Rivotril Dosage/Direction for Use

Standard dosage in Epilepsy: The dosage of Clonazepam must be individually adjusted according to the patient's clinical response, tolerance of the drug and the patient's age. To ensure optimum dosage adjustment, infants should be given the drops. The 0.5 mg tablets facilitate the administration of lower daily doses to adults in the initial stages of treatment. As a general rule, Clonazepam is given as low-dose, single-drug therapy in new, non-therapy-resistant cases.
A single oral dose of Clonazepam begins to take effect within 30-60 minutes and remains effective for 6-8 hours in children and 8-12 hours in adults. An i.v. dose has an immediate effect which lasts for 2-3 hours.
Oral treatment: To avoid adverse reactions at the beginning of therapy, it is essential to start treatment with Clonazepam 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. If Clonazepam is prescribed as drops they 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 previously mentioned) and those for adults (see as follows) 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 Clonazepam 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.
Duration of treatment: Maintenance treatment is recommended for at least 12–24 months, and in some cases, indefinitely.
After at least 1 year of response gradual discontinuation should be attempted, with close follow-up of the patient. Relapsing patients should then begin taking medication again.
Treatment should be discontinued gradually, with down-titration of 0.25 mg every 3 days, until the drug is completely withdrawn.
Special Dosage Instructions: Epilepsy and Panic Disorder: Clonazepam tablets 2 mg can be divided into equal halves or quarters to facilitate dosing.
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 Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Renal Failure under Actions).
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 General under Precautions).
Epilepsy: Clonazepam 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 Clonazepam must not be stopped abruptly, but must be reduced in a stepwise fashion (see Adverse Reactions).
Panic disorder: Pediatric Patients: The safety and efficacy of clonazepam for the treatment of Panic Disorder in children has not been studied.