CLOMA 2 MG TABLET

COMPOSITION

• Cloma  0.5 mg Tablet: Each tablet contains Clonazepam USP 0.5 mg.
• Cloma  1 mg Tablet: Each tablet contains Clonazepam USP 1 mg.
• Cloma  2 mg Tablet: Each tablet contains Clonazepam USP 2 mg.

DESCRIPTION

Clonazepam is a derivative of the benzodiazepine class which is mainly used as an anticonvulsant drug. It has sedative, hypnotic, and anticonvulsant properties. Its basic anticonvulsive properties are also similar to those of other benzodiazepines.

INDICATION

• Cloma is indicated for the treatment of the following diseases
• Anxiety as well as panic disorder, with or without agoraphobia,
• Epilepsy and other seizure disorders
• Alone or as an adjunct in the management of myoclonic and akinetic seizures and petit mal variant (Lennox-Gastaut syndrome).

DOSAGE AND 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: 1 mg (elderly, 0.5 mg), initially at night for 4 nights, increased according to response over 2-4 weeks to a usual maintenance dose of 4-8 mg usually at night (may be given in 3-4 divided doses if necessary).
• Children: Up to 1 year, initially 0.25 mg, increased as above to the 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.

SIDE EFFECT

• The most frequently occurring side effects of Clonazepam are CNS depression, drowsiness, fatigue, dizziness, muscle hypotonia, coordination disturbance, hypersalivation in infants, paradoxical aggression, irritability, and mental change.

PRECAUTION

Although simultaneous administration of several anticonvulsants may be considered with clonazepam, such combined therapy may result in an increase in central depressant adverse effects. When used in patients in whom several different types of seizures co-exist, clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic

seizures (grand mal).

CONTRAINDICATION

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.

USE IN PREGNANCY AND LACTATION

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

DRUG INTERACTION

The CNS depressant action of the benzodiazepine class of drugs may be potentiated by alcohol, narcotics, barbiturates, nonbarbiturate hypnotics, anxiolytic 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.

STORAGE

• Store in a cool & dry place, and protect from light.
• Keep out of reach of children.

COMMERCIAL PACK

• Cloma 0.5 mg Tablet: Box containing 5 X 10 tablets in blister pack.
• Cloma 1 mg Tablet: Box containing 5 X 10 tablets in blister pack.
• Cloma 2 mg Tablet: Box containing 3 X 10 tablets in blister pack.