Roflumilast

Indications & Dose:

Adjunct to bronchodilators for the maintenance treatment of patients with severe chronic obstructive pulmonary disease associated with chronic bronchitis and a history of frequent exacerbations 

• BY MOUTH

Adult: 500 micrograms once daily 

Contraindications:

Cancer (except basal cell carcinoma) . concomitant treatment with immunosuppressive drugs (except short-term systemic corticosteroids) . history of depression associated with suicidal ideation or behaviour . moderate to severe cardiac failure . severe acute infectious disease . severe immunological disease

Side Effects:

Common or very common Abdominal pain . decreased appetite . diarrhoea . headache . insomnia . nausea . weight loss Uncommon Anxiety . back pain . dizziness . dyspepsia . gastritis . gastro-oesophageal reflux . malaise . muscle spasm . myalgia . palpitation . rash . tremor . vertigo . vomiting Rare Constipation . depression . gynaecomastia . haematochezia . nervousness . raised creatine kinase . respiratory tract infections . suicidal behaviour . suicidal ideation . taste disturbances . urticaria
CONCEPTION AND CONTRACEPTION Women of childbearing age should use effective contraception.
PREGNANCY Manufacturer advises avoid— toxicity in animal studies.
BREAST FEEDING Manufacturer advises avoid— present in milk in animal studies.
HEPATIC IMPAIRMENT Caution in mild impairment. Avoid in moderate to severe impairment. SYMPATHO

Cautions:

History of psychiatric illness (discontinue if new or worsening psychiatric symptoms occur) . latent infection (such as tuberculosis, viral hepatitis, herpes infection)

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Lactations:

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Counselling:

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