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The results presented here are from the combined studies supporting FDA approval of Qsymia. The dosing schedule in those studies differ from the dosing schedule that your physician may recommend. As a result of this dosing differential, your results may vary depending on your BMI, diet, activity, dose of Qsymia, and other factors. 1 Please see additional study design information below. You don’t have to try to lose weight on your own. Extensively studied and prescribed, once-daily Qsymia helps you manage your weight-loss plan and set realistic expectations.
‡ Qsymia was studied in 2 large trials supporting FDA approval that involved 3754 patients whose BMI was 27 kg/m 2 or greater. Patients were randomized to placebo, phentermine 3.75 mg/topiramate 23 mg, phentermine 7.5 mg/topiramate 46 mg, or phentermine 15 mg/topiramate 92 mg. In these trials, it was recommended that patients eat a well-balanced diet and reduce their caloric intake by 500 kcal/day. Your weight loss may vary depending on your BMI, diet, activity, dose of Qsymia, and other factors.
1,2 Talk to your doctor about powering your weight-loss plan with once-daily Qsymia. It is not known if Qsymia is safe and effective in children under 18 years old Important Safety Information 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 the Medication Guide for a complete list of ingredients in 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. Mocha Ae V3 Keygenguru. 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 have a negative pregnancy test before taking Qsymia and every month while taking Qsymia and 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: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity or talking (mania); other unusual changes in behavior or mood.