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CLOBAZAM ACCORD 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.
4). Treatment of anxiety The usual anxiolytic dose for adults is 20-30mg 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. Treatment should be given for the shortest possible duration. It should not be used for longer than 4 weeks, including tapering off. 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Treatment should always be withdrawn gradually.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. A benzodiazepine can be withdrawn in steps of about one-eighth (range one- tenth to one-quarter) of the daily dose every fortnight.
A suggested withdrawal protocol for patients who have difficulty is as follows: 1. Transfer patient to equivalent daily dose of diazepam preferably taken at night 2. 5mg; if withdrawal symptoms occur, maintain this dose until symptoms improve 3.
Reduce dose further, if necessary in smaller fortnightly steps; it is better to reduce too slowly rather than too quickly 4. Stop completely; time needed for withdrawal can vary from about 4 weeks to a year or more Counselling may help; beta-blockers should only be tried if other measures fail; antidepressants should be used only for clinical depression or for panic disorder; avoid antipsychotics (which may aggravate withdrawal symptoms).
Elderly:
Doses of 10-20mg 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 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.
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, hallucinations, 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)* Injury, poisoning and procedural complications Uncommon: fall *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.
• Amnesia Amnesia may occur with benzodiazepines. In case of loss or bereavement psychological adjustment may be inhibited by benzodiazepines. • 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. • Suicidal ideation, suicide attempt, suicide and depression 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). • Personality disorders Disinhibiting effects may be manifested in various ways. Suicide may be precipitated in patients who are depressed and aggressive behaviour towards self and others may be precipitated. Extreme caution should therefore be used in prescribing benzodiazepines in patients with personality disorders.
• Drug Dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.
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). - 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 and 3 years, 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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By mouth Adults:
In epilepsy a starting dose of 20-30mg daily is recommended, increasing as necessary up to a maximum of 60mg daily. Adjunctive therapy for epilepsy Monotherapy under specialist supervision for catamenial (menstruation) seizures (usually for 7–10 days just before and during menstruation) Cluster seizures 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. As there is no age appropriate formulation to enable safe and accurate dosing, no dosage recommendations can be made in children under 6 years of age.
Tablets should be swallowed without chewing with sufficient amount of liquid (1/2 glass). 2). Clobazam can be given with or without food. 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.
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. When used as an adjuvant in the treatment of epilepsy, this preparation may in rare cases cause restlessness and muscle weakness.
Reporting of Suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on- line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for treatment with clobazam should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
• Drug withdrawal syndrome Prior to starting treatment with clobazam, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome. A withdrawal strategy for ending treatment with clobazam should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care, and for use in epilepsy).
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months.
Patients should be informed of this when the medication is first prescribed. The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction.
If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions. Suggest a slow stepwise rate of reduction proportionate to the existing dose, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
A withdrawal syndrome may also occur when abruptly changing over from a benzodiazepine with a long duration of action (for example, clobazam) to one with a short duration of action. • 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 Respiratory function should be monitored in patients with chronic or acute […]