Amotril Clonazepam

Composition: Each tablet contains: 0.5mg or 2mg Clonazepam.

Properties: -    Clonazepam Amotril^® has a direct inhibitory effect on the cortical and subcortical epileptogenic foci and prevents generalization of the convulsive activity.
-    Thus Amotril^® has a beneficial effect on primary generalized seizures and on focal epilepsy.
-    Clonazepam potentiates the pre and post-synaptic inhibitory action of - aminobutyric acid in the CNS. It reduces over compensatory excitation with minimal effect on other physiological neuronal activity.

Pharmacokinetics:
-    Clonazepam is rapidly and completely absorbed after oral administration reaching peak plasma concentrations within 1-4 hours with a bioavailability of about 90%.
-    Plasma half-life ranges from 18-45 hours with a mean of 24 hours.
-    Clonazepam is highly lipid soluble, thus extensively distributed throughout the body and easily crosses the blood brain barrier.
-    It crosses the placental barrier and is excreted in breast milk.
-    Clonazepam is extensively metabolized in the liver.
-    After an oral dose of 2mg of Clonazepam, the onset of action usually occurs within 30-60 minutes and the duration of action lasts up to 12 hours in adults.
-    In about 4-10 days, 50-70% of the oral dose is excreted in urine, 10-30% in feces and less than 0.5% unchanged in urine.

Indications: All Types of Epilepsy and Seizures:
Adults:       Epilepsy and focal seizures.
Children:  Typical and atypical absences (Lennox Gastat Syndrome), nodding spasm, primary or secondary generalized tonic-clonic spasms.

N.B.:
To avoid adverse reactions at the beginning of therapy, it is essential to increase the daily dose progressively until the maintenance dose suitable to the individual patient has been reached.

If several doses are required, the largest dose should be given in the evening.

Contra-Indictions: -    Hypersensitivity to Clonazepam
-    Patients with myasthenia gravis

Pregnancy and Lactation
It is contra-indicated in both pregnancy and lactation.

Adverse Effects:Transient side effects that spontaneously disappear or upon reducing the dose during the course of treatment e.g. tenderness, sleep disturbances, dizziness, muscular hypotonia, ataxia and light-headedness.

Drug Interactions:
-    Concurrent administration with other anti-epileptics necessitates adjustment of both drugs' dosages to give the maximum desired effect.
-    Use with caution with other drugs that have a depressant effect on the central nervous system since the central depressant effects are additive e.g. barbiturates and alcohol.

Dosage & Administration: For Adults:
-    Initial dose: 1-2mg daily
-    Maintenance dose: 2-4 mg daily in the evening.
-    Dose should be adjusted according to the patient’s response and tolerance to the drug with maximal recommended daily dose of 20mg.

For Children 10-16 Years:
-    Initial dose: 1-2mg daily
-    Maintenance dose: 1.5-3mg daily in the evening.

Instruction to Patients:
Keep the drug out of reach of children and store at room temperature.

How supplied: Amotril^® Strips of 10 Tablets (0.5 mg) or (2mg) in packs of 3 strips.

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