Levocetirizine
لووسیتیریزین
🫁 Respiratory SystemSecond-generation antihistamine
Market / country: 🇺🇸 USA
Xyzal (US)
🧮 Dose calculator
Chronic idiopathic urticaria · Regimen source: FDA Levocetirizine tab · 2.2
- • Some patients are controlled with 2.5 mg. FDA Levocetirizine tab · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to levocetirizine or cetirizine. FDA Levocetirizine tab · 4
- ⛔ End-stage renal disease (CrCl <10 mL/min) or haemodialysis. FDA Levocetirizine tab · 4
- ⚠️ Children 6 months–11 years with renal impairment. FDA Levocetirizine tab · 4
Warnings
- • Somnolence; avoid driving and alcohol; caution with urinary retention. FDA Levocetirizine tab · 5
Formulations
- 5 mg tablet (scored) — tablet 🇺🇸 USA FDA Levocetirizine tab · 3
- 2.5 mg / 5 mL oral solution — solution 🇺🇸 USA FDA Levocetirizine sol. · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Levocetirizine tab · 8.1
“Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Levocetirizine tab · 8.2
“Risk Summary There are no data on the presence of levocetirizine in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Levocetirizine tab · 8.4
“The recommended dose of levocetirizine dihydrochloride for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older [see Clinical Studies ( 14 )].”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Levocetirizine tab · 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, or cardiac function and of concomitant disease or other drug therapy.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA090385
- DailyMed (FDA label)FDA Levocetirizine tabFDA Levocetirizine sol.
- MedlinePlus (NIH)Levocetirizine
- WHO ATC/DDDR06AE09
- Darooyab (Iran)Levocetirizine
🇮🇷 Registered in Iran Darooyab · G-805/Levocetirizine
Dosage forms with Iranian generic codes, per Darooyab.
- 09640 · LEVOCETIRIZINE 5MG TAB · قرص لووستیریزین ۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Levocetirizine tab · 3FDA Levocetirizine sol. · 3FDA Levocetirizine tab · 2.2FDA Levocetirizine sol. · 2.2FDA Levocetirizine sol. · 2.1FDA Levocetirizine tab · 4FDA Levocetirizine tab · 5FDA Levocetirizine tab · SPL approval / marketing categoryFDA Levocetirizine tab · 8.1FDA Levocetirizine tab · 8.2FDA Levocetirizine tab · 8.4FDA Levocetirizine tab · 8.5
- 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-805/Levocetirizine
- Clinical review⚠ Unverified