Ganaxolone Dosage

Medically reviewed by Drugs.com. Last updated on Sep 13, 2022.

Applies to the following strengths: 50 mg/mL

Usual Adult Dose for Seizures

Weight greater than 28 kg:

Days 1 to 7: 150 mg orally 3 times a day
Days 8 to 14: 300 mg orally 3 times a day
Days 15 to 21: 450 mg orally 3 times a day
Days 22 to ongoing: 600 mg orally 3 times a day

Comments:

Dosage should be increased based on tolerability no more frequently than every 7 days.
Titration increments should not exceed those shown above.
When discontinuing therapy, the dose should be decreased gradually; abrupt discontinuation should be avoided, when possible, to minimize the risk of increased seizure frequency and status epilepticus.

Use: For the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)

Usual Pediatric Dose for Seizures

2 years or older:
Weight up to 28 kg:

Days 1 to 7: 6 mg/kg orally 3 times a day
Days 8 to 14: 11 mg/kg orally 3 times a day
Days 15 to 21: 16 mg/kg orally 3 times a day
Days 22 to ongoing: 21 mg/kg orally 3 times a day

Weight greater than 28 kg:

Days 1 to 7: 150 mg orally 3 times a day
Days 8 to 14: 300 mg orally 3 times a day
Days 15 to 21: 450 mg orally 3 times a day
Days 22 to ongoing: 600 mg orally 3 times a day

Comments:

Dosage should be increased based on tolerability no more frequently than every 7 days.
Titration increments should not exceed those shown above.
When discontinuing therapy, the dose should be decreased gradually; abrupt discontinuation should be avoided, when possible, to minimize the risk of increased seizure frequency and status epilepticus.

Use: For the treatment of seizures associated with CDD

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Liver dysfunction: Reduced dosage may be required; however, no specific guidelines have been suggested. Caution recommended.

Comments:

Patients with liver dysfunction should be monitored for the occurrence of side effects.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Data not available

Dialysis

Data not available

Other Comments

Administration advice:

Consult the manufacturer product information (Instructions for Use) regarding proper administration.
Administer with food.
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 provided oral syringe(s); do not use a household teaspoon or tablespoon (not adequate measuring devices).
Use within 30 days of first opening the bottle, or before the "Discard After" date on the bottle, whichever is sooner, then discard any remainder.

Storage requirements:

Store in original bottle in an upright position at 15C to 30C (59F to 86F).
Keep the cap tightly closed.

Reconstitution/preparation techniques:

The manufacturer product information (Instructions for Use) should be consulted regarding proper preparation.

Patient advice:

Read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
This drug can cause somnolence and sedation; do not operate hazardous machinery (including motor vehicles) until you are reasonably certain that this drug does not affect you adversely (e.g., impair judgement, thinking, or motor skills).
Be alert for development/worsening of symptoms of depression, any unusual changes in mood/behavior, or emergence of suicidal thoughts, behavior, or thoughts of self-harm; report behaviors of concern immediately to health care providers.
Do not stop using this drug without consulting health care provider.
Use the adaptor and oral dosing syringe provided by the pharmacist.
Notify health care provider if you become pregnant or intend to become pregnant during therapy; enroll in the North American Antiepileptic Drug Pregnancy Registry if you become pregnant.