We also supply Leptos, an Indian manufactured generic - Sibutramine Capsules in 15mg.
Obestat capsules are sibutramine hydrochloride. Sibutramine hydrochloride is sold in the UK and Europe under the brand name Reductil - Sold under the brand name Meridia in the US.
Obestat is made in India. Even though it contains the exact same chemical as Reductil / Meridia its cost is significantly less than that of Reductil / Meridia.
Cipla is allowed by Indian patent law to make drugs that are patented by other companies internationally as the law protects only the processes by which drugs are made, and not the drugs themselves. Under current Indian law, which recognizes patents on ways to make drugs but not the drugs themselves. This means Indian companies can make drugs under patent in the West, provided they use a process that is different from the original. Manufacturers are able to produce and sell medicines here at a tiny fraction of the prices charged in the United States. In some cases, though, the generic makers have been blocked from selling their wares in other developing countries that have Western-style patent laws. Sibutramine is also sold in India under brand names Obestat, Sibutrim and Slenfig.
Composition
Obestat-5
Each capsule contains sibutramine hydrochloride monohydrate 5 mg.
Obestat-10
Each capsule contains sibutramine hydrochloride monohydrate 10 mg.
Description
Sibutramine produces its therapeutic effect by norepinephrine, serotonin and dopamine reuptake inhibition. Sibutramine and its major pharmacologically active metabolites (M1 and M2) have low affinity for serotonin (5 HT1, 5 HT1A, 5 HT1B, 5 HT2A, 5 HT2C), norepinephrine (b1 and b3, a1 and a2), dopamine (D1 and D2) benzodiazepine and glutamate receptors as well as lack monoamine oxidase inhibitory activity.
Indications
Obestat is indicated for the management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. Obestat is recommended for obese patients with an initial body mass index > 30 kg/m2 or > 27 kg/m2 in the presence of other risk factors (e.g. hypertension, diabetes, dyslipidemia). Body mass index is calculated by taking the patient's weight, in kg, and dividing by the square of the height of the patient, in metres.
Dosage and administration
The recommended starting dose of Obestat is 10 mg once daily with or without food. If there is inadequate weight loss, the dose may be titrated after four weeks to a total of 15 mg once daily. Doses above 15 mg daily are not recommended. The 5 mg dose should be reserved for patients who do not tolerate the 10 mg dose. Blood pressure and heart rate changes should be taken into account when making decisions regarding dose titration.
Contraindications
Hypersensitivity to sibutramine.
Patients receiving monoamine oxidase inhibitors.
Patients taking other centrally acting appetite suppressant drugs.
Anorexia nervosa.
Warnings and precautions
Drug Interactions
CNS active drugs: Sibutramine should not be used concomitantly with monoamine oxidase inhibitors (MAOI) and serotonergic drugs (selective serotonin reuptake inhibitors) since rare, but serious, constellation of symptoms termed ‘serotonin syndrome’ have been reported. At least two weeks should elapse between discontinuation of an MAOI and initiation of treatment with sibutramine. Similarly, at least two weeks should elapse between discontinuation of sibutramine and an MAOI.
Drugs that may raise blood pressure and/or heart rate: Concomitant use of sibutramine and other agents that may raise blood pressure or heart rate (e.g. certain decongestants, cough, cold and allergy medications that contain agents such as phenylpropanolamine, ephedrine or pseudoephedrine) have not been evaluated. Caution should be used when prescribing sibutramine to patients who use these medications.
Drugs that inhibit cytochrome P450 (3A4) metabolism: In vitro studies have shown that ketoconazole, erythromycin and cimetidine inhibit the cytochrome P450 (3A4) mediated metabolism of sibutramine but the magnitude of such an interaction appears to be small and not of clinical significance.
Alcohol: The concomitant use of sibutramine and excess alcohol is not recommended.
Blood Pressure and Pulse
Sibutramine substantially increases blood pressure in some patients. Hence regular monitoring of blood pressure is required when prescribing sibutramine. For patients who experience a sustained increase in blood pressure or pulse rate while receiving sibutramine, either dose reduction or discontinuation should be considered. Sibutramine should be given with caution to those patients with a history of hypertension and should not be given to patients with uncontrolled or poorly controlled hypertension.
Concomitant Cardiovascular Disease
Treatment with sibutramine has been associated with increases in heart rate and/or blood pressure. Therefore, sibutramine should not be used in patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Glaucoma
Because sibutramine can cause mydriasis, it should be used with caution in patients with narrow angle glaucoma.
Pulmonary Hypertension
Certain centrally-acting weight loss agents that cause release of serotonin from nerve terminals have been associated with pulmonary hypertension (PPH), a rare but lethal disease. In pre-marketing clinical studies, no cases of PPH have been reported with sibutramine. Because of the low incidence of this disease in the underlying population, however, it is not known whether or not sibutramine may cause this disease.
Seizures
During premarketing testing, seizures were reported in <0.1% of sibutramine-treated patients. Sibutramine should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops seizures.
Gallstones
Weight loss can precipitate or exacerbate gallstone formation.
Renal / Hepatic Dysfunction
Patients with severe renal impairment or severe hepatic dysfunction have not been systematically studied; sibutramine should therefore not be used in such patients.
Interference with Cognitive and Motor Performance
Although sibutramine did not affect psychomotor or cognitive performance in healthy volunteers, any CNS active drug has the potential to impair judgment, thinking or motor skills.
Miscellaneous
Organic causes of obesity (e.g. untreated hypothyroidism) should be excluded before prescribing sibutramine.
Pregnancy
There are no adequate and well controlled studies with sibutramine in pregnant women. The use of sibutramine during pregnancy is not recommended Women of child-bearing potential should employ adequate contraception while taking sibutramine. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.
Nursing Mothers
It is not known whether sibutramine or its metabolites are excreted in human milk. Sibutramine is not recommended for use in nursing mothers. Patients should be advised to notify their physician if they are breast feeding.
Pediatric Use
The safety and efficacy of sibutramine in pediatric patients under 16 years of age have not been established.
Side Effects
Sibutramine is generally well tolerated. Dry mouth, anorexia, insomnia and constipation are the commonly observed side effects. Convulsions have been reported in patients who had potentially predisposing factors for seizures. Ecchymosis/bleeding have been observed due to its possible effects on platelet function as a result of its effect on serotonin uptake.
Other side effects observed are
- diarrhea
- flatulence
- gastroenteritis
- peripheral oedema
- arthritis
- agitation
- hypertonia
- bronchitis
- pruritis
- menstrual disorders
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