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These brands contain the same active ingredient (Clobazam). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Clobazam is indicated for:
Pharmacology
Clobazam attaches to its own binding sites that are linked with the chloride ion channel on the post-synaptic GABA receptor. These GABA receptors are found in several parts of the central nervous system (CNS), including the limbic system and the reticular formation. Clobazam keeps the chloride ion channel open for a longer time. As a result, the cell membrane becomes hyperpolarised and more stable, because the inhibitory effect of GABA on the post-synaptic side is strengthened.
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: decreased appetite is common. Psychiatric disorders: Common effects are irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use) and agitation. Nervous system disorders: Somnolence is very common, especially at the beginning of treatment and when higher doses are used. Common effects are sedation, dizziness, disturbance in attention, slow speech, dysarthria or other speech disorder (particularly with high doses or in long-term treatment, and these are reversible), headache, tremor and ataxia. Eye disorders: Diplopia is uncommon. It is seen particularly with high doses or in long-term treatment, and it is reversible. Respiratory, thoracic and mediastinal disorders: Respiratory depression and respiratory failure have an unknown frequency. They occur particularly in patients with pre-existing compromised respiratory function, for example patients with bronchial asthma or brain damage. Gastrointestinal disorders: Dry mouth, nausea and constipation are common. Skin and subcutaneous disorders: Rash is uncommon. Photosensitivity reaction and urticaria have an unknown frequency. Steven Johnson syndrome and toxic epidermal necrolysis are also of unknown frequency, and some cases have had a fatal outcome. Musculoskeleteal and connective tissue disorders: Muscle spasms and muscle weakness have an unknown frequency. General disorders and administration site conditions: Fatigue is very common, especially at the beginning of treatment and when higher doses are used. Slow response to stimuli and hypothermia have an unknown frequency. Investigations: Weight increase is uncommon, particularly with high doses or in long-term treatment.
Cautions & Contraindications
Warnings & Precautions
Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with Colax in both children and adults since the medicine was released. Most of these cases also involved other drugs, including some antiepileptic drugs that are linked to serious skin reactions. SJS and TEN can be fatal. Patients should be watched closely for signs or symptoms of SJS or TEN, especially during the first 8 weeks of treatment. If SJS or TEN is suspected, Colax should be stopped straight away. If the signs point to SJS or TEN, Colax must not be restarted, and another treatment should be considered. Respiratory depression: Colax can slow breathing, especially at high doses. So in patients with chronic or acute respiratory insufficiency, breathing must be monitored, and the dose may need to be lowered. Colax is contraindicated in patients with severe respiratory insufficiency. Muscle weakness: Colax can cause muscle weakness. It is contraindicated in patients with myasthenia gravis. Renal and hepatic impairment: In patients with kidney or liver problems, the body responds more strongly to Colax and is more likely to have side effects, so the dose may need to be reduced. During long-term treatment, kidney and liver function should be checked regularly. Elderly patients: Older people are more sensitive to side effects such as drowsiness, dizziness and muscle weakness, which raises the risk of falls that can cause serious injury. A lower dose is recommended. Tolerance in epilepsy: When benzodiazepines, including Colax, are used to treat epilepsy, it must be kept in mind that the anticonvulsant effect may fall over the course of treatment (development of tolerance). CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylColax are expected to be higher than in extensive metabolizers. The dose of Colax may need adjusting, for example a low starting dose with careful dose titration. Suicidality: Several epidemiological studies show a higher rate of suicide and suicide attempts in patients, with or without depression, treated with other benzodiazepines and hypnotics. Very limited data are available for Colax in these studies. Cases of suicidal behaviour have been reported with Colax in post-marketing surveillance, but all of these cases had confounding factors. Concomitant use of CYP2C19 inhibitors: Taking Colax together with CYP2C19 inhibitors, including cannabidiol-containing medicines, dietary supplements and recreational products, may raise exposure to N-desmethylColax (NCLB). This can lead to more side effects, such as somnolence and sedation. When Colax is used with medicines that are CYP2C19 inhibitors, the dose may need adjusting. Dietary supplements and recreational products containing cannabidiol must not be taken with Colax, as they contain unknown amounts of cannabidiol and their quality varies.
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.
Pregnancy & Breastfeeding
Pregnancy: Clobazam is not recommended in the first trimester of pregnancy, or in women of childbearing potential who are not using contraception. During pregnancy, clobazam should be used only if the possible benefit justifies the possible risk to the fetus. Animal studies have shown reproductive toxicity, and clobazam crosses the placenta. Only limited data on exposed pregnancies are available in the post-marketing safety database.
A large amount of data from cohort studies has not shown any evidence of malformations after benzodiazepine exposure in the first trimester. However, some epidemiological case-control studies have found a higher incidence of cleft lip and palate with benzodiazepines. Reduced fetal movement and fetal heart rate variability have been reported after benzodiazepines were given in the second and/or third trimester.
If clobazam is given late in pregnancy or during childbirth, the newborn may develop respiratory depression (including respiratory distress and apnea). This can come with other problems such as signs of sedation, hypothermia, hypotonia and feeding difficulties, which may lead to poor weight gain. Together these signs and symptoms are known as "floppy infant syndrome". Infants born to mothers who took benzodiazepines for longer periods in the later stages of pregnancy may also have developed physical dependence, and they may be at risk of a withdrawal syndrome after birth. The newborn should be monitored appropriately in the postnatal period.
Women of childbearing potential should be told about the risks and benefits of using clobazam during pregnancy. If a woman plans a pregnancy or becomes pregnant, the risks and benefits should be weighed carefully, including whether clobazam treatment should be stopped. If treatment is continued, clobazam should be used at the lowest effective dose.
Lactation: Clobazam must not be used by breastfeeding women, because it passes into breast milk.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Don't use Clobazam after the expiry date. Store it below 30° and keep it away from light. Keep it out of the reach of children.
Drug Interactions
Common questions about Clobazam 10 mg
What is Clobazam 10 mg Tablet?
Clobazam 10 mg Tablet is a medicine that contains Clobazam. It is made by EDCL (Dhaka). It belongs to the Benzodiazepine hypnotics group of medicines.
What is Clobazam used for?
Clobazam is used for: Epilepsy, Depression, Anxiety.
What are the side effects of Clobazam?
Metabolism and nutrition disorders: decreased appetite is common. Psychiatric disorders: Common effects are irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use) and agitation.
Can I take Clobazam during pregnancy or while breastfeeding?
Pregnancy: Clobazam is not recommended in the first trimester of pregnancy, or in women of childbearing potential who are not using contraception. During pregnancy, clobazam should be used only if the possible benefit justifies the possible risk to the fetus. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Clobazam?
Don't use Clobazam after the expiry date. Store it below 30° and keep it away from light.
Can I take other medicines with Clobazam?
Some medicines can interact with Clobazam, for example: Carbamazepine, Paroxetine, Nebivolol, Omeprazole, Nitrous Oxide, Phenytoin. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Clobazam?
Clobazam is a prescription (Rx) medicine. Take it as your doctor advises.