Sibutramine

Sibutramine Brands

Brand Name	Manufacturer Name	Distributor	Drug Strength	Packaging	Formulation	Formulation Strength	Price
Cipflon	Cipla Ltd.	Surgipharm Ltd	450mg/50mg	30	Tablet	per tablet	KES 454.25

Sibutramine More info
Drug Indication	As a short-term (8-12 weeks) adjunct in a course of weight reduction based on diet restriction.
Precautions	Haemorrhoids; breastfeeding.
Contra-Indications	Organic cause of obesity; MAOIs; diethylpropion; phentermine; anorexia nervosa; bulimia nervosa; bipolar disorder.
Side Effects	Tachycardia; hypertension; headache; light headedness; worsening of haemorrhoids; insomnia; dry mouth; paraesthesia; sweating; taste disorders; constipation; vasodilation.
Dosage	10mg OD in the morning. If the weight loss is less than 2kg after 4 weeks increase to 15mg OD if 10mg is well tolerated. (Treatment stopped if weight if less than 5% of the weight is lost after 3months or 6 months for diabetics).NB: The European Medicine Agency (EMA) suspended the marketing authorization of sibutramine in January 2010 due to the risks of cardiovascular diseases upon using it

Abbott Labs, in conjunction with the U.S. Food and Drug Administration (FDA) and Health Canada, has voluntarily withdrawn sibutramine (Meridia®) from both the U.S. and Canadian markets. This decision comes as a result of postmarketing data from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, which indicated an increased risk of heart attack and stroke in sibutramine-treated patients with cardiovascular disease.

• Promptly contact their healthcare providers with the onset of adverse cardiovascular events (eg, angina, palpitations, abnormal heart rate, dizziness)

Initial: 10 mg once daily; may increase to 15 mg once daily after 4 weeks as needed and tolerated (maximum daily dose: 15 mg); may be used for up to 2 years, per manufacturer labeling

Severe renal impairment (CLcr ≤30 mL/minute): Use not recommended in this patient population (including patients on dialysis)

Management of obesity in patients with an initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (eg, diabetes, hyperlipidemia, hypertension)

Cardiovascular: Tachycardia (3%), vasodilation (2%), hypertension (2%), palpitation (2%), chest pain (2%), peripheral edema (≥1%)

Central nervous system: Dizziness (7%), nervousness (5%), anxiety (5%), depression (4%), CNS stimulation (2%), migraine (2%), somnolence (2%), emotional lability (1%), agitation (≥1%), fever (≥1%), thinking abnormal (≥1%)

Gastrointestinal: Appetite increased (9%), nausea (6%), abdominal pain (5%), dyspepsia (5%), gastritis (2%), taste perversion (2%), vomiting (2%), diarrhea (≥1%), flatulence (≥1%), gastroenteritis (≥1%), tooth disorder (≥1%)

Neuromuscular & skeletal: Back pain (8%), weakness (6%), arthralgia (6%), neck pain (2%), myalgia (2%), paresthesia (2%), tenosynovitis (1%), arthritis (≥1%), hypertonia (≥1%), leg cramps (≥1%)

Respiratory: Pharyngitis (10%), rhinitis (10%), sinusitis (5%), cough (4%), bronchitis (≥1%), dyspnea (≥1%)

Miscellaneous: Flu-like syndrome (8%), diaphoresis (3%), allergic reactions (2%), thirst (2%)

<1%, postmarketing, and/or case reports (limited to important or life-threatening): Amnesia, anaphylactic shock, anaphylactoid reaction, anemia, angina, angioedema, atrial fibrillation, cardiac arrest, cerebrovascular accident, CHF, cholecystitis, cholelithiasis, depression, GI hemorrhage, GI ulcers (duodenal, mouth, stomach), hyper-/hypoglycemia, hyper-/hypothyroidism, hypersensitivity reaction, impotence, interstitial nephritis, intestinal obstruction, intraocular pressure increased, leukopenia, lymphadenopathy, mania, MI, mydriasis, photosensitivity, psychosis, seizure, serotonin syndrome, stroke, suicidal ideation, supraventricular tachycardia, syncope, thrombocytopenia, torsade de pointes, Tourette's syndrome, transient ischemic attack, ventricular extrasystoles, ventricular fibrillation, ventricular tachycardia, vertigo

Hypersensitivity to sibutramine or any component of the formulation; patients >65 years of age; during or within 2 weeks of MAO inhibitors or concomitant centrally-acting appetite suppressants; anorexia nervosa, bulimia nervosa; poorly-controlled or uncontrolled hypertension; history of coronary artery disease, heart failure (HF), arrhythmia, stroke, tachycardia, TIA, or peripheral arterial disease

• CNS effects: May impair the ability to engage in potentially hazardous activities.

