What is Qsymia?
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 with a reduced calorie diet and increased physical activity. It is not known if Qsymia changes your risk of heart problems, stroke or death.
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.
[box type=”warning”] Qsymia is a federally controlled substance (IV) 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 controlled medicine is strictly against the law.[/box]
Who can take Qsymia?
Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult 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
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WARNING: Qsymia is a Pregnancy Category X Medication, it contains Topiramate
Topiramate, a component of Qsymia, in pregnancy is associated with a 2- to 5-fold increase in risk of oral clefts.
Females of reproductive potential are women who have NOT had a hysterectomy, bilateral oophorectomy, or medically documented spontaneous ovarian failure, and have not gone through menopause. Menopause should be clinically confirmed by an individual’s healthcare provider.
ALL women, except those who have gone through menopause or undergone surgical sterilization, should be advised to consistently use effective contraception, even women who have had difficulty getting pregnant in the past.
If there is a female of reproductive potential in the house, the patient knows to keep Qsymia in a secure location and not share it with anyone else.
What are the dangers of Qsymia?
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.
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. Talk to your healthcare provider about how to prevent pregnancy.
If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away. Healthcare providers and patients should report all cases of pregnancy to:
•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.
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
o thoughts about suicide or dying
o attempts to commit suicide
o new or worse depression
o new or worse anxiety
o feeling agitated or restless
o panic attacks
o trouble sleeping (insomnia)
o new or worse irritability
o acting aggressive, being angry, or violent
o acting on dangerous impulse
o an extreme increase in activity and talking (mania)
o 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.
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.
Initial Qsymia dosing guidelines: (Once daily, in the morning, with or without food)
- 14 days on Qsymia 3.75 mg/23 mg
- 30 days on recommended dose of Qsymia 7.5 mg/46 mg
After 12 weeks at recommended dose of 7.5 mg/46 mg:
- 14 days on Qsymia 11.25 mg/69 mg
- 30 days on Qsymia 15 mg/92 mg
How do I get my Qsymia?
Qsymia is available only through certiﬁed mail order pharmacies that provide a Medication Guide and Risk of Birth Defects patient brochure with every prescription and refill.
Patients may receive their Qsymia every 30 days
Patients may receive up to 5 refills
CVS PHARMACY WALGREENS
F: 1-401-652-1807 F: 1-800-332-9581