity in the brain, especially in the areas that help regulate behavior and attention. It also helps to boost levels of dopamine and noradrenaline – two chemical messengers or neurotransmitters – by preventing their re-uptake from the space between nerve cells (neurons) in the brain. Low levels of these chemical messengers have been found in people with ADHD.

Methylphenidate-containing medications, such as QuilliChew ER, are schedule II federally controlled substances because they can be a target for people who abuse prescription medicines or street drugs. Selling or giving away QuilliChew ER may harm others, and is against the law.

QuilliChew ER was approved for use by the US Food and Drug Administration (FDA) in 2015, although the first methylphenidate-containing medication was approved many years earlier in 1955.

What is QuilliChew ER used for?

QuilliChew ER is a prescription medicine used for the treatment of ADHD. It may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if it is safe and effective in children under 6 years of age.

Important information

QuilliChew ER can cause serious side effects, including:

• Abuse and dependence. This medication contains methylphenidate. QuilliChew ER, other methylphenidate containing products, and amphetamines, have a high chance for abuse and can cause physical and psychological dependence. Tell your health care provider if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
• Heart-related problems, including:
  • sudden death, stroke, and heart attack in adults
  • sudden death in children who have heart problems or heart defects
  • increased blood pressure and heart rate
    
    Tell your health care provider if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
    
    Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with this medication.
    
    Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment.
• Mental (psychiatric) problems, including:
  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
    
    Tell your healthcare provider about any mental problems you or your child has, or about a family history of suicide, bipolar illness, or depression.
    
    Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
• Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:
  • Fingers or toes may feel numb, cool, painful
  • Fingers or toes may change color from pale, to blue, to red

Tell your health care provider if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.

Call your health care provider right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking this medication.

Who should not take QuilliChew ER?

Do not take QuilliChew ER if you or your child is:

• allergic to methylphenidate hydrochloride, or any of the ingredients in QuilliChew ER. See below for a complete list of ingredients.
• taking or has taken within the last 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

What should I tell my doctor before taking QuilliChew ER?

Before taking QuilliChew ER, tell your or your child’s healthcare provider about all medical conditions (or a family history of), including if you or your child:

• have heart problems, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• have circulation problems in fingers or toes
• have phenylketonuria (PKU). QuilliChew ER contains phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU or who are allergic to phenylalanine.

How should I take QuilliChew ER?

• Take this medication exactly as prescribed. Your health care provider may adjust the dose, if needed, until it is right for you or your child. During dose adjustment, you or your child may still have ADHD symptoms.
• Take 1 time each day in the morning. This medication is an extended-release chewable tablet that releases medicine into your body throughout the day.
• The 20 mg and 30 mg QuilliChew ER chewable tablets are scored (bisected) and can be cut in half if needed, for you to get the right dose. QuilliChew ER 40mg is not scored (bisected) and cannot be divided.
• This medication can be taken with or without food.
• From time to time, your health care provider may stop treatment for a while to check ADHD symptoms.
• Your health care provider may do regular checks of the blood, heart, and blood pressure while taking this medication.
• Children should have their height and weight checked often while taking QuilliChew ER. Treatment may be stopped if a problem is found during these check-ups.

What happens if I miss a dose?

If a dose is missed, you or your child should talk to your health care provider about dosing.

What happens if I overdose?

If you or your child takes too much QuilliChew ER, call your poison control center right away, or go to the nearest hospital emergency room.

What should I avoid while taking QuilliChew ER?

Avoid drinking alcohol during treatment with QuilliChew ER. This may cause a faster release of the medicine.

Do not take with MAOI medicines. Do not start taking this medication if you stopped taking an MAOI in the last 14 days.

Dosing information

For patients 6 years and above, the recommended starting dose is QuilliChew ER 20 mg given orally once daily in the morning. The dose may be increased or decreased weekly in increments of 10 mg, 15 mg or 20 mg. Daily dosage above 60 mg is not recommended.

See the Full Prescribing Information for further details about QuilliChew ER dosing.

What are the side effects of QuilliChew ER?

QuilliChew ER can cause serious side effects, including:

• See “Important information” above.
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develops priapism, get medical help right away. Priapism can cause long lasting damage, it should be checked by a health care provider right away.
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment. Treatment may be stopped if your child is not gaining weight or height.

The most common side effects of QuilliChew ER include:

• decreased appetite
• trouble sleeping
• nausea
• vomiting
• indigestion
• stomach pain
• weight loss
• anxiety
• dizziness
• irritability
• mood swings
• fast heart beat
• increased blood pressure

These are not all the possible side effects of this medication.

Call your doctor for medical advice about side effects.

Interactions

Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

QuilliChew ER and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment.

Your healthcare provider will decide whether QuilliChew ER can be taken with other medicines.

Especially tell your healthcare provider if you or your child takes medicine to treat depression, including MAOIs.

Know the medicines that you or your child takes. Keep a list of the medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

Do not start any new medicine during treatment without talking to your or your child’s healthcare provider first.

Pregnancy and breastfeeding

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether QuilliChew ER will harm your unborn baby.

There is a pregnancy registry for females who are exposed to this medication during pregnancy. The purpose of the registry is to collect information about the health of females exposed to QuilliChew ER and their baby. If you or your child becomes pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants. You can register by calling 1-866-961-2388.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. QuilliChew ER passes into breast milk. You and your doctor should decide if you will take QuilliChew ER or breastfeed.

Storage

• Store QuilliChew ER at room temperature between 68°F to 77°F (20°C to 25°C).
• Store in a safe place, like a locked cabinet, to protect it from theft. Never give it to anyone else, because it may cause death or harm them.

Keep out of the reach of children.

What are the ingredients in QuilliChew ER?

Active Ingredient: methylphenidate hydrochloride

Inactive Ingredients: aspartame, cherry flavor, citric acid, crospovidone, D&C red #30 (for 30 mg strength), D&C red #7 (for 40 mg strength), guar gum, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl acetate, polyvinyl alcohol, povidone, silicon dioxide, sodium polystyrene sulfonate, talc, triacetin, xanthan gum.

What is Quillivant XR?

Quillivant XR is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Quillivant XR extended-release oral suspension is used to treat attention deficit hyperactivity disorder (ADHD). The extended-release oral suspension formulation releases methylphenidate into your body throughout the day.

Quillivant XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if Quillivant XR is safe and effective in children under 6 years of age.

Warnings

You should not use Quillivant XR if you have glaucoma, tics or Tourette’s syndrome, or severe anxiety, tension, or agitation.

Do not use Quillivant XR if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Methylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Methylphenidate may be habit-forming, Misuse can cause addiction, overdose, or death.. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems – chest pain, feeling light-headed or short of breath; signs of psychosis – paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems – unexplained wounds on your fingers or toes.

Before taking this medicine

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

You may not be able to use Quillivant XR if you are allergic to methylphenidate, or if you have:

• glaucoma;
• a personal or family history of tics (muscle twitches) or Tourette’s syndrome; or
• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

To make sure Quillivant XR is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• motor tics (muscle twitches) or Tourette’s syndrome;
• blood circulation problems in the hands or feet;
• seizures or epilepsy;
• problems with the esophagus, stomach, or intestines;
• an abnormal brain wave test (EEG); or
• drug or alcohol addiction.

Tell your doctor if you are pregnant or breastfeeding.

Quillivant XR is not approved for use by anyone younger than 6 years old.

How should I take Quillivant XR?

Take Quillivant XR 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.

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

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Never share this medicine with another person. Keep the medicine where others cannot get to it. Selling or giving away Quillivant XR is against the law.

To prevent sleep problems, take this medicine in the morning.

Quillivant XR can be taken with or without food. Taking Quillivant XR with food may shorten the time it takes for the medicine to start working.

Measure liquid Quillivant XR oral suspension with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Tell your doctor if you have a planned surgery.

Your doctor will need to check your progress on a regular basis. Tell any doctor who treats you that you are using Quillivant XR.

Store at room temperature away from moisture and heat.

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

Dosing information

Usual Adult Dose for Attention Deficit Disorder:

Initial Dose: 20 mg orally once a day in the morning. Titrate in increments of 10 to 20 mg weekly until a well-tolerated, therapeutic dose is achieved.
Maximum Dose: 60 mg/day.

Usual Pediatric Dose for Attention Deficit Disorder:

6 years or older:
Initial Dose: 20 mg orally once a day in the morning. Titrate in increments of 10 to 20 mg weekly until a well-tolerated, therapeutic dose is achieved.
Maximum Dose: 60 mg/day.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is later than 6:00 p.m. Do not use two doses at one time.

What happens if I overdose?

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

What should I avoid while taking Quillivant XR?

Avoid drinking alcohol.

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

Quillivant XR side effects

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

Call your doctor at once if you have:

• signs of heart problems – chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis – hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems – numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer (rare).

Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate.

Common Quillivant XR side effects may include:

• excessive sweating;
• mood changes, feeling nervous or irritable, sleep problems (insomnia);
• fast heart rate, pounding heartbeats or fluttering in your chest, increased blood pressure;
• loss of appetite, weight loss;
• dry mouth, nausea, stomach pain; or
• headache.

What is quinapril?

Quinapril is used in adults alone or in combination with other medications to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Quinapril is also used in adults together with other medications to treat heart failure.

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

Quinapril 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.

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

• chest pain, fast, slow, or uneven heart rate;
• a light-headed feeling, like you might pass out;
• heart problems–swelling, rapid weight gain, feeling short of breath;
• kidney problems–swelling, urinating less, feeling tired or short of breath;
• liver problems–loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), abnormal liver function tests;
• signs of infection–fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• high blood potassium–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects of quinapril may include:

• headache;
• nausea, vomiting, stomach pain;
• cough; or
• dizziness, tiredness.

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

Warnings

Do not use if you are pregnant. Stop using quinapril and tell your doctor right away if you become pregnant.

You should not use quinapril if you have ever had angioedema. Do not take quinapril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use quinapril together with any medication that contains aliskiren (a blood pressure medicine).

Before taking this medicine

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

• have a history of angioedema; or
• you are allergic to any other ACE inhibitor, such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, ramipril, or trandolapril.

Do not take quinapril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use quinapril together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking quinapril with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• a connective tissue disease such as Marfan syndrome, Sjogren’s syndrome, lupus, scleroderma, or rheumatoid arthritis;
• heart problems;
• low blood pressure;
• high blood levels of potassium (hyperkalemia);
• if you are on a low-salt diet;
• low white blood cell counts;
• diabetes;
• kidney disease (or if you are on dialysis); or
• liver disease.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Quinapril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

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

How should I take quinapril?

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.

Your blood pressure will need to be checked often. Your kidney or liver function may also need to be tested.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking quinapril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Tell your doctor if you have a planned surgery.

If you have high blood pressure, keep using quinapril even if you feel well. High blood pressure often has no symptoms.

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

Quinapril dosing information

Usual Adult Dose for Hypertension:

Initial dose: 10 or 20 mg orally once a day in patients not on diuretics
Maintenance dose: 20 to 80 mg orally per day, administered as a single dose or in two equally divided doses

Use:
-Treatment of hypertension

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 5 mg orally twice a day
Maintenance dose: 20 to 40 mg orally per day administered in two equally divided doses

Comments:
-This dose may improve symptoms of heart failure, but increases in exercise duration have generally required higher doses.
-If the initial dosage is well tolerated, patients should then be titrated at weekly intervals until an effective dose.

Use:
-Management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis

Usual Geriatric Dose for Congestive Heart Failure:

10 mg orally once a day

Comments: Dose should be titrated the same way as for other adult patients.

Uses:
-Treatment of hypertension
-Management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis

Usual Geriatric Dose for Hypertension:

10 mg orally once a day

Comments: Dose should be titrated the same way as for other adult patients.

Uses:
-Treatment of hypertension
-Management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis

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 quinapril?

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

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Avoid strenuous exercise if you are being treated for heart failure. Ask your doctor about your risk.

What other drugs will affect quinapril?

Tell your doctor about all your other medicines, especially:

• lithium;
• a diuretic or “water pill”;
• gold injections to treat arthritis;
• temsirolimus, sirolimus, or everolimus; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

What is quinidine?

Quinidine is used to help keep the heart beating normally in people with certain heart rhythm disorders, usually after other treatments have failed. Quinidine has not been proven to lower the risks of stroke or death.

Quinidine is also used to treat a life-threatening form of malaria.

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

Quinidine 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.

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

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• vomiting and diarrhea;
• confusion, ringing in your ears, hearing loss;
• severe eye redness, vision problems, increased sensitivity to light;
• wheezing, chest tightness, trouble breathing;
• easy bruising, unusual bleeding;
• pale or yellowed skin, stomach pain (upper right side), dark urine;
• fever, chills, sore throat, mouth sores, swollen glands;
• skin itching, flaking, blistering, peeling, or rash on your cheeks or arms that worsens in sunlight;
• muscle or joint pain; or
• dry mouth, trouble swallowing.

Common side effects of quinidine may include:

• chest pain, pounding heartbeats;
• dizziness;
• heartburn, nausea, vomiting, diarrhea;
• flushing (sudden warmth, redness, or tingly feeling);
• feeling weak or tired; or
• pain or tenderness where the medicine was injected (may last for several weeks).

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

Warnings

quinidine may increase your risk of death, especially if you have heart problems affecting the tissues or valves of your heart (including heart problems you may have been born with). Ask your doctor about the risks and benefits of using quinidine.

Before taking this medicine

Although quinidine can reduce episodes of irregular heart rhythm, this medicine may increase your risk of death. Your risk may be higher if you have heart problems affecting the tissues or valves of your heart (including heart problems you may have been born with). Ask your doctor about the risks and benefits of using quinidine.

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

• a serious heart condition called “AV block” (unless you have a pacemaker);
• myasthenia gravis; or
• a history of bruising or bleeding after using quinidine or quinine.

Tell your doctor if you have ever had:

• a heart condition called “sick sinus syndrome”;
• slow heartbeats;
• congestive heart failure;
• a heart valve disorder, a hole in your heart, an enlarged heart, or mitral valve prolapse;
• long QT syndrome (in you or a family member);
• Marfan syndrome;
• heart rhythm problems with past use of quinidine;
• liver or kidney disease; or
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

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

You should not breastfeed while using quinidine.

How is quinidine given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Your blood pressure and heart rate should be monitored in a hospital or clinic setting when you start using quinidine, and whenever your dose is changed.

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

Quinidine oral is taken by mouth. Quinidine injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Do not crush or chew an extended-release tablet. Swallow it whole. You may break the tablet in half if your doctor instructs you to.

When quinidine is given to treat malaria, you may also be given antibiotic medication. Keep using the antibiotic for as long as your doctor has prescribed.

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.

Because you will receive quinidine injection in a clinical setting, you are not likely to miss a dose.

What happens if I overdose?

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

Overdose can cause vomiting, diarrhea, ringing in your ears, hearing loss, severe dizziness, double vision, confusion, irregular heartbeats, or feeling like you might pass out.

What should I avoid while using quinidine?

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

What other drugs will affect quinidine?

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.

What is quinine?

The U.S. Food and Drug Administration has banned the sale of all non-approved brands of quinine. Do not purchase quinine on the Internet or from vendors outside of the United States.

Quinine is used to treat uncomplicated malaria, a disease caused by parasites. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Quinine will not treat severe forms of malaria, and it should not be taken to prevent malaria.

Some people have used quinine to treat leg cramps, but this is not an FDA-approved use. Using this medication improperly or without the advice of a doctor can result in serious side effects or death.

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

Quinine side effects

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

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

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with balance;
• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• problems with vision or hearing;
• pain, swelling, warmth, or redness in one or both legs;
• severe pain in your side or lower back, blood in your urine, little or no urine;
• low blood sugar (more common in pregnant women)–headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); 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 quinine may include:

• headache, blurred vision, changes in color vision;
• sweating or flushing (warmth, redness, or tingly feeling);
• mild dizziness, spinning sensation, ringing in your ears; or
• upset stomach, vomiting, stomach pain.

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

Warnings

Quinine can cause serious side effects on your heart, kidneys, or blood cells. Stop taking quinine and call your doctor at once if you have headache with chest pain and severe dizziness, fast or pounding heartbeats, unusual bruising or bleeding (nosebleeds, bleeding gums, purple or red spots under your skin), signs of infection (fever, chills, mouth sores), severe lower back pain, or blood in your urine.

You should not take quinine if you have a heart rhythm disorder called Long QT syndrome, a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G-6-PD), myasthenia gravis, optic neuritis (inflammation of the nerves in your eyes), if you have taken quinine in the past and it caused a blood cell disorder or severe bleeding.

Some people have used quinine to treat leg cramps, but this is not an FDA-approved use. Using this medication improperly or without the advice of a doctor can result in serious side effects or death.

Before taking this medicine

You should not use this medication if you have ever had an allergic reaction to quinine or similar medicines such as mefloquine or quinidine, or if you have:

• a heart rhythm disorder called Long QT syndrome;
• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G-6-PD);
• myasthenia gravis;
• optic neuritis (inflammation of the optic nerve); or
• if you have taken quinine in the past and it caused a blood cell disorder, severe bleeding, or kidney problems.

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

• heart disease or a heart rhythm disorder;
• low levels of platelets in your blood;
• low potassium levels in your blood (hypokalemia); or
• liver or kidney disease.

FDA pregnancy category C. It is not known whether quinine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Quinine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 16 years old.

How should I take quinine?

Follow all directions on your prescription label. Do not take quinine in larger or smaller amounts or for longer than recommended.

Take with food if quinine upsets your stomach.

Take this medication for the full prescribed length of time. Your symptoms may get better before your condition is completely cleared.

If you need surgery or medical tests, tell your caregivers ahead of time that you are using quinine. You may need to stop using the medicine for a short time.

Call your doctor if your symptoms do not improve after 2 days of treatment, or if your symptoms return after you have finished the medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 4 hours late for your dose, skip the missed dose and take the medicine at your next scheduled dose time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking quinine?

Avoid taking other anti-malaria medications without your doctor’s advice. This includes chloroquine, halofantrine, and mefloquine.

Avoid using antacids without your doctor’s advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb quinine.

Quinine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Do not use quinine to treat any condition that has not been checked by your doctor.

What other drugs will affect quinine?

Many drugs can interact with quinine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with quinine, especially:

• acetazolamide, sodium bicarbonate;
• aminophylline, theophylline;
• arsenic trioxide, vandetanib;
• bosentan;
• imatinib;
• methadone;
• tacrolimus;
• St. John’s wort;
• an antibiotic–azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine, telithromycin, tetracycline;
• an antidepressant–amitriptyline, citalopram, clomipramine, desipramine, nefazodone, venlafaxine;
• antifungal medication–itraconazole, ketoconazole, posaconazole, voriconazole;
• cholesterol-lowering medicine–atorvastatin, simvastatin, lovastatin;
• cough medicine that contains dextromethorphan;
• heart medication–amiodarone, digoxin, dofetilide, disopyramide, dronedarone, flecainide, ibutilide, metoprolol, procainamide, propafenone, quinidine, sotalol, verapamil;
• hepatitis C medications–boceprevir, telaprevir;
• HIV/AIDS medication–atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir;
• medicine to prevent or treat nausea and vomiting–dolasetron, droperidol, ondansetron;
• medicine to treat a psychiatric disorder–chlorpromazine, clozapine, haloperidol, mesoridazine, pimozide, thioridazine, ziprasidone;
• seizure medication–carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone;
• stomach acid reducers–cimetidine, ranitidine; or
• tuberculosis medication–rifabutin, rifampin, rifapentine.

What is quizartinib?

Quizartinib is used in adults alone or in combination with other cancer treatments to treat acute myeloid leukemia.

Quizartinib is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of quizartinib.

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

Quizartinib 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.

Quizartinib can cause a serious heart problem, especially if you use certain medicines at the same time. Call your doctor right away if you have irregular heartbeat, a light-headed feeling, like you might pass out, or have diarrhea or vomiting.

Your dose may be decreased and your treatment may be delayed or permanently discontinued if you have certain side effects.

Common side effects of quizartinib may include:

• nausea, vomiting, stomach pain, upset stomach, diarrhea, loss of appetite;
• fungal infections;
• sepsis (a severe reaction to an infection);
• eye irritation;
• nosebleeds;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• herpes infection;
• trouble sleeping;
• low levels of platelets in your blood;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• changes in liver function tests;
• an abnormal electrocardiogram or ECG (sometimes called an EKG); or
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

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

Warnings

Quizartinib can cause a serious heart problem, especially if you use certain medicines at the same time. Call your doctor right away if you have irregular heartbeat, a light-headed feeling, like you might pass out, or have diarrhea or vomiting.

Quizartinib is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of quizartinib.

Before taking this medicine

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

• very low magnesium level;
• very low potassium level;
• long QT syndrome; or
• history of ventricular arrhythmias or torsades de pointes.

Tell your doctor if you have or have ever had:

• heart problems; or
• low blood levels of potassium or magnesium.

Quizartinib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you will need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 7 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

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

How should I take quizartinib?

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

Do not change your dose or stop taking the medicine without your doctor’s advice.

Quizartinib is usually taken once per day with or without food at the same time each day.

If you vomit shortly after taking quizartinib, do not take another dose. Take your next dose as scheduled.

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

You may need medical tests before and during your treatment with quizartinib to check your heart function using an electrocardiograph or ECG (sometimes called an EKG).

Your blood will be tested before and during treatment with quizartinib.

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 line .

What should I avoid while taking quizartinib?

Avoid taking an herbal supplement containing St. John’s wort.

What other drugs will affect quizartinib?

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

What is Qulipta?

Qulipta is used to help prevent episodic and chronic migraine headaches in adults. These are severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound or light. Qulipta is an oral tablet taken once a day.

Qulipta (atogepant) belongs to a class of medications called CGRP inhibitors. 

Qulipta gained FDA approval on September 28, 2021. There is no Qulipta generic available.

How does Qulipta work?

Qulipta’s mechanism of action involves blocking the effect of CGRP, a small protein that is highly prevalent in the sensory nerves that supply the head and neck. CGRP is involved in pain transmission, inflammation, and blood vessel dilation, and research has shown that levels of CGRP increase during a migraine attack. It may also play a causative role in the initiation of migraine attacks. By blocking CGRP, Qulipta helps prevent migraine headaches (see How does Qulipta work? for more information).

Clinical trials have shown that Qulipta starts working within the first week of treatment. Research also shows a 54% reduction in monthly migraine days in patients with episodic migraine and a 36% reduction in patients with chronic migraine headaches .

Side effects

The most common side effects of Qulipta are:

• nausea
• constipation
• feeling tired or sleepy.

Serious side effects and warnings

Qulipta may cause the following serious side effects:

• Allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen when you take Qulipta or days after. Stop taking Qulipta and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction:
  • swelling of the face, lips, or tongue
  • itching
  • trouble breathing
  • hives
  • rash.
• High blood pressure: High blood pressure or worsening of high blood pressure can happen when you take Qulipta. Contact your healthcare provider if you have an increase in blood pressure.
• Raynaud’s phenomenon: This is a type of circulation problem that can worsen or happen when you take Qulipta. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale to blue to red. Contact your healthcare provider if these symptoms occur.

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

Before taking this medicine

Do not take Qulipta if you are allergic to atogepant, Qulipta, or any of the inactive ingredients in the tablets.

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

• kidney disease (or if you are on dialysis)
• liver disease
• are pregnant or planning to become pregnant
• are breastfeeding or intend to breastfeed.

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

Pregnancy

In animal trials, Qulipta caused pregnancy problems such as low birth weight or birth defects. It is not known if these effects could occur in humans. Ask your doctor about the risk.

Having migraine headaches during pregnancy may increase the risk of dangerously high blood pressure that can lead to medical problems in both mother and baby. The benefit of preventing migraines may outweigh any risk. Tell your doctor if you become pregnant.

Breastfeeding

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

How should I take Qulipta?

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

• Qulipta is usually taken 1 time daily.
• You may take Qulipta with or without food.
• The dosage of Qulipta depends on what other medications you are currently taking.

Qulipta dosing

Usual Qulipta Adult Dose for Episodic Migraine Prophylaxis:

• Qulipta 10 mg, 30 mg, or 60 mg orally once a day.
• The specific dosage depends on how often you get migraines.
• The dosage may need adjusting in severe liver or kidney disease and in those taking interacting medicines.

Usual Qulipta Adult Dose for Chronic Migraine Prophylaxis:

• Qulipta 60 mg orally once a day.

Qulipta dosage adjustments

Dosage adjustments are needed when Qulipta is taken with certain other medications and for people with severe kidney disease. The table below outlines the recommended Qulipta dosing modifications for drug interactions and specific populations.

Qulipta cost

The cost of Qulipta depends on your insurance and the pharmacy you use. With the Qulipta Complete Savings Card, eligible commercially insured patients may pay as little as $0.

This Qulipta co-pay assistance program is not available to patients receiving prescription reimbursement under Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs, or where prohibited by law. Call 1-855-QULIPTA for additional information.

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 Qulipta?

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

What other drugs will affect Qulipta?

Tell your doctor about all your current medicines. Many drugs can affect atogepant, especially:

• cyclosporine;
• St. John’s wort;
• an antibiotic such as clarithromycin or rifampin;
• antifungal medicine such as itraconazole or ketoconazole;
• antiviral medicine to treat HIV, such as efavirenz or etravirine; or
• seizure medicine such as carbamazepine or phenytoin.

This list is not complete, and many other drugs may affect Qulipta. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Qulipta ingredients

Active ingredient: atogepant
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.

Qulipta is supplied as 10 mg, 30 mg, and 60 mg tablets.

Storage

Store Qulipta at room temperature away from moisture and heat.

Who makes Qulipta?

Qulipta (atogepant) is made by AbbVie, headquartered in North Chicago, Illinois.

Key medications in AbbVie’s portfolio include:

• Humira (arthritis, psoriasis)
• Botox (cosmetic and therapeutic uses)
• Vraylar (schizophrenia, bipolar)
• Rinvoq (arthritis)
• Skyrizi (psoriasis)
• Ubrelvy (migraine).

What is Qutenza?

Qutenza (capsaicin 8% patch) is used to treat postherpetic neuralgia (PHN) or nerve pain of the feet caused by diabetic peripheral neuropathy (DPN). It is a prescription medication applied directly to the affected area by a healthcare professional for 30 to 60 minutes every 3 months.

Qutenza gained FDA approval on November 16, 2009. There is no generic available.

• Lower strength capsaicin patches, topical creams, and lotions can be brought from a drugstore without a prescription. 
• Qutenza is approximately 80 times stronger than typical OTC products.

Mechanism of action

Qutenza contains capsaicin, which is the substance that gives heat to chili peppers. Capsaicin works by selectively targeting TRPV1 receptors (pain receptors) in the skin. When applied it:

• Initially causes a burning or tingling sensation
• Gradually desensitizes the pain receptors
• Reduces the transmission of pain signals to the brain
• Provides prolonged pain relief even after the patch is removed.

FDA-Approved Indications

Qutenza is indicated for the treatment of:

• Postherpetic neuralgia (PHN): Persistent pain following a shingles infection
• Diabetic peripheral neuropathy (DPN): Pain in the extremities (typically feet or legs) caused by nerve damage from diabetes.

Qutenza side effects

Common Side Effects

The most common side effects of Qutenza are skin reactions where the patch was applied, such as:

• A burning sensation
• Pain
• Redness
• Itching
• Swelling
• Skin bumps and lumps (papules)
• Dryness.

A mild burning sensation may last several hours or days, especially after the first time Qutenza is applied.

Less Common Side Effects

• Temporary increases in blood pressure during and immediately after treatment
• Nausea
• Headache
• Cough
• Sneezing (due to breathing in airborne capsaicin).

Precautions and Warnings

Qutenza patches must only be applied by a healthcare professional. Never apply or remove Qutenza yourself.

Do not touch Qutenza or items exposed to capsaicin. Touching Qutenza and then accidentally touching other areas of your body can cause severe irritation of the eyes, mucous membranes, respiratory tract, and skin.

• This includes your eyes or other unintended target areas during the Qutenza application.
• Qutenza is not for use near eyes or mucous membranes.
• Do not sniff or inhale near Qutenza as this may cause you to cough or sneeze. Stop using Qutenza and call your doctor at once if you have trouble breathing or swallowing (after accidental inhalation of capsaicin odor or dried residue).
• If irritation of eyes or airways occurs or any side effects become severe, notify your doctor immediately.

You may experience substantial pain during the treatment. Tell your healthcare provider if you are experiencing pain; a cool compress or medicine for the pain can be provided to help lessen your discomfort.

• You may get frostbite if you cool your skin too much.
• You can use a cooling pack from the refrigerator (not the freezer) and avoid putting it directly on skin.
• Seek medical attention if you experience strong and continuous pain or skin lesions such as blisters after treatment.

Qutenza can cause serious side effects, including pain, severe burns, and increases in blood pressure during or right after treatment. Your healthcare provider should check your blood pressure during treatment with Qutenza.

• If you have high blood pressure that is not well controlled by medicine, or have had recent heart problems, stroke, or other vascular problems, you may be at increased risk and should discuss with your doctor whether Qutenza is right for you.

Tell your doctor if you have reduced sensation in the feet. You may notice that you have less feeling for hot or sharp pain where Qutenza was applied, but this is usually minor and temporary.

Treated areas may be sensitive to heat (such as hot water, direct sunlight, vigorous exercise) for a few days after treatment.

Hypersensitivity reactions. Qutenza may cause an allergic reaction in some people. Get emergency medical help if you have signs of an allergic reaction, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or 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 the FDA at 1-800-FDA-1088.

Before receiving this medicine

• Do not receive Qutenza if you are allergic to chili peppers, capsaicin, Qutenza, or any other ingredients in the formulation.
• Should not be used on broken or irritated skin.
• Not recommended to be applied to the face, scalp, or mucous membranes (for example, inside the nose or on the lips).

Before Qutenza is applied to your skin, tell your healthcare provider about all your medical conditions, including if you:

• have any allergies
• have high blood pressure or take medications for blood pressure
• have any skin conditions, such as eczema or psoriasis
• are pregnant or intend to become pregnant. It is not known whether Qutenza will harm an unborn baby
• are breastfeeding or intend to breastfeed. It is not known whether capsaicin passes into breast milk or if it could harm a nursing baby. Do not apply Qutenza to your breast area if you are breast-feeding a baby.

Qutenza is only approved for use in adults.

How is Qutenza applied?

Qutenza patches must only be applied by a healthcare professional. It should not be applied to open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medicine gets in your eyes, nose, or mouth, rinse with water.

• Remove jewelry or metal objects from the treatment area.
• Your skin should be clean and dry before the patches are applied.
• Do not touch Qutenza, treatment areas, and all used supplies or other materials placed in contact with the treatment area without wearing nitrile gloves.
• This medicine is for use only on the skin.

Your healthcare provider will pre-treat the area with a topical anesthetic to reduce discomfort associated with the application of Qutenza.

• To keep the medication from getting on their hands, they will wear nitrile gloves. They will prepare the patches and press them on the skin.
• Once the patch has been applied, they will leave it in place for 60 minutes for postherpetic neuralgia, and 30 minutes for diabetic peripheral neuropathy of the feet.
• The treated skin should not be covered with a bandage or heating pad, because this can increase the burning sensation. It may be covered with clothing.

Post-Treatment Care

• The treated area may remain sensitive for a few days.
• Cooling measures (ice packs) may help alleviate discomfort.
• Avoid hot showers or baths immediately after treatment.
• Avoid vigorous exercise that might irritate the treated area.
• Keep the area clean and avoid applying other topical products unless directed.

Dosing information

Usual Adult Qutenza Dose for Postherpetic Neuralgia:

Up to 4 patches in a single, 60-minute application.

• Treatment may be repeated every three months or as warranted by the return of pain (but not more frequently than every 3 months).

Usual Adult Qutenza Dose for Diabetic Peripheral Neuropathy (DPN) of the Feet:

Up to 4 patches in a single, 30-minute application.

• Treatment may be repeated every three months or as warranted by the return of pain (but not more frequently than every 3 months).

What should I avoid while using Qutenza?

Avoid inhaling the odor or dried residue of Qutenza during treatment. Inhaling capsaicin can cause coughing, sneezing, or watery eyes, and can irritate your throat or lungs.

Avoid touching your eyes, mouth, nose, genitals, or rectum until the medication has been washed off the treatment area.

Avoid exposing treated skin to sunlight, sunlamps, tanning beds, or a hot tub. 

Do not use other medicated skin products, including muscle pain creams or lotions, on areas where Qutenza has been applied, unless your doctor has told you to.

Efficacy and Clinical Response

• Pain relief may begin within days after treatment.
• Clinical trials report the full effect typically develops over 1-2 weeks.
• Relief can last for up to 3 months, at which point treatment can be repeated.
• Not all patients respond equally; individual results may vary.

Insurance Coverage and Availability

• Requires a prescription from a healthcare provider.
• Coverage varies by insurance plan; prior authorization may be required.
• Available only as patches containing 8% capsaicin (179 mg).

Drug interactions

Qutenza is not known to have significant interactions with other medications as it acts locally with minimal systemic absorption.

Ingredients

Active: capsaicin 179 mg.

Inactive ingredients: diethylene glycol monoethyl ether, dimethicone, ethyl cellulose, polyester film, silicone adhesive, and white ink. 

Each Qutenza patch contains 8% capsaicin (640 mcg per cm²), for a total of 179 mg of capsaicin.

Who makes Qutenza?

Qutenza (capsaicin 8% patch) is manufactured by Averitas Pharma, Inc., a subsidiary of Grünenthal GmbH, headquartered in Aachen, Germany. Averitas Pharma, the U.S. subsidiary handling Qutenza, operates from its U.S. headquarters in Morristown, New Jersey. Other notable products by Grünenthal are:

• Tramadol (Ultram, Zydol) – for moderate to moderately severe pain
• Buprenorphine patches (Transtec) – for moderate to severe chronic pain
• Versatis (lidocaine medicated plaster) – a topical anesthetic for post-herpetic neuralgia
• Palexia SR (extended-release tapentadol) – a long-acting formulation for chronic pain management.

What is Quviviq?

Quviviq (daridorexant) is a prescription medicine that may be used to encourage sleep in adults who have trouble falling asleep or staying asleep (insomnia).

Quviviq’s mechanism of action involves blocking a chemical in the brain called orexin, that keeps the brain alert. Quviviq stops orexin from binding to its receptors, which helps the brain to calm down and prepare for sleep. Quviviq is designed to help adults fall asleep more easily and sleep through the night. Quviviq is not a benzodiazepine and belongs to the drug class called orexin antagonists .

Quviviq gained FDA approval on January 7, 2022. There is no Quviviq generic available.

Is Quviviq a controlled substance?

Quviviq is a federally controlled substance (schedule IV) because it can be abused or lead to dependence.

Keep Quviviq in a safe place to prevent misuse and abuse. Selling or giving away Quviviq may harm others and is against the law.

What does Quviviq cost?

Quviviq costs just over $500 for a supply of 30 tablets. Some people may be eligible for a Quviviq coupon or Quviviq copay card.

Quviviq side effects

The most common side effects of Quviviq are headache and sleepiness.

Quviviq has not been associated with weight gain.

Serious side effects and warnings

Quviviq may cause the following serious side effects.

Decreased awareness and alertness. The morning after you take Quviviq, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.

• Do not take more Quviviq than prescribed.
• Do not take Quviviq unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again.
• Take Quviviq in the evening within 30 minutes before going to bed.

