Roflumilast
500 ug · Tablet
- Prescription only
- Phosphodiesterase 4 Inhibitor
- Active substance
- Roflumilast
- Made by
- Zydus Lifesciences Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
This information is not included in the verified source. Open the official leaflet
How it works
From the US prescribing label for the same active substance (ROFLUMILAST). It describes the substance, not this exact product.
Roflumilast and its active metabolite (roflumilast N-oxide) are selective inhibitors of phosphodiesterase 4 (PDE4).
Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic-3′,5′-adenosine monophosphate (cyclic AMP)-metabolizing enzyme in lung tissue) activity leads to accumulation of intracellular cyclic AMP.
Roflumilast is extensively metabolized via Phase I (cytochrome P450) and Phase II (conjugation) reactions.
Food has no effect on total drug absorption, but delays time to maximum concentration (T max ) of roflumilast by one hour and reduces C max by approximately 40%, however, C max and T max of roflumilast N-oxide are unaffected.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-09-01
Safety of the active substance
From the US prescribing label for the same active substance (ROFLUMILAST). It describes the substance, not this exact product.
- The use of Roflumilast tablets are 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) ( 4 )
Most common adverse reactions (≥2%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
Spain2 matching products
CanadaNo exact match for this strength and form
Netherlands1 matching products
Details
| Made by | Zydus Lifesciences Limited |
|---|---|
| Active substance | Roflumilast |
| Strength | 500 ug |
| Form | Tablet |
| Route | Oral |
| Packs | 30 TABLET in 1 BOTTLE · 90 TABLET in 1 BOTTLE |
| NDC | 70771-1674 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
26 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet26 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.