Clobazam

Clobazam belongs to a class of medicines known as benzodiazepines. It is a prescription medicine used to treat epilepsy (seizures) and severe anxiety. It alters brain activity, calms it and provides relief from panic attacks by relaxing the nerves. Clobazam may be taken with or without food. However, it is advised to take it at the same time each day as this helps to maintain a consistent level of medicine in the body. Take this medicine in the dose and duration as advised by your doctor as it has a high potential of habit forming. If you have missed a dose, take it as soon as you remember and finish the full course of treatment even if you feel better. It is important that this medication is not stopped suddenly without talking to your doctor as it may increase seizure frequency.

Clobazam is a benzodiazepine. It works by increasing the action of a chemical messenger (GABA) which suppresses the abnormal and excessive activity of the nerve cells in the brain.

• Acute and chronic anxiety states
• Seizures associated with Lennox-Gastaut syndrome (adjunctive therapy)
• Epilepsy (when not adequately stabilized with anticonvulsant monotherapy)

Clobazam binds at distinct binding sites associated with the chloride ionopore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionopore is open. As a result, hyperpolarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.

Clobazam binds to one or more specific GABA receptors at several sites within the CNS including the limbic system and reticular formation. Increased permeability of neuronal membrane to chloride ions results in GABA's inhibitory effect leading to hyperpolarization and stabilization.

Anxiety (Adults & >15 years): Initial: 20 mg/day (max 30 mg/day); Elderly: 10-15 mg/day; Children (3-15 years): 5-10 mg/day.

Epilepsy (Adults & >15 years): Initial: 5-15 mg/day, gradually increase to max 80 mg/day.

Children (3-15 years): Initial: 5 mg/day; Maintenance: 0.3-1.0 mg/kg/day.

Lennox-Gastaut syndrome: >30 kg: 5 mg q12h (max 40 mg/day); ≤30 kg: 5 mg/day (max 20 mg/day).

Hepatic Dose: Mild-moderate (Child-Pugh 5-9): Half the typical adult dose; Severe: Not recommended.

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Clobazam may be taken with or without food, but it is better to take it at a fixed time.

If you miss a dose of Clobazam, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Very Common (≥1/10): Somnolence (especially at start and with higher doses), fatigue

Common (≥1/100 and <1/10): Sedation, dizziness, disturbance in attention, slow speech/dysarthria, headache, tremor, ataxia, irritability, aggression, restlessness, depression, decreased appetite, dry mouth, nausea, constipation

Uncommon (≥1/1,000 and <1/100): Diplopia, weight increased, rash

Not Known: Respiratory depression, photosensitivity reaction, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, muscle weakness, muscle spasms, hypothermia

• [UNSAFE] Clobazam may cause side effects which could affect your ability to drive. You may feel sleepy or have concentration or memory problems.
• The addiction/habit-forming potential is very high; take only as per the dose and duration advised by your doctor.
• Avoid consuming alcohol as it may increase dizziness and drowsiness.
• Inform your doctor if you notice sores or blisters on your skin, lips, or inside your mouth.
• Do not stop taking medication suddenly without talking to your doctor as that may lead to nausea, anxiety, agitation, flu-like symptoms, sweating, tremor, and confusion.
• Contraindicated during the first trimester of pregnancy and lactation.

• Hypersensitivity
• History of drug dependence
• Myasthenia gravis
• Pregnancy (1st trimester)
• Lactation
• Serious liver damage
• Sleep apnoea syndrome
• Impaired respiratory function

Increased hepatic clearance with phenytoin, phenobarbital or carbamazepine. Cimetidine may increase levels. Alcohol, hypnotics and sedative antidepressants potentiate CNS side effects. Opioids increase risk of sedation, respiratory depression, coma, and death. Stiripentol increases plasma levels of clobazam and its active metabolite. CYP2C19 inhibitors (cannabidiol, fluconazole, fluvoxamine) increase exposure to active metabolite.

[UNSAFE] Clobazam may cause excessive drowsiness with alcohol.

[CONSULT YOUR DOCTOR] Clobazam may be unsafe to use during pregnancy. Not recommended during the first trimester. Pregnancy Category D. Administration during late pregnancy may cause neonatal respiratory depression, "floppy infant syndrome," and withdrawal syndrome.

Clobazam must not be used in breastfeeding women, as it passes into breast milk.

Pediatric dose: Anxiety (3-15 years): 5-10 mg/day; Epilepsy (3-15 years): Initial 5 mg/day, Maintenance 0.3-1.0 mg/kg/day. Lennox-Gastaut: 2 years or older; 6 months-3 years: only in exceptional cases.

Elderly patients are more susceptible to adverse effects; low initial doses and gradual increments are required.

[CAUTION] Clobazam should be used with caution in patients with kidney disease. Dose adjustment may be needed. No dose adjustment is recommended in patients with mild to moderate kidney disease.

[CAUTION] Clobazam should be used with caution in patients with liver disease. Dose adjustment may be needed. Not recommended in severe liver disease.

Clobazam overdose symptoms include somnolence, confusion, coma, and respiratory depression. Treatment is symptomatic and supportive. Flumazenil may be used as an antidote.

Store below 30°C, protect from light. Keep out of reach of children. Do not use after the expiry date.

Clobazam