Sympazan

Generic name: clobazam

Drug class: Benzodiazepine anticonvulsants

Dosage form: Oral film

Route of administration: Oral

Dose:

• Adults and children over 30 kg: Starting dose of 10 mg daily, increasing to 20 mg on day 7, and up to 40 mg on day 14, administered in divided doses twice daily. A 5 mg daily dose can be administered as a single dose. Dose adjustments should be made based on clinical efficacy and tolerability.
• Children 30 kg or less: Starting dose of 5 mg daily, increasing to 10 mg on day 7, and up to 20 mg on day 14, administered in divided doses twice daily. A 5 mg daily dose can be administered as a single dose. Dose adjustments should be made based on clinical efficacy and tolerability.

Mechanism of action: Clobazam is a benzodiazepine that enhances the effect of the neurotransmitter gamma-aminobutyric acid (GABA) at the GABA-A receptor, leading to increased neuronal inhibition and reduced neuronal excitability, thereby controlling seizures.

Drug usage cases:

• Adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients aged 2 years and older.

Drug contraindications:

• Hypersensitivity to clobazam or any component of the formulation.
• Concomitant use with opioids due to increased risk of respiratory depression.

Side effects:

• Somnolence or sedation
• Constipation
• Pyrexia
• Lethargy
• Drooling
• Slurred speech
• Aggression, anger, or violence
• Difficulty sleeping
• Urinary tract infections
• Respiratory depression
• Skin rash
• Fever
• Cough

Warnings:

• Risk of severe drowsiness, breathing problems, coma, and death when taken with opioids, alcohol, or other central nervous system depressants.
• Potential for abuse, misuse, and addiction.
• Risk of physical dependence and withdrawal reactions; gradual tapering is recommended to discontinue or reduce dosage.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported; discontinue if rash develops.
• Increased risk of suicidal thoughts or behavior; monitor for mood changes.
• Concomitant use with other CNS depressants or alcohol may increase the risk of sedation and somnolence.
• Hormonal contraceptives metabolized by CYP3A4 may have reduced effectiveness; consider alternative contraception methods.

Use during pregnancy or breastfeeding:

Pregnancy: Clobazam may cause fetal harm and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Breastfeeding: Clobazam is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment with clobazam.