Arotril

Clonazepam

Description:

Arotril (Clonazepam), a derivative of benzodiazepine mainly used as anticonvulsant drug. Clonazepam brings about direct inhibition of cortical and sub-cortical epileptogenic focus and prevents the formation of convulsive activity. It displays several pharmacological properties, which are shown in the benzodiazepine class of drugs. At the spinal cord level Clonazepam depresses more reflux pathways and potentiates pre synaptic inhibition of GABA in the CNS. Over compensatory excitation processes are thereby reduced via negative feedback without substantiation of other physiologic neuronal activity.

Composition

Arotril- 0.5 mg: Each tablet contains Clonazepam USP 0.5 mg

Arotril- 2 mg: Each tablet contains Clonazepam USP 2.0 mg

Pharmacokinetics:

Clonazepam is rapidly and well absorbed following oral administration. The plasma half-life of Clonazepam is relatively long and varies from individual to individual. Clonazepam is distributed extensively throughout the body. It is mainly metabolized in liver. Up to 70 % of the metabolite is excreted by the urine and 30 % in the feces.

Indications:

1. Epilepsy

2. Drug-induced dyskinesias

3. Fulgurant pain

4. Bipolar affective disorder

5. Choreiform movement

6. Panic attacks

Dosage and administration:

The standard dose of Clonazepam must be individually adjusted according to the patient's clinical response and tolerance of the drug. As a general rule, Clonazepam is given as low dose, single drug therapy in new non- therapy resistant case.

Adults: 1 mg (elderly, 0.5 mg), initially at night for 4 nights, increased over 2-4 weeks to a usual maintenance dose of 4-8 mg daily in divided doses.

Child: Up to 1 year start with 0.25 mg, increased as above to 0.5-1 mg, 1-5 years start with 0.25 mg, increased to 1-3 mg, 5-12 years initial dose 0.5 mg, increased to 3-6 mg.

Use in Pregnancy & Lactation:

The use of Clonazepam during pregnancy or lactation should be avoided. The drug should only be administered to pregnant woman if the potential benefits outweigh the risk of fetus. Since Clonazepam passes into the breast milk, it must not be taken during feeding.

Side-effects:

Adverse effects like tiredness, sleepiness, lassitude, muscular hypotonia, dizziness, co-ordination disturbance, hyper salivation in infants, paradoxical aggression, irritability, light-headedness and ataxia. These effects are usually transients and generally disappear spontaneously in the course of treatment or on the reduction of dosage.

Contraindications:

Clonazepam must not be used in patients with known hypersensitivity to Clonazepam or any of the drugs excipients, in patients dependent on medications, drugs of abuse or alcohol, or in patients suffering from myasthenia gravis. Clonazepam may used only with particular caution in patients with spinal or cerebellar ataxia, in the event of acute intoxication with alcohol, other anti epileptic drugs, hypnotics, analgesics, neuroleptic agents, antidepressants or lithium, in patients with severe liver damage (cirrhosis of the liver).

Precautions:

The dosages of Clonazepam must be carefully adjusted to individual requirements in elderly patients, patients with pre-existing diseases of the respiratory system (e.g. chronic obstructive pulmonary disease), liver or kidney, and in patients under going treatment with other centrally acting medications or anticonvulsant (anti epileptic) agents.

Drug Interactions:

Narcotics, barbiturates, non-barbiturate hypnotic, anti-anxiety agents, MAO inhibitors, tricyclic antidepressant and other anticonvulsant drugs may potentate the CNS-depressant action of the benzodiazepine class of drugs.

Packing:

Arotril 0.5 mg Tablet: Box containing 5x10's in blister pack.

Arotril 2 mg Tablet: Box containing 3x10's in blister pack.