What is Roflumilast used for?

1 INDICATIONS AND USAGE Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use Roflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. Roflumilast tablet

How does Roflumilast work?

11 DESCRIPTION The active ingredient in roflumilast tablets is roflumilast.

What pharmaceutical form is Roflumilast available in?

Roflumilast: Tabletki powlekane 500 mcg (doustna)

Is Roflumilast OTC or prescription only?

Roflumilast requires a doctor's prescription.

What are the side effects of Roflumilast?

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Psychiatric Events Including Suicidality [see Warnings and Precautions (5.2) ] Weight Decrease [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥2%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-79

Who should NOT take Roflumilast?

4 CONTRAINDICATIONS The use of roflumilast tablets is contraindicated in the following condition: Moderate to severe liver impairment (Child-Pugh B or C) [see Clinical Pharmacology ( 12.3 ) and Use in Specific Populations ( 8.6 )]. Moderate to severe liver impairment (Child-Pugh B or C)

Does Roflumilast interact with other medications?

7 DRUG INTERACTIONS A major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2 [see Clinical Pharmacology (12.3) ]. Use with inhibitors of CYP3A4 or dual inhibitors of CYP3A4 and CYP1A2 (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) will increase roflumilast systemic exposure and may result in increased adverse reactions. The risk of such concurrent use should be weighed carefully against benefit.(

Can Roflumilast be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Roflumilast tablets should not be used by women who are nursing as excretion of roflumilast and/or its metabolites into human milk is probable and there are no human studies that have investigated effects of roflumilast tablets on breast-fed infants. ( 8.2 ) 8.1 Pregnancy Risk Summary There are no randomized clinical studies of roflumilast tablets in pregnant women. In animal reproductive toxicity studies, roflumilast tablets admin

What ATC class does Roflumilast belong to?

Roflumilast: ATC R03DX07. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Roflumilast

500 mcg, Tabletki powlekane

INN: Roflumilastum

Data updated: 2026-04-13

Available in:

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Form

Tabletki powlekane

Dosage

500 mcg

Route

doustna

Storage

—

About This Product

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