Sibutramine Hydrochloride
Indications
Sibutramine Hydrochloride is used for:
Obesity
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.
Child Dose
Renal Dose
Administration
Contra Indications
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.
Precautions
Pulmonary Hypertension
Seizures
Bleeding
Gallstones
Renal Impairment
Hepatic Dysfunction
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity
Impairment of Fertility
Pregnancy-Lactation
Pregnancy
Limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy; there are risks to mother and fetus from untreated pulmonary arterial hypertension
Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death
Lactation
Limited published data from a case report describe presence of sildenafil and its active metabolite in human milk; there is insufficient information about effects of sildenafil on breastfed infant and no information on effects of sildenafil on milk production; limited clinical data during lactation preclude a clear determination of risk of drug to an infant during lactation
Interactions
Adverse Effects
Side effects of Sibutramine Hydrochloride :
The most common events were dry mouth, anorexia, insomnia, constipation and headache.
Mechanism of Action
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.