Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: MEDOCHEMIE LTD., 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Aklonil tablets are indicated for all clinical forms of epileptic seizures and disease in infants, children and adults, especially absence seizures (petit mal) including atypical absence; primary or secondarily generalized tonic-clonic seizures (grand mal), tonic or clonic seizures; partial (focal) seizures of elementary or complex symptomatology; various forms of myoclonic seizures, myoclonus and associated abnormal movements.
Initial dosage should not exceed 1 mg/day. The maintenance dosage for adults normally falls within the range 4 to 8 mg.
The elderly are particularly sensitive to the effects of centrally depressant drugs and may experience confusion. It is recommended that the initial dosage of Aklonil should not exceed 0.5 mg/day.
These are total daily dosages which should be divided into 3 or 4 doses taken at intervals throughout the day. If necessary, larger doses may be given at the discretion of the physician, up to a maximum of 20 mg daily. The maintenance dose should be attained after 2 to 4 weeks of treatment.
To ensure optimum dosage adjustment, children should be given the 0.5 mg tablets.
Initial dosage should not exceed 0.25 mg/day for infants and small children (1 to 5 years) and 0.5 mg/day for older children. The maintenance dosage normally falls within the ranges:
In some forms of childhood epilepsy, certain patients may cease to be adequately controlled by clonazepam. Control may be re-established by increasing the dose, or interrupting treatment with Aklonil for 2 or 3 weeks. During the interruption in therapy, careful observation and other drugs may be needed.
Treatment should be started with low doses. The dose may be increased progressively until the maintenance dose suited to the individual patient has been found.
The dosage of Aklonil must be adjusted to the needs of each individual and depends on the individual response to therapy. The maintenance dosage must be determined according to clinical response and tolerance.
The daily dose should be divided into 3 equal doses. If doses are not equally divided, the largest dose should be given before retiring. Once the maintenance dose level has been reached, the daily amount may be given in a single dose in the evening.
Simultaneous administration of more than one antiepileptic drug is a common practice in the treatment of epilepsy and may be undertaken with Aklonil. The dosage of each drug may be required to be adjusted to obtain the optimum effect. If status epilepticus occurs in a patient receiving oral clonazepam, intravenous clonazepam may still control the status. Before adding Aklonil to an existing anticonvulsant regimen, it should be considered that the use of multiple anticonvulsants may result in an increase of undesired effects.
The symptoms of overdosage or intoxication vary greatly from person to person depending on age, bodyweight and individual response. Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of clonazepam is seldom life-threatening if the drug is taken alone, but may lead to coma, areflexia, apnoea, hypotension and cardiorespiratory depression. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients.
Benzodiazepine respiratory depressant effects are more serious in patients with severe chronic obstructive airways disease. Benzodiazepines potentiate the effects of other central nervous system depressants, including alcohol.
1. Maintain a clear airway and adequate ventilation if indicated.
2. Supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects.
3. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients.
4. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure.
5. Patients who are asymptomatic at 4 hours are unlikely to develop symptoms.
6. Flumazenil, a benzodiazepine antagonist is available but should rarely be required. If CNS depression is severe consider the use of flumazenil. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug. Flumazenil is NOT TO BE USED IN MIXED OVERDOSE OR AS A “DIAGNOSTIC TEST”.
The use of flumazenil is not indicated in patients with epilepsy who have been treated with benzodiazepines. Although flumazenil exerts a slight intrinsic anticonvulsant effect, its abrupt suppression of the protective effect of a benzodiazepine agonist can give rise to convulsions in epileptic patients.
If excitation occurs, barbiturates should not be used.
5 years.
Store below 25°C, in the original package in order to protect from light and moisture.
Aluminium foil-polyvinylchloride blisters in card carton with leaflet. Packs with 40 tablets are available. Dispensing packs of 100 and 500 tablets and boxes of 1000 tablets are available. Securitainers of polyvinylchloride containing 100, 500 or 1000 tablets are also available.
No special requirements for disposal.
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