Clobazam

The US label says clobazam tablets are used as add-on treatment for seizures linked to Lennox-Gastaut syndrome (LGS) in patients aged 2 years or older.

Lennox-Gastaut syndrome is a severe form of childhood-onset epilepsy. The label describes clobazam as a benzodiazepine.

The label says the exact way clobazam works is not fully understood.

It is thought to involve boosting the action of GABA, a calming chemical messenger in the brain, by binding at the benzodiazepine site of the GABA-A receptor.

The dosing here comes from a US tablet label (clobazam tablets, taken by mouth) for people aged 2 years and older. Other Indian pack forms exist, and the prescriber decides.

The US label gives dosing by body weight group. At 30 kg or less it starts at 5 mg daily and goes up as tolerated to 20 mg daily. Above 30 kg it starts at 10 mg daily and goes up to 40 mg daily.

Doses above 5 mg a day are divided into two doses. The label says not to increase faster than once a week.

Tablets can be taken with or without food, swallowed whole, split along the score line, or crushed in applesauce.

For elderly people the label says to start at 5 mg a day and go up slowly.

To stop, the label says to taper gradually, for example 5 to 10 mg a day each week, to lower the risk of withdrawal and seizures.

This is label information, not a prescription. Indian pack labels may differ from the US label, and your prescriber's instruction always comes first.

Boxed warning: using benzodiazepines with opioids may cause profound sedation, slowed breathing, coma and death. The label also warns of abuse, misuse and addiction, and of dependence and withdrawal that can be life-threatening if the medicine is stopped suddenly.

Allergy: not for people with a history of allergy to clobazam or its ingredients. Serious skin reactions can happen.

Pregnancy: the label says it may cause fetal harm based on animal data. Newborns exposed late in pregnancy may be sedated or show withdrawal. Use only if the benefit justifies the risk.

Elderly: levels are higher at any dose, so the label gives a lower starting dose.

Liver problems: the label says dose adjustment is needed in mild or moderate liver impairment and gives no information for severe impairment.

Children: not established below 2 years of age.

Alertness: it may cause sleepiness. Do not drive or use machines until you know how it affects you.

• Opioids: serious breathing risk
• Alcohol: about 50% higher clobazam levels and more sedation
• Hormonal contraceptives: may be less effective
• CYP2C19 inhibitors (fluconazole, omeprazole): dose adjustment
• Opioids: using them together may cause severe sedation and breathing problems.
• Alcohol and other CNS depressants: more sedation.
• The label says alcohol raises clobazam levels by about 50%.
• Hormonal contraceptives may work less well.
• The label advises an extra non-hormonal method.
• Strong or moderate CYP2C19 inhibitors, such as fluconazole, fluvoxamine, ticlopidine and omeprazole, may raise clobazam's active metabolite, so a dose change may be needed.
• Clobazam can raise levels of medicines handled by CYP2D6, so lower doses of those may be needed.

No match in this label text. Ask your pharmacist about any medicine you take.

The label says benzodiazepine overdose causes central nervous system depression, from drowsiness to coma. Severe cases can cause slowed breathing. Alcohol or opioids with it can be fatal.

Treatment is supportive. The label notes flumazenil can cause withdrawal and seizures and is not for everyone. Get emergency help.

The label says to store tablets at 20 to 25 degrees C (68 to 77 degrees F).

In the Drugs Rules schedules we checked, clobazam is listed under Schedule H (Schedule H, serial 120 (rules 65 and 97)). Schedule H medicines are sold only on a doctor's prescription. Clobazam is a benzodiazepine, so treat it as a controlled medicine.

Clobazam appears in the National List of Essential Medicines 2022 on page 65. Forms in the list are 10 mg tablets and an oral liquid of 2 mg per 5 mL.

NPPA lists ceiling prices for several clobazam formulations. The table shows the rows we found. Check NPPA directly for the current list.

Banned combinations: we found no mention of clobazam in the banned-combination list we checked. Use the checker for your exact combination.

NPPA ceiling prices set the most a seller can charge per unit for the listed formulations, before local taxes. Check the pack and the seller.

Jan Aushadhi (PMBJP) lists clobazam products in the file we checked. We have not shown a brand price here.

• Clobazam Tablet IP 5mg (pack 10's)
• Clobazam Tablets IP 10 mg (pack 15's)