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Sibutramine

    Discontinued

    DEA Class;  Discontinued

    Common Brand Names; Meridia

    • Anorexiants

    Meridia (sibutramine hydrochloride or sibutramine hydrochloride monohydrate) assists with weight-loss by altering neurotransmitters within the brain and is used along with a low-calorie diet to help people with obesity lose weight. Meridia (sibutramine) was withdrawn from the U.S. market due to the risk of serious cardiovascular events.

    Sibutramine, formerly sold under the brand name Meridia among others, is an appetite suppressant which has been discontinued in many countries.

    MERIDIA (sibutramine hydrochloride monohydrate) 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 (sibutramine hydrochloride monohydrate) 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).

    BMI Calculator

    • 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))
    • with inadequately controlled hypertension > 145/90 mm Hg 
    • over 65 years of age.
    • receiving monoamine oxidase inhibitors (MAOIs)
    • 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.

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

    Stop using sibutramine and call your doctor at once if you have a serious side effect such as:

    • fast, pounding, or uneven heartbeats;

    • new or worsening shortness of breath;

    • agitation, hallucinations, fever, tremor, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, dilated pupils;

    • very stiff (rigid) muscles, high fever, sweating, confusion, feeling like you might pass out;

    • easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop);

    • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, seizure);

    • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling; or

    • sudden numbness or weakness (especially on one side of the body), problems with vision, speech, or balance.

    Sibutramine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

    Do not take any other prescription or over-the-counter weight-loss products without your doctor’s advice.

    Avoid taking cough and cold or allergy medications while taking sibutramine.

    Avoid drinking alcohol while taking sibutramine.

    Pregnancy Category C. 

    Lactation

    It is not known whether sibutramine or its metabolites are excreted in human milk. MERIDIA (sibutramine hydrochloride monohydrate) is not recommended for use in nursing mothers. Patients should be advised to notify their physician if they are breast-feeding.

    Usual Adult Dose for Obesity:

    Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

    Initial Dose: 10 mg orally once a day.

    Usual Geriatric Dose for Obesity:

    Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

    Clinical studies of sibutramine did not include sufficient numbers of patients over 65 years of age. Sibutramine is contraindicated in this group of patients.

    Usual Pediatric Dose for Obesity:

    Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

    Based on one study (n=60)

    14 to 17 years:
    Initial Dose: 10 mg orally once a day.

    Sibutramine hydrochloride monohydrate

    Tablet

    • 5mg
    • 10mg
    • 20mg