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CLOBAZAM ATNAHS is a brand name for Clobazam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Clobazam is a 1,5-benzodiazepine indicated for the short-term relief (2-4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short term psychosomatic, organic or psychotic illness. The use of clobazam to treat…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology If low doses are required, the 5 mg/5ml product is a more suitable presentation. If high doses are required, the 10 mg/ 5 ml strength product is a more suitable presentation. Treatment of anxiety Treatment should be as short as possible.
The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. e. including tapering-off process) must not exceed 8 to 12 weeks.
In certain cases extension beyond the maximum treatment period may be necessary; if so it should not take place without re-evaluation of the patient’s status with special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependance.
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. Due regard must be paid to the possibility of interference with alertness and reaction time. 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Treatment should always be withdrawn gradually.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 clobazam 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 The oral suspension is suitable for any epilepsy patient in whom the clinician feels an oral suspension is preferable to clobazam tablets.
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). g. 4 Warnings and Precautions) Gastrointestinal disorders Common: dry mouth, nausea, constipation Skin and subcutaneous tissue disorders Uncommon: rash Not known: urticaria; Steven-Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome); Musculoskeletal and connective tissue disorders Not known: muscle spasms, muscle weakness General 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, hypothermia Investigations Uncommon: weight increased (particularly with high doses or in long-term treatment) Injury poisoning and procedural complications Uncommon: fall Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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Amnesia Benzodiazepines may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have an uninterrupted sleep of 7-8 hours (see also Undesirable Effects).
Muscle weakness Clobazam can cause muscle weakness. Therefore, in patients with pre-existing muscle weakness or spinal or cerebellar ataxia or sleep apnoea, special observation is required and a dose reduction may be necessary. Clobazam is contraindicated in patients with myasthenia gravis.
Depression and personality disorders Some epidemiological studies suggest an increased incidence of suicidal ideation, suicide attempt and suicide in patients with or without depression, and treated with benzodiazepines and other hypnotics, including clobazam.
8). Dependence Use of benzodiazepines - including clobazam - may lead to the development of physical and psychological dependence upon these products. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse.
2 Posology). Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms (or rebound phenomena). These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
In severe cases the following symptoms may occur; derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Rebound insomnia and anxiety: a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form, may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness.
1. • 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 Pregnancy and Lactation). • In breast-feeding women. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Clobazam must not be used in children between the ages of 6 months to 2 years old, other than in exceptional cases for anticonvulsant treatment where there is a compelling indication. 2).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In all cases, treatment should be initiated at the lowest effective dose with gradual dose increments under careful observation. 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 aged 6 years and above When prescribed for children treatment requires low initial doses and gradual dose increments under careful observation.
It is recommended that normally treatment should be started at 5mg daily. 3 to 1mg/kg body weight daily is usually sufficient. 1 mg/kg/day for younger patients. 2 mg/kg/day at 7 days intervals, until the required clinical effect is achieved or side effects occur.
3 to 1 mg/kg/day. The daily dose can be taken in divided doses or as single dose at night.
Paediatric population aged 6 month-2 years:
Clobazam oral suspension should only be used in children from 6 month to 2 years old, under exceptional situations, when there is a clear epilepsy indication. 1mg/kg/day and titrate upwards very slowly (increasing not more often than every 5 days) to achieve required clinical effect, in divided doses twice daily.
The patient must be re-assessed after a period not exceeding 4 weeks and regularly 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.
Patients with impairment of renal or hepatic function:
Increased responsiveness and higher susceptibility to adverse effects may be present in these patients and require low initial doses and gradual dose increments under careful observation. The maximum dose should not be exceeded. The patient should be checked regularly at the start of the treatment in order to decrease if necessary, the dose or frequency of administration to prevent overdose due to accumulation.
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.
Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually. Serious Skin Reaction Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam 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.
Clobazam should be immediately discontinued when SJS/TEN is suspected. 8). Respiratory Depression A lower dose is also recommended for patients with chronic or acute severe respiratory insufficiency due to the risk of respiratory depression (respiratory functions must be monitored and a dose reduction of clobazam may be necessary).
3 Contraindications). Renal and hepatic impairment In patients with impairment of renal or hepatic function, responsiveness to clobazam 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.
Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy. 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 Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks. In the treatment of epilepsy with benzodiazepines - including clobazam - consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.
CYP2C19 poor metabolisers In patients who are CYP2C19 poor metabolisers, levels of the active metabolite N- desmethylclobazam are expected to be increased as compared to extensive metabolisers. g. 2). 5). Benzodiazepines including clobazam, should be used with extreme caution in patients with a history of alcohol or drug abuse.
Concomitant use of opioids and benzodiazepines Concomitant use of clobazam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of benzodiazepines such as clobazam with opioids should be reserved for patients for whom alternative treatment options are not possible.
2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). In the treatment of epilepsy with benzodiazepines - including clobazam - consideration must be given to […]