Generic
Roflumilast
Indications
Roflumilast is indicated: As add-on therapy to bronchodilator treatment. For the maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis (i.e. patients with a history of chronic cough and sputum) in adult patients with a history of frequent exacerbations. Roflumilast should not be used as a rescue medication.
Contraindications
Hypersensitivity to Roflumilast or to any of the excipients. Moderate to severe liver impairment.
Side Effects
General disorders: Fatigue. Metabolism and nutrition disorders: Decreased appetite, Weight decreased. Musculoskeletal and connective tissue disorders: Back pain, muscle spasms. Nervous system disorders: Dizziness, Headache, Tremor. Psychiatric disorders: Anxiety, Depression, Insomnia.
Pregnancy And Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Roflