This medication is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by people who are significantly overweight (obese) and have not been able to lose enough weight with diet and exercise alone. Losing weight and keeping it off can reduce the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life.
It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, by increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is a combination of phentermine and topiramate. Phentermine is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines. Topiramate is known as an anticonvulsant or antiepileptic drug.
Because of the risk to an unborn baby, only doctors and pharmacies enrolled in a special distribution program (Qsymia REMS) may prescribe or dispense this medication. Ask your doctor or pharmacist for details.
Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Taking this medication late in the day may cause trouble sleeping (insomnia). Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects.
The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.
To prevent kidney stones from forming, drink plenty of liquids while taking this medication unless your doctor instructs you otherwise.
This medication should not be taken with other appetite suppressants (see also Drug Interactions section). The possibility of serious side effects increases with longer use of this medication and use of this drug along with certain other diet drugs.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Take this medication exactly as prescribed to lessen the risk of addiction.
When this medication is used for several weeks, it may not work as well. Talk with your doctor if this medication stops working well. Your doctor may direct you to stop taking this medication.
Dizziness, drowsiness, dry mouth, difficulty sleeping, tiredness, tingling of the hands/feet, constipation, and metallic taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: temporary difficulty concentrating/finding words/remembering things, signs of kidney stones (such as painful urination, fever, chills, pink/bloody urine), rapid breathing, fast/slow/irregular heartbeat, bone pain/broken bones, loss of consciousness, change in sexual ability/interest.
A small number of people who take anticonvulsants for any reason (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Rarely, topiramate may cause a very serious eye problem, generally within 1 month of starting treatment. If untreated, this eye problem can lead to permanent blindness. Therefore, get medical help right away if any of these side effects occur: sudden vision changes (such as decreased vision, blurred vision), eye pain/redness.
This medication can rarely cause a serious metabolic problem (high amount of ammonia in the blood), especially if you are also taking valproic acid. Tell your doctor right away if you experience sudden/unexplained tiredness, vomiting, or mental changes (such as decreased alertness).
Get medical help right away if you have any very serious side effects, including: severe headache, slurred speech, seizure, weakness on one side of the body.
This drug may infrequently cause serious (sometimes fatal) lung or heart problems (pulmonary hypertension, heart valve problems). The risk increases with longer use of this medication and use of other appetite-suppressant drugs/herbal products along with this drug. If you notice any of the following unlikely but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: chest pain, difficulty breathing with exercise/decreased ability to exercise, fainting, swelling of the legs/ankles/feet.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines (including decongestants such as pseudoephedrine, stimulants such as amphetamine, appetite suppressants such as diethylpropion); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: uncontrolled high blood pressure, glaucoma, history of alcohol/drug abuse, vascular heart disease (such as chest pain, heart attack), other heart problems (such as heart murmur, fast/irregular heartbeat, heart valve problems), mental/mood problems (such as depression, thoughts of suicide, severe anxiety/agitation), high blood pressure in the lungs (pulmonary hypertension), stroke, overactive thyroid (hyperthyroidism), seizures, kidney disease (including kidney stones), liver disease, a certain metabolic imbalance (metabolic acidosis), a diet high in fat and low in carbohydrates (ketogenic diet).
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.
If you have diabetes, check your blood sugar levels regularly as directed by your doctor. Your doctor may need to adjust your diabetes medication during treatment with this medication.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially dizziness and high blood pressure. Dizziness can increase the risk of falling.
Children may be more sensitive to the side effects of this drug, especially weakened bones, slowed growth rate, and decreased sweating. Consult your doctor or pharmacist for more details.
This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately. You will need to have a negative pregnancy test before starting this medication. You will also need to take a pregnancy test every month while on this medication.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.
Topiramate passes into breast milk. It is unknown if phentermine passes into breast milk; however, similar drugs pass into breast milk. This medication may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Some products that may interact with this drug include: other stimulants (including amphetamines, methylphenidate, street drugs such as cocaine or MDMA/"ecstasy").
Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).
Check the labels on all your medicines (including allergy or cough-and-cold products containing decongestants such as pseudoephedrine, diet aids such as phenylpropanolamine, ephedra/ma huang) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely.
If you are taking or have taken other appetite-suppressant drugs in the past year (such as diethylpropion, ephedra/ma huang), tell your doctor or pharmacist before starting this medication.
If you are taking hormonal birth control (such as pills, patch, or ring) with this medication, tell your doctor if you have any new spotting or breakthrough bleeding.
Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking nonprescription products that contain caffeine.
This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: rapid breathing, unusual restlessness, fast/slow/irregular heartbeat, chest pain, hallucinations, seizures, loss of consciousness, severe drowsiness.
Do not share this medication with others. It is against the law.
Laboratory and/or medical tests (such as blood pressure, heart tests, eye exams, kidney function tests, blood sugar, potassium and bicarbonate blood levels) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.
If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2014. Copyright(c) 2014 First Databank, Inc.
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