Clonium®

Clonazepam

Prescribing Details



Description
Clonium ® is a preparation of Clonazepam which exerts its antiseizure and antipanic effects by enhancing activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system.

Uses
No Data

Indications
  1. All clinical forms of epileptic disease and seizures in infants, children and adults including-
    1. Atypical absence (Petit mal)
    2. Primary or secondary generalized tonic-clonic (grand mal)
    3. Tonic or clonic seizures
    4. Partial (focal) seizure
    5. Myoclonic seizures
    6. Myoclonous
  2. Panic attack
  3. Bipolar affective disorder
  4. Drug-induced dyskinesia
  5. Choreiform movement
  6. Fulgurant pain
  7. Tourette's syndrome
  8. Resistant depression
  9. Nocturnal myoclonus
  10. Trigeminal neuralgia

Dosage and administration
Adult and elderly
Initial dose: 1 mg/day in divided dose (Elderly 0.5 mg) at night for 4 nights
Maintenance dose: According to response the usual maintenance dose of 4-8 mg daily in 3-4 divided doses over 2-4 weeks.

Infants & children
Up to 1 year: 0.25 mg/day in divided dose increases up to 0.5-1 mg
Up to 5 year: 0.25 mg/day in divided dose increases up to 1-3 mg
Up to 5-12 year: 0.5 mg/day in divided dose increases up to 3-6 mg

Use in pregnancy & lactation
Use of Clonazepam during pregnancy and lactation should be avoided. Clonazepam is excreted into breast milk. Mothers receiving clonazepam should not breast-feed their infants.

Geriatric use
No Data

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. The abrupt withdrawal of clonazepam, particularly in those patients on long-term, high-dose therapy, may precipitate status epilepticus. Caution should be exercised in the administration of the drug to patients with impaired renal function. Clonazepam may produce an increase in salivation. Clonazepam should be used with caution in patients with chronic respiratory diseases.

Side effects
The common side effects of Clonazepam are fatigue, muscle weakness, dizziness, light headedness, somnolence, hypersalivation in infants, occasional hypotonia and co-ordination disturbances.

Contraindications
Patients with known hypersensitivity to benzodiazepines or any other drug excipients; acute pulmonary insufficiency; severe respiratory insufficiency, sleep apnoea syndrome , myasthenia gravis and severe hepatic insufficiency.

Drug interactions
The CNS-depressant action of benzodiazepines class of drugs may be potentiated by alcohol, narcotics, barbiturates hypnotics, antianxiety agents, the phenothiazines, thioxanthenes and butrophenone classes of antipsychotic agents, mono-amino oxidaes inhibitors and the tricyclic antidepressants and other anticonvulsants.

Overdose
Symptoms of clonazepam overdosage include somnolence, confusion, coma, and diminished reflexes. Management treatment includes monitoring of respiration, pulse and blood pressure, general supportive measures and immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained.

Preparation
No Data

Pharmaceutical precautions
Store in a cool place. Protect from light.

Presentation
Clonium ® 0.5 mg tablet: Beige colored, round tablet. Each tablet contains Clonazepam BP 0.5mg.
Clonium ® 1 mg tablet: Light pink colored, round tablet. Each tablet contains Clonazepam BP 1mg.
Clonium ® 2 mg tablet: Light orange tablet. Each tablet contains Clonazepam BP 2mg.

Package quantitie
Clonium ® 0.5 mg: Carton of 100 tablets in Alu-PVC blister.
Clonium ® 1 mg tablet: Carton of 50 tablets in Alu-PVC blister.
Clonium ® 2 mg tablet: Carton of 50 tablets in Alu-PVC blister.