Home Drug Guide Pitolisant Hydrochloride

Drug Guide

Generic Name

Pitolisant Hydrochloride

Brand Names Wakix

Classification

Therapeutic: Central Nervous System Stimulant / Wakefulness-Promoting Agent

Pharmacological: Histamine H3 Receptor Antagonist / Inverse Agonist

FDA Approved Indications

  • Narcolepsy with or without cataplexy

Mechanism of Action

Pitolisant acts as an antagonist/inverse agonist at histamine H3 receptors, leading to increased release of histamine and other neurotransmitters, which promotes wakefulness.

Dosage and Administration

Adult: Initial dose of 8.9 mg once daily, can be increased to 17.8 mg once daily based on response and tolerability.

Pediatric: Not approved for pediatric use.

Geriatric: No specific adjustments, but caution and close monitoring recommended due to potential for increased adverse effects.

Renal Impairment: Use with caution; no specific adjustment provided.

Hepatic Impairment: Start at lower doses; monitoring advised.

Pharmacokinetics

Absorption: Well absorbed orally, with a Tmax of approximately 1 hour.

Distribution: Highly protein-bound (~90%).

Metabolism: Metabolized primarily via CYP2D6 and CYP3A4 pathways.

Excretion: Excreted mainly in urine as metabolites; half-life approximately 10 hours.

Half Life: Approximately 10 hours.

Contraindications

  • Hypersensitivity to pitolisant or excipients.

Precautions

  • Use cautiously in patients with history of QT prolongation or arrhythmias, hepatic impairment, or significant cardiovascular disease. Monitoring of cardiac status is recommended.

Adverse Reactions - Common

  • Insomnia (Common)
  • Nausea (Common)
  • Headache (Common)

Adverse Reactions - Serious

  • QT prolongation / arrhythmias (Rare)
  • Seizures (Rare)
  • Liver function abnormalities (Rare)

Drug-Drug Interactions

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) increase plasma concentrations of pitolisant.
  • CYP3A4 inhibitors (e.g., ketoconazole) may increase risk of adverse effects.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of central nervous system stimulation, sleep disturbances, and cardiac issues, including ECG if indicated.

Diagnoses:

  • Disturbed sleep pattern related to drug effects.
  • Risk for cardiac arrhythmias related to QT prolongation.

Implementation: Administer as prescribed, usually once daily in the morning. Monitor EKGs if patient has risk factors.

Evaluation: Assess improvements in wakefulness and alertness, and monitor for adverse effects.

Patient/Family Teaching

  • Take medication as directed, preferably in the morning.
  • Report any signs of abnormal heartbeat, chest pain, or seizures.
  • Avoid alcohol and CNS depressants.
  • Inform healthcare provider about all medications, especially CYP2D6 or CYP3A4 inhibitors.

Special Considerations

Black Box Warnings:

  • QT prolongation and risk of arrhythmias, including torsade de pointes.

Genetic Factors: CYP2D6 poor metabolizers may have increased exposure.

Lab Test Interference: No specific known interference.

Overdose Management

Signs/Symptoms: Severe dizziness, cardiac arrhythmias, seizures.

Treatment: Supportive care; consider activated charcoal if ingestion is recent; cardiac monitoring; ECG; manage seizures as per protocols.

Storage and Handling

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

Stability: Stable under recommended storage conditions.

🛡️ 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.