Zafirlukast
زافیرلوکاست
🌬️ Respiratory SystemLeukotriene receptor antagonist
Market / country: 🇺🇸 USA
Accolate (US)
🧮 Dose calculator
Asthma and chronic lung disease (reversible airflow obstruction) · Regimen source: FDA Zafirlukast · Dosage and Administration
- • At least 1 h before or 2 h after meals. Not for acute bronchospasm. FDA Zafirlukast · Dosage and Administration
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to zafirlukast; hepatic impairment including cirrhosis. FDA Zafirlukast · Contraindications
Warnings
- • Hepatotoxicity including life-threatening hepatic failure — stop and test if hepatic symptoms. FDA Zafirlukast · Warnings
Formulations
- 20 mg tablet — tablet 🇺🇸 USA FDA Zafirlukast · How Supplied
- 10 mg tablet — tablet 🇺🇸 USA FDA Zafirlukast · How Supplied
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Zafirlukast · Precautions/Warnings – Pregnancy
“Category B: No teratogenicity was observed at oral doses up to 1600 mg/kg/day in mice (approximately 160 times the maximum recommended daily oral dose in adults on a mg/m 2 basis), up to 2000 mg/kg/day in rats (approximately 410 times the maximum recommended daily oral dose in adults on a mg/m 2 basis) and up to 2000 …”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Zafirlukast · Precautions/Warnings – Nursing Mothers
“Zafirlukast is excreted in breast milk.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Zafirlukast · Precautions/Warnings – Pediatric Use
“The safety and effectiveness of zafirlukast for pediatric patients less than 5 years of age has not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Zafirlukast · Precautions/Warnings – Geriatric Use
“Based on cross-study comparison, the clearance of zafirlukast is reduced in patients 65 years of age and older such that C max and AUC are approximately 2- to 3-fold greater than those of younger patients (see”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA020547
- DailyMed (FDA label)FDA Zafirlukast
- MedlinePlus (NIH)Zafirlukast
- WHO ATC/DDDR03DC01
- Darooyab (Iran)Zafirlukast
🇮🇷 Registered in Iran Darooyab · G-1501/Zafirlukast
Dosage forms with Iranian generic codes, per Darooyab.
- 01894 · ZAFIRLUKAST 20MG TAB · قرص زافیرلوکاست ۲۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Zafirlukast · How SuppliedFDA Zafirlukast · Dosage and AdministrationFDA Zafirlukast · ContraindicationsFDA Zafirlukast · WarningsFDA Zafirlukast · SPL approval / marketing categoryFDA Zafirlukast · Precautions/Warnings – PregnancyFDA Zafirlukast · Precautions/Warnings – Nursing MothersFDA Zafirlukast · Precautions/Warnings – Pediatric UseFDA Zafirlukast · Precautions/Warnings – Geriatric Use
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-1501/Zafirlukast
- Clinical review⚠ Unverified