Roflumilast (Roflumilast)
Also sold as: Daliresp
Pregnancy
Cat C
Lactation
Unknown
Schedule
H
Forms
Tablet 250mcg, 500mcg
Indications
- COPD maintenance (severe, chronic bronchitis phenotype)
- Reduction of COPD exacerbations
- Adjunctive to bronchodilators
Adult Dosing
COPD exacerbation prevention
250 mcg PO daily × 4 weeks, then 500 mcg daily
Daily, long-term
Maintenance (after titration)
500 mcg PO daily
Long-term
Pediatric Dosing
Adult use only
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| CrCl > 30 mL/min | No adjustment |
| CrCl < 30 mL/min | Not recommended |
Hepatic Adjustment
Mild: no adjustment. Moderate-severe: contraindicated.
Pregnancy & Lactation
Pregnancy: Category C
Limited data; use only if clearly necessary.
Lactation: Unknown
Unknown if excreted; avoid.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| CYP3A4 inhibitors (ketoconazole, erythromycin) | Increased roflumilast levels | Moderate |
| CYP1A2 inducers (smoking, rifampin) | Reduced roflumilast levels | Moderate |
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Side Effects
Common
- Diarrhea
- Nausea
- Weight loss
- Insomnia
- Tremor
- Headache
Serious / Discontinue If
- Depression / suicidal ideation (rare)
- Diarrhea (severe)
- Hepatotoxicity (rare)
- Weight loss significant
- Psychiatric events
Contraindications
- Moderate-severe hepatic impairment
- CrCl <30 mL/min
- Untreated depression / suicidal ideation
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Daliresp 500 mcg | Forest Pharma | 10 tab ₹800-1000 (indicative) |
Monitoring Required
- LFT at baseline and periodically
- Mood and psychiatric symptoms
- Weight and GI symptoms
- COPD exacerbation frequency
Patient Counseling Points
- Take 500 mcg once daily; start at 250 mcg for 4 weeks then increase
- Report depression, suicidal thoughts, or significant diarrhea
- Weight loss common; monitor nutritional intake
- Use with bronchodilators for optimal COPD control
- Smoking reduces efficacy (quit if possible)
- Adjunctive therapy; not a bronchodilator
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Clinically reviewed by: Dr. Sunil Kadam, MD (Pulmonary/Critical Care), COPD Specialist
Last reviewed: 2026-04-13
References
- BNF — Roflumilast
- COPD Gold Guidelines 2024
- FDA Depression Warning