• Cardiovascular effects: May cause increase in blood pressure and/or heart rate; monitor baseline and on-therapy blood pressure and heart rate. For patients experiencing a sustained increase in blood pressure and/or heart rate, discontinuation should be considered. Caution should be used in patients with controlled hypertension; use is contraindicated in patients with poorly-controlled or uncontrolled hypertension.

• Primary pulmonary hypertension (PPH): A rare and frequently fatal pulmonary disease (PPH), 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; patients should be monitored closely.

• Serotonin syndrome (SS)/neuroleptic malignant syndrome (NMS)-like reactions: SS and NMS-like reactions have occurred with serotonin/norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), including sibutramine, when used alone and particularly when used in combination with serotonergic agents (eg, triptans) or antidopaminergic agents (eg, antipsychotics). The diagnosis of SS can be made using the Hunter Serotonin Toxicity Criteria (Dunkley, 2003). Identification and differentiation of SS (eg, tremor, myoclonus, agitation) and more severe NMS-like reactions (eg, hyperthermia, muscle rigidity, autonomic instability, mental status changes) can be complex; monitor patients closely for either syndrome. Discontinue treatment (and any concomitant serotonergic and/or antidopaminergic agents) immediately if signs/symptoms arise.

• Valvular heart disease: The use of some anorexigens has been associated with the development of valvular heart disease. Avoid stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that could increase the risk of sudden death that these conditions alone carry.

• Bleeding disorders: Use with caution in patients with bleeding disorders; rare cases of bleeding have occurred.

• Cardiovascular disease (CVD): Use of sibutramine in patients with CVD increased the risk of cardiovascular events in one clinical trial. Use is contraindicated in patients with a history of coronary artery disease, HF, tachycardia, arrhythmia, stroke or TIA, or peripheral arterial disease.

• Diabetes: Use with caution in patients with diabetes mellitus; antidiabetic agent requirements may be altered with anorexigens and concomitant dietary restrictions.

• Gallstones: Use with caution in patients with a history of gallstones; weight loss may precipitate or exacerbate gallstone formation.

• Glaucoma: Use with caution in patients with narrow-angle glaucoma; mydriasis has been reported.

• Hepatic impairment: Use with caution in patients with mild-moderate hepatic impairment; avoid use in severe impairment.

• Renal impairment: Use with caution in patients with mild-moderate renal impairment; avoid use in severe impairment (including patients on dialysis).

• Psychiatric disorders: Use with caution and monitor closely in patients with a history of psychiatric symptoms; rare reports of depression, mania, psychosis, suicide, and suicidal ideation have been documented in patients on sibutramine.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with use.

• Tourette's syndrome: Use with caution in patients with Tourette's syndrome; stimulants may unmask tics.

• Serotonergic agents: As sibutramine blocks neuronal serotonin uptake, there is a potential for development of serotonin syndrome if used with other serotonergic agents; concurrent use of serotonergic agents (eg, SSRIs, sumatriptan, dihydroergotamine, dextromethorphan, meperidine, pentazocine, fentanyl, lithium) should be avoided.

• Appropriate use: Obesity: Pharmacotherapy for weight loss is recommended only for obese patients with a body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors, such as hypertension, diabetes, and/or dyslipidemia or a high waist circumference; therapy should be used in conjunction with a comprehensive weight management program. Rule out organic causes of obesity (eg, untreated hypothyroidism) prior to use. Discontinue or reevaluate therapy/dose if significant weight loss has not occurred (eg, <4 pounds within the first 4 weeks of treatment)

Food: Administration with a standard breakfast reduced the peak concentrations of the active metabolites, M1 and M2 (27% and 32%, respectively) and delayed the time to peak by ~3 hours; AUC and was not significantly altered.

Teratogenic effects were not observed in animal studies except at doses also causing maternal toxicity. Weight loss therapy is generally not recommended for pregnant women. Obese and overweight women should be encouraged to participate in weight reduction programs prior to attempting pregnancy; weight gain during pregnancy should be determined by their prepregnancy BMI and current guidelines. Women of childbearing potential should be instructed to use effective contraception while taking sibutramine.

Weight loss therapy is generally not recommended for lactating women. Weight loss programs which include physical activity and nutrition components should be discussed at the 6-week postpartum visit.

Most effective when combined with a low calorie diet and behavior modification counseling. May be taken without regard to meals