Clobazam

Generic Name: clobazam

Benzodiazepine [EPC]Over-the-Counter (OTC)

Brand Names:

Clobazam

Clobazam is a white or almost white, crystalline powder; a benzodiazepine for oral administration containing 10 mg or 20 mg active ingredient with inactive components including corn starch, lactose monohydrate, and magnesium stearate.

Overview

Clobazam is a white or almost white, crystalline powder; a benzodiazepine for oral administration containing 10 mg or 20 mg active ingredient with inactive components including corn starch, lactose monohydrate, and magnesium stearate.

Uses

Clobazam tablets are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

Dosage

Initial dosing based on weight: 30 kg or less starts at 5 mg daily; greater than 30 kg starts at 10 mg daily. Titrate weekly to maximum doses of 20 mg or 40 mg respectively. Tablets may be taken with or without food or crushed in applesauce.

Side Effects

Most common include somnolence or sedation, lethargy, pyrexia, constipation, and drooling at rates exceeding placebo by at least 10%.

Interactions

Alcohol increases clobazam exposure approximately 50%; CYP2D6 substrate drugs may need dose adjustment; CYP2C19 inhibitors increase active metabolite levels.

Warnings

Warns of respiratory depression and coma with opioid co-use, abuse and addiction risks, and life-threatening withdrawal reactions requiring gradual tapering. CNS depression, serious dermatological reactions, DRESS syndrome, suicidal ideation risk, and neonatal sedation or withdrawal. Contraindicated in patients with hypersensitivity to the drug or its ingredients.

Pregnancy

Animal studies showed developmental toxicity at doses below therapeutic human exposure; neonates may experience sedation and withdrawal. Clobazam is excreted in breast milk; infants may experience sedation and poor feeding.

Storage

Store tablets at 20 to 25 degrees C (68 to 77 degrees F).

Frequently Asked Questions

What is Clobazam used for?

Clobazam tablets are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

What are the side effects of Clobazam?

Most common include somnolence or sedation, lethargy, pyrexia, constipation, and drooling at rates exceeding placebo by at least 10%.

Can I take Clobazam during pregnancy?

Animal studies showed developmental toxicity at doses below therapeutic human exposure; neonates may experience sedation and withdrawal. Clobazam is excreted in breast milk; infants may experience sedation and poor feeding.

What are the important warnings for Clobazam?

Warns of respiratory depression and coma with opioid co-use, abuse and addiction risks, and life-threatening withdrawal reactions requiring gradual tapering. CNS depression, serious dermatological reactions, DRESS syndrome, suicidal ideation risk, and neonatal sedation or withdrawal. Contraindicated in patients with hypersensitivity to the drug or its ingredients.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.