RIVOTRIL Tablet Ref.[2673] Active ingredients: Clonazepam

The scored 0.5mg tablets facilitate the administration of lower daily doses in the initial stages of treatment.

Adults

Initial dosage should not exceed 1mg/day. The maintenance dosage for adults normally falls within the range 4 to 8mg.

Elderly

The elderly are particularly sensitive to the effects of centrally depressant drugs and may experience confusion. It is recommended that the initial dosage of Rivotril should not exceed 0.5mg/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 20mg daily. The maintenance dose should be attained after 2 to 4 weeks of treatment.

Infants and children

To ensure optimum dosage adjustment, children should be given the 0.5mg tablets.

Initial dosage should not exceed 0.25mg/day for infants and small children (1 to 5 years) and 0.5mg/day for older children. The maintenance dosage normally falls within the ranges:

School children (5 to 12 years): 3 to 6mg.

Small children (1 to 5 years): 1 to 3mg.

Infants (0 to 1 year): 0.5 to 1mg.

In some forms of childhood epilepsy, certain patients may cease to be adequately controlled by Rivotril. Control may be re-established by increasing the dose, or interrupting treatment with Rivotril for 2 or 3 weeks. During the interruption in therapy, careful observation and other drugs may be needed.

Mode of administration

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 Rivotril 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 Rivotril. 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 Rivotril, intravenous Rivotril may still control the status. Before adding Rivotril to an existing anticonvulsant regimen, it should be considered that the use of multiple anticonvulsants may result in an increase of undesired effects.

As with other benzodiazepine drugs, overdosage should not present undue problems of management or threat to life. Patients have recovered from overdoses in excess of 60mg without special treatment. Severe somnolence with muscle hypotonia will be present.

Symptoms

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 Rivotril is seldom life-threatening if the drug is taken alone, but may lead to coma, areflexia, apnoea, hypotension and cardiorespiratory depression. Coma usually lasts a few hours but in elderly people it may be more protracted and cyclical. 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.

Management

1. Maintain a clear airway and adequate ventilation if indicated.
2. The benefit of gastric decontamination is uncertain. Consider activated charcoal (50g for an adult, 10-15g for a child) in adults or children who have taken more than 0.4mg/kg within 1 hour, provided they are not too drowsy.
3. Gastric lavage is unnecessary if these drugs have been taken alone.
4. Patients who are asymptomatic at 4 hours are unlikely to develop symptoms.
5. 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.
6. Flumazenil (Anexate), a benzodiazepine antagonist is available but should rarely be required. It has a short half-life (about an hour). Flumazenil is NOT TO BE USED IN MIXED OVERDOSE OR AS A “DIAGNOSTIC TEST” (see separate prescribing information).

Warning

The use of flumazenil is not recommended in epileptic patients who have been receiving benzodiazepine treatment for a prolonged period. 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 in the original container and in the outer carton, in order to protect from light.

Rivotril 0.5mg Tablets: Amber glass bottles with polyethylene screw closures, containing 50, 100 or 150 tablets.

Rivotril 2mg Tablets: Amber glass bottles with polyethylene screw closures, containing 30 or 100 tablets.

Not all pack sizes may be marketed.

There are no special instructions.

Any unused product or waste material should be disposed of in accordance with local requirements.