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Rivotril®

Description

Description

Active ingredient:  Clonazepam

Rivotril oral drops

Oral solution, 2.5 mg clonazepam/ml

(corresponds to 25 drops; 1 drop corresponds to 0.1 mg clonazepam)

Rivotril is the brand innovator for Clonazepam (known as KLONOPIN in USA)

– FDA approved

Indications:

Majority of the clinical forms of infant and child epilepsy, in particular typical and atypical absences (Lennox syndrome), BNS spasms, primary or secondary generalized tonic-clonic crises.

Rivotril can also be used in adult epilepsy and focal seizures.

Dosage and route of administration

general information The dosage of Rivotril must be adjusted in each individual case to the clinical response, tolerability and age of the patient

Oral treatment

In order to avoid undesirable effects at the beginning of treatment, it is of particular importance to gradually increase the daily dose (tablets or drops) until the maintenance dose required for the patient is reached.

Rivotril drops are taken with a spoon – mixed with water, tea or fruit juice. The drops should never be put directly into the mouth. Each time the bottle is opened, check that the dropper is firmly seated in the neck of the bottle.

Infants and children up to 10 years (or 30 kg body weight)

The starting dose is 0.01-0.03 mg per kg body weight/day divided into 2-3 doses per day. This dosage may be increased by no more than 0.25-0.5 mg every third day until either a daily maintenance dose of 0.05-0.1 mg/kg body weight per day is reached, or until seizures are controlled, or until undesired effects preclude a further increase.

The maximum dose in children should not exceed 0.2 mg per kg body weight per day.

If Rivotril is prescribed as drops, they should be administered with a spoon and may be mixed with water, tea, or fruit juice.

Children over 10 years (or over 30 kg)

Based on the established doses for children up to 10 years of age (see above) and for adults (see below), the recommended starting dose is 1 to 1.5 mg per day divided into 3 doses. The dosage can be increased by 0.25- 0.5 mg every third day until the individual maintenance dose of 3-6 mg/day is reached.

Adult

The initial dose should not exceed 1.5 mg/day divided into 3 doses. This dosage may be increased by 0.5 mg every third day until seizures are either adequately controlled or adverse effects prohibit an increase. The maintenance dose must be individualized for each patient depending on the clinical response. In general, a maintenance dose of 4-8 mg per day is sufficient. The maximum therapeutic dose in adults is 20 mg/day and should not be exceeded.

The daily initial dosage should be divided into three equal single doses. Where multiple unequal intakes are required, the highest dose should be taken in the evening. The daily maintenance dose is best reached over the course of 1 to 3 weeks of treatment. After reaching the maintenance dose, the daily dose can be taken in a single dose in the evening.

Method of administration

Oral.