Ztalmy Dosage

Generic name: ganaxolone 50mg in 1mL
Dosage form: oral suspension
Drug class: Gamma-aminobutyric acid analogs

Medically reviewed by Drugs.com. Last updated on Jun 27, 2023.

Dosage Information

ZTALMY is administered by mouth three times daily and must be taken with food [see Clinical Pharmacology (12.3)].

The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients weighing 28 kg or less are included in Table 1, and dosage recommendations for patients weighing more than 28 kg are included in Table 2. Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 1 and Table 2.

Table 1 ZTALMY Recommended Titration Schedule for Patients Weighing 28 kg or Less
Dosage	Total Daily Dosage	Days
6 mg/kg three times daily	18 mg/kg/day	1 to 7
11 mg/kg three times daily	33 mg/kg/day	8 to 14
16 mg/kg three times daily	48 mg/kg/day	15 to 21
21 mg/kg three times daily	63 mg/kg/day	22 to ongoing

Table 2 ZTALMY Recommended Titration Schedule for Patients Weighing More Than 28 kg
Dosage	mL per Dose	Total daily dosage	Days
150 mg three times daily	3	450 mg	1 to 7
300 mg three times daily	6	900 mg	8 to 14
450 mg three times daily	9	1350 mg	15 to 21
600 mg three times daily	12	1800 mg	22 to ongoing

Administration Instructions

See the Instructions for Use for complete instructions on how to properly prepare and administer ZTALMY.

Shake the bottle thoroughly for at least 1 minute and then wait for 1 minute before measuring and administering each dose.

Measure and administer the prescribed dose using the oral syringe(s) provided by your pharmacist. A household teaspoon or tablespoon is not an adequate measuring device and should not be used.

ZTALMY must be administered with food [see Clinical Pharmacology (12.3)].

Discard any unused ZTALMY oral suspension after 30 days of first opening the bottle [see How Supplied/Storage and Handling (16.2)].

Dosage in Patients with Severe Hepatic Impairment

ZTALMY is administered by mouth three times daily and must be taken with food [see Clinical Pharmacology (12.3)].

The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients with severe hepatic impairment and weighing 28 kg or less are included in Table 3, and dosage recommendations for patients with severe hepatic impairment (Child-Pugh class C) weighing more than 28 kg are included in Table 4. Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 3 and Table 4.

No dosage adjustment is necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.

Table 3 ZTALMY Recommended Titration Schedule for Patients with Severe Hepatic Impairment and Weighing 28 kg or Less
Dosage	Total Daily Dosage	Days
2 mg/kg three times daily	6 mg/kg/day	1 to 7
3.66 mg/kg three times daily	11 mg/kg/day	8 to 14
5.33 mg/kg three times daily	16 mg/kg/day	15 to 21
7 mg/kg three times daily	21 mg/kg/day	22 to ongoing

Table 4 ZTALMY Recommended Titration Schedule for Patients with Severe Hepatic Impairment and Weighing More Than 28 kg
Dosage	mL per Dose	Total daily dosage	Days
50 mg three times daily	1	150 mg	1 to 7
100 mg three times daily	2	300 mg	8 to 14
150 mg three times daily	3	450 mg	15 to 21
200 mg three times daily	4	600 mg	22 to ongoing

Discontinuation of ZTALMY

Decrease the dose of ZTALMY gradually when discontinuing treatment. As with all antiepileptic drugs, abrupt discontinuation should be avoided, when possible, to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.3)].