Worsening depression and suicidal thoughts. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying while taking Quviviq.

Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up. Quviviq may cause sleep paralysis or hallucinations. Talk to your healthcare provider immediately if you experience these.

Complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex, or doing other activities while not fully awake that you may not remember the next morning, have been reported by people taking Quviviq. Stop taking Quviviq and call your healthcare provider right away if you experience any of these behaviors.

It is not known if Quviviq is safe and effective for use in children.

These are not all of the possible side effects. Call your doctor for medical advice about side effects.

Before taking

Do not take Quviviq if you have narcolepsy (a condition where you fall asleep suddenly, often at unexpected or inappropriate times.

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

• have a history of depression, mental illness, or suicidal thoughts or actions
• have a history of drug or alcohol abuse or addiction
• have a history of a sudden onset of muscle weakness (cataplexy)
• have a history of daytime sleepiness
• have lung or breathing problems, including sleep apnea
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Quviviq can harm your unborn baby. There is a pregnancy registry for women who are exposed to Quviviq during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. For more information or to participate in the registry, call 1-833-400-9611. Talk with your healthcare provider about the risk to your unborn baby if you take Quviviq during pregnancy.

Breastfeeding

It is not known if Quviviq passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

How should I take Quviviq?

Take Quviviq exactly as your healthcare provider tells you to take it. Do not change your dose without first talking to your healthcare provider.

• Take Quviviq 1 time each night, within 30 minutes before going to bed. 
• Only take Quviviq when you can stay in bed for a full night (at least 7 hours). There should be at least 7 hours remaining before you plan to wake up
• It may take Quviviq longer to start working if you take it with or soon after food.

Call your healthcare provider if you still can’t sleep properly and you have been taking Quviviq for 7 to 10 days. This may mean that another condition is causing your sleep problem.

Quviviq dosage

The usual adult dose of Quviviq is 25 mg to 50 mg once per night.

What happens if I take too much Quviviq?

If you take too much Quviviq or overdose, call your healthcare provider immediately or go to the nearest hospital emergency room right away.

What should I avoid while taking Quviviq?

Do not drink alcohol while taking Quviviq because it may increase the effects of alcohol or Quviviq, which may be dangerous.

You may still feel drowsy the next day after taking Quviviq.

• Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you have taken Quviviq as prescribed but do not feel fully awake, you have taken Quviviq and have less than a full night of sleep (at least 7 hours), or if you have taken more Quviviq than prescribed by your healthcare provider.

What other drugs will affect Quviviq?

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

Taking Quviviq with certain medicines can cause serious side effects. Quviviq may affect the way other medicines work and other medicines may affect the way Quviviq works.

Taking Quviviq with medicines that have drowsiness as a side effect (such as sedating antihistamines, benzodiazepines, or muscle relaxants).

Do not take Quviviq with other medicines that are used to promote sleep, such as Ambien (see Quviviq vs Ambien).

Other drugs may affect Quviviq, 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.

Quviviq storage

Store Quviviq at room temperature between 68°F to 77°F (20°C to 25°C).

Keep out of the reach of children and pets.

Quviviq ingredients

Quviviq active ingredient: daridorexant hydrochloride
Quviviq inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, and silicon dioxide.

The tablet film coating contains: glycerin, hypromellose, iron oxide black, iron oxide red, microcrystalline cellulose, talc, titanium dioxide, and, in the 50 mg tablet only, iron oxide yellow.

Uses for Qvar

Beclomethasone is used to help control the symptoms of asthma and improve breathing. It is used when a patient’s asthma has not been controlled sufficiently on other asthma medicines, or when a patient’s condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.

Beclomethasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

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

Before using Qvar

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of inhaled QVAR® inhaler in children 5 years of age and older and inhaled QVAR® Redihaler in children 4 years of age and older. Safety and efficacy have not been established in children younger than 5 years of age for QVAR® inhaler and in children younger than 4 years of age for QVAR® Redihaler.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled beclomethasone in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution for patients receiving inhaled beclomethasone.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

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.

• Aspirin
• Bemiparin
• Lutetium Lu 177 Dotatate
• Macimorelin
• Nadroparin
• Sargramostim
• Somatrogon-ghla

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.

• Auranofin

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:

• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute—Should not be used in patients with these conditions.

• Cataracts or
• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, fungus, or parasite) or
• Measles or
• Tuberculosis, active or history of—Inhaled beclomethasone can reduce the body’s ability to fight off these infections.

• Immobilization for long periods of time or
• Osteoporosis, family history of—Beclomethasone may make your bones weaker and increase the chance of a broken bone after a minor fall or injury.

Proper use of Qvar

Inhaled beclomethasone is used to prevent asthma attacks. It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

Inhaled beclomethasone is used with a special inhaler that comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the QVAR® inhaler or QVAR® Redihaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Do not stop using this medicine or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

To use the QVAR® inhaler:

• Do not use the inhaler for this medicine with any other medicine. Do not remove the canister from the actuator.
• Remove the cap and look at the mouthpiece to make sure it is clean.
• Before you use an inhaler for the first time, prime it by pointing it away from your face and spraying into the air 2 times. If the inhaler has not been used for 10 days or longer, prime it again.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
• While pressing down firmly and fully on the metal canister, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Take the inhaler out of your mouth. Hold your breath for about 10 seconds, then breathe out slowly.
• If you are supposed to use more than one puff, wait 1 to 2 minutes before inhaling the second puff. Repeat these steps for the next puff.
• Wipe the mouthpiece dry with a cloth or tissue. Do not wash it with water. Put the cap back on right away.
• Gargle and rinse your mouth with water after each dose.
• The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the count is 0. You may not receive the right amount of medicine.

To use the QVAR® Redihaler:

• Take the inhaler out of the carton before you use it for the first time.
• Do not use the inhaler for this medicine with any other medicine.
• This medicine does not require priming. Do not shake the inhaler. Do not use it with a spacer or volume holding chamber.
• Always use the inhaler in an upright position with the mouthpiece facing downwards.
• Do not open the white cap of the inhaler or leave it open unless you are ready to use it. Close the cap before each use or if it has been left open for more than 2 minutes.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• Close the white cap to prepare for the next inhalation.
• If your doctor has told you to take more than 1 inhalation per dose, make sure the cap is closed and repeat the previous steps.
• Keep the inhaler dry and clean at all times. Gently wipe the mouthpiece with a dry cloth or tissue as needed. Do not wash or put any part of the inhaler in water.
• The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the dose counter displays 0 after opening the carton.

Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.

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 inhalation dosage form (aerosol):
  • QVAR® inhaler:
    • For preventing an asthma attack:
      • For patients who have received bronchodilators alone:
        • Adults and children 12 years of age and older—At first, one puff two times a day. Each puff contains 40 or 80 micrograms (mcg) of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 320 mcg two times a day.
        • Children 5 to 11 years of age—At first, one puff two times a day. Each puff contains 40 mcg of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mcg two times a day.
        • Children younger than 5 years of age—Use and dose must be determined by your doctor.
      • For patients who have received inhaled corticosteroids:
        • Adults and children 12 years of age and older—At first, one to two puffs two times a day. Each puff contains 40 or 80 micrograms (mcg) of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 320 mcg two times a day.
        • Children 5 to 11 years of age—At first, one puff two times a day. Each puff contains 40 mcg of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mcg two times a day.
        • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • QVAR® Redihaler:
    • For preventing an asthma attack:
      • For patients who have not received inhaled corticosteroids:
        • Adults and children 12 years of age and older—At first, 40 to 80 micrograms (mcg) beclomethasone 2 times a day. The doses should be at least 12 hours apart. Your doctor may increase your dose as needed. However, the dose is usually not more than 320 mcg two times a day.
        • Children 4 to 11 years of age—At first, 40 mcg of beclomethasone 2 times a day. The doses should be at least 12 hours apart. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mcg two times a day.
        • Children younger than 4 years of age—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.

