CLONAZEPAM CELIX

Posology Adults Initial dose not to exceed 1 mg/day. The maintenance dosage for adults normally falls with the range 4 – 8 mg. 5 mg/day. The elderly are particularly sensitive to the effects of centrally depressant drugs and may experience confusion.

5 mg tablets to ensure optimum dosage adjustment. 25 mg/day for infants and small children (1-5 yrs). 5 mg/day for older children. 5 – 1 mg/day Small children (1 – 5 years) 1 – 3 mg/day School children (5-12 years) 3 – 6 mg/day In some forms of childhood epilepsy, certain patients may cease to be adequately controlled by clonazepam.

Control may be re-established by increasing the dose or interrupting treatment with clonazepam for 2 or 3 weeks. During the interruption in therapy, careful observation and other drugs may be needed. Hepatic Impairment In patients with mild to moderate hepatic impairment the dose should be adjusted to individual requirements and will probably be lower.

Method of administration For oral 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 cross- scored tablets facilitate the administration of lower daily doses in the initial stages of treatment.

The dosage of clonazepam 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 or 4 doses throughout the day.

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 clonazepam.

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 clonazepam, intravenous clonazepam may still control the status. 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.

If necessary, larger doses may be given at the discretion of the physician, up to a maximum of 20 mg daily. The maintenance dose should be attained after 2-4 weeks of treatment.

Frequencies are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

The side effects marked with an asterisk (*) are usually transitory and disappear spontaneously as treatment continues or with dose reduction. They tend to occur early in treatment and can be greatly reduced, if not avoided, by commencing with low dosages followed by progressive increases.

Blood and the lymphatic system disorders Isolated cases of blood dyscrasias. Immune system disorders Allergic reaction and a very few cases of anaphylaxis and angioedema. Endocrine disorders Isolated cases of reversible development of premature secondary sex characteristics in children (incomplete precocious puberty) have been reported.

Psychiatric disorders and Paradoxical Reactions Anterograde amnesia (risk increases at higher dosages). Amnestic effects may be associated with inappropriate behaviour. Depression, loss of libido, impotence. Use of benzodiazepines may lead to the development of physical and psychological dependence upon these products.

4). Paradoxical effects such as aggressiveness, excitability, nervousness, hostility, anxiety, sleep disturbances, nightmares, vivid dreams, irritability, agitation, psychotic disorders and activation of new types of seizures may occur.

If these occur, the benefit of continuing the drug should be weighed against the adverse effect. It may be necessary to add another suitable drug to the regimen or to discontinue clonazepam therapy. Nervous system disorders Dizziness*, light-headedness*, somnolence*, fatigue*, co-ordination disturbances*, poor concentration, restlessness, confusion and disorientation, headache.

Suicidal behaviour:

Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.

The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for clonazepam. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.

Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Patients with a history of depression and/or suicide attempts should be kept under close supervision.

Use with caution in patients with chronic pulmonary insufficiency, or with renal or hepatic function impairment, and in the elderly or debilitated. In these cases dosage should generally be reduced. g. chronic obstructive pulmonary disease) and in patients undergoing treatment with other centrally acting medications or anticonvulsant (antiepileptic) agents (see section

Known hypersensitivity to benzodiazepines. 1. Acute pulmonary insufficiency; severe respiratory insufficiency, sleep apnoea syndrome, myasthenia gravis, severe hepatic insufficiency. Clonazepam must not be used in patients in a coma, or in patients known to be abusing pharmaceuticals, drugs or alcohol.