Obesity With a history of coronary artery disease (e.g., angina, history of myocardial infarction), congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or transient ischemic attack (TIA)) (see WARNINGS). with inadequately controlled hypertension > 145/90 mm Hg (see WARNINGS). over 65 years of age. receiving monoamine oxidase inhibitors (MAOIs) (see WARNINGS). with hypersensitivity to sibutramine or any of the inactive ingredients of MERIDIA (sibutramine hydrochloride monohydrate) . who have a major eating disorder (anorexia nervosa or bulimia nervosa). taking other centrally acting weight loss drugs.

Adult Dose: The recommended starting dose of (sibutramine hydrochloride monohydrate) 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. Doses above 15 mg daily are not recommended.

With a history of coronary artery disease (e.g., angina, history of myocardial infarction), congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or transient ischemic attack (TIA)) (see WARNINGS). with inadequately controlled hypertension > 145/90 mm Hg (see WARNINGS). over 65 years of age. receiving monoamine oxidase inhibitors (MAOIs) (see WARNINGS). with hypersensitivity to sibutramine or any of the inactive ingredients of MERIDIA (sibutramine hydrochloride monohydrate) . who have a major eating disorder (anorexia nervosa or bulimia nervosa). taking other centrally acting weight loss drugs.

The most common events were dry mouth, anorexia, insomnia, constipation and headache.

Precaution: Pulmonary Hypertension Seizures Bleeding Gallstones Renal Impairment Hepatic Dysfunction Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Impairment of Fertility

Sibutramine produces its therapeutic effects by inhibition of norepinephrine (NE), serotonin (5-hydroxytryptamine, 5-HT), and to a lesser extent, dopamine reuptake at the neuronal synapse. By inhibiting the reuptake of these neurotransmitters, sibutramine promotes a sense of satiety and decrease in appetite, thereby reducing food intake.