If you miss a dose of QVAR® Redihaler, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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 Qvar

If you will be using this medicine for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child have white patches in the mouth or throat, or pain when eating or swallowing.

You should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.

Talk with your doctor or get medical care right away if:

• Your or your child’s symptoms do not improve after using this medicine for 2 weeks or if they become worse.
• You or your child have a big decrease in your peak flow when measured as directed by your doctor.

Using too much of this medicine or using it for a long time may cause problems with your adrenal gland. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Follow your doctor’s directions carefully if you are switching from an oral corticosteroid to this medicine.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. This may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine. Use a short acting inhaler right away to treat your symptoms.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.

This medicine may cause children to grow more slowly than usual. Talk to your child’s doctor if you have any concerns.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

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 Qvar

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

• Body aches or pain
• congestion
• cough
• difficulty with breathing
• dryness or soreness of the throat
• fever
• hoarseness
• runny nose
• tender, swollen glands in the neck
• trouble swallowing
• voice changes

Incidence not known

• Attack, assault, or force
• blindness
• blurred vision
• changes in behavior
• chills
• darkening of the skin
• decreased vision
• diarrhea
• dizziness
• eye pain
• fainting
• headache
• loss of appetite
• lower back or side pain
• mental depression
• nausea
• painful or difficult urination
• skin rash
• sore mouth or tongue
• tearing
• thoughts of killing oneself
• unusual tiredness or weakness
• vomiting
• white patches in the mouth or on the tongue

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:

Less common

• Cramps
• heavy bleeding
• pain
• pain or tenderness around the eyes and cheekbones
• stuffy or runny nose
• tightness of the chest

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects.

Commonly used brand name(s)

In the U.S.

• Beclovent
• Qvar
• Qvar Redihaler

Available Dosage Forms:

• Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

What is Qvar Redihaler?

Beclomethasone is an inhaled steroid that is used to prevent asthma attacks in adults and children at least 4 years old.

Qvar Redihaler will not treat an asthma attack that has already begun.

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

Qvar Redihaler 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.

Beclomethasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using Qvar Redihaler.

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

• wheezing, choking, or other breathing problems after using this medicine;
• worsening asthma symptoms;
• white patches or sores inside your mouth or on your lips;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• signs of infection–fever, chills, body aches, vomiting;
• signs of low adrenal gland hormones–worsening tiredness, lack of energy, weakness, feeling light-headed, nausea, vomiting; or
• increased adrenal gland hormones–hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes.

Common side effects of Qvar Redihaler may include:

• a yeast infection in the mouth;
• sinus pain, irritation in your nose; 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.

Warnings

Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Before taking this medicine

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

Tell your doctor if you have ever had:

• any type of bacterial, fungal, or viral infection;
• tuberculosis;
• herpes infection of the eyes;
• osteoporosis, or low bone mineral density;
• a weak immune system; or
• cataracts, glaucoma, or increased pressure inside your eyes.

Tell your doctor if you are pregnant or breastfeeding.

How should I use Qvar Redihaler?

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

Qvar Redihaler is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Read and carefully follow any instructions for using Qvar Redihaler, priming the inhaler device, and cleaning the device. Ask your doctor or pharmacist if you do not understand these instructions.

Do not allow a young child to use this medicine without help from an adult.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor’s instructions about tapering your dose.

To reduce the chance of developing a yeast infection in your mouth, rinse with water (but do not swallow) after using Qvar Redihaler.

It may take up to 4 weeks or longer before your symptoms improve. Keep using the medicine and call your doctor if your symptoms do not begin to improve after 2 weeks.

You should not stop using Qvar Redihaler suddenly. Stopping suddenly may make your condition worse.

Use all asthma medications as directed. Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your dose or stop using a medicine without your doctor’s advice. Tell your doctor if any of your medicines seem to stop working.

Store at room temperature away from moisture and heat. Keep the cover on your inhaler when not in use. Keep away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Throw away the inhaler device when the inhalations counter shows “0” or the expiration date on the label has passed. Get your prescription refilled before you run out of medicine completely.

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Qvar Redihaler?

Rinse with water if Qvar Redihaler gets in your eyes.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Medication Guide

Read this Medication Guide before you start treatment. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Warnings

Serious side effects can happen to people taking Qternmet XR, including:

• Lactic Acidosis. Metformin, one of the medicines in Qternmet XR, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Call your healthcare provider right away if you have any of the following symptoms, which could be signs of lactic acidosis:

• you feel cold in your hands or feet
• you feel dizzy or lightheaded
• you have a slow or irregular heartbeat
• you feel very weak or tired
• you have unusual (not normal) muscle pain
• you have trouble breathing
• you feel unusual sleepiness or sleep longer than usual
• you have stomach pains, nausea, or vomiting

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin use, led to the lactic acidosis. Tell your healthcare provider if you have any of the following, because you have a higher chance for getting lactic acidosis with Qternmet XR if you:

• have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye
• have liver problems
• drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
• have surgery
• have a heart attack, severe infection, or stroke.

The best way to keep from having a problem with lactic acidosis from metformin is to tell your healthcare provider if you have any of the problems in the list above. Your healthcare provider may decide to stop your Qternmet XR for a while if you have any of these problems.

• Inflammation of the pancreas (pancreatitis). Saxagliptin, one of the medicines in Qternmet XR, can cause inflammation of the pancreas, which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.

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Before you start treatment, tell your healthcare provider if you have ever had:

• inflammation of your pancreas (pancreatitis)
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels

It is not known if having these medical problems will make you more likely to get pancreatitis with Qternmet XR.

Stop taking Qternmet XR and contact your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Heart failure. Heart failure means your heart does not pump blood well enough. Before you start treatment, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys.

Contact your healthcare provider right away if you have any of the following symptoms:

• increasing shortness of breath or trouble breathing, especially when you lie down
• swelling or fluid retention, especially in the feet, ankles, or legs
• an unusually fast increase in weight
• unusual tiredness

These may be symptoms of heart failure.

Dehydration. Qternmet XR can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you:

• have low blood pressure
• take medicines to lower your blood pressure, including water pills (diuretics)
• are 65 years of age or older
• are on a low salt diet
• have kidney problems

Qternmet XR can have other serious side effects. See Qternmet XR side effects./p>

What is Qternmet XR?

Qternmet XR is a prescription medicine that contains dapagliflozin, saxagliptin, and metformin hydrochloride.

This medicine is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

Qternmet XR is NOT for:

• people with type 1 diabetes.
• people with diabetic ketoacidosis (increased ketones in your blood or urine).
• Qternmet XR is only for people currently taking metformin.
• It is not known if this medicine is safe and effective in children younger than 18 years of age.

Who should not take Qternmet XR?

Do not take Qternmet XR if you:

• are allergic to dapagliflozin, saxagliptin, metformin, or any of the ingredients. See the end of this Medication Guide for a list of ingredients.

Symptoms of a serious allergic reaction may include:

• swelling of the face, lips, throat and other areas of your skin
• difficulty with swallowing or breathing
• skin rash, itching, flaking or peeling
• raised red areas on your skin (hives)

If you have any of these symptoms, stop taking Qternmet XR and contact your healthcare provider or go to the nearest hospital emergency room right away.

• have moderate to severe kidney problems or are on dialysis.
• have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).

Before taking Qternmet XR

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

• have type 1 diabetes or have had diabetic ketoacidosis (increased ketones in your blood or urine).
• are going to have surgery.
• are eating less due to illness, surgery or a change in your diet.
• drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).
• have kidney problems.
• have liver problems.
• have a history of urinary tract infections or problems urinating.
• have heart problems, including heart failure.
• have had swelling of the face, lips, tongue and throat (angioedema) when you used a medicine called a dipeptidyl peptidase-4 (DPP-4) inhibitor like saxagliptin, one of the medicines in Qternmet XR. If you are not sure if you have taken this medicine, ask your healthcare provider.
• have or have had bladder cancer.
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
• are going to get injection of dye or contrast agents for an x-ray procedure. Qternmet XR may need to be stopped for a short time. Talk to your healthcare provider about when you should stop treatment and when you should start again. See Important information.
• are pregnant or plan to become pregnant. Qternmet XR may harm your unborn baby. If you are pregnant or plan to become pregnant, call your healthcare provider right away to talk about the best way to control your blood sugar.
• are a woman who has not gone through menopause (premenopausal) who does not have periods regularly or at all. Qternmet XR can cause the release of an egg from an ovary in a woman (ovulation). This can increase your chance of getting pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Qternmet XR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment. Breastfeeding is not recommended while taking Qternmet XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Qternmet XR may affect the way other medicines work, and vice versa. Contact your healthcare provider if you will be starting or stopping certain other types of medicines, such as antibiotics, or medicines that treat fungus or HIV/AIDS, because your dose might need to be changed.

How should I take Qternmet XR?

• Take Qternmet XR tablets exactly as your healthcare provider tells you to take it.
• Do not change your dose without talking to your healthcare provider.
• Take the tablets by mouth one time each day in the morning with food.
• Swallow the tablets whole. Do not cut, crush or chew the tablets.
• You may sometimes pass a soft mass in your stools (bowel movement) that looks like Qternmet XR tablets.
• During periods of stress on the body, such as fever, trauma, infection or surgery, contact your healthcare provider right away as your medicine needs may change.
• Stay on your prescribed diet and exercise program during treatment.
• Your healthcare provider may do certain blood tests before you start, and during your treatment.
• Your healthcare provider should test your blood to measure how well your kidneys are working before and during your treatment.
• Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.
• Follow your healthcare provider’s instructions for treating low blood sugar (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you.
• Qternmet XR will cause your urine to test positive for glucose.
• If you miss your daily dose, and it is more than 12 hours until your next dose, take the missed dose as soon as possible with food.
• If you miss a daily dose and it is less than 12 hours until your next dose, skip the missed dose. Take the next dose at your regular time.
• If you take too much or overdose, call your healthcare provider, or go to the nearest hospital emergency room right away.

What to avoid

• Avoid drinking alcohol very often or drinking a lot of alcohol in a short period of time (“binge” drinking). It can increase your chances of getting serious side effects.

Qternmet XR side effects

Qternmet XR may cause serious side effects, including:

• See Important information.
• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with dapagliflozin, one of the medicines in Qternmet XR. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with dapagliflozin even if your blood sugar is less than 250 mg/dL.
  Stop taking Qternmet XR and call your healthcare provider right away if you get any of the following symptoms:
  • nausea
  • tiredness
  • vomiting
  • trouble breathing
  • stomach area (abdominal) pain
  If you get any of these symptoms during your treatment, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
• Kidney problems. Sudden kidney injury has happened to people taking dapagliflozin. Talk to your healthcare provider right away if you:
  • reduce the amount of food or liquid you drink, for example if you are sick and cannot eat, or
  • you start to lose liquids from your body with vomiting, diarrhea, or being in the sun too long.
• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
• Low blood sugar (hypoglycemia). If you take Qternmet XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, this can increase your risk of getting low blood sugar. Tell your healthcare provider if you take other diabetes medicines. Signs and symptoms of low blood sugar may include:
  • shaking or feeling jittery
  • hunger
  • change in mood
  • sweating
  • headache
  • confusion
  • rapid heartbeat
  • drowsiness
  • irritability
  • change in vision
  • weakness
• A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take dapagliflozin, one of the medicines in Qternmet XR. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:
  • pain or tenderness
  • swelling
  • redness of skin (erythema)
• Serious allergic reaction. Qternmet XR may cause serious allergic reactions. Stop taking Qternmet XR and get medical help right away if you develop any of the following symptoms of a serious allergic reaction including:
  • swelling of the face, lips, tongue, throat and other areas of your skin
  • difficulty with swallowing or breathing
  • skin rash, itching, flaking, or peeling
  • raised red patches on your skin (hives)
• Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 levels before. Your healthcare provider may do blood tests to check your vitamin B12 levels.
• Vaginal yeast infection. Women who take Qternmet XR may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
  • vaginal odor
  • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
  • vaginal itching
• Yeast infection of the penis (balanitis). Men who take Qternmet XR may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of a yeast infection of the penis include:
  • redness, itching, or swelling of the penis
  • rash of the penis
  • foul smelling discharge from the penis
  • pain in the skin around the penis
  Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medicine and your symptoms do not go away.
• Increased fats in your blood (bad cholesterol or LDL).
• Bladder cancer. In studies of dapagliflozin in people with diabetes, bladder cancer occurred in a few more people who were taking dapagliflozin than in people who were taking other diabetes medicines. There were too few cases to know if bladder cancer was related to dapagliflozin. You should not take Qternmet XR if you have bladder cancer. Tell your healthcare provider right away if you have any of the following symptoms:
  • blood or a red color in your urine
  • pain while you urinate
• Joint pain. Some people who take DPP-4 inhibitors like saxagliptin, may develop joint pain that can be severe. Call your healthcare provider right away if you have severe joint pain.
• Skin reaction. Some people who take DPP-4 inhibitors, one of the medicines in Qternmet XR, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking Qternmet XR.

The most common side effects include:

• upper respiratory tract infection
• abnormal amounts of fats in the blood (dyslipidemia)
• urinary tract infection

These are not all of the possible side effects. Call your healthcare provider for medical advice about side effects. 

How should I store Qternmet XR?

Store Qternmet XR at room temperature between 68°F to 77°F (20°C to 25°C).

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Qternmet XR.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information that is written for health professionals.

What are the ingredients in Qternmet XR?

Active ingredients: dapagliflozin, saxagliptin, and metformin hydrochloride

Inactive ingredients: carboxymethyl cellulose sodium, crospovidone, hypromellose 2208, iron oxides, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, macrogol/polyethylene glycol, silicon dioxide, talc, and titanium dioxide.