topiramate extended-release capsules
Generic Name: phentermine/topiramate (FEN-ter-meen/toe-PIR-a-mate)
Brand Name: Qsymia
Phentermine/topiramate extended-release capsules is used for:
Reducing weight in certain patients when used in combination with exercise, diet, and behavioral modification.
Phentermine/topiramate extended-release capsules is a combination of 2 medicines used to control appetite. Exactly how it works is not known, but it is thought to help to release certain chemicals in the brain that control appetite.
Do NOT use phentermine/topiramate extended-release capsules if:
- you are allergic to any ingredient in phentermine/topiramate extended-release capsules or other sympathomimetics (eg, pseudoephedrine)
- you are pregnant or are planning to become pregnant
- you have an overactive thyroid, glaucoma, pulmonary hypertension, severe liver problems, or severe narrowing of the blood vessels
- you have a history of stroke, heart problems (eg, heart blood vessel disease, irregular heartbeat, heart failure, recent heart attack), or uncontrolled high blood pressure
- you are in an agitated state, or have a history of substance abuse or of suicidal thoughts or actions
- you have severe kidney problems and are on dialysis
- you are taking bosutinib, cabazitaxel, a carbonic anhydrase inhibitor (eg, acetazolamide), dexfenfluramine, fenfluramine, furazolidone, guanadrel, guanethidine, linezolid, or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or you have taken linezolid or an MAOI within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using phentermine/topiramate extended-release capsules:
Some medical conditions may interact with phentermine/topiramate extended-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have kidney or liver problems, lung or breathing problems, diarrhea, or high cholesterol or lipid levels
- if you have a history of heart problems (eg, heart attack, heart failure, irregular heartbeat), blood vessel problems (eg, stroke), eye problems, mental or mood problems (eg, depression), status epilepticus (continuous seizure activity or a series of seizures without a full return to consciousness), high blood acid levels (metabolic acidosis), diabetes, high blood pressure, kidney stones, osteoporosis (weak bones) or other bone problems, or seizures
- if you are on a diet high in fat and low in carbohydrates (ketogenic diet), or you have recently had or will be having surgery
- if you are taking insulin or other diabetes medicines (eg, glyburide), medicines to treat high blood pressure, or any other medicine or supplement (prescription or nonprescription) for weight loss
Some MEDICINES MAY INTERACT with phentermine/topiramate extended-release capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Carbonic anhydrase inhibitors (eg, acetazolamide, zonisamide) because the risk of developing kidney stones may be increased
- Valproic acid because the risk of high blood ammonia levels or low body temperature may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood potassium levels may be increased
- Dexfenfluramine or fenfluramine because the risk of possibly fatal lung problems may be increased
- Furazolidone, linezolid, or MAOIs (eg, phenelzine) because the risk of serious side effects, such as increasing headache, high blood pressure, slow heart rate, or elevated temperature, may be increased
- Carbamazepine or hydantoins (eg, phenytoin) because they may decrease phentermine/topiramate extended-release capsules's effectiveness
- Bosutinib, cabazitaxel, dienogest, guanadrel, guanethidine, hormonal birth control (eg, birth control pills), or ulipristal because their effectiveness may be decreased by phentermine/topiramate extended-release capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if phentermine/topiramate extended-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use phentermine/topiramate extended-release capsules:
Use phentermine/topiramate extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Phentermine/topiramate extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get phentermine/topiramate extended-release capsules refilled.
- Take phentermine/topiramate extended-release capsules by mouth with or without food.
- Take phentermine/topiramate extended-release capsules in the morning unless your doctor directs you otherwise. Taking phentermine/topiramate extended-release capsules in the evening may cause trouble sleeping.
- Drinking extra fluids while you are taking phentermine/topiramate extended-release capsules is recommended. Doing so may help to prevent kidney stones from forming. Check with your doctor for instructions.
- Do not suddenly stop taking phentermine/topiramate extended-release capsules. You may have an increased risk of seizures. If you need to stop phentermine/topiramate extended-release capsules, your doctor will gradually lower your dose.
- If you miss a dose of phentermine/topiramate extended-release capsules, skip the missed dose and go back to your regular dosing schedule the next morning or as directed by your doctor. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use phentermine/topiramate extended-release capsules.
Important safety information:
- Phentermine/topiramate extended-release capsules may cause dizziness or trouble concentrating. These effects may be worse if you take it with alcohol or certain medicines. Use phentermine/topiramate extended-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Follow the diet and exercise program given to you by your health care provider.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Doing so may increase the risk of serious side effects.
- Do not drink alcohol while you are using phentermine/topiramate extended-release capsules.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using phentermine/topiramate extended-release capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Phentermine/topiramate extended-release capsules may cause serious eye problems that could lead to permanent loss of vision if not treated. Seek medical attention right away if you experience new eye symptoms (eg, blurred vision or other vision changes, eye pain or redness).
- Phentermine/topiramate extended-release capsules may reduce sweating, which could raise body temperature, especially in children. This risk is greater in hot weather and/or during vigorous exercise. Drink plenty of fluids. Dress lightly in hot climates or when exercising. Check carefully for signs of decreased sweating. If this occurs, promptly seek cooler or air-conditioned shelter and/or stop exercising. Seek medical attention right away if you have decreased sweating, fever, mental or mood changes, headache, or dizziness.
- Phentermine/topiramate extended-release capsules may cause high blood acid levels (metabolic acidosis). The risk may be greater in children and in patients with kidney problems, severe breathing problems, or diarrhea. It may also be greater in patients who are taking certain other medicines (eg, acetazolamide), will be having surgery, or are on a ketogenic diet. Over a period of time, metabolic acidosis may cause kidney stones or bone problems. Contact your doctor immediately if you experience fast breathing, unusual tiredness or weakness, sluggishness, persistent loss of appetite, or fast or irregular heartbeat.
- Tell your doctor or dentist that you take phentermine/topiramate extended-release capsules before you receive any medical or dental care, emergency care, or surgery.
- Patients who take phentermine/topiramate extended-release capsules may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take phentermine/topiramate extended-release capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Women who are able to become pregnant should have a negative pregnancy test before starting phentermine/topiramate extended-release capsules and every month while taking it. Women who are able to become pregnant should also use an effective form of birth control while taking phentermine/topiramate extended-release capsules. If you have questions about this information, talk with your doctor.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using phentermine/topiramate extended-release capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms). The risk of irregular menstrual bleeding (spotting) may also be increased in patients taking hormonal birth control. Talk with your doctor if your menstrual bleeding changes. Discuss any questions or concerns with your doctor.
- Diabetes patients - Phentermine/topiramate extended-release capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including blood electrolyte levels and kidney function tests, may be performed while you use phentermine/topiramate extended-release capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Phentermine/topiramate extended-release capsules should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use phentermine/topiramate extended-release capsules if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Phentermine/topiramate extended-release capsules is found in breast milk. Do not breast-feed while taking phentermine/topiramate extended-release capsules.
After you have taken phentermine/topiramate extended-release capsules for a few weeks, it will usually not work as well as when you began taking it. This is known at TOLERANCE. Talk with your doctor if phentermine/topiramate extended-release capsules stops working well. Do not take more medicine than prescribed.
Some people who use phentermine/topiramate extended-release capsules for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking phentermine/topiramate extended-release capsules suddenly, you may have WITHDRAWAL symptoms. These may include extreme tiredness; seizures; trouble sleeping; irritability; or mental, mood, or personality changes (eg, depression).
Possible side effects of phentermine/topiramate extended-release capsules:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; dry mouth; headache; nausea; nose or throat irritation; numbness or tingling in the hands, arms, feet, or face; taste changes; tiredness; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bone pain; chest pain; confusion; dark urine; decreased, difficult, or painful urination; decreased sweating; eye pain or redness; fast breathing; fast or irregular heartbeat; fever; memory problems; menstrual changes; muscle pain, weakness, or cramping; new or worsening mental, mood, or behavior changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); pale stools; pounding in the chest; red, swollen, blistered, or peeling skin; severe or persistent headache; severe stomach, side, or back pain; sluggishness; stupor; suicidal thoughts or actions; tremor; trouble speaking, thinking, or concentrating; unusual tiredness or weakness; vision changes (eg, blurred vision, loss of vision, sudden decrease in vision); yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include behavior changes (eg, aggressiveness, irritability); confusion; diarrhea; fainting; hallucinations; irregular heartbeat; loss of coordination; mental or mood changes (eg, depression); nausea; overactive reflexes; panic attacks; rapid breathing; restlessness; seizures; severe dizziness, drowsiness, or headache; severe or persistent stomach pain; sluggishness; speech problems; stomach cramps; stupor; tiredness; tremor; vision problems (eg, blurred or double vision); vomiting.Proper storage of phentermine/topiramate extended-release capsules:
Store phentermine/topiramate extended-release capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep phentermine/topiramate extended-release capsules out of the reach of children and away from pets.
- If you have any questions about phentermine/topiramate extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
- Phentermine/topiramate extended-release capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take phentermine/topiramate extended-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about phentermine/topiramate extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to phentermine/topiramate extended-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using phentermine/topiramate extended-release capsules.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.