Each tablet contains: 0.5 mg or 2 mg clonazepam.
Chonazepam 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 postsynaptic inhibitory action of gamma aminobutyric acid in the CNS. It reduces over compensatory excitation with minimal effect on other physiological neuronal activity.
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 2 mg 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 ub yrube 10-30% in feces and less than 0.5% unchanged in urine.
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 spasms.
- Hypersensitivity to clonazepam
- Patients with myasthenia gravis
- During pregnancy and lactation
- Modify dosage according to individual need in patients with preexisting diseases of respiratory system, e.g. chronic obstructive pulmonary diseases (COPD), renal and/or hepatic impairment.
- Clonazepam may affect the ability to drive and/or operate machinery.
- Avoid abrupt withdrawal by gradually reducing the dose.
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, lightheadedness.
Concurrent administration with other antiepileptics necessitates adjustment of dosage of both drugs 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 and Administation
- Initial dose: 1-2 mg 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 20 mg.
For Children: 10 -16 years
Initial dose: 1–2 mg daily.
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
Amotril® 0.5 mg: Strips of 10 tablets (0.5mg) or (2mg) in packs of 3 strips.
Keep all medicaments out of reach of children
Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: N03AE01