Indications

Clepam is indicated for:

• Panic disorder: For the treatment of panic disorder, with or without agoraphobia.
• Seizure disorders: Alone or as an add-on therapy for Lennox-Gastaut Syndrome, akinetic, and myoclonic seizures. It may also be used for absence seizures (petit mal) in patients who have not responded to succinimides. The long-term effectiveness (more than 9 weeks) has not been systematically studied, and the long-term usefulness should be periodically reevaluated by a physician.

Pharmacology

Clonazepam, the active ingredient in Clepam, is a benzodiazepine that has anticonvulsant, sedative, muscle-relaxing, and anxiolytic effects. These effects are mediated by enhancing GABAergic neurotransmission at inhibitory synapses. Clonazepam increases the affinity of the GABA receptor for its neurotransmitter, leading to an increased action of GABA. It also suppresses various types of paroxysmal activity in the brain, including those seen in absence seizures.

Dosage & Administration

• Oral (Adults):
  • Seizures: Initial dose should not exceed 1.5 mg/day, divided into three doses. The dosage can be increased by 0.5 to 1 mg every 3 days, up to a maximum daily dose of 20 mg.
  • Panic disorder: Initial dose is 0.25 mg, given in two divided doses. The target dose of 1 mg/day may be reached after 3 days.
• Oral (Pediatric Patients):
  • Seizures: Initial dose for children up to 10 years or 30 kg is 0.01 to 0.03 mg/kg/day, not to exceed 0.05 mg/kg/day, in two or three divided doses.
• Injection:
  • Infants and children: 0.5 mg by slow IV injection or infusion.
  • Adults: 1 mg by slow IV injection or infusion. The dose can be repeated as needed, with a maximum injection rate of 0.25-0.5 mg per minute and a total dose not exceeding 10 mg.

Interaction

Clepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine, or phenobarbital. Its effect on other drugs has not been investigated.

Contraindications

Clepam is contraindicated in patients with:

• A history of hypersensitivity to benzodiazepines.
• Clinical or biochemical evidence of significant liver disease.
• Acute narrow-angle glaucoma (but can be used with appropriate therapy for open-angle glaucoma).

Side Effects

The most common side effects are related to CNS depression. In patients being treated for seizures, drowsiness occurred in about 50% and ataxia in about 30%. Behavioral problems have been noted in about 25% of patients. Other side effects may include abnormal eye movements, coma, confusion, depression, amnesia, and palpitations.

Pregnancy & Lactation

• Pregnancy: Clonazepam may cause congenital malformations. It should be used during pregnancy only if the potential benefits outweigh the risks to the fetus. High doses in the last trimester can cause irregularities in the newborn, such as hypothermia, hypotonia, and poor feeding. Withdrawal symptoms in newborns have also been reported.
• Lactation: Clonazepam passes into breast milk in small amounts. Mothers should not breastfeed while on this medication.

Precautions & Warnings

• Seizures: In patients with coexisting seizure disorders, Clepam may increase the incidence of generalized tonic-clonic seizures. The concomitant use of valproic acid and Clepam may produce absence status.

Use in Special Populations

• Pediatric Use: In infants and small children, Clepam may increase the production of saliva and bronchial secretions, so special attention must be paid to maintaining a clear airway.
• Geriatric Use: The pharmacologic effects of benzodiazepines may be greater in elderly patients.
• Renal Impairment: No dose adjustment is required.
• Hepatic Impairment: The influence of hepatic impairment has not been fully investigated, but clearance of the drug may be reduced in liver cirrhosis.

Overdose Effects

Overdose commonly causes drowsiness, ataxia, and slurred speech. If taken alone, it is rarely life-threatening but can lead to apnea, hypotension, and coma. Coma may be prolonged, especially in the elderly. Treatment is supportive and symptomatic, with monitoring of vital signs. Activated charcoal may be used. The benzodiazepine antagonist flumazenil can be considered for severe cases, but it has a short half-life and should be used with caution, especially in patients taking drugs that lower the seizure threshold.

Therapeutic Class

Clepam is classified as an adjunct anti-epileptic drug and a benzodiazepine hypnotic.

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.