Finished product reference
Clobazam
Suspension · Oral · 2.5 mg/1mL · 120 mL
- List code
- 53342
- Pharmacologic class
- Benzodiazepine
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate.
What it is and how it works
Mechanism of Action The exact mechanism of action for clobazam, a 1,5-benzodiazepine, is not fully understood but is thought to involve potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABA A receptor.
Mechanism class: Cytochrome P450 2D6 Inhibitors · Cytochrome P450 3A4 Inducers
Indications
Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam oral suspension is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older
Dosage and administration (summary)
For doses above 5 mg/day administer in two divided doses Patients ≤30 kg body weight: Initiate at 5 mg daily and titrate as tolerated up to 20 mg daily Patients greater than 30 kg body weight: Initiate at 10 mg daily and titrate as tolerated up to 40 mg daily Dosage adjustment needed in following groups: o Geriatric patients ( 2.4 , 8.5 ) o Known CYP2C19 poor metabolizers o Mild or moderate hepatic impairment.
Contraindications
Clobazam oral suspension is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions . History of hypersensitivity to the drug or its ingredients
Warnings and precautions
Somnolence or Sedation: Monitor for central nervous system (CNS) depression. Risk may be increased with concomitant use of other CNS depressants ( 5.4 , 5.5 ) Serious Dermatological Reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis): Discontinue clobazam oral suspension at first sign of rash unless the rash is clearly not drug-related Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternative etiology Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behaviors Neonatal Sedation and Withdrawa…
Pregnancy
Pregnancy Pregnancy Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as clobazam, during pregnancy. Healthcare providers are encouraged to recommend that pregnant women taking clobazam enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 o…
Storage and supply
Clobazam oral suspension is a berry flavored white to off-white suspension supplied in a bottle with child- resistant closure. The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter. Store and dispense clobazam oral suspension in its original bottle in an upright position.
Source: Clobazam (Clobazam) — US FDA prescribing information, 2026-07-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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