MERIDIA is indicated for the management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. MERIDIA is recommended for obese patients with 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).

Below is a chart of Body Mass Index (BMI) based on various heights and weights.

BMI is calculated by taking the patient's weight, in kg, and dividing by the patient's height, in meters, squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.

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

Doses above 15 mg daily are not recommended. In most of the clinical trials, MERIDIA was given in the morning.

Analysis 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 MERIDIA 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 do not lose 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 physician should consider reevaluation of therapy which may include increasing the dose or discontinuation of MERIDIA.

The safety and effectiveness of MERIDIA, as demonstrated in double-blind, placebo-controlled trials, have not been determined beyond 2 years at this time.

MERIDIA® (sibutramine hydrochloride monohydrate) Capsules contain 5 mg, 10 mg, or 15 mg sibutramine hydrochloride monohydrate and are supplied as follows:

5 mg, NDC 0074-2456-12, blue/yellow capsules imprinted with "MERIDIA" on the cap and "-5-" on the body, in bottles of 30 capsules.

10 mg, NDC 0074-2457-12, blue/white capsules imprinted with "MERIDIA" on the cap and "-10-" on the body, in bottles of 30 capsules.

15 mg, NDC 0074-2458-12, yellow/white capsules imprinted with "MERIDIA" on the cap and "-15-" on the body, in bottles of 30 capsules.

5 mg, NDC 0074-2456-13, blue/yellow capsules imprinted with "MERIDIA" on the cap and "-5-" on the body, in bottles of 100 capsules.

10 mg, NDC 0074-2457-13, blue/white capsules imprinted with "MERIDIA" on the cap and "-10-" on the body, in bottles of 100 capsules.

15 mg, NDC 0074-2458-13, yellow/white capsules imprinted with "MERIDIA" on the cap and "-15-" on the body, in bottles of 100 capsules.

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP controlled room temperature]. Protect capsules from heat and moisture. Dispense in a tight, light-resistant container as defined in USP.

Manufactured for: Abbott Laboratories, North Chicago, IL 60064, U.S.A. By: KNOLL BV, Barceloneta, PR 00617. IMITREX is a registered trademark of Glaxo Group Limited. Sibutramine is covered by US Patent Nos. 4,746,680; 4,929,629; and 5,436,272. FDA Rev date: 8/23/2006

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