Obsessive-Compulsive Disorder: Fluvoxamine Maleate are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in?ÿDSM-III-R or?ÿDSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.
The mechanism of action of fluvoxamine maleate in obsessive compulsive disorder is presumed to be linked to its specific serotonin reuptake inhibition in brain neurons. Fluvoxamine has been shown to be a potent inhibitor of the serotonin reuptake transporter in preclinical studies, both in vitro and in vivo.In in vitro studies, fluvoxamine maleate had no significant affinity for histaminergic, alpha or beta adrenergic, muscarinic, or dopaminergic receptors. Antagonism of some of these receptors is thought to be associated with various sedative, cardiovascular, anticholinergic, and extrapyramidal effects of some psychotropic drugs.
Adults: The recommended starting dose for Fluvoxamine Maleate Tablets in adult patients is 50 mg, administered as a single daily dose at bedtime. In the controlled clinical trials establishing the effectiveness of Fluvoxamine Maleate Tablets in OCD, patients were titrated within a dose range of 100 to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 300 mg per day. It is advisable that a total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.Pediatric Population (children and adolescents): The recommended starting dose for Fluvoxamine Maleate Tablets in pediatric populations (ages 8-17 years) is 25 mg, administered as a single daily dose at bedtime. In a controlled clinical trial establishing the effectiveness of Fluvoxamine Maleate Tablets in OCD, pediatric patients (ages 8-17) were titrated within a dose range of 50 to 200 mg/day. Physicians should consider age and gender differences when dosing pediatric patients. The maximum dose in children up to age 11 should not exceed 200 mg/day. Therapeutic effect in female children may be achieved with lower doses. Dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit. The dose should be increased in 25 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved. It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.Elderly Or Hepatically Impaired Patients: Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to modify the initial dose and the subsequent dose titration for these patient groups.
Co-admin with fluvoxamine may increase carbamazepine toxicity and serum levels of theophylline. Lithium enhances the serotonergic effects of fluvoxamine. Anticoagulants may require dosage adjustments. Diltiazem with fluvoxamine may lead to bradycardia. Avoid alcohol.Potentially Fatal: Fluvoxamine should not be used in combination with MAOIs, or within 14 days of discontinuing treatment with MAOIs.
Hypersensitivity. Not to be used with thioridazine, terfenadine, astemizole, cisapride, pimozide, aloestron, tizanidine. Lactation.
Nausea, vomiting, asthenia, headache, malaise, palpitations/tachycardia, abdominal pain, anorexia, constipation, diarrhoea, dry mouth, dyspepsia, agitation, anxiety, dizziness, insomnia, nervousness, somnolence, tremor, sweating.
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
History of mania or seizures; liver dysfunction; presence of depressive symptoms; smokers. Treatment with MAOI should only be started at least 2 wk after stopping fluvoxamine treatment. Increased risk of suicidal ideation and behaviour when used in children, adolescents and young adults <24 yr. Pregnancy, elderly; operating hazardous machinery; withdraw gradually. Monitor prothrombin time in patients who are taking oral anticoagulants concurrently.
Store Fluvoxamine Maleate Tablets at room temperature between 15?øC to 30?øC. Keep Fluvoxamine Maleate Tablets away from high humidity.
|Manufactured By||General Pharmaceuticals Ltd.|