Posology : מינונים

4.2    Posology and method of administration

WARNING: Rivotril Oral liquid
Measure the prescribed dose of Rivotril oral liquid as drops only. Do not administer drops directly into the mouth from the bottle.
After each administration, ensure that the dropper is secure in the neck of the bottle.
Drops should be given with a spoon.
After each opening, make sure the dropper is secured within the neck of the bottle.

Standard Dosage in Epilepsy
The dosage of Rivotril must be individually adjusted according to the patient’s clinical response, tolerance of the drug and the patient’s age.
As a general rule, Rivotril is given as low-dose, single-drug therapy in new, non-therapy- resistant cases.
A single oral dose of Rivotril begins to take effect within 30-60 minutes and remains effective for 6-8 hours in children and 8-12 hours in adults.
Oral treatment
To avoid adverse reactions at the beginning of therapy, it is essential to start treatment with Rivotril at a low dose and increase the daily dose progressively until the maintenance dose suited to the individual patient has been reached.
The initial dose for infants and children up to the age of 10 years (or up to 30 kg bodyweight) is 0.01-0.03 mg/kg daily given in 2-3 divided doses. The dose should be increased by no more than 0.25-0.5 mg every third day until either a daily maintenance dose of approximately 0.1 mg/kg of bodyweight daily has been reached or seizures are controlled or undesired effects preclude further increase. The daily maximum dose in children is 0.2 mg/kg of bodyweight and should not be exceeded.
Rivotril should be given with a spoon and may be mixed with water, tea or fruit juice.
Based on established dosages for children up to 10 years (see above) and those for adults (see below) the following can be recommended for children between 10 and 16 years: The initial dose is 1-1.5 mg/day given in 2-3 divided doses. The dose may be increased by 0.25-0.5 mg every third day until the individual maintenance dose (usually 3-6 mg/day) is reached.
The initial dose for adults should not exceed 1.5 mg/day divided into 3 doses. The dose may be increased in increments of 0.5 mg every three days until either seizures are adequately controlled or undesired effects preclude any further increase. The maintenance dose must be individualized for each patient depending upon response. Usually a maintenance dose of 3-6 mg per day is sufficient. The maximum therapeutic dose for adults is 20 mg daily and should not be exceeded.
The daily dose should be divided into 3 equal doses. If doses are not equally divided, the largest dose should be given before retiring. The maintenance dose level is best attained after 1-3 weeks of treatment. Once the maintenance dose level has been reached, the daily amount may be given in a single dose in the evening.
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.
Dosage in Panic Disorder
Adults
The initial dose for adults with Panic Disorder is 0.25 mg twice daily (0.5 mg/day).
An increase to 0.5 mg twice daily (1 mg/day) may be made after 3 days. Subsequent up- titration should be made at intervals of 3 days until Panic Disorder is controlled or until limited by side effects.
The usual maintenance dose is 1 mg twice daily (2 mg/day). A maximum dose of 2 mg twice daily (4 mg/day) may be prescribed in exceptional cases.
Once a stable dose is achieved, patients may switch to a once daily dose, usually taken at bedtime.
There is no body of evidence available to answer the question of how long the patient treated with clonazepam should remain on it. Therefore, the physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Treatment should be discontinued gradually, with down-titration of 0.25 mg every 3 days, until the drug is completely withdrawn.

Discontinuation or Dosage Reduction of Rivotril:
To reduce the risk of withdrawal reactions, increased seizure frequency, and status epilepticus, use a gradual taper to discontinue Rivotril or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly.

Caution
Do not administer drops directly into the mouth from the bottle.
After each administration, ensure that the dropper is secure in the neck of the bottle.
Drops should be given with a spoon.
Clonazepam is compatible with water, tea or fruit juice.

Special Populations
Epilepsy and Panic Disorder
Elderly Patients
Particular care should be taken during up-titration in elderly patients.


Renal Impairment
The safety and efficacy of clonazepam in patients with renal impairment has not been studied, however based on pharmacokinetic considerations no dose adjustment is required in these patients (see 5.2 Pharmacokinetics in Special Populations).
Hepatic Impairment
The safety and efficacy of clonazepam in patients with hepatic impairment has not been studied. No data are available on the influence of hepatic disease on clonazepam pharmacokinetics (see 4.4 Special Warnings and Precautions for Use).
Epilepsy
Rivotril can be administered concurrently with one or several other antiepileptic agents, in which case the dosage of each drug must be adjusted to achieve the optimum effect.
As with all antiepileptic agents, treatment with Rivotril must not be stopped abruptly, but must be reduced in a stepwise fashion (see 4.8 Undesirable Effects).
Panic disorder
Pediatric Patients
The safety and efficacy of clonazepam for the treatment of Panic Disorder in children has not been studied.