Tradename
Apetryl
Generic Name
Clonazepam
Category
Central Nervous System
Form
Tablets
Composition
Clonazepam............0.5 and 2.0 mg
Description
Antiepileptic agent
Properties/Actions
Pharmacodynamics
In humans, Clonazepam has shown to bring about direct inhibition of the cortical and subcortical epileptogenic focus and thus can prevent generalization of the convulsion activity. Apetryl has a beneficial effect on primary generalized seizures and on focal epilepsy. Clonazepam potentiates the pre- and postsynaptic inhibitory action of GABA in the CNS. Clonazepam reduces overcompensatory excitation with minimum effect on other physiological neuronal activity.

Pharmacokinetics

Clonazepam is quickly and totally absorbed after oral administration. In most cases, peak plasma concentrations are reached from one to four hours. Bioavailability on average is 90%.
Clonazepam crosses the palcental barrier and is excreted in maternal milk. After an oral dose of 2 mg Apetryl, the onset of action is after 30-60 minutesand the duration of action lasts up to 12 hours in adults. Within 4 to 10 days, 50-70% of the oral dose is excreted in urine, 10-30% in feces and less than 0.5% unchanged in urine.
Indications
Apetryl may be used in all types of epilepsy and seizures.
  1. Adults: Epilepsy and focal seizures.
  2. Children: Typical and atypical absences (Lennox syndrome), nodding spasms, primary or secondary generalized tonic and clonic spasm.
Contraindications
Not to be given in patients with hypersensitivity to clonazepam or in patients with myasthenia gravis. It is also contraindicated during breast-feeding.
Drug Interactions
When Apetryl is administered together with other antiepileptics the dosage of each drug must be adjusted to give optimal combination effect. Apetryl must not be taken with alcohol under any circumstances because it may alter the effect of the drug and produce unexpected side effects.
Side Effects/Adverse Effects
Apetryl does not have side effects on the liver, kidneys or blood.
Frequent undesirable effects include tiredness, sleep disturbances, dizziness, muscular hypotonia, ataxia, and light-headedness. These side effects are transient and disappear spontaneously or after reduction of the dose.
Poor concentration, aggressive behavior, irritability, excitability, and anterograde amnesia may occur.
In rare cases, rash, angioedema, urticaria, pruritus, pharyngeal edema, transient hair loss, pigmentation changes, nausea/vomiting, headache, chest pain, reduction in blood platelets, loss of libido, and epigastric symptoms may be observed. Clonazepam can lead to dependence, particularly with higher doses.
Pregnancy & Lactation
Apetryl should not be given to pregnant women unless the potential benefits outweigh the risk to the fetus.
Dosage & Administration
Adults:
  • Initial dose: 1-2 mg daily.
  • Maintenance dose: 2-4 mg, daily in the evening.

Children (10-16 years):

  • Initial dose: 1-2 mg daily.
  • Maintenance dose: 1.5-3 mg, daily in the evening.

Children (Below 10 years):

  • Initial dose: 0.01-0.03 mg/kg/daily
  • Maintenace dose: 0.05-0.1 mg/kg/daily

If several dosages are required, the largest dose should be given at bedtime.

Overdosage
Warnings
Careful adjustment of Apetryl dosage accroding to individual requirements is a must in the elderly, patients with diseases of the respiratory system (COPD), liver or kidneys and in patients under treatment with other centrally acting drugs or anticonvulsants.
Apetryl may affect patients' reactions so that the ability to drive and operate machinery is impaired.
Abrupt discontinuance of Apetryl may lead to withdrawal symptoms, therefore Apetryl should be stopped by gradually reducing the dose.
Notes
Storage
Packaging
Apetryl 0.5 mg: Box of 50 tablets in strips of 10 tablets each.
Apetryl 2.0 mg: Box of 30 tablets in strips of 10 tablets each.
Manufacturer
Multi-APEX Pharma
Date Added/Updated
3rd February 2012 2:12pm

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