Rivotril- Clonazepam by Roche

Rivotril is indicated for most clinical forms of epilepsy in infants and children, in  particular typical and atypical absences (Lennox syndrome), infantile spasms, primary or secondary generalised tonic-clonic spasms.Rivotril i.v. or i.m. is a drug of choice in all form of status epilepticus.

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

Rivotril- Information Leaflet
Rivotril- Information Leaflet

Pharmaceutical form and active substance

  • Rivotril solution for i.v.(or i.m.) injection (double ampoules): Injection solution (1 ampoule of 1 ml) contains 1 mg Clonazepam per 1 ml.Diluent (1 ampoule of 1 ml): water for injections: 
  • Rivotril 0.5 mg tablets:Light-orange scored tablets, 0,5 mg clonazepam.
  • Rivotril 2 mg tablets:While cross-scored tablets, 2.0 mg clonazepam.
  • Rivotril oral drops:Oral solution. 2.5 mg clonazepam/ ml [equivalent to 25 drops:1i drop is equivalent to 0.1 mg clonazepam]. 

Dosage and administration

Standard dosage: The dosage of Rivotril must be individually adjusted according to the patient’s clinical response. tolerance of the medicine,and age.

To ensure optimum dosage adjustment, infants should he given the drops and children the 0.5 mg tablets. The scored 0.5 mg tablets facilitate the administration of lower daily doses to adults in the initial stages of treatment.

As a general rule Rivotril is given as low-dose monotherapy in new, non-therapy-resistant cases.

A single oral dose of Rivotril  begins to take effect within 30 to 60 minutes and remain effective for 8 o 12 hours in children and 8 to 11 hours in adults.

An i.v. dose has an immediate effect which lasts for 2 to 3 hours.

Oral treatment: To avoid adverse reactions at the beginning of treatment, it is particularly important to increase the daily dose progressively unlit the maintenance dose required for the individual patient has been reached. 

infants and children up to the age of 10 year( or up to 30 kg body weight): the initial dose is 0.01 to 0.03 mg/ kg body weight daily given in 2 to 3 divided doses. This dose may be increased by no more than 0.25 to 0.5 mg every  three days until a daily maintenance dose of 0.05 to 0.1 mg/ kg bodyweight daily has been reached or seizures are controlled or undesirable effects preclude further increase. 

The maximum daily dose in children should not exceed 0.2 mg/ kg body weight.

When Rivotril drops are prescribed. they should be given with a spoon and may be mixed with water, tea or fruit juice.

Children above the age of 10 years( or over 30 kg body weight): Based on the established dosages for  children up to 10 years (see above) and adults, the recommended initial dose is 1 to 1.5 mg/ day given in 3 divided doses. The dose may be increased by 0.25 to 0.5  every three days until the individual maintenance dose of 3 to 6 mg/ day is reached.

Adults: The initial dose should not exceed 1.5 mg/day given in 3 divided doses. This dose may be increased by 0.5 mg every three days until either seizures are adequately controlled or undesirable effects preclude an increase. The maintenance dose must be  individually adjusted for each patient, depending on clinical response. Generally a maintenance dose of 4 to 8 mg/day is sufficient. The maximum therapeutic dose for adults is 10 mg/day and should not be exceeded. for more information about the Dosage and Administration,click here, to review the patient information leaflet.

Undesirable effects

Blood and lymphatic system:  Decreased platelets (thrombocytopenia).

Immune system: Allergic reactions, in very rare cases anaphylactic shock.

Endocrine disorders: Isolated cases of reversible premature development of secondary sex characteristics in children (incomplete precocious puberty) have been reported.

Psychiatric disorders: Disturbances of concentration ,  restlessness, confusion and disorientation have been observed. 

Depression can developed during treatment with Rivotril; however, it may also be associated with the underlying disease. 

The following paradoxical reactions have been observed: excitability, irritability, aggressive behaviour, restlessness,  nervousness, hostility, anxiety. sleep disturbances. nightmares and vivid dreams.

In rare cases, decrease in sexual drive (loss of libido) and impotence. 

These effects are generally transient and in most cases resolve spontaneously  after dose reduction during treatment. They can sometimes be prevented by increasing the dose slowly at the start of treatment. 

Dependance: Treatment with benzodiazepines, such as  clonazepam can lead to psychological dependence. This risk is more pronounced with high doses and prolonged treatment and is particular! pronounced n predisposed patients with a history  of alcoholism, drug addiction, personality disorders or serious psychiatric disorders. 

Withdrawal symptoms may develop during long-term treatment, especially with high doses or If the daily dose is reduced rapidly  or the drug is abruptly discontinued. The symptom may include restlessness, sleep disturbances. anxiety, extreme anxiety, tension , confusion, and irritability. for more information about the Undesirable effects,click here, to review the patient information leaflet.

Patient information leaflet

ENG - Patient Information Leaflet
RIVOTRIL – Patient Information Leaflet

أضف تعليقك

لن يتم نشر عنوان بريدك الإلكتروني.