Home Drug Guide Ganaxolone

Drug Guide

Generic Name

Ganaxolone

Brand Names Ztalmy

Classification

Therapeutic: Anticonvulsant / Neurologic

Pharmacological: Neuron 3α,5α,17β-Pregnanolone analog (GABA-A receptor modulator)

FDA Approved Indications

  • Treatment of seizures associated with CDKL5 deficiency disorder in patients 2 years of age and older

Mechanism of Action

Ganaxolone is a synthetic neurosteroid that modulates GABA-A receptors, enhancing GABAergic inhibitory neurotransmission, which helps to reduce neuronal excitability and seizure activity.

Dosage and Administration

Adult: Typically, 300 mg to 600 mg twice daily, titrated based on response and tolerability.

Pediatric: Dosing based on weight; specific dosing guidelines should be provided by the prescribing information.

Geriatric: No specific dosage adjustments recommended; monitor for increased sensitivity.

Renal Impairment: No specific adjustment recommended; use with caution.

Hepatic Impairment: No specific adjustment recommended; evaluate hepatic function prior to initiation.

Pharmacokinetics

Absorption: Well absorbed orally.

Distribution: Widely distributed; crosses blood-brain barrier.

Metabolism: Primarily via hepatic glucuronidation and reduction pathways.

Excretion: Excreted mainly in urine as inactive metabolites.

Half Life: Approximately 16-18 hours.

Contraindications

  • Known hypersensitivity to ganaxolone or any component of the formulation

Precautions

  • Use caution in patients with hepatic impairment.
  • Potential for central nervous system depression; caution when operating machinery or driving.
  • Pregnancy Category C; benefits must outweigh risks during pregnancy.
  • Lactation: Discontinue or exercise caution as drug may pass into breast milk.

Adverse Reactions - Common

  • Dizziness (Common)
  • Somnolence (Common)
  • Fatigue (Common)

Adverse Reactions - Serious

  • Hypersensitivity reactions (Serious but rare)
  • Seizure worsening (Rare)

Drug-Drug Interactions

  • CNS depressants (increase sedation risk)

Drug-Food Interactions

  • No specific food interactions identified

Drug-Herb Interactions

  • Potential interactions with herbs affecting CYP enzymes; consult guidelines

Nursing Implications

Assessment: Monitor seizure frequency, neurological status, and hepatic function.

Diagnoses:

  • Risk for ineffective cerebral tissue perfusion
  • Risk for CNS depression

Implementation: Administer as prescribed; monitor for adverse effects; educate patient about signs of hypersensitivity.

Evaluation: Assess seizure control and adverse reactions regularly.

Patient/Family Teaching

  • Take medication exactly as prescribed and not to discontinue without medical advice.
  • Report signs of hypersensitivity or adverse reactions.
  • Be cautious when performing tasks requiring alertness.
  • Inform healthcare provider of all medications being taken.

Special Considerations

Black Box Warnings:

  • No black box warnings reported to date

Genetic Factors: Genetic variations in metabolism may affect response; specific testing not routinely required.

Lab Test Interference: No known interference.

Overdose Management

Signs/Symptoms: Dizziness, confusion, somnolence, respiratory depression.

Treatment: Supportive care; maintain airway; activated charcoal if ingestion was recent; call poison control or emergency services.

Storage and Handling

Storage: Store at room temperature between 20°C to 25°C (68°F to 77°F).

Stability: Stable according to manufacturer specifications.

🛡️ 5 Critical Medication Safety Tips for Nurses

1

Triple-Check High-Risk Medications

Always have another nurse verify insulin, heparin, warfarin, and chemotherapy drugs. These "high-alert" medications cause the most serious errors. Check concentration, dose calculation, and pump settings twice.

2

Know Look-Alike, Sound-Alike Drugs

Common mix-ups: hydromorphone/morphine, Celebrex/Celexa, Zyprexa/Zyrtec. Always use BOTH generic and brand names, read labels twice, and use barcode scanning when available. One wrong letter can be fatal.

3

Assess Before AND After Giving Meds

Check vitals before cardiac meds, pain levels before analgesics, and blood glucose before insulin. Always reassess within 30 minutes to evaluate effectiveness and watch for adverse reactions.

4

Watch for Drug Interactions

Common dangerous combinations: warfarin + aspirin (bleeding), ACE inhibitors + potassium (hyperkalemia), digoxin + diuretics (toxicity). Always check drug interactions before administering new medications.

5

Educate Your Patients

Teach patients medication names, purposes, major side effects, and what to report. Informed patients catch errors and improve compliance. Always encourage questions - an educated patient is a safer patient.

⚡ Remember: When in doubt, don't give it out! It's always safer to double-check than regret later.

⚠️ Medical Disclaimer

This drug guide is for educational purposes only and is NOT intended for clinical use. Always consult current prescribing information, healthcare providers, and institutional protocols before administering any medication. Do not use this information for patient care decisions.