Rivotril 0.5mg(Clonazepam USP)

Description

COMPOSITION
Rivotril 0.5 mg tablet: Each tablet contains Clonazepam USP 0.5 mg.
Rivotril 1 mg tablet: Each tablet contains Clonazepam USP 1 mg.
Rivotril 2 mg tablet: Each tablet contains Clonazepam USP 2 mg.
PHARMACOLOGY
Clonazepam has pharmacological properties of the benzodiazepine
class of drugs. Clonazepam has sedative, hypnotic and
anticonvulsant properties. Its basic anticonvulsive properties are
also similar to those of other benzodiazepines.
INDICATION
● Anxiety as well as panic disorder, with or without agoraphobia
● Epilepsy and other seizure disorders
● Alone or as an adjunct in the management of myoclonic and
akinetic seizures and petit mal variant (Lennox-Gastaut syndrome).
May also be of some value in patients with absence spells (petit mal)
who have failed to respond to succinimides.
DOSAGE & ADMINISTRATION
Dosage must be determined in each patient according to clinical
response and tolerance. Children: The initial dose for infants and
children (up to 10 years of age or 30 kg of body weight) should be
between 0.01 and 0.03 mg/kg/day and should not exceed 0.05
mg/kg/day given in two or three divided doses.
Adults: The initial dose for adults should not exceed 1.5 mg/day
divided into three doses. Dosage may be increased in increments of
0.5 to 1 mg every three days until seizures are adequately controlled.
Maintenance dosage must be individualized for each patient
depending upon response. A recommended maintenance dose for
adults is 8 to 10 mg/day in three divided doses. Dosages in excess of
20 mg/day should be administered with caution. The use of multiple
anticonvulsants may result in an increase of depressant adverse
effects. This should be borne in mind whenever Clonazepam is
added to an already existing anticonvulsant regimen.
CONTRAINDICATION
Significant liver disease, narrow angle glaucoma, sensitivity to
benzodiazepines.
SIDE EFFECT
The most frequently occurring adverse reactions to Clonazepam are
referable to CNS depression, drowsiness ataxia. In some cases, these
may diminish with time. Behavioral problems and salivation have
been noted.
DRUG INTERACTION
Interactions have been reported between some benzodiazepines
and other anticonvulsants, with changes in the serum concentration.
PREGNANCY & LACTATION
Pregnancy category is ‘C’. The use of Clonazepam during pregnancy
should be avoided. Mothers receiving Clonazepam should not
breast feed their infants.
OVERDOSE
The cardinal manifestations of overdosage are drowsiness and
confusion, reduced reflexes and coma. There are minimal effects on
respiration, pulse and blood pressure, unless the overdosage is
extreme.
STORAGE
Store below 30o C. Keep away from light. Keep all the medicine out
of reach of children.