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MERIDIA is indicated for the management of obesity that includes weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. MERIDIA is recommended for obese patients having an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., diabetes, dyslipidemia, controlled hypertension).

The recommended starting dose of MERIDIA is 10 mg administered once a day with or without food. If there is insufficient weight loss, the dose may be titrated after four weeks to a total of 15 mg once daily. The 5 mg dose should be intended for patients who do not tolerate the 10 mg dose. Blood pressure and heart rate changes should be taken into consideration when making decisions regarding dose titration.

Doses above 15 mg a day are not recommended. In most of the clinical trials, MERIDIA is recommended to be administered in the morning. Studies of numerous variables has indicated that approximately 60% of patients who lose at least 4 pounds in the first 4 weeks of treatment with a given dose of this drug in combination with a reduced-calorie diet lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose of MERIDIA. Conversely, approximately 80% of patients who didn’t lose their weight at least 4 pounds in the first 4 weeks of treatment with a given dose of MERIDIA do not lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose. If a patient has not lost at least 4 pounds in the first 4 weeks of treatment, the doctor should consider reevaluation of therapy which may include increasing the dose or discontinuation of MERIDIA.