Qsymia (phentermine and topiramate extended-release) was approved by US FDA in July 2012 as an addition to a reduced-calorie diet and exercise for chronic weight management.
The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.
“Obesity threatens the overall well being of patients and is a major public health concern,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet. Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches.
Side Effects Of Qsymia Weight Loss Medication
Qsymia can cause serious side effects, including:
• Birth defects (cleft lip/cleft palate). If you take Qsymia during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.
Contra-indications Of Qsymia Weight Loss Medication
Women who are pregnant must not take Qsymia.
Women who can become pregnant should:
1. Have a negative pregnancy test before taking Qsymia and every month while taking Qsymia.
2. Use effective birth control (contraception) consistently while taking Qsymia.
If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away.
• FDA MedWatch at 1-800-FDA-1088, and The Qsymia Pregnancy Surveillance Program at 1-888-998-4887
• Increases in heart rate. Qsymia can increase your heart rate at rest. Your healthcare provider should check your heart rate while you take Qsymia. Tell your healthcare provider if you experience, while at rest, a racing or pounding feeling in your chest lasting several minutes when taking Qsymia.
• Suicidal thoughts or actions. Topiramate, an ingredient in Qsymia, may cause you to have suicidal thoughts or actions.
Things to watch fow while on Qsymia weight loss drug
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attackstrouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
• Serious eye problems which include:
o any sudden decrease in vision, with or without eye pain and redness,o a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma).
These problems can lead to permanent vision loss if not treated. Tell your healthcare provider right away if you have any new eye symptoms.
What is Qsymia weight loss medication?
Qsymia is a prescription medicine that contains phentermine and topiramate extended-release that may help some obese adults or some overweight adults who also have weight-related medical problems lose weight and keep the weight off.
Qsymia should be used in addition to a low calorie or very low calorie diet under medical supervision.
It is not known if Qsymia changes your risk of heart problems or stroke or of death due to heart problems or stroke.
It is not known if Qsymia is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.
It is not known if Qsymia is safe and effective in children under 18 years old.
Qsymia is a federally controlled substance (CIV) because it contains phentermine and can be abused or lead to drug dependence. Keep Qsymia in a safe place, to protect it from theft. Never give your Qsymia to anyone else, because it may cause death or harm them. Selling or giving away this medicine is against the law.
Who should not take Qsymia for weight loss?
Do not take Qsymia if you:
• are pregnant, planning to become pregnant, or become pregnant during Qsymia treatment.
• have glaucoma
• have thyroid problems (hyperthyroidism)
• are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days.
• are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in Qsymia. See the end of this Medication Guide for a complete list of ingredients in Qsymia.
How should I take Qsymia?
• Your healthcare provider should start you on a diet and exercise program when you start taking Qsymia. Stay on this program while you are taking Qsymia.
• Do not change your dose without talking to your healthcare provider.
• Qsymia can be taken with or without food.
• If you miss a dose of Qsymia, wait until the next morning to take your usual dose of Qsymia. Do not double your dose.
• To start treatment with Qsymia
o Take one Qsymia 3.75 mg/23 mg capsule once each morning for the first 14 days
o After taking Qsymia 3.75 mg/23 mg capsule for 14 days, then take one Qsymia 7.5 mg/46 mg capsule (Figure B) once each morning
• After taking Qsymia for 12 weeks
o Your healthcare provider should either (1) tell you to stop taking Qsymia or (2) increase your dose of Qsymia if you do not lose a certain amount of weight within the first 12 weeks of treatment at the recommended dose.
• If your healthcare provider increases the dose of Qsymia
o Take one Qsymia 11.25 mg/69 mg capsule (Figure C) once each morning for 14 days
o After taking 14 days of Qsymia 11.25 mg/69 mg capsule, then take one Qsymia 15 mg/92 mg capsule (Figure D) once 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 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.
What should I avoid while taking Qsymia?
• Do not get pregnant while taking Qsymia. See “What is the most important information I should know about Qsymia.”
• Do not drink alcohol while taking Qsymia. Qsymia and alcohol can affect each other causing side effects such as sleepiness or dizziness.
• Do not drive a car or operate heavy machinery, or do other dangerous activities until you know how Qsymia affects you. Qsymia can slow your thinking and motor skills, and may affect vision.
What are the possible side effects of Qsymia?
• See “What is the most important information I should know about Qsymia?” at the beginning of this Medication Guide
• Mood changes and trouble sleeping. Qsymia may cause depression or mood problems, and trouble sleeping. Tell your healthcare provider if symptoms occur.
• Concentration, memory, and speech difficulties. Qsymia may affect how you think and cause confusion, problems with concentration, attention, memory or speech. Tell your healthcare provider if symptoms occur.
• Increases of acid in bloodstream (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms.
Common side effects of Qsymia include:
• numbness or tingling in the hands, arms, feet, or face (paraesthesia)
• change in the way foods taste or loss of taste (dysgeusia)
• trouble sleeping (insomnia)
• dry mouth
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of Qsymia. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects.
How should I store Qsymia?
• Store Qsymia at room temperature between 59°F to 77°F (15°C to 25°C).
• Keep Qsymia and all medicines out of the reach of children.
General Information about Qsymia
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Qsymia for a condition for which it was not prescribed. Do not give Qsymia to other people, even if they have the same symptoms you have. It may harm them.
A physician trained in Obesity Medicine or any physician familiar with these weight loss medications might be able to help. W8MD Medical Weight Loss Centers Physicians do offer these options when medically appropriate to their patients after evaluation in office by one of the weight loss doctors. We have offices in New York City, Greater Philadelphia and Connecticut.
The best news is that most W8MD centers accept health insurance so you can be evaluated for weight loss and your insurance might cover the cost of the physician visits.
How can W8MD help me lose fat weight?
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