Apetryl Tablets
Antiepileptic agent
COMPOSITION :
• Apetryl 0.5 mg: 0.5mg Clonazepam. • Apetryl 2 mg: 2.0 mg Clonazepam.
PROPERTIES :
• In humans, Clonazepam has shown to bring about-direct inhibition of the cortical ana 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. Clonazepam is quicldy 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 placenta barrier and is excreted in matemal milk. – After an oral dose of 2 mg Apetryl, the onset of action is after 30-60 minutes and the duration of action lasts up to twelve 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.
Adults: Epilepsy and focal seizures
Children: Typical and atypical absences (Lennox Syndrome) nodding spasms, primary or secondary generalized tonic-clonic spasm.
DOSAGE AND ADMINISTRATION :
Initial Dose Maintenance Dose
For adults 1 – 2 mg daily 2 – 4 mg daily in the evening
For children 10-16 years 1 – 2 mg daily 1.5 – 3 mg daily in the evening
Below 10 years 0.01 – 0.03 mg/kg/daily 0.05 – 0.1 mg/kg/daily
If several dosages are required, largest dose should be given at bedtime.
CONTRAINDICATIONS :
Not to be given in patients with hypersensitivity to Clonazepam or in patients with myasthenia gravis. Apetryl is also contraindicated during breast-feeding.
PRECAUTIONS & WARNINGS :
Anli-epileptic drugs (AEDs). increase the risk of suicidal thoughts or liehavior in patients taking these drugs for any
indication, Patients treated with any AED for any indication should be monitored for the emergence worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
– Careful adjustment of Apetryl dosage according 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.
– Apetryl should not be given to pregnant women unless the potential benefits outweigh the risk to the fetus. Abrupt discontinu-
ance of Apetryl may lead to withdrawal symptoms. therefore Apetryl should be stopped by gradually reducing the dose.
SIDE EFFECTS :
– petryl doe-s not have side effects-on the liver. kidneys-or blood.
– Frequent undesirable effects include tiredness, sleep disturbances, dizziness, muscular hypotonia, ataxia, light-headedness
– These side effects are transient and disappear spontaneously or after reduction of the dose.
– Poor concentration, aggressive behavior, irritability, excitability, anterograde amnesia my 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.
INTERACTIONS :
When Apetryl administered together with other anti-epileptics, 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.
PACKS :
Apetryl 0.5 mg: 50 tablets/box.
Apetryl 2.0 mg: 30 tablets/box.
Keep All Medicine Out of Reach of Children
Manufactured by:
Multi-Apex for Pharmaceutical Industries – S.A.E. Badr City – Egypt.
