Disopan
Clonazepam tablet & Drops

Presentation
Disopan 0.5 : Each tablet contains Clonazepam USP 0.5 mg.
Disopan 2 : Each tablet contains Clonazepam USP 2 mg.
Disopan Drops : Each 5ml drops contains Clonazepam USP 12.5 mg.

Description
Chemically, clonazepam is a benzodiazepine derivative. It exhibits several pharmacologic properties, which are characteristics of the benzodiazepine class of drugs. In human it is capable of suppressing the spike and wave discharge in absence seizure (petit mal) and decreasing the frequency, amplitude, duration and spread of discharge in minor motor seizure.

Indications and Uses
1. Panic attack 3. Bipolar affective disorder
2. Epilepsy 4. Drug-induced dyskinesia
Status epilepticus 5. Choreiform movement
Lennox-Gastaut syndrome 6. Fulgurant pain
Infantile spasm 7. Tourette's syndrome
Absence seizure 8. Resistant depression
Myoclonic seizure 9. Nocturnal myoclonus
Tonic-clonic seizure 10. Trigeminal neuralgia
Akinetic and atonic seizure
Partial seizure

Contraindications
Clonazepam should not be used in patients with a history of sensitivity to benzodiazepine, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow angle glaucoma.

Dosage And Administration
Infants and children
Initial dose: 0.01 - 0.03 mg/kg/day Up to 1 year: 0.25 mg daily in divided dose,
not to exceed 0.05 mg/kg/day increase gradually to 0.5 - 1 mg.
Increment dose: not more than 0.25 - 0.5 mg 1 - 5 years: 0.25 mg daily in divided dose, at intervals of 3 days increase to 1 - 3 mg.
Maintenance dose: 0.1 - 0.2 mg/kg/day 5 - 12 years: 0.5 mg daily in divided dose,
Dosing interval: b.i.d. / t.i.d. increase to 3 - 6 mg.

Adults and elderly
Initial dose: 1 mg daily in divided dose (Elderly 0.5 mg), not to exceed 1.5 mg/day
Increment dose: 0.5 - 1 mg at intervals of 3 days
Maintenance dose: 4 - 8 mg/day
Maximum dose: 20 mg/day should be administered with caution
Dosing interval: b.i.d. / t.i.d.

Initial dose should be low and increased gradually to a maintenance dose that controls seizure without toxic effects. During discontinuation, the dose should be tapered.



Precautions
When used in patients in whom several different types of seizure disorders coexist, clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures (grand mal). This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and clonazepam may produce absence status. Periodic blood counts and liver function tests are advisable during long term therapy with clonazepam.

The abrupt withdrawal of clonazepam, particularly in those patients on long-term, high-dose therapy, may precipitate status epilepticus. Therefore when discontinuing clonazepam, gradual withdrawal is essential.

Clonazepam may produce an increase in salivation. This should be considered before giving the drug to patients who have difficulty handling secretions. Because of this and the possibility of respiratory depression, clonazepam should be used with caution in patients with chronic respiratory diseases.

Because of the possibility that adverse effects on physical or mental development could become apparent only after many years, a benefit-risk consideration of the long-term use of clonazepam is important in pediatric patients.

Side Effects
The most frequently occurring side effects of clonazepam are referable to CNS depression, drowsiness, fatigue, dizziness, muscle hypotonia, co-ordination disturbance, hypersalivation in infants, paradoxical aggression, irritability and mental change.

Use in pregnancy & lactation
The use of clonazepam during pregnancy or lactation should be avoided. Clonazepam is excreted into the breast milk and should therefore be avoided in breast-feeding mothers.

Overdosage
Symptoms of clonazepam overdosage, like those produced by other CNS depressants, include somnolence, confusion, coma and diminished reflexes.

Commercial Pack
Disopan 0.5 : Each box contains 10 blister strips of 10 tablets.
Disopan 2 : Each box contains 5 blister strips of 10 tablets.
Disopan Drops : Each bottle contains 10 ml drops.
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