Each film coated tablet contains Roflumilast INN 500 mcg.
Roflumilast is an anti-inflammatory medicine called selective phosphodiesterase 4 inhibitor. Roflumilast reduces the activity of phosphodiesterase 4, a protein occurring naturally in body cells. When the activity of this protein is reduced, there is less inflammation in the lungs. This helps to stop narrowing of airways due to inflammation in chronic obstructive pulmonary disease (COPD). Thus Roflumilast eases breathing.
Roflumilast is used to treat asthma and COPD in adults. Roflumilast is to be used in addition to bronchodilators in asthma and COPD patients.
Dosage & Administration
In adults (above 18 years of age), the recommended dose of Roflumilast is one 500 microgram (mcg) tablet per day with or without food for both asthma and COPD. As there is lack of safety information of this drug in children so, it should be avoided in children and adolescent under 18 years of age.
Normally, Roflumilast is well tolerated. Common side-effects are Weight decrease, decreased appetite, sleeplessness, headache, diarrhoea, nausea, stomach ache etc.
Roflumilast is not a bronchodilator and should not be used for the treatment of a sudden attack of breathlessness. Patients treated with this drug should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, this should be evaluated, and discontinuation of Roflumilast should be considered. Roflumilast should be given with caution in patients with severe immunological diseases (HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy and others), severe acute infectious diseases (tuberculosis or acute hepatitis), cancer (except basal-cell carcinoma), and severe impairment of the heart function.
Roflumilast is contraindicated to patients with a history of hypersensitivity to Roflumilast or any of other ingredients of the tablet and if a patient has moderate to severe liver impairment.
Use in Pregnancy & Lactation
Roflumilast is pregnancy category C drug. There are no adequate and well controlled studies of it in pregnant women and lactating mothers. Roflumilast should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and should not be used by women who are nursing.
Roflumilast may be taken with medicines used in the treatment of COPD such as: inhaled or oral corticosteroids or bronchodilators. But it shows drug interactions with: rifampicin, phenobarbital, carbamazepine, phenytoin, erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine and ethinyl estradiol.
No case of overdose has been reported in clinical studies with Roflumilast. The sign and symptoms of overdosages are: headache, gastrointestinal disorders, dizziness, palpitations, light headedness, clamminess and arterial hypotension.
Roxair tablet: Each box contains 3 blister strips of 10 film coated tablets.