Adjunct to caloric restriction, increased physical activity, and behavioral modification in the management of exogenous obesity; used for weight loss and maintenance of weight loss.
Use in patients with initial body mass index (BMI) of ≥30 kg/m2; also use in those with BMI of ≥27 kg/m2 in the presence of risk factor or disease (e.g., hypertension, diabetes mellitus, dyslipidemia).
Effect of sibutramine on the morbidity and mortality associated with obesity not established.
Dosage and Administration
General
Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of sibutramine and vice versa.
Administration
Oral Administration
Administer orally without regard to meals.
Administered once daily in the morning in clinical studies.
Dosage
Available as sibutramine hydrochloride monohydrate; dosage expressed in terms of the monohydrate.
Adults
Obesity
Oral
Initially, 10 mg once daily.
If weight loss is inadequate (e.g., <1.8 kg of weight loss) after 4 weeks of treatment, consider increasing dosage to 15 mg daily or discontinuance; take BP and heart rate into account.
Reserve 5-mg daily dose for patients who do not tolerate 10 mg daily.
Safety and efficacy >2 years not established in clinical studies.
Prescribing Limits
Adults
Obesity
Oral
Maximum 15 mg daily.
Special Populations
Hepatic Impairment
Mild or moderate hepatic impairment: Dosage adjustment not needed. (See Special Populations under Pharmacokinetics.)
Geriatric Patients
Select dosage with caution.
Cautions
Contraindications
Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor. (See Drug Interactions under Cautions.)
Concurrent therapy with another centrally acting anorexigenic drug. (See Specific Drugs under Interactions.)
Known hypersensitivity to sibutramine or any ingredient in the formulation.
Warnings/Precautions
Warnings
Cardiovascular Effects
Substantially increases BP and increases pulse in some patients, particularly when initiated at higher dosages. Measure BP and pulse before starting therapy; monitor at regular intervals.
Consider decreased dosage or discontinuance in patients with sustained increases in BP or pulse rate.
Caution in patients with a history of hypertension.
Should not be used in those with uncontrolled or poorly controlled hypertension.
Drug Interactions
Concomitant use with MAO inhibitor associated with serotonin syndrome. Serotonin syndrome requires immediate medical attention; symptoms include excitement, hypomania, restlessness, loss of consciousness, confusion, disorientation, anxiety, agitation, motor weakness, myoclonus, tremor, hemiballismus, hyperreflexia, ataxia, dysarthria, incoordination, hyperthermia, shivering, pupillary dilation, diaphoresis, emesis, tachycardia. (See Contraindications under Cautions.)
Glaucoma
May cause mydriasis; caution in patients with angle-closure (narrow-angle) glaucoma.
Cardiovascular Disease
Should not be used in those with a history of CAD, CHF, arrhythmias, stroke, or in those with uncontrolled or poorly controlled hypertension. (See Cardiovascular Effects under Cautions.)
Other Warnings
Exclude organic causes (e.g., untreated hypothyroidism) of obesity before initiating sibutramine.
General Precautions
Pulmonary Hypertension
Pulmonary hypertension associated with anorexigenic drugs that induce serotonin release; risk with sibutramine unknown.
Seizures
Seizures reported rarely. Caution in patients with history of seizures; discontinue if seizures occur.
Bleeding
Bleeding events reported; causal relationship unclear. Caution in patients predisposed to bleeding and in those receiving drugs that affect hemostasis or platelet function.
Cholelithiasis
Weight loss can exacerbate or precipitate gallstone formation.
CNS Effects
Like other CNS-active drugs, may impair judgment, thinking, or motor skills.
Not known whether sibutramine is distributed into milk. Use not recommended.
Pediatric Use
Safety and efficacy in children <16 years of age not established.
In one clinical study in obese adolescents, 2 patients reported suicidal ideation and one patient attempted suicide. Sibutramine inhibits reuptake of serotonin and norepinephrine similarly to the mechanism of some antidepressants; not known whether the drug increases the risk of suicidality in pediatric patients.
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution due to greater frequency of decreased renal, hepatic, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.
Hepatic Impairment
Use not recommended in patients with severe hepatic impairment; not systematically evaluated in these individuals.
Renal Impairment
Do not use in patients with severe renal impairment, including those with end-stage renal disease receiving dialysis. Use with caution in patients with mild or moderate renal impairment.
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