SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE

SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE
(si-bu'tra-meen)
Meridia
Classifications: cns stimulant, anorexiant;
Therapeutic:appetite suppressant

Pregnancy Category: C
Controlled Substance: Schedule IV

Availability

5 mg, 10 mg, 15 mg capsules

Action

Inhibits central reuptake of serotonin (5-HT3), monoamine reuptake, as well as norepinephrine and dopamine reuptake, by blocking their receptors.

Therapeutic Effect

Appetite suppression by enhancing satiety and raising the metabolic rate. Indicated by a loss of at least 4 lb during the first 4 wk of therapy.

Uses

Management of obesity, including weight loss and maintenance of weight loss, in patients with BMI of at least 30 kg/m2 or BMI of at least 27 kg/m2 and other risk factors (hypertension, diabetes, dyslipidemia).

Contraindications

Major eating disorders; anorexia nervosa, bulimia; arrhythmias; concurrent administration with other serotonin reuptake inhibitors (e.g., fluoxetine), MAOIs, lithium, tryptophan; severe hepatic or renal impairment; ESRD, dialysis; CHF, stroke, CAD; uncontrolled or poorly controlled hypertension; seizures; pregnancy (category C), lactation.

Cautious Use

History of hypertension; older adults; narrow-angle glaucoma; mild or moderate hepatic disease; renal impairment. Safety and efficacy in patients <16 y are not established.

Route & Dosage

Weight Loss
Adult: PO 10 mg once daily, preferably in morning, may be increased to 15 mg if inadequate weight loss (<4 lb) in 4 wk

Administration

Oral
  • Note: Doses above 15 mg/d are not recommended.
  • Allow at least 2 wk to elapse between discontinuing an MAOI and starting sibutramine.
  • Store at 15°–30° C (59°–86° F) in a tightly closed container; protect from light.

Adverse Effects (≥1%)

Body as a Whole: Back pain, flu-like syndrome, asthenia, arthralgia. CNS: Headache, insomnia, migraine headache, dizziness, nervousness, anxiety, depression, paresthesias, seizures (rare). CV: Increase in BP, tachycardia, vasodilation, palpitations. GI: Dry mouth, anorexia, constipation, abdominal pain, increased appetite, nausea, dyspepsia, taste perversion. Respiratory: Rhinitis, pharyngitis, sinusitis, cough. Skin: Rash, sweating. Urogenital: Dysmenorrhea, UTI.

Interactions

Drug: decongestants, cough and allergy medications may cause additional increase in BP; maois, ergot derivatives, sumatriptan, naratriptan, rizatriptan, zolmitriptan, dextromethorphan, meperidine, pentazocine, fentanyl, lithium; ssris may predispose to serotonin syndrome (see Appendix F); ketoconazole, erythromycin may inhibit metabolism of sibutramine. Herbal: St. John's wort may cause serotonin syndrome (headache, dizziness, sweating, agitation).

Pharmacokinetics

Absorption: Rapidly from GI tract. Peak: 1.2 h. Distribution: 97% protein bound; concentrates in liver and kidneys. Metabolism: In liver by cytochrome P450 3A4 to 2 active metabolites. Elimination: Primarily in kidneys. Half-Life: 14–16 h (active metabolites).

Nursing Implications

Assessment & Drug Effects

  • Monitor weight changes carefully to determine therapeutic effect.
  • Lab tests: Periodic liver function, bilirubin, alkaline phosphatases, lipid profile.
  • Monitor BR and HR regularly; report sustained increases in BP or HR immediately.
  • Monitor for and immediately report S&S of serotonin syndrome (see Appendix F).
  • Monitor persons with narrow-angle glaucoma closely for worsening intraocular pressure.

Patient & Family Education

  • Notify physician if any of the following develop: Rash, hives, or other S&S of an allergic reaction; signs of hyperstimulation such as restlessness, shivering, profuse sweating, irritability, and tremor.
  • Take in the morning; causes less interference with sleep.
  • Check with physician before taking any OTC cough, cold, allergy, or weight-loss drugs.
  • Maintain strict adherence to prescribed antihypertensives.
  • Inform physician of all drugs being taken. Serious adverse effects may be experienced with concomitant use of some drugs used to treat depression.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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