Arotril® (Clonazepam)

Description

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

Presentation

Arotril^® 0.5 mg Tablet: Each tablet contains Clonazepam USP 0.5 mg.
Arotril^® 1 mg Tablet: Each tablet contains Clonazepam USP 1 mg.
Arotril^® 2 mg Tablet: Each tablet contains Clonazepam USP 2 mg.

Indications

Epilepsy: Status epilepticus, Lennox-Gastaut syndrome, Infantile spasms, Absences seizure, Myoclonic seizures, Tonic – clonic seizures, Akinetic and atonic seizures & Partial seizures 2. Drug- induced dyskinesias 3. Fulgurant pain 4. Bipolar affective disorder 5. Choreiform movements 6. Panic attacks

Dosage & 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 started with a low single dose in a new patient.
Adults: 1mg (elderly, 0.5mg), initially at night for 4 nights, increased according to response over 2-4 weeks to the usual maintenance dose of 4-8 mg which is usually given at night as a single dose or may be given in 3-4 divided doses if necessary.
Children: Up to 1 year, initially 0.25 mg, increased as above to usual maintenance dose of 0.5-1 mg, 1-5 years initially 0.25 mg, increased as above to 1-3 mg, 5-12 years, initially 0.5 mg, increased as above to 3-6 mg.

Contrainidications

Clonazepam must not be used in patients with known hypersensitivity to any components of this preparation, in patients dependent on medications, drugs of abuse, or alcohol, or suffering from myasthenia gravis.

Warning & Precautions

The dosages of Clonazepam must be carefully adjusted to individual requirements in elderly patients, patients with pre-existing diseases of liver, kidney & respiratory system (e.g. chronic obstructive pulmonary disease), or undergoing treatment with other centrally-acting medications. Special care should be taken while administering clonazepam in patients with spinal or cerebellar ataxia and in the event of acute intoxication with alcohol other centrally-acting medications and analgesics.

Side effects

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

Drug interaction

Narcotics, barbiturates, non-barbiturates, hypnotics, anti-anxiety agents, MAO inhibitors, tricyclic antidepressant and anticonvulsant drugs may potentiate the CNS-depressant action of clonazepam.

Use in special groups

The use of clonazepam during pregnancy or lactation should be avoided. The drug should only be administered to pregnant women if the potential benefits to the patient outweigh the risk to the fetus. Nursing mothers must stop breastfeeding while taking clonazepam or vice versa.

Packing

Arotril^® 0.5 mg Tablet: Each box contains 100’s tablets in blister pack.
Arotril^® 1 mg Tablet: Each box contains 50’s tablets in blister pack.
Arotril^® 2 mg Tablet: Each box contains 30’s tablets in blister pack.