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| Drug class description : | Anti-obesity agents |
| Generic Name : | Sibutramine |
| Drug description : | 10mg, hard capsules with blue cap and yellow body; 15mg, hard capsules with a blue cap and a white body. |
| Presentation : | Capsules, sibutramine hydrochloride monohydrate 10mg (equivalent to 8.37mg sibutramine), 15mg (equivalent to 12.55mg sibutramine). |
| Indications : | Adjunctive therapy within a weight management programme for: patients with nutritional obesity and a body mass index (BMI) of 30kg/m2 or higher; patients with nutritional excess weight and a BMI of 27kg/m2 or higher, if other obesity-related risk factors such as type 2 diabetes or dyslipidaemia are present. Reductil may only be prescribed to patients who have not adequately responded to an appropriate weight-reducing regimen alone, ie, patients who have difficulty achieving or maintaining >5% weight loss within three months. |
| Adult Dosage : | Initially, 10mg once daily, in the morning, increasing to 15mg once daily in patients with an inadequate response to Reductil 10mg (defined as less than 2kg weight loss after four weeks treatment). Discontinue treatment in patients who respond inadequately to Reductil 15mg (defined as less than 2kg weight loss after four weeks treatment). Reductil capsules should be swallowed whole with liquid and may be taken with or without food. Reductil treatment must be discontinued in patients who have not responded adequately, ie, whose weight loss stabilises at less than 5 per cent of their initial bodyweight or whose weight loss within three months after starting therapy has been less than 5 per cent of their initial bodyweight. Treatment should not be continued in patients who regain 3kg or more after previously achieved weight loss. In patients with associated co-morbid conditions, treatment with Reductil should be continued only if it can be shown that the weight loss induced is associated with other clinical benefits. Data on use of Reductil for more than one year are limited. |
| Child Dosage : | Under 18 years, not recommended. |
| Contra Indications : | Known hypersensitivity to sibutramine hydrochloride monohydrate or any other component of the product. Organic causes of obesity. History of major eating disorders. Psychiatric illness (sibutramine has shown potential antidepressant activity in animal studies and, therefore the risk that sibutramine could induce a manic episode in bipolar patients cannot be excluded). Gilles de la Tourette's syndrome. Concomitant use, or use during the past two weeks, of monoamine oxidase inhibitors (MAOIs), or of other centrally-acting drugs for the treatment of psychiatric disorders (such as antidepressants, antipsychotics) tryptophan for sleep disturbances. History of coronary artery disease, congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or TIA). Inadequately controlled hypertension (>145/90mmHg). Hyperthyroidism. Severe hepatic impairment. Severe renal impairment. Benign prostatic hyperplasia with urinary retention. Phaeochromocytoma. Narrow angle glaucoma. History of drug, medication or alcohol abuse. Pregnancy and lactation. Children and young adults up to the age of 18 years, patients above the age of 65 years (owing to insufficient data in these age groups). |
| Special Precautions : | Monitor blood pressure and pulse rate every two weeks in first three months of treatment, monthly between months four and six, and regularly thereafter at maximum intervals of three months. Discontinue treatment if blood pressure rises by more than 10mmHg (or pulse rate rises by more than 10 bpm) on two consecutive visits. Discontinue treatment in previously well controlled hypertensive patients if blood pressure exceeds 145/90 mmHg at two consecutive readings. Patients with sleep apnoea syndrome; take care when monitoring blood pressure. Observe patients for signs of progressive dyspnoea, chest pain and ankle oedema; advise patients to consult doctor immediately if any of these symptoms occur. Epilepsy. Mild to moderate hepatic or renal impairment. Family history of motor or verbal tics. Women of child bearing potential should employ adequate contraception while taking Reductil. Allow two weeks between stopping sibutramine and starting MAOIs. |
| Interactions : | Drugs which inhibit CYP3A4 enzyme activity (eg, ketoconazole, itraconazole, erythromycin, clarithromycin, troleandomycin induce CYP3A4 enzyme activity (eg, rifampicin, phenytoin, carbamazepine, phenobarbital [phenobarbitone], dexamethasone), other drugs which increase serotonin levels in the brain. Use with caution in patients using other drugs that may increase the blood pressure or heart rate including certain cough, cold and allergy preparations (eg, ephedrine, pseudoephedrine) and certain decongestants (eg, xylometazoline). MAOIs. |
| Adverse Reactions : | Most commonly, loss of appetite, constipation, dry mouth, insomnia. Also, tachycardia, palpitations, raised blood pressure/hypertension, vasodilatation (hot flush), nausea, haemorrhoid aggravation, light-headedness, paraesthesia, headache, anxiety, sweating, taste perversion. Rarely, blurred vision, withdrawal symptoms such as headache and increased appetite. Cardiovascular changes (increase in heart rate and blood pressure). Refer to Summary of Product Characteristics. |
| Manufacturer : | Knoll |
| Drug Availability : | (POM) |
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