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Other brands with the same active ingredient
These brands contain the same active ingredient (Clobazam). Strength and form may differ — confirm substitution with your doctor or pharmacist before switching.
Indications & Uses
Prozium is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
General dosage guidance: The dose and length of treatment should be tailored to the condition being treated, how severe it is, and how the individual patient responds. Because clobazam can affect alertness and reaction time, the guiding rule is to use the lowest dose that works. For treating anxiety in adults and adolescents over 15 years: the usual starting dose is 20 mg of clobazam a day. This can be increased if needed, but the total daily dose should generally not go above 30 mg. For elderly patients: older adults may respond more strongly to the medicine and are more prone to side effects, so treatment should start with a low dose and be increased gradually while the patient is monitored closely. A maintenance dose of 10 to 15 mg a day is often enough. For children aged 3 to 15 years: children, too, may respond more strongly and are more prone to side effects, so treatment should begin with a low dose and be increased gradually under close observation. A daily dose of 5 to 10 mg is often enough. Benzodiazepines should only be given to children after the need for them has been carefully assessed. Secondary dosage adjustment: once symptoms improve, the dose may be lowered. Timing of doses: when the daily dose is split into more than one portion, the larger portion should be taken in the evening. Duration of treatment: treatment should be kept as short as possible. The patient should be reviewed within 4 weeks of starting and at regular intervals afterward to check whether treatment is still needed, particularly once symptoms have resolved. In general, the total treatment period, including the time taken to taper off the dose, should not exceed 8 to 12 weeks. In some cases treatment may need to continue beyond this, but only after the patient's condition has been reassessed by someone with the appropriate expertise. Long, uninterrupted courses of treatment are best avoided, since they can lead to dependence. Discontinuation of treatment: after extended use, clobazam should not be stopped abruptly. The dose should instead be lowered gradually under medical supervision, since stopping suddenly can bring on withdrawal symptoms. For treating epilepsy alongside one or more other anticonvulsant medicines, in adults and adolescents over 15 years: treatment is usually started at a low dose of 5 to 15 mg a day, and if needed this can be increased step by step up to a maximum of about 80 mg a day. For children aged 3 to 15 years: treatment normally begins at 5 mg a day. A maintenance dose of 0.3 to 1.0 mg per kilogram of body weight per day is usually sufficient. Children may be more prone to side effects, so the dose should be increased gradually under close observation, and benzodiazepines should only be used in children after careful assessment of the need for them. For elderly patients: because older adults may be more prone to side effects, treatment should start with a low dose and be increased gradually under close observation. Timing of doses: when the daily dose is divided across the day, the larger portion should be taken in the evening. Doses of up to 30 mg can also be given as a single dose in the evening. Duration of treatment: the patient should be reviewed within 4 weeks of starting and at regular intervals afterward to assess whether treatment should continue. Discontinuation of treatment: at the end of treatment, including in cases where it has not worked well, clobazam should not be stopped abruptly. The dose should be reduced gradually, since sudden withdrawal can increase the risk of seizures as well as other withdrawal symptoms.
Side Effects
Metabolism and nutrition disorders: Common: decreased appetitePsychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.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 are reversible), headache, tremor, ataxia.Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)Gastrointestinal disorders: Common: dry mouth, nausea, constipationSkin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weaknessGeneral disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermiaInvestigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
Cautions & Contraindications
Warnings & Precautions
Serious Skin Reactions: Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with Colax in both children and adults during the post-marketing experience. A majority of the reported cases involved the concomitant use of other drugs, including antiepileptic drugs that are associated with serious skin reactions. SJS/TEN could be associated with a fatal outcome. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment. Colax should be immediately discontinued when SJS/TEN is suspected. If signs or symptoms suggest SJS/TEN, use of Colax should not be resumed and alternative therapy should be considered.Respiratory depression: Colax can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Colax is contraindicated in patients with severe respiratory insufficiency.Muscle weakness: Colax can cause muscle weakness. Colax is contraindicated in patients with myasthenia gravis.Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to Colax and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Colax, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylColax are expected to be increased as compared to extensive metabolizers. Dosage adjustment of Colax may be necessary (e.g. low starting dose with careful dose titration).Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for Colax in these studies. Cases of suicidal behavior have been reported with Colax in post-marketing surveillance. All of these cases had confounding factors.Concomitant use of CYP2C19 inhibitors: The concomitant use of Colax with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylColax (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of Colax may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with Colax as they contain unknown quantities of cannabidiol and are of variable quality
Contraindications
Clobazam should not be used in patients who are hypersensitive to clobazam or to any of its excipients, in patients with myasthenia gravis, since it can worsen muscle weakness, in patients with severe respiratory insufficiency, since it can lead to further deterioration, in patients with sleep apnoea syndrome, since it can lead to further deterioration, in patients with severe impairment of liver function, since it can precipitate encephalopathy, and in women who are breast feeding. Benzodiazepines should not be given to children without a careful assessment of the need for their use, and clobazam should not be used in children between the ages of 6 months and 3 years, except in exceptional cases for anticonvulsant treatment where there is a compelling indication.