Drug Details
Drug Name(s)\tQSYMIA
FDA Application No.\t(NDA) 022580
Active Ingredient(s)\tPHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Company\tVIVUS
Original Approval or Tentative Approval Date\tJuly 17, 2012
Chemical Type\t4 New combination
Review Classification\tS Standard review drug
Uses
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 certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen 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.
How to use Qsymia
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 right away.
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.
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.
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.
Side Effects
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, unusual bleeding/bruising.
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 rarely 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 right away: 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.
Precautions
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: high blood pressure, glaucoma, history of alcohol/drug abuse, heart disease (such as chest pain, heart attack, 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 right away. 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.