Arotril (Clonazepam)

Therapeutic Group : Antipsychotic, Neurotonic & Sedative

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:

1. 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 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 usual maintenance dose of 4-8mg 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 alcohole 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 woman if the potential benefits of the patient outweigh the risk of fetus. Nursing mother must stop breast-feeding while taking clonazepam or vise 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.