Ganaxolone

Generic name: Ganaxolone
Brand names: Ztalmy
Dosage form: oral suspension (50 mg/mL)
Drug class: Gamma-aminobutyric acid analogs

Usage of Ganaxolone

Ganaxolone is used to treat seizures associated with a disorder called cyclin-Dependent kinase-like 5 deficiency disorder (CDD) in people 2 years and older.

Ganaxolone may also be used for purposes not listed in this medication guide.

Ganaxolone side effects

Get emergency medical help if you have signs of an allergic Reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Common side effects of ganaxolone may include:

drowsiness;

fever;

excessive saliva or drooling; or

seasonal allergy.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Ganaxolone

Tell your doctor if you have ever had:

liver disease;

depression, or suicidal thoughts or behavior; or

alcohol or drug addiction.

Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ganaxolone on the baby.

Ask a doctor if it is safe to breastfeed while using ganaxolone.

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How to use Ganaxolone

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 dayComments:-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 dayWeight 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 dayComments:-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

Warnings

Some people have thoughts about suicide while taking ganaxolone. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

What other drugs will affect Ganaxolone

Tell your doctor about all your other medicines, especially:

drink alcohol;

opioids; or

antidepressants.

This list is not complete. Other drugs may affect ganaxolone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

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