Ztalmy

Generic Name: Ganaxolone
Dosage Form: oral suspension

Medically reviewed by A Rash MD. Updated on 21 March 2022.

What is Ztalmy?

Ztalmy is an oral suspension containing ganaxolone that is prescribed to treat seizures that are caused by the cyclin-dependent kinase-like 5 (CDKL5) deficiencies (CDD) for people who are 2 years old or older.

There is a pending DEA decision on the regulation of Ztalmy (ganaxolone) under the Controlled Substances Act. A patient’s statement on dependence and abuse risks can’t be made at this point.It is

It is unclear whether this medication has been proven safe or effective for infants under 2 years of age.

Ganaxolone oral suspension comprises ganaxolone, a neuroactive steroid that acts as a positive modulator of the gammaaminobutyric acid A (GABAA) receptor. 1-[(3R, 5S, 8R, 9S, 10S, 13S, 14S, 17S)] ganaxolone 2, 4, 5, 6, 7, 8, 9, 11, 12, 14, 15, 16, 17 tetradecahydrocyclopenta[a]phenanthren-17-yl]ethanone) is a methyl-substituted (at the 3ß position) cyclopenta[a]phenanthren-17-yl]ethanone.

Allopregnanolone, a progesterone derivative, is an analog of the endogenous neurosteroid allopregnanolone. Its empirical formula is C22H36O2, and the molecular weight is 332.53 g/mol

Ztalmy

Ganaxolone is a white to off-white crystalline powder that only exists in one crystal form and has low
water solubility.
Inactive ingredients in Ztalmy include artificial cherry flavor, citric acid, hypromellose,
methylparaben, polyvinyl alcohol, propylparaben, purified water, simethicone emulsion, sodium
benzoate, sodium citrate, sodium lauryl sulfate, and sucralose.

Mechanism of Action

Although the exact mechanism by which ganaxolone exerts its anticonvulsant benefits in the treatment of seizures associated with CDD is unknown, its anticonvulsant actions are likely to be due to positive allosteric regulation of the GABAA receptor in the CNS.

Precautions and warnings

Ztalmy may cause serious side effects, such as:

What can I do to look for the early signs of suicidal thinking and behaviors?

Contact your doctor whenever you need to particularly if you’re concerned about any symptoms.

Before taking Ztalmy

Before beginning treatment, inform your healthcare professional about all of your child’s medical issues and those in which either of you

What other medications can impact Ztalmy?

Discuss with your doctor all medications that you or your child is taking for both prescription and non-prescription medications as well as vitamins and herbal supplements. Ztalmy can affect how other medicines function and other medications may alter the way Ztalmy functions. Do not stop or change the way you are using other medications without speaking with your doctor.

Tell your doctor that either of you is taking:

Be aware of the medications you or your child are taking. Keep a record of them to show your doctor or pharmacist whenever the child or you receive an upcoming medication.

What is the best way to take  Ztalmy?

What should I be aware of when taking Ztalmy?

Dosing and administration

Dosage Information

Ztalmy
Ztalmy is administered by mouth three times daily and must be taken with food
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 28 kg or more 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.

Ztalmy is administered by taking a drink three times per day. It should be taken with food.

Table: 1 Recommendation for Titration Schedules for Patients Weighing 28kg or less

Dosage The Daily Dosage Total Days
6 mg/kg 3 times a day 18 mg/kg/day 1-7
11 mg/kg three times a day 33 mg/kg/day 8-14
16 mg/kg three times per day 48 mg/kg/day 15-21
21 mg/kg 3 times a day 63 mg/kg/day 22 to continue

Table 2: Recommendation for Titration Schedules for Patients who weigh more than 28kg

Dosage mL per Dose Daily dose total Days
150 mg 3 times daily 3 350 mg 1-7
300 mg 3 times daily 6 800 mg 8-14
Three times a day, 450 mg 9 1350 mg 15-21
Three times a day, 600 mg per day 12 1800 mg 22 to continue

Treatment for seizures caused by cyclin-dependent kinase-like five (CDKL5) in deficiency disorders (CDD) for patients who are 2 years old or older.

Discontinuation of Ztalmy

Reduce the dose of Ztalmyslowly when you stop treatment. Like all antiepileptic medications, abrupt withdrawal should be avoided, if feasible, to reduce the chance of an increase in seizures or status epilepticus 

Dosage form and strengths

Oral suspension: 50 mg/mL ganaxolone. Each bottle has 110 mL of off-white to white cherry-flavored suspension.

Ztalmy side effects

Ztalmy can have severe side effects, which include:

The most frequent adverse effects are:

They aren’t all the possible adverse consequences. For more details, consult your physician or pharmacist. Inform your healthcare provider of any side effects that are bothering your child or you, or that doesn’t go away. disappear. Consult your physician for advice from a medical professional regarding adverse effects. It is possible to report the side effects to the FDA via 1-800-FDA-1088. You can also reach Marinus Pharmaceuticals at 844-627-4687.

What should I do with my Ztalmy?

Make sure that all medications are away from the reach of pets and children.

General Information on the safe and efficient usage of Ztalmy.

Sometimes, medicines are prescribed for reasons that are not the ones listed in the Medication Guide. Don’t use this medication to treat a problem for which it is not recommended. Don’t give it to others even if they suffer from similar symptoms to those you are suffering from. It could harm them.
Ask your healthcare professional or pharmacist for information on the specific written for health professionals.

More details

Always consult your doctor to confirm that the information provided on this page is applicable to your particular situation.

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