Concise Prescribing Info
Maintenance treatment of severe COPD (FEV1 post-bronchodilator <50% predicted) associated w/ chronic bronchitis in adult patients w/ a history of frequent exacerbations, as add on to bronchodilator treatment.
Dosage/Direction for Use
May be taken with or without food: Take at the same time each day. Swallow w/ water.
Hypersensitivity. Moderate or severe hepatic impairment (Child-Pugh B or C).
Special Precautions
Not indicated as rescue medicinal product for the relief of acute bronchospasms. Decrease in body wt; check body wt regularly. Patients w/ severe immunological diseases (eg, HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma) or patients treated w/ immunosuppressive medicinal products (ie, methotrexate, azathioprine, infliximab, etanercept or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids); patients w/ latent infections eg, TB, viral hepatitis, herpes viral infection & herpes zoster; CHF (NYHA grades 3 & 4). Increased risk of psychiatric disorders eg, insomnia, anxiety, nervousness & depression. Reassess treatment in case of persistent intolerability especially in special populations that may have higher exposure eg, black patients, non-smoking females or in patients concomitantly treated w/ CYP1A2/ 2C19/3A4 inhibitors (eg, fluvoxamine & cimetidine) or the CYP1A2/3A4 inhibitor enoxacin. Higher risk of sleep disorders (mainly insomnia) in patients w/ a baseline body wt of <60 kg. Concomitant treatment w/ theophylline is not recommended. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Mild hepatic impairment (Child-Pugh A). Women of childbearing potential should use effective method of contraception during treatment. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Decreased wt & appetite; insomnia; headache; diarrhoea, nausea, abdominal pain. Concomitant treatment w/ long acting muscarinic antagonists (LAMA): Decreased wt & appetite, headache, depression.
Drug Interactions
Increased exposure & persistent intolerability w/ CYP1A2/3A4 inhibitor enoxacin & the CYP1A2/2C19/3A4 inhibitors cimetidine & fluvoxamine. Possible reduced therapeutic efficacy w/ strong CYP450 enzyme inducers (eg, phenobarb, carbamazepine, phenytoin).
ATC Classification
R03DX07 - roflumilast ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.
Daxas film-coated tab 500 mcg
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