ROFLUZON
ROFLUMILAST · by HORIZON
Composition
Tab 500mcg: Roflumilast 500mcg
Indications & Dosage
Adjunct to bronchodilators maintenance treatment of severe chronic obstructive pulmonary disease associated with chronic bronchitis and a history of frequent exacerbations: Adult: 500 mcg once daily.
Contraindications
Moderate to severe cardiac failure, moderate to severe hepatic impairment, history of depression associated with suicidal ideation or behavior, severe acute infections, cancer, concomitant treatment with immunosuppressive drugs, severe immunological disease
Precautions
History of psychiatric illness; discontinue if new or worsening psychiatric symptoms occur, latent infection (such as tuberculosis, viral hepatitis, herpes infection), mild hepatic impairment. Monitor body-weight
Interactions
Aminophylline, antiepileptics (carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone), combined hormonal contraceptives, enzalutamide, H2 receptor antagonists (cimetidine), quinolones (ciprofloxacin), rifampicin, SSRIs (fluvoxamine), Theophylline
Pregnancy
Caution advised
Lactation
Caution advised
Side Effects
Abdominal pain, decreased appetite, diarrhoea, headache, insomnia, nausea, weight loss, anxiety, dizziness, dyspepsia, gastritis, GORD, constipation, malaise, muscle spasm, myalgia, palpitation, rash, tremor, vertigo .Rare: Depression, gynaecomastia, haematochezia, nervousness, raised creatine kinase, respiratory tract infections, suicidal behavior, suicidal ideation, taste disturbances, urticaria