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Clobazam | Frisium is benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect.

Therapeutic Class

Benzodiazepine hypnotics

Pharmacology

Clobazam/Onfi binds at distinct binding sites associated with the chloride ionophore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionophore is open.

As a result, hyper polarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.

Dosage

Pharmaceutical presentation dosage, and duration of treatment must be adjusted to the individual clinical response, the indication, and the severity of the condition. Due regard must be paid to the possibility of interference with alertness and reaction time.In patients with impairment of hepatic or renal function, Clobazam must be administered in reduced doses; in long term treatment hepatic and renal functions should be checked regularly, as a precaution.

When treatment with Clobazam/Onfi is to be discontinued after prolonged administration, the dosage should normally be tapered off over a period.

Treatment of anxiety states: The initial dose is usually 20 mg Clobazam daily. If necessary, the daily dose may be increased to 30 mg. For elderly patients, a total daily dose of 10-15 mg is often enough. For Children between 3 and 15 years of age, a daily dose of 5-10 mg is frequently enough.

Discontinuation of treatment of anxiety states: After improvement of the symptoms, the dose may be reduced. After prolonged treatment, Clobazam should not be withdrawn suddenly. The dose should be reduced gradually under medical supervision, of a decrease in anticonvulsant efficacy in the course of treatment must be borne in mind.

Dosage in adults and adolescents over 75 years of age: Small doses (5-15 mg/day as the initial dose), gradually increasing to maximum daily dose of about 80 mg. Furthermore, constant doses (e.g. 20 mg/day) and intermittent therapy (discontinuing Clobazam/Onfi and subsequently

Combined treatment with one or more other antiepileptics in children from 3 to 15 years of age: Treatment should normally be started with 5 mg, and a maintenance dose of 0.3-1.0 mg/ kg body weight daily is usually enough.

Discontinuation of treatment or combined treatment of epilepsy: At the end of treatment- also in cases where there has been a poor response to therapy- the dose should be gradually reduced, because otherwise an increased proneness to seizures cannot be excluded.

Administration

The tablets should be swallowed whole with some liquid. If the dose is to be distributed over the day, the larger portion should be taken in the evening. Doses of up to 30 mg Clobazam/Onfi can also be administered as a single evening dose.

The duration of treatment is determined by the doctor, after a period not exceeding 4 weeks, the doctor should decide whether continuation of treatment is necessary. Prolonged spells of uninterrupted treatment should be avoided, since they may lead to dependence.

Interaction

Especially when Clobazam is applied in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as analgesics, sedatives and hypnotics) or alcohol are consumed at the same time.

If Clobazam/Onfi is administered simultaneously with anticonvulsants in the treatment of epilepsy, the doses must be adjusted under regular medical supervision (EEG monitoring) as there may be interactions with the patient’s basic anticonvulsant medication.

Contraindications

Clobazam/Onfi must not be administered to patient with hypersensitivity to clobazam or any of the excipients, or with any history of drug dependence.

Side Effects

Symptoms of tiredness may sometimes appear, especially at the beginning of treatment and when higher doses are used. Also, in rare instances and usually only temporarily-the patient may experience dryness of the mouth, constipation, loss of appetite, nausea, dizziness, or a fine tremor of the fingers.

Another possibility is the emergence of paradoxical reactions (e.g. restlessness, irritability, acute agitational states, anxiety, suicidal tendencies, frequent muscle spasms, difficulty in falling asleep and to sleep through).

Impairment of respiratory function may become manifest in certain diseases of the respiratory passages (airways obstruction, e.g. in bronchial asthma) and in patients with brain damage. After prolonged use of benzodiazepine, impairment of consciousness, sometimes combined with

Pregnancy & Lactation

Clobazam/Onfi should not be used in the first trimester of pregnancy, and in the later stages only if there are compelling indications for its use.

Precautions & Warnings

Special caution is necessary if Clobazam/Onfi is to be administered to patients with serious pathological muscle weakness (myasthenia gravis), unsteadiness of movement and gait due to diseases of the spinal cord and cerebellum (spinal and cerebellar ataxia),

and in case of acute poisoning by alcohol, hypnotics, analgesics, neuroleptic agents, ant depressives or lithium, in patients with serious liver damage (e.g. cholestatic jaundice), and in patients with transient cessation of respiration in sleep (sleep apnea syndrome).

Storage Conditions

Store in a cool dry place. Protect from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.