Roflumilast Tablets (Daxas) are a selective phosphodiesterase 4 (PDE4) inhibitor, primarily indicated for the treatment of chronic obstructive pulmonary disease (COPD).

What are the Indications for Roflumilast Tablets (Daxas)?

Core Indications

This medication is indicated for adult patients with severe COPD who have a history of acute exacerbations and are diagnosed with chronic bronchitis.

As a long-term treatment, it is used to reduce the frequency of future COPD acute exacerbations (e.g., sudden worsening of symptoms, which usually requires the use of systemic glucocorticoids or antibiotics, and even hospitalization).

Usage Limitations and Important Notes

Roflumilast Tablets are not bronchodilators and should not be used for relieving acute bronchospasm or treating sudden onset of dyspnea.

Patients must keep other emergency medications (e.g., short-acting bronchodilators) as prescribed by physicians for the management of acute symptom attacks.

Specifications and Properties of Roflumilast Tablets (Daxas)

Specifications

250 mcg tablets: Each tablet contains 250 mcg of roflumilast.

500 mcg tablets: Each tablet contains 500 mcg of roflumilast. This is the recommended maintenance dose.

Properties

Scoring and Markings: One side of the tablet is embossed with the letter "D", and the other side is embossed with the corresponding dosage numbers "250" or "500".

Active Ingredient: The main active ingredient of each tablet is roflumilast.

Excipient Ingredients: Including lactose monohydrate, corn starch, povidone and magnesium stearate. It is contraindicated in patients with hypersensitivity to any of these ingredients.

Storage and Handling Methods for Roflumilast Tablets (Daxas)

Storage Conditions

Temperature Requirement: Roflumilast Tablets should be stored at room temperature between 20°C and 25°C (68°F and 77°F).

Allowable Temperature Fluctuation Range: For short periods, temperatures may fluctuate between 15°C and 30°C (59°F and 86°F). This complies with the United States Pharmacopeia (USP) requirements for "controlled room temperature" storage.

Environmental Requirement: Store in a cool and dry place, away from direct sunlight, moisture and excessive heat (e.g., bathrooms, near kitchen stoves or inside vehicles).

Safe Handling

Child Safety: All medications must be kept out of the reach and sight of children to prevent accidental ingestion.

Storage in Original Packaging: It is recommended to keep the tablets in their original packaging (e.g., aluminum foil blisters or medicine bottles) until administration. This helps protect against moisture and light exposure, and preserves medication identification information.

Disposal of Expired Medications: Do not use expired medications. Unwanted or expired tablets should be disposed of in accordance with local regulations for pharmaceutical waste, and should not be discarded in household garbage or flushed down the drain.