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Ztalmy Generic Name & Formulations
Legal Class
CV
General Description
Ganaxolone 50mg/mL; oral susp; cherry flavor.
Pharmacological Class
GABAA receptor modulator.
How Supplied
Oral susp (135mL)—1, 5
Manufacturer
Generic Availability
NO
Ztalmy Indications
Indications
Seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).
Ztalmy Dosage and Administration
Adults and Children
<2yrs: not established. Take with food. Give 3 times daily in equally divided doses using oral syringe. ≥2yrs (≤28kg; dose based on body wt.): initially 18mg/kg/day for Days 1–7; 33mg/kg/day for Days 8–14; 48mg/kg/day for Days 15–21; then 63mg/kg/day thereafter; (>28kg): initially 450mg/day for Days 1–7; 900mg/day for Days 8–14; 1350mg/day for Days 15–21; then 1800mg/day thereafter.
Ztalmy Contraindications
Not Applicable
Ztalmy Boxed Warnings
Not Applicable
Ztalmy Warnings/Precautions
Warnings/Precautions
Monitor for somnolence and sedation. Monitor for depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. Avoid abrupt cessation. Withdraw gradually. Hepatic impairment: monitor; may need lower dose. Pregnancy. Nursing mothers.
Ztalmy Pharmacokinetics
See Literature
Ztalmy Interactions
Interactions
Avoid concomitant strong or moderate CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, phenobarbital, primidone); if unavoidable, consider increasing Ztalmy dose (up to max daily dose). May increase the risk of somnolence and sedation with concomitant other CNS depressants (eg, opioids, antidepressants, alcohol).
Ztalmy Adverse Reactions
Adverse Reactions
Somnolence, pyrexia, upper respiratory tract infection, salivary hypersecretion, seasonal allergy, sedation, bronchitis, influenza, gait disturbance, nasal congestion.
Ztalmy Clinical Trials
See Literature
Ztalmy Note
Not Applicable
Ztalmy Patient Counseling
See Literature
