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PERIZAM is a brand name for Clobazam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Perizam is a 1,5-benzodiazepine indicated in adults for the short-term symptomatic treatment (2-4 weeks, maximum 4 weeks including tapering off period) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress. In treatment of anxiety states associated with affective disorders,…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Treatment should be given for the shortest possible duration. If this medicine is being used for the treatment of epilepsy this medicine should be used for as long as the prescriber considers it necessary. 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 (including the tapering off period). 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Treatment should always be withdrawn gradually.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.
The following CIOMS frequency rating is used, when applicable:
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). 4), initial insomnia, anger, hallucination, psychotic disorder, poor sleep quality, suicidal ideation Nervous system disorders Very common: somnolence, especially at the beginning of treatment and when higher doses are used Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/speech disorder (particularly with high doses or in long- term treatment, and is reversible), headache, tremor, ataxia Uncommon: emotional poverty, amnesia (may be associated with abnormal behaviour), memory impairment, anterograde amnesia (in the normal dose range, but especially at higher dose levels) Not known: cognitive disorder, altered state of consciousness (particularly in elderly patients, may be combined with respiratory disorders), nystagmus (particularly with high doses or in long-term treatment), gait disturbance (particularly with high doses or in long-term treatment, and is reversible).
g. 4 Special warnings and precautions)*. *Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.
These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.
Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment. Indeed, in patients with anxiety associated with depression, Perizam must be used only in conjunction with adequate concomitant treatment.
Use of benzodiazepine (such as Perizam) alone, can precipitate suicide in such patients. Switching between formulations In some individuals taking Perizam, the drug reaches higher plasma levels than the same dose taken as a tablet. This may lead to an increased risk of respiratory depression and sedation which may be most noticeable when switching to this medicine from tablets.
Therefore, caution must be taken when switching between clobazam products as the mean Cmax on single dose administration for the suspension is higher than that observed for the tablet formulation. Children There is a lack of data regarding the use of the product in patients under 2 years old.
For this reason, careful assessment and monitoring is required by the treating physician for use in children under 2 years for anticonvulsant treatment. • Alcohol It is recommended that patients abstain from drinking alcohol during treatment with clobazam (increased risk of sedation and other adverse effects (please refer to section
Perizam must not be used: − In patients with hypersensitivity to benzodiazepines or any of the excipients of Perizam. − In patients with any history of drug or alcohol dependence (increased risk of development of dependence). − In patients with myasthenia gravis (risk of aggravation of muscle weakness).
− In patients with severe respiratory insufficiency (risk of deterioration). − In patients with sleep apnoea syndrome (risk of deterioration). − In patients with severe hepatic insufficiencies (risk of precipitating encephalopathy). 6).
− In breast-feeding women. - Acute intoxication with alcohol and CNS-active substances. Benzodiazepines must not be given to children without careful assessment of the need for their use. Perizam should not be used in children from 6 months to 2 years old, unless under exceptional situations as an anti-convulsivant treatment, when there is a clear epilepsy indication.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 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.
2 mg/kg every week up to the targeted dose. 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. 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. 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.
Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. Investigations Uncommon: weight increased (particularly with high doses or in long-term treatment, and is reversible) Injury, poisoning and procedural complications Uncommon: fall Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continuing monitoring of the benefit/ risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.