Leptic 2 mg Tab

Leptic 2 mg Tab

Description

Leptic

(Clonazepam) is available as scored tablets containing 0.5 mg, 1 mg & 2 mg Clonazepam USP. 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.

Composition

Leptic

0.5 : Each tablet contains Clonazepam USP 0.5 mg.

Leptic

1 : Each tablet contains Clonazepam USP 1 mg.

Leptic

2 : Each tablet contains Clonazepam USP 2 mg.

Indications

 All clinical forms of epileptic disease & seizures in infants, children & adults, especially absence seizures including :

 atypical absence

 primary & secondarily generalized tonic-clonic (grand mal)

 tonic-clonic seizures

 partial (focal) seizures with elementary or complex symptomatology

 various forms of myoclonic seizures

 myoclonus & associated abnormal movements

 Panic disorder with or without agoraphobia

Dosage and administration

Infants and children

 Initial dosage : 0.01 - 0.03 mg/kg/day not to exceed 0.05 mg/kg/day

 Increment dosage : not more than 0.25 - 0.5 mg at intervals of 3 days

 Maintenance dosage : 0.1-0.2 mg/kg/day

 Dosing interval: b.i.d./ t.i.d.

 Up to 1 year: 0.25 mg daily in divided dose, increase gradually to 0.5 - 1 mg.

 1-5 years : 0.25 mg daily in divided dose, increase to 1-3 mg

 5-12 years : 0.5 mg daily in divided dose increase to 3-6 mg. Adults and elderly Initial dosage: 1 mg daily in divided dose (Elderly 0.5 mg), not to exceed 1.5 mg/day

 Increment dosage : 0.5 - 1 mg at intervals of 3 days

 Maintenance dosage : 4 - 8 mg/day

 Maximum dosage : 20 mg/day should be administered with caution

 Dosing interval : b.i.d./t.i.d. Initial dosage should be low and increased gradually to a maintenance dosage that controls seizure without toxic effects.

During discontinuation, the dosage should be tapered. 

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 and 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.

Precautions

When used in patients in whom several different types of seizure disorders co-exist, 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 effect 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.

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.

Drug Interactions

The CNS-depressant action of the benzodiazepine class of drugs may be potentiated by alcohol, narcotics, barbiturates, nonbarbiturate hypnotics, antianxiety agents, the phenothiazines, thioxanthene and butyrophenone classes of antipsychotic agents, monoamine oxidase inhibitors, tricyclic antidepressants and by other anticonvulsant drugs.

Overdosage

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

Supply

Leptic

0.5: Each box contains 10x10 tablets in AluPVC/PVDC blister strips.

Leptic

1 : Each box contains 5x10 tablets in Alu-PVC/PVDC blister strips

Leptic

2 : Each box contains 5x10 tablets in Alu-PVC/PVDC blister strips.