Roflumilast
روفلومیلاست
🌬️ Respiratory SystemPDE4 inhibitor
Market / country: 🇺🇸 USA
Daliresp (US)
🧮 Dose calculator
Chronic obstructive pulmonary disease (COPD) · Regimen source: FDA Daliresp · 2
- • Optional: 250 mcg daily for 4 weeks to improve tolerability, then 500 mcg (250 is not a therapeutic dose). Not for acute bronchospasm. FDA Daliresp · 2FDA Daliresp · 5
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Moderate to severe liver impairment (Child-Pugh B or C). FDA Daliresp · 4
Warnings
- • Psychiatric events including suicidality; weight loss. FDA Daliresp · 5
Formulations
- 250 mcg tablet (starter) — tablet 🇺🇸 USA FDA Daliresp · 3
- 500 mcg tablet — tablet 🇺🇸 USA FDA Daliresp · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Daliresp · 8.1
“Risk Summary There are no randomized clinical studies of DALIRESP in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Daliresp · 8.2
“Risk Summary There is no information regarding the presence of DALIRESP in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Daliresp · 8.4
“The safety and effectiveness of DALIRESP in pediatric patients have 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 Daliresp · 8.5
“Of the 4438 COPD subjects exposed to DALIRESP for up to 12 months in 8 controlled clinical trials, 2022 were >65 years of age and 471 were >75 years of age.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA022522
- DailyMed (FDA label)FDA Daliresp
- MedlinePlus (NIH)RoflumilastRoflumilast topical
- WHO ATC/DDDR03DX07
- Darooyab (Iran)Roflumilast
🇮🇷 Not found in Iran list Darooyab · G-1488/Roflumilast
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Daliresp · 3FDA Daliresp · 2FDA Daliresp · 5FDA Daliresp · 4FDA Daliresp · 8.1FDA Daliresp · 8.2FDA Daliresp · 8.4FDA Daliresp · 8.5FDA Daliresp · 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-1488/Roflumilast
- Clinical review⚠ Unverified