RIVOPAM TABLET 0.5 MG : A white 7 mm round tablet with marking 'd' and a'
RIVOPAM TABLET 2 MG : A white 7 mm round tablet with marking 'DUO 861' and a
RIVOPAM TABLET 0.5 MG : Each tablet contains Clonazepam 0.5 mg.
RIVOPAM TABLET 2 MG : Each tablet contains Clonazepam 2 mg.
The active substance of
clonazepam is a benzodiazepine derivative, closely related to nitrazepam and
diazepam, exhibiting marked anticonvulsant properties in animals. Clonazepam
prevents generalisation of convulsive activity. In the majority of cases,
clonazepam improves both focal seizures and primarily generalised attacks.
Clonazepam is nearly completely
absorbed after oral administration with peak serum levels being reached
between 2 and 3 hours. The volume of distribution is 2-3 litres/kg.
Clonazepam is metabolised by the liver and pathways include hydroxylation
and reduction of the nitro group.
The majority of clinical forms of
epileptic disease in infants and children, especially typical or atypical
petit mal epilepsies, tonic-clonic seizures generalised from the onset or
secondarily, status epileptics in all its clinical forms. Clonazepam has
also demonstrated efficacy in both major and minor seizures in adults
including grand mal, petit mal, (classical and atypical forms) and in
psychomotor, myoclonic, focal and tonic and atonic seizures.
Oral Treatment: Dosage of clonazepam is essentially individual and depends in the first instance on
the age of the patient. It will be determined in each patient according to
clinical response and tolerance. In order to minimise initial adverse
reaction it is essential to commence with low doses and increase the daily
dose progressively until a maintenance dose suited to the individual patient
has been reached. Some degree of tolerance may be observed to both the
adverse and therapeutic effects.
The above to be in 3 or 4 divided doses with a larger dose in the evening.
For children, initial dosage is based on 0.01 mg - 0.03 mg/kg per day.
Average dosage range for maintenance therapy (individuals may require and
tolerate larger doses)
||Dose in mg
||Tablets 0.5 mg
||Tablets 2 mg
||0.5 - 1
||1 - 2
||2 - 5
||1.5 - 3
||3 - 6
||¾ - 1½
||6 - 12
||3 - 6
||6 - 12
||1½ - 3
||4 - 6
||8 - 16
||2 . 4
The daily quota should if possible be divided into three to four doses
spread over the day. The maintenance dose should be attained after 2-4 weeks
of treatment. To obtain optimum adjustment of the dose in infants and
children, the tablets 0.5 mg is recommended. The double-scored tablets 0.5
mg facilitate administration of low doses in the early phase of treatment.
Respiratory depression and acute
pulmonary insufficiency. Rivopam should not be used in patients with a
history of sensitivity to the benzodiazepines.
WARNING & PRECAUTIONS
Patients should abstain from
alcohol since alcohol can provoke epileptic seizures, modify its action, and
gives rise to unpredictable side effects. Patient's reactions like driving
ability, behaviour in traffic may be modified depending on dosage and
individual susceptibility. Care to be taken before administration with other
CNS acting drugs or other anti epileptic drugs. Renal impairment may
necessitate lower dose of clonazepam. Withdrawal of Clonazepam must be done
USE IN PREGNANCY & LACTATION
Use in pregnancy: It is likely that clonazepam is transferred across the
placenta and clonazepam should be given to women who are or may become
pregnant only when the potential benefits have been weighed against the
possible hazard to the mother and child.
Studies in female rabbits doses at 2.5 mg/kg daily have shown a decrease in
foetal weight and an increase in prenatal mortality.
Use in lactation: If clonazepam is given to the nursing mothers, it should
be borne in mind that benzodiazepine (like clonazepam) have been found to be
excreted in breast milk.
Adverse reactions to clonazepam
occur in about 50% of patients and are usually referable to its sedative and
muscle-relaxant effects, being most frequently somnolence 18%, fatigue 8%,
muscle weakness 5%, co-ordination disturbances (ataxia) 5% and vertigo 5%.
These effects occur at a higher incidence early in treatment and to a
certain extent can be minimised by progressive increases in dosage to the
optimum level. Clonazepam may give rise to salivary or bronchial
hyper-secretion infants and small children (see Precautions). The effect of
clonazepam on behavioural disturbances in epileptic patients is generally
favourable. In 1.5% of cases, however, aggressiveness, irritability or
agitation may arise during treatment. Other adverse effects reported include
confusion, dysarthria, hypotension, gastric disturbances and depression.
Clonazepam has provoked a generalised seizure or activated preexisting
seizures in 0.5% of cases and the concurrent administration of other
antiepileptics may be indicated. Rarely, the following have been reported -
abnormal liver function tests, leucopenia, thrombocytopenia, eosinophilia.
Sedation or drowsiness, hyperkinesis (principally in children), abnormal eye
movements, coma, diplopia, dysdiadochokinesis, glassy-eyed appearance,
headache, hemiparesis, nystagmus, respiratory depression, slurred speech,
tremor, dizziness, vertigo, mental depression, forgetfulness,
hallucinations, hysteria, increased libido, insomnia, psychosis or suicidal
tendencies, muscle weakness. Increased salivation hypersecretion in upper
respiratory passages, chest congestion, rhinorrhoea, shortness of breath,
difficulty in swallowing occurred in infants receiving the drug,
constipation, diarrhoea, encopresis, gastritis, increased or decreased
appetite, weight gain or loss, dyspepsia, nausea, coated tongue, dry mouth,
abnormal thirst, sore gums. Dysuria, enuresis, nocturia, urinary retention,
hair loss, hirsuitism, skin rash, ankle and facial oedema.
SYMPTOMS AND TREATMENT OF OVERDOSE
Overdosage: Four overdose
incidents have been reported to date, none was fatal. Two examples are:
1. A child, 2% years old, who ingested 60 mg of onazepam. Gastric lavage was
performed approximately one hour later to recover a small quantity of
tablets. No other treatment was undertaken. The child become drowsy and
ataxic but was obviously recovering in 12 hours and was ataxic for a total
of 60 hours.
2. A five year old who ingested 80 mg was stomach pumped at two hours - no
result, become somnolent for 2-3 hours and then was quite recovered.
Store below 25°C. Protect from
light. Keep out of reach of children.
50 x 10's and 10 x 10's in
Please refer to outer package.