Daxas Dosage/Direction for Use




Full Prescribing Info
Dosage/Direction for Use
Posology: The recommended dose is 500 micrograms (one tablet) roflumilast once daily.
Daxas may need to be taken for several weeks to achieve its effect (see Pharmacology: Pharmacodynamics under Actions). Daxas has been studied in clinical trials for up to one year.
Special populations: Elderly: No dose adjustment is necessary.
Renal impairment: No dose adjustment is necessary.
Hepatic impairment: The clinical data with Daxas in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see Pharmacology: Pharmacokinetics under Actions) and therefore Daxas should be used with caution in these patients.
Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daxas (see Contraindications).
Paediatric population: There is no relevant use of Daxas in the paediatric population (under 18 years) in the indication COPD.
Method of administration: For oral use.
The tablet should be swallowed with water and taken at the same time every day. The tablet can be taken with or without food.
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