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Sibutramine hydrochloride monohydrate
Sibutramine hydrochloride monohydrate (Meridia)
Sibutramine hydrochloride monohydrate
(sih-BYOU-trah-meen)
Pregnancy Category: C
Meridia (Rx) (C-IV)
Classification:
Anti-obesity drug
Action/Kinetics:
Main effect is likely due to primary and secondary amine metabolites of sibutramine. Inhibits reuptake of norepinephrine (NE) and serotonin (5HT), resulting in enhanced NE and 5HT activity and reduced food intake. Significant improvement in serum uric acid. Rapidly absorbed from GI tract. Extensive first-pass metabolism in liver. Peak plasma levels of active metabolites: 3-4 hr. t1/2, sibutramine: 1.1 hr; t1/2, active metabolites: 14-16 hr. Excreted in urine and feces.
Uses:
Management of obesity, including weight loss and maintenance of weight loss. Recommended for obese clients with initial body mass index of 30 kg/m2 or more or 27 kg/m2 in presence of hypertension, diabetes, or dyslipidemia. Use in conjunction with reduced calorie diet. Safety and efficacy have not been determined for more than 1 year.
Contraindications:
Lactation. Use in clients receiving MAO inhibitors, who have anorexia nervosa, those taking centrally-acting appetite suppressant drugs, those with history of coronary artery disease, CHF, arrhythmias, or stroke. Use in severe renal impairment or hepatic dysfunction. Use with serotonergic drugs, such as fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, sumatriptan, and dihydroergotamine; also, use with dextromethorphan, meperidine, pentazocine, fentanyl, lithium, or tryptophan.
Special Concerns:
Use with caution in geriatric clients. Safety and efficacy have not been determined in children less than 16 years of age. Use with caution in narrow angle glaucoma, history of seizures, or with drugs that may raise BP (e.g., phenylpropanolamine, ephedrine, pseudoephedrine). Exclude organic causes (e.g., untreated hypothyroidism) before use.
Side Effects:
Body as a whole: Headache, back pain, flu syndrome, injury/accident, asthenia, chest pain, neck pain, allergic reaction. GI: Dry mouth, anorexia, abdominal pain, constipation, N&V;, rectal disorder, increased appetite, dyspepsia, gastritis. CNS: Insomnia, dizziness, paresthesia, nervousness, anxiety, depression, somnolence, CNS stimulation, emotional lability. CV: Increased blood pressure, tachycardia, vasodilation, migraine, palpitation. Dermatologic: Sweating, rash, herpes simplex, acne. Musculoskeletal: Arthralgia, myalgia, tenosynovitis, joint disorder. Respiratory: Rhinitis, pharyngitis, sinusitis, increase cough, laryngitis. GU: Dysmenorrhea, UTI, vaginal monilia, metrorrhagia. Otic: Ear disorder, ear pain. Miscellaneous: Thirst, generalized edema, taste perversion.
How Supplied:
Capsules: 5 mg, 10 mg, 15 mg
Dosage
•Capsules
Obesity.
Adults, initial: 10 mg once daily (usually in morning) with or without food. If there is inadequate weight loss, dose may be titrated after 4 weeks to total of 15 mg once daily. Do not exceed 15 mg daily.
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