Daxas

Daxas

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Roflumilast
Indications/Uses
Maintenance treatment of severe COPD associated w/ chronic bronchitis in adults w/ history of frequent exacerbations as add-on to bronchodilator treatment.
Dosage/Direction for Use
Administration
May be taken with or without food: Swallow w/ water. Take at the same time each day.
Contraindications
Hypersensitivity. Moderate or severe hepatic impairment (Child-Pugh B or C).
Special Precautions
Not as emergency treatment for relief of acute bronchospasm. Monitor body wt regularly. Severe immunological disease & acute infections, cancers (except basal cell carcinoma). Latent infections eg, TB, viral hepatits, herpes viral infection & herpes zoster. Not recommended in patients w/ CHF (NYHA grades III & IV) & history of depression associated w/ suicidal ideation or behavior. Black, non-smoking females. Concomitant use w/ CYP1A2/2C19/3A4 inhibitors, immunosuppressants; theophylline. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Mild hepatic impairment. Not recommended in women of childbearing potential not using contraception. Not recommended during pregnancy. Not to be used during lactation.
Adverse Reactions
Decreased wt & appetite; insomnia; headache; diarrhea, nausea, abdominal pain.
Drug Interactions
Increased exposure & persistent intolerability w/ enoxacin, cimetidine, fluvoxamine. Reduced therapeutic efficacy w/ phenobarb, carbamazepine, phenytoin. Increased total PDE4 inhibitory activity w/ erythromycin, ketoconazole, theophylline, OCs.
ATC Classification
R03DX07 - roflumilast ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.
Presentation/Packing
Form
Daxas FC tab 500 mcg
Packing/Price
30's
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