PERIZAM Oral suspension Ref.[7160] Active ingredients: Clobazam

Posology

If low doses are required, the 1mg/ml strength product the most suitable presentation. If high doses are required, the 2mg/ml strength product is the most suitable presentation.

Treatment of anxiety

Adults

The usual anxiolytic dose for adults is 20-30 mg daily in divided doses or as a single dose given at night. Doses up to 60mg daily have been used in the treatment of adult in-patients with severe anxiety.

The lowest dose that can control symptoms should be used. After improvement of the symptoms, the dose may be reduced.

It should not be used for longer than 4 weeks. Long term chronic use as an anxiolytic is not recommended. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without re-evaluation of the patient’s status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence. Treatment should always be withdrawn gradually. Patients who have taken Perizam for a long time may require a longer period during which doses are reduced.

Elderly

Doses of 10-20 mg daily in anxiety may be used in the elderly, who are more sensitive to the effects of psychoactive agents. Treatment requires low initial doses and gradual dose increments under careful observation.

Treatment of epilepsy in association with one or more other anticonvulsants

Adults

In epilepsy a starting dose of 20-30 mg/day is recommended, increasing as necessary up to a maximum of 60 mg daily.

Elderly

Treatment requires low initial doses and gradual dose increments under careful observation.

Paediatric patients over 2 years

Perizam doses should be adapted individually. Doses can be taken once a day or divided in 2–3 times a day, keeping the same total dose.

The patient must be re-assessed after a period not exceeding 4 weeks and every 4 weeks thereafter in order to evaluate the need for continued treatment. A break in therapy may be beneficial if drug exhaustion develops, recommencing therapy at a low dose. At the end of treatment (including in poor-responding patients), since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended to gradually decrease the dosage.

When prescribed for children treatment requires low initial doses and gradual dose increments under careful observation. Clobazam is typically initiated at a low dose, often 5 mg/day or 0.1 mg/kg/day for younger patients, and increased by step of 0.1 to 0.2 mg/kg/day at 7 days intervals, until a minimum effective dose is reached or side effects occur. Studies have suggested that slow titration may help avoid adverse effects and that when present, side effects may be reduced or eliminated with dose reduction.

The following up-titration regimen has been proposed in the literature in order to take into account the high metabolism variability linked to the P450 system maturation – especially in the presence of inducers and inhibitors – and should be used with increase of the dose by 0.1 to 0.2 mg/kg every week up to the targeted dose.

A maintenance dose of 0.3 to 1mg/kg body weight daily is usually sufficient.

The oral suspension is particularly recommended for children and adults with swallowing difficulties, as it allows a secure and precise dosage.

Perizam should not be used as an anticonvulsivant treatment in children from 6 months to 2 years old, unless under exceptional situations, when there is a clear epilepsy indication. The starting dose in this exceptional circumstances should be the lowest one (0.1 mg/kg/day) and titration should be even more cautious, not more than 0.1 mg/kg/day as in this population the metabolic pathways for clobazam may not be fully mature. Up-to-date, no precise dosage recommendation can be made in this population.

Hepatic and renal failure

Treatment requires low initial doses and gradual dose increments under careful observation regardless of the age group of the patient.

Method of administration

For oral use only.

Once titrated to an effective dose of Clobazam, patients should remain on their treatment and care should be exercised when changing between different formulations. (See section 4.4-Switching between formulations)

This product may settle during storage. Please shake the bottle thoroughly before use.

Perizam can be taken with or without food.

Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol).

In the management of overdose, it is recommended that the possible involvement of multiple agents be taken into consideration.

Following overdose with oral benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious, or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiovascular functions in intensive care.

Secondary elimination of clobazam (by forced diuresis or haemodialysis) is ineffective.

Consideration should be given to the use of flumazenil as a benzodiazepine antagonist.

Unopened: 3 years.

After opening: 28 days.

Do not store above 25°C. Do not refrigerate or freeze.

Bottle: Amber (Type III glass)

Closure: HDPE, EPE wadded, child resistant closure.

Pack size: 150ml

Syringe: Polypropylene body and HDPE plunger with a capacity of 5ml.

Bottle adaptor: Low Density Polyethylene. The bottle adaptor is not pre-fitted.

Any unused product or waste material should be disposed of in accordance with local requirements.