Pitolisant

پیتولیسانت

⚠ Unverified

🧠 Nervous SystemH3 antagonist/inverse agonist

Market / country: 🇺🇸 USA

Wakix (US)

🧮 Dose calculator

Narcolepsy and excessive daytime sleepiness · Regimen source: FDA Wakix · 2.2

Enter age (weight is optional for this regimen).

🛡️ Safety & information

Contraindications

  • ⛔ Hypersensitivity to pitolisant; severe hepatic impairment. FDA Wakix · 4

Warnings

  • • QT prolongation — avoid with other QT-prolonging drugs. FDA Wakix · 5

Formulations

👥 Special populations

  • 🤰 PregnancyUse with caution

    Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Wakix · 8.1

    “Risk Summary Available case reports from clinical trials and postmarketing reports with WAKIX use in pregnant women have not determined a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”
  • 🤱 BreastfeedingUse with caution

    Label: use with caution while breastfeeding; see the label text. FDA Wakix · 8.2

    “Risk Summary The transfer of pitolisant into breastmilk is low based on data from a lactation study.”
  • 👶 ChildrenUse with caution

    The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Wakix · 8.4

    “The safety and effectiveness of WAKIX have been established for the treatment of excessive daytime sleepiness or cataplexy in pediatric patients 6 years of age and older with narcolepsy.”
  • 👴 Older adultsUse with caution

    Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Wakix · 8.5

    “In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, and cardiac function, concomitant diseases, and other drug therapy.”
  • ⚥ Females & males of reproductive potentialUse with caution

    Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Wakix · 8.3

    “Contraception WAKIX may reduce the effectiveness of hormonal contraceptives.”

📚 Reference status for this drug

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