Fluticasone furoate/vilanterol
فلوتیکازون فوروات/ویلانترول
🌬️ Respiratory SystemInhaled corticosteroid + LABA
Market / country: 🇺🇸 USA
Breo Ellipta (US)
🧮 Dose calculator
Chronic obstructive pulmonary disease (COPD) · Regimen source: FDA Breo Ellipta · 2.1
- • Rinse mouth after use (candidiasis). Not more than once every 24 h. Use a SABA for breathlessness between doses. FDA Breo Ellipta · 2.3FDA Breo Ellipta · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Primary treatment of status asthmaticus or acute COPD/asthma episodes; severe milk-protein hypersensitivity or hypersensitivity to fluticasone furoate/vilanterol. FDA Breo Ellipta · 4
Warnings
- • Serious asthma events with LABA; oral candidiasis; pneumonia in COPD; immunosuppression and adrenal suppression; strong CYP3A4 inhibitors; reduced bone density; effect on growth; glaucoma and cataract. FDA Breo Ellipta · 5
Formulations
- 100/25 mcg per actuation (fluticasone furoate dose shown) — inhaler 🇺🇸 USA FDA Breo Ellipta · 3
- 200/25 mcg per actuation — inhaler 🇺🇸 USA FDA Breo Ellipta · 3
- 50/25 mcg per actuation — inhaler 🇺🇸 USA FDA Breo Ellipta · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Breo Ellipta · 8.1
“Risk Summary There are insufficient data on the use of BREO ELLIPTA or its individual components, fluticasone furoate and vilanterol, in pregnant women to inform a drug-associated risk.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Breo Ellipta · 8.2
“Risk Summary There is no information available on the presence of fluticasone furoate or vilanterol in human milk, the effects on the breastfed child, 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 Breo Ellipta · 8.4
“The safety and effectiveness of BREO ELLIPTA for the maintenance treatment of asthma in pediatric patients 5 years of age and older have been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Breo Ellipta · 8.5
“No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA204275
- DailyMed (FDA label)FDA Breo Ellipta
- MedlinePlus (NIH)Fluticasone and Vilanterol Oral InhalationFluticasone, Umeclidinium, and Vilanterol Oral Inhalation
- WHO ATC/DDDR03AK10
- Darooyab (Iran)Fluticasone-Vilanterol
🇮🇷 Registered in Iran Darooyab · G-5553/Fluticasone-Vilanterol
Dosage forms with Iranian generic codes, per Darooyab.
- 53247 · VILANTEROL/FLUTICASONE CAPSULE RESPIRATORY 0.1 mg/0.025 mg · کپسول ویلانترول / فلوتیکازون ۰٫۱ میلیگرم / ۰٫۰۲۵ میلیگرم
- 53248 · VILANTEROL/FLUTICASONE CAPSULE RESPIRATORY 0.2 mg/0.025 mg · کپسول ویلانترول / فلوتیکازون ۰٫۲ میلیگرم / ۰٫۰۲۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Breo Ellipta · 3FDA Breo Ellipta · 2.1FDA Breo Ellipta · 2.3FDA Breo Ellipta · 2.2FDA Breo Ellipta · 2FDA Breo Ellipta · 4FDA Breo Ellipta · 5FDA Breo Ellipta · 8.1FDA Breo Ellipta · 8.2FDA Breo Ellipta · 8.4FDA Breo Ellipta · 8.5FDA Breo Ellipta · 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-5553/Fluticasone-Vilanterol
- Clinical review⚠ Unverified