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Rivopam

 

DESCRIPTION
RIVOPAM TABLET 0.5 MG : A white 7 mm round tablet with marking 'd' and a' flower.
RIVOPAM TABLET 2 MG : A white 7 mm round tablet with marking 'DUO 861' and a 'd',

COMPOSITION:
RIVOPAM TABLET 0.5 MG : Each tablet contains Clonazepam 0.5 mg.
RIVOPAM TABLET 2 MG : Each tablet contains Clonazepam 2 mg.

PHARMACODYNAMICS

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.

PHARMACOKINETICS

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.

INDICATIONS

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.

RECOMMENDED DOSAGE

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.

 

Infants

 

0.3 mg/day

Children

2-5 years

0.5 mg/day

6-12 years

Adults

 

1 mg/day

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)

 

  Age Daily dose
    Dose in mg Tablets 0.5 mg Tablets 2 mg
Infants   0.5 - 1 1 - 2 -
Children 2 - 5 1.5 - 3 3 - 6 - 1
  6 - 12 3 - 6 6 - 12 1 - 3
Adults   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.

CONTRAINDICATIONS

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 gradually.

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.

SIDE EFFECTS

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.

STORAGE CONDITIONS

Store below 25C. Protect from light. Keep out of reach of children.

 

PACK SIZE

50 x 10's and 10 x 10's in blister pack.

 

SHELF LIFE

Please refer to outer package.

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