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Rivotril

Rivotril

clonazepam

Manufacturer:

Recipharm Leganés

Distributor:

Zuellig
Concise Prescribing Info
Contents
Clonazepam
Indications/Uses
1st-line drug in typical absences (petit mal), atypical absences (Lennox-Gastaut syndrome), myoclonic & atonic (drop syndrome) seizures. 2nd-line agent in infantile spasms (West-Syndrome). 3rd-line drug in tonic-clonic seizures (grand mal), simple & complex partial seizures, secondary generalized tonic-clonic seizures. Panic disorder, w/ or w/o agoraphobia.
Dosage/Direction for Use
Epilepsy Adult Initial dose should not exceed 1.5 mg/day divided into 3 doses. May be increased in 0.5 mg increments every 3 days until either seizures are adequately controlled or undesired effects preclude any further increase. Maintenance: 3-6 mg/day. Max therapeutic dose: 20 mg daily. Childn 10-16 yr Initially 1-1.5 mg/day given in 2-3 divided doses. May be increased by 0.25-0.5 mg every 3rd day until maintenance dose (usually 3-6 mg/day) is reached. Infant & childn up to 10 yr (or up to 30 kg body wt) Initially 0.01-0.03 mg/kg daily given in 2-3 divided doses. Increase by no more than 0.25-0.5 mg every 3rd day until either a daily maintenance dose (approx 0.1 mg/kg daily) has been reached, or seizures are controlled or undesired effects preclude further increase. Max: 0.2 mg/kg daily. Panic disorder Adult Initially 0.25 mg bid, may be increased to 0.5 mg bid after 3 days. Subsequent up-titration should be made at 3-day intervals. Maintenance: 1 mg bid. Max: 2 mg bid. Duration of treatment: 12-24 mth.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to clonazepam or benzodiazepines. Severe resp & hepatic insufficiency. Avoid administration to neonates, especially premature infants.
Special Precautions
Should not be discontinued abruptly. Caution in patients w/ spinal or cerebellar ataxia, acute intoxication w/ alcohol or drugs, severe liver damage; history of alcohol or drug abuse; history of depression &/or suicide; porphyria. Carefully adjust dose in patients w/ pre-existing resp disease (eg, COPD) or liver disease & in patients undergoing treatment w/ other centrally-acting medications or anticonvulsants. Avoid concomitant use w/ alcohol &/or CNS depressants. Risk of physical & psychic dependence. Patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Driving, operating machinery & other hazardous activities should be avoided or at least during the 1st few days of treatment. Safety & efficacy have not been studied in patients w/ renal or hepatic impairment, & for the treatment of panic disorder in childn. May be administered only during pregnancy if there is a compelling indication. Mothers undergoing treatment should not breastfeed, or discontinue breastfeeding if there is a compelling indication for clonazepam. Risk of increased production of saliva & bronchial secretion in infants & small childn. Particular care should be taken during up-titration in elderly patients.
Adverse Reactions
Somnolence, headache, URTI, fatigue, flu, depression, dizziness, irritability, insomnia, ataxia, balance loss, nausea, abnormal coordination, lightheaded feeling, sinusitis, impaired concentration.
Drug Interactions
Increased risk of unwanted effects (eg, sedation & apathy) w/ other antiepileptic agents. Increased clearance w/ phenytoin, phenobarb, carbamazepine, & valproate. Risk of petit mal status epilepticus w/ valproic acid. Enhanced effects on sedation, respiration & hemodynamics w/ CNS depressants including alcohol.
MIMS Class
Anticonvulsants
ATC Classification
N03AE01 - clonazepam ; Belongs to the class of benzodiazepine derivatives antiepileptic.
Presentation/Packing
Form
Rivotril tab 2 mg
Packing/Price
100's
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