Frisium (Clobazam) 10mg by Sanofi Aventis 10 x 10 Tablets / Strip

Clobazam information from DrugsUpdate  P - Contraindicated in pregnancyL - Contraindicated in lactation Clobazam, (marketed under the brand names Frisium and Urbanol), is a drug which is a benzodiazepine derivative. Pharmacodynamics Pharmacokinetics Clobazam binds to one or more specific GABA receptors at several sites within the CNS including the limbic system and reticular formation. Increased permeability of neuronal membrane to chloride ions results in GABA's inhibitory effect leading to hyperpolarisation and stabilisation. AbsorptionWell absorbed from the GI tract (oral); peak plasma concentrations after 1-4 hours.DistributionRapidly crosses the blood-brain barrier. Protein-binding: 85%.MetabolismHepatic by demethylation and hydroxylation.ExcretionUrine (as unchanged drug and metabolites); 18- 42 hours (elimination half-life). Clobazam Indications / Clobazam Uses Information Not Available Clobazam Adverse Reactions / Clobazam Side Effects Constipation, anorexia, nausea; dizziness, fine tremors; worsening of respiratory symptoms in predisposed individuals; ataxia, drowsiness, headache, confusion; loss of libido, motor dysfunction; dependence; visual disturbances and weight gain. Potentially Fatal: Respiratory depression. Precautions OverdosageDrowsiness, mental confusion, lethargy, ataxia, hypotonia, hypotension, respiratory depression, coma and very rarely death. Treatment includes emptying stomach by inducing vomiting (if within 1 hour) or gastric lavage. Activated charcoal may be used to reduce absorption. Monitor respiratory and CV functions. Flumazenil may be given if necessary. Forced diuresis or haemodialysis unlikely to be effective. Special Precautions May impair ability to perform skilled tasks and hazardous activities; elderly; renal or hepatic impairment; alcoholics; obesity; withdrawal should be gradual. Other Drug Interactions Increased hepatic clearance of clobazam when administered with phenytoin, phenobarbital or carbamazepine. Cimetidine may increase levels of clobazam. Potentially Fatal: Concurrent alcohol, hypnotics and sedative antidepressants can potentiate CNS side effects of clobazam. Other Interactions Information Not Available Dosage Oral Short-term management of anxiety, Adjunct in epilepsyAdult: 20-30 mg as a single dose at night or as daily divided doses, increased to 60 mg/day in severe conditions.Child: 3-12 years: 125 mcg/kg bid increased every 5 days. Usual maintenance dose: 250 mcg/kg bid. Max: 500 mcg/kg bid. Elderly: or debilitated patients: 10-20 mg daily. Renal impairment: Dose adjustment may be needed. Hepatic impairment: Dose adjustment may be needed. Food(before/after) May be taken with or without food List of Contraindications Clobazam and Pregnancy Contraindicated in pregnancy Clobazam and Lactation Contraindicated in lactation Clobazam and Children Information Not Available Clobazam and Geriatic Information Not Available Clobazam and Other Contraindications Hypersensitivity; history of drug dependence; myasthaenia gravis; pregnancy (1st trimester), lactation; serious liver damage; sleep apnoea syndrome; impaired respiratory function. Storage OralStore at 15-30°C. Lab interference Information Not Available