Roflumilast Tablets
Dosage form: tablet
Drug class:Selective phosphodiesterase-4 inhibitors
Medically reviewed by Drugs.com. Last updated on Jun 21, 2021.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
- Medication Guide
Indications and Usage for Roflumilast Tablets
Roflumilast Tablets are 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 are not bronchodilators and are not indicated for the relief of acute bronchospasm.
Roflumilast Tablets Dosage and Administration
The maintenance dose of Roflumilast Tablets is one 500 micrograms (mcg) tablet per day, with or without food.
Dosage Forms and Strengths
Roflumilast Tablets 500 mcg are supplied as white to off white, round shaped, flat faced, beveled edge uncoated tablets debossed with "76" on one side and plain on other side.
Contraindications
The use of roflumilast is contraindicated in the following condition:
Moderate to severe liver impairment (Child-Pugh B or C) [see Clinical Pharmacology (12.3)and Use in Special Populations (8.6)].
Warnings and Precautions
Treatment of Acute Bronchospasm
Roflumilast is not a bronchodilator and should not be used for the relief of acute bronchospasm.
Psychiatric Events including Suicidality
Treatment with roflumilast is associated with an increase in psychiatric adverse reactions. In 8 controlled clinical trials 5.9% (263) of patients treated with Roflumilast Tablets 500 m...
