Generic name: Ganaxolone
Pregnancy & Lactation: Risk data not available
What is Ztalmy?
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.
Warnings
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 this medicine.
How should I use Ztalmy
Use Ztalmy (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take ganaxolone with food.
Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).
Seizures may increase if you stop using ganaxolone suddenly. Ask your doctor before stopping the medicine.
Do not share this medicine with another person, even if they have the same symptoms you have.
Store tightly closed in the original container at room temperature, away from moisture and heat. Throw away any unused medicine after 30 days.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Ztalmy 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 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.
What other drugs will affect Ztalmy?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.