Approved by FDA Supplementary display For Phentermine / Topiramate Sustained Release Capsules (Qsymia), it is used for chronic weight management in obese adolescents over 12 years of age, defined as Body Mass Index (BMI) above the 95th percentile.
The Originally received medicine Approved by the FDA in July 2012 for adults with overweight or obesity, and at least one comorbidity associated with body weight. This is recommended for both adults and teens, along with increased physical activity and a low-calorie diet.
According to the CDC19.7% of adolescents aged 12-19 years are obese, which adversely affects current and future health.
The FDA said obese children are often obese and reach adulthood. Initially, lifestyle changes are recommended, but if the intervention fails, dosing may be considered.
The efficacy and safety of phentermine / topiramate were evaluated in a 56-week, double-blind, placebo-controlled trial in 223 adolescents aged 12 to 16 years with very high BMI. These adolescents failed to lose weight or maintain weight loss through exercise. Only diet.
Participants received phentermine / topiramate 7.5 mg / 46 mg (n = 54), phentermine / topiramate 15 mg / 92 mg (n = 113), or placebo (n = 56) once daily after the titration period. Randomized to do. Participants also received counseling on lifestyle changes such as reducing calories and increasing physical activity.
At the end of the study, participants at the 7.5 mg / 46 mg dose lost an average of 4.8% of BMI, and participants at the 15 mg / 92 mg dose lost an average of 7.1% of BMI. People who received placebo gained an average of 3.3% of BMI.
Patients starting this drug are advised to undergo a pregnancy test before use and continue to use contraceptives during treatment as the drug is harmful to the fetus.
Phentermine / topiramate is also not recommended for people with glaucoma, hyperthyroidism, or those who are currently taking or have taken monoamine oxidase inhibitors in the last two weeks.
Common adverse events experienced in adolescence include depression, fever, flu, joint pain, dizziness, and ankle sprains, and adults often have dizziness, dry mouth, constipation, pin and needle sensations, and taste changes. , Experience insomnia. The drug is also associated with increased heart rate and suicidal ideation.
