Montelukast
مونتهلوکاست
🌬️ Respiratory SystemLeukotriene receptor antagonist
Market / country: 🇺🇸 USA
Singulair (US)
🧮 Dose calculator
Asthma and chronic lung disease (reversible airflow obstruction) · Regimen source: FDA Montelukast · 2.1, Table 1
- • Once daily in the evening. If a dose is missed, take the next at the usual time; never two doses together. FDA Montelukast · 2.1
- • 12–23 months: 4 mg oral granules only. FDA Montelukast · 2.1, Table 1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to any component. FDA Montelukast · 4
Warnings
- • Boxed warning: serious neuropsychiatric events (agitation, aggression, depression, sleep disturbance, suicidal thoughts). FDA Montelukast · WARNING: SERIOUS NEUROPSYCHIATRIC EVENTSFDA Montelukast · 5.1
Formulations
- 4 mg oral granules (packet) — sachet 🇺🇸 USA FDA Montelukast · 3
- 4 mg chewable tablet — chewable tablet 🇺🇸 USA FDA Montelukast · 3
- 5 mg chewable tablet — chewable tablet 🇺🇸 USA FDA Montelukast · 3
- 10 mg tablet — tablet 🇺🇸 USA FDA Montelukast · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Montelukast · 8.1
“Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data] .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Montelukast · 8.2
“Risk Summary A published clinical lactation study reports the presence of montelukast in human milk.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Montelukast · 8.4
“Safety and effectiveness of montelukast sodium for asthma have been established in pediatric patients with asthma 6 to 14 years of age.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Montelukast · 8.5
“No dosage adjustment in the elderly is required.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA090984
- DailyMed (FDA label)FDA Montelukast
- MedlinePlus (NIH)Montelukast
- WHO ATC/DDDR03DC03
- Darooyab (Iran)Montelukast
🇮🇷 Registered in Iran Darooyab · G-1474/Montelukast
Dosage forms with Iranian generic codes, per Darooyab.
- 09448 · MONTELUCAST 4MG GRANULE SACHET ORAL · ساشه مونتلوکاست ۴ میلیگرم
- 06043 · MONTELUKAST SODIUM 10MG TAB · قرص مونتهلوکاست سدیم ۱۰ میلیگرم
- 01895 · MONTELUKAST SODIUM 5MG CHEWABLE TAB · قرص جویدنی مونتهلوکاست سدیم ۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Montelukast · 3FDA Montelukast · 2.1, Table 1FDA Montelukast · 2.1FDA Montelukast · 2.3, Table 3FDA Montelukast · WARNING: SERIOUS NEUROPSYCHIATRIC EVENTSFDA Montelukast · 2.2, Table 2FDA Montelukast · 2.2FDA Montelukast · 4FDA Montelukast · 5.1FDA Montelukast · 8.1FDA Montelukast · 8.2FDA Montelukast · 8.4FDA Montelukast · 8.5FDA Montelukast · SPL approval / marketing category
- 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-1474/Montelukast
- Clinical review⚠ Unverified