No

Anorexiant

Management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet

5'0"

140 lb: BMI = 27

150 lb: BMI = 29

160 lb: BMI = 31

170 lb: BMI = 33

180 lb: BMI = 35

190 lb: BMI = 37

200 lb: BMI = 39

210 lb: BMI = 41

220 lb: BMI = 43

230 lb: BMI = 45

240 lb: BMI = 47

250 lb: BMI = 49

5'3"

140 lb: BMI = 25

150 lb: BMI = 27

160 lb: BMI = 28

170 lb: BMI = 30

180 lb: BMI = 32

190 lb: BMI = 34

200 lb: BMI = 36

210 lb: BMI = 37

220 lb: BMI = 39

230 lb: BMI = 41

240 lb: BMI = 43

250 lb: BMI = 44

5'6"

140 lb: BMI = 23

150 lb: BMI = 24

160 lb: BMI = 26

170 lb: BMI = 28

180 lb: BMI = 29

190 lb: BMI = 31

200 lb: BMI = 32

210 lb: BMI = 34

220 lb: BMI = 36

230 lb: BMI = 37

240 lb: BMI = 39

250 lb: BMI = 40

5'9"

140 lb: BMI = 21

150 lb: BMI = 22

160 lb: BMI = 24

170 lb: BMI = 25

180 lb: BMI = 27

190 lb: BMI = 28

200 lb: BMI = 30

210 lb: BMI = 31

220 lb: BMI = 33

230 lb: BMI = 34

240 lb: BMI = 36

250 lb: BMI = 37

6'0"

140 lb: BMI = 19

150 lb: BMI = 20

160 lb: BMI = 22

170 lb: BMI = 23

180 lb: BMI = 25

190 lb: BMI = 26

200 lb: BMI = 27

210 lb: BMI = 29

220 lb: BMI = 30

230 lb: BMI = 31

240 lb: BMI = 33

250 lb: BMI = 34

6'3"

140 lb: BMI = 18

150 lb: BMI = 19

160 lb: BMI = 20

170 lb: BMI = 21

180 lb: BMI = 23

190 lb: BMI = 24

200 lb: BMI = 25

210 lb: BMI = 26

220 lb: BMI = 28

230 lb: BMI = 29

240 lb: BMI = 30

250 lb: BMI = 31

CIV; Recommended only for obese patients with a body mass index greater than or equal to 30 kg/m² or greater than or equal to 27 kg/m² in the presence of other risk factors such as hypertension, diabetes, and/or dyslipidemia

C

Hypersensitivity to sibutramine or any component; during or within 2 weeks of MAO inhibitors (eg, phenelzine, selegiline) or concomitant centrally-acting appetite suppressants; anorexia nervosa; uncontrolled or poorly controlled hypertension; congestive heart failure; coronary heart disease; conduction disorders (arrhythmias); stroke

Use with caution in severe renal impairment or severe hepatic dysfunction, seizure disorder, hypertension, gallstones, narrow-angle glaucoma, nursing mothers, elderly patients. Primary pulmonary hypertension (PPH), a rare and frequently fatal pulmonary disease, has been reported to occur in patients receiving other agents with serotonergic activity which have been used as anorexiants. Although not reported in clinical trials, it is possible that sibutramine may share this potential, and patients should be monitored closely.

>10%

Central nervous system: Headache, insomnia

Gastrointestinal: Anorexia, xerostomia, constipation

Respiratory: Rhinitis

1% to 10%

Cardiovascular: Tachycardia, vasodilation, hypertension, palpitations, chest pain, edema

Central nervous system: Migraine, dizziness, nervousness, anxiety, depression, somnolence, CNS stimulation, emotional liability

Dermatologic: Rash

Endocrine & metabolic: Dysmenorrhea

Gastrointestinal: Increased appetite, nausea, dyspepsia, gastritis, vomiting, taste perversion, abdominal pain

Neuromuscular & skeletal: Weakness, arthralgia, back pain

Respiratory: Pharyngitis, sinusitis, cough, laryngitis

Miscellaneous: Diaphoresis, flu-like syndrome, allergic reactions, thirst

There is no specific antidote; treatment should consist of general supportive measures employed in the management of overdosage. Cautious use of beta-blockers to control elevated blood pressure and tachycardia may be indicated; the benefits of forced diuresis and hemodialysis remain unknown.

CYP3A3/4 enzyme substrate

Avoid concurrent use with other serotonergic agents such as venlafaxine, selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), sumatriptan, dihydroergotamine, lithium, tryptophan, some opioid/analgesics (eg, meperidine, tramadol), serotonin syndrome may result

Dextromethorphan, MAO inhibitors and other drugs that can raise the blood pressure can worsen the possibility of sibutramine-associated cardiovascular complications (eg, decongestants, centrally acting weight loss products, amphetamines, and amphetamine-like compounds)

Possible interaction with ketoconazole, erythromycin, and other agents metabolized by the CYP3A4 enzyme system

Sibutramine blocks the neuronal uptake of norepinephrine and, to a lesser extent, serotonin and dopamine

Adults greater than or equal to 16 years: Initial: 10 mg once daily; after 4 weeks may titrate up to 15 mg once daily as needed and tolerated

Avoid concurrent excess alcohol ingestion; sibutramine, as an appetite suppressant, is the most effective when combined with a low calorie diet and behavior modification counseling

Do initial blood pressure and heart rate evaluation and then monitor regularly during therapy. If patient has sustained increases in either blood pressure or pulse rate, consider discontinuing or reducing the dose of the drug.

No information available to require special precautions

No effects or complications reported

Take exactly as directed (do not increase dose or frequency without consulting prescriber). Take with or without meals; if gastric distress occurs, may be taken with meals (do not take at bedtime). Avoid alcohol, caffeine, or OTC medications that act as stimulants. You may experience restlessness, dizziness, sleepiness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); experience insomnia (taking medication early in morning may help, warm milk and quiet environment at bedtime may help); increased appetite, nausea or vomiting (small frequent meals, frequent mouth care may help); constipation (increased exercise, dietary fiber, fruit, or fluid may help); diarrhea (buttermilk, boiled milk, or yogurt may help); or altered menstrual periods (reversible). Report chest pain, palpitations, or irregular heartbeat; excessive nervousness, excitation, or sleepiness; back pain, muscle weakness, or tremors; CNS changes (acute headache, aggressiveness, restlessness, excitation, sleep disturbances); menstrual pattern changes; rash; blurred vision; runny nose, sinusitis, cough, or difficulty breathing. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Breast-feeding is not recommended.

Capsule, as hydrochloride: 5 mg, 10 mg, 15 mg

Colchamiro R, "FDA Clears Obesity Drug," Am Druggist, 1998, 12.

King DJ and Devaney N, "Clinical Pharmacology of Sibutramine Hydrochloride (BTS 54524), A New Antidepressant, in Healthy Volunteers," Br J Clin Pharmacol, 1988, 26(5):607-11.