Ganaxolone (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SUSPENSION.
Routes of administration: ORAL.
Brand Names
- ZTALMY
Indications and Usage
ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
Contraindications
None.
Adverse Reactions
The following important adverse reactions are described elsewhere in the labeling: Somnolence and Sedation [see Warnings and Precautions (5.1)] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2)] Withdrawal of Antiepileptic Drugs [see Warnings and Precautions (5.3)]
Mechanism of Action
The precise mechanism by which ganaxolone exerts its therapeutic effects in the treatment of seizures associated with CDD is unknown, but its anticonvulsant effects are thought to result from positive allosteric modulation of the gamma-aminobutyric acid type A (GABA A) receptor in the CNS.
Overdosage
There is limited clinical trial experience regarding overdose with ZTALMY. Unintentional overdose has been reported in 1 pediatric patient. This patient received ten times the prescribed dose. The patient was hospitalized for evaluation, including an electrocardiogram (ECG) and blood tests, and recovered. Patients who overdose should be closely monitored and receive standard supportive care. No specific information is available regarding treatment of overdose. In the event of overdose, a certified poison control center should be contacted for updated information on the management of overdose with ZTALMY.