Sibutramine Hydrochloride

A to Z Drug Facts

 Action Inhibits reuptake of norepinephrine, serotonin and dopamine. May stimulate satiety center in brain, causing appetite suppression.

 Indications As an adjunct to a reduced calorie diet for the management of obesity, including weight loss and maintenance of weight loss. Recommended for patients with an initial body mass index > 30 kg/M², or > 27kg/M² in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).

 Contraindications Concurrent use of, or within 2 wks of discontinuing, a MAO inhibitor, anorexia nervosa; concurrent use of other centrally acting appetite suppressants; allergy to sibutramine or any product component; uncontrolled or poorly controlled hypertension.

 Route/Dosage

ADULTS & CHILDREN > 16 YR: PO 10 mg once daily. May titrate to 15 mg/d after 4 wks if necessary.

 Interactions

MAO inhibitors: Do not use concomitantly with sibutramine. Separate therapy with either agent by at least 2 wks. Centrally acting appetite suppressants (eg, prescription, otc and herbal products): Concurrent use is contraindicated. 5–HT receptor agonists (eg, sumatriptan), bupropion, dextromethorphan, ergots (eg, dihydroergotamine), fentanyl, lithium, meperidine, pentazocine, selective serotonin reuptake inhibitors (eg, fluoxetine), tetracyclic antidepressants (eg, trazodone), tricyclic antidepressants (eg, amitriptyline), tryptophan: May precipitate “serotonin syndrome” if used concurrently with sibutramine. Avoid concurrent use. Ephedrine, phenylpropanolamine, pseudoephedrine: Use with caution. Potential additive effects on BP and pulse.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Tachycardia; vasodilation; hypertension; palpitations. CNS: Headache; migraine; dizziness; nervousness; anxiety; depression; paresthesia; somnolence; CNS stimulation; emotional lability; agitation; hypertonia; abnormal thinking; insomnia. DERM: Rash; sweating; herpes simplex; acne; pruritis. EENT: Amblyopia; ear disorder; ear pain; rhinitis; sinusitis; laryngitis; pharyngitis. GI: Abdominal pain; anorexia; constipation; increased appetite; nausea; dyspepsia; gastritis; vomiting; rectal disorder; dry mouth; taste perversion; diarrhea; flatulence; gastroenteritis; tooth disorder; thirst. GU: Dysmenorrhea; urinary tract infection; vaginitis; metrorrhagia; menstrual disorder. RESP: Cough; bronchitis; dyspnea. OTHER: Back, chest, or neck pain; flu syndrome; accidental injury; asthenia; allergic reactions; edema; arthralgia; myalgia; tenosynovitis; fever; leg cramps.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy in children < 16 yr not established. Elderly: Use with caution in patients > 65 yr. Renal/hepatic function impairment: Do not use in patients with severe renal or hepatic impairment. Blood pressure/pulse: Sibutramine can cause tachycardia and hypertension. Use with caution in patients with a history of hypertension. Do not administer to patients with uncontrolled or poorly controlled hypertension. Concomitant cardiovascular disease: Do not use in patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Glaucoma: Use with caution in patients with narrow angle glaucoma. Seizures: Use with caution in patients with a history of seizures. Discontinue use in any patient who develops seizures. Gallstones: Weight loss can precipitate or exacerbate gallstone formation. Drug abuse: Carefully evaluate patients for a history of drug abuse. Follow such patients closely, observing for signs of misuse or abuse. Primary pulmonary hypertension/cardiac valve dysfunction: Although not reported with sibutramine, these have occurred in patients receiving certain other centrally-acting appetite suppressants.

 Administration/Storage

• Administer as a single daily dose without regard to meals.
• Consider administering in the morning.
• Store at room temperature in a tightly closed container. Protect from heat and moisture.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note cardiovascular disease, hepatic or renal impairment, history of seizures or glaucoma.
• Obtain baseline BP and pulse and then regularly thereafter. Notify physician if patient develops hypertension or tachycardia.
• Monitor patients weight.
• Implement protective measures and supervise and assist with ambulation if dizziness or drowsiness are problems.
• Monitor patient for side effects. Report significant findings to physician.

 Patient/Family Education

• Advise patient to take drug daily as prescribed. Remind patient that it can be taken without regard to food.
• Instruct patient not to change the dose or discontinue therapy unless advised to do so by their physician.
• Encourage patient to follow medically supervised weight reduction program. Emphasize that this medication will only work in conjunction with a diet and exercise program.
• Advise patient to avoid alcohol and other CNS depressants.
• Emphasize importance of follow up visits for monitoring BP and pulse as well as weight loss.
• Advise patient to contact their physician if they note any of the following: unexplained shortness of breath, swelling of ankles, decreased exercise tolerance, skin rash, hives or other signs of an allergic reaction.
• Advise patient that drug may cause drowsiness or dizziness and to use caution while driving or performing other tasks requiring mental alertness.
• Advise women of childbearing potential to use an effective birth control method while on this drug.
• Instruct patient to notify physician if they become pregnant, plan on becoming pregnant or are breastfeeding.
• Instruct patient not to take any other medications (including otc and herbal products) unless advised to do so by their physician. Many drugs can interact with sibutramine and cause potentially life-threatening reactions.
• Advise patient that safety of long term (> 1 yr) use has not been determined.

Books@Ovid
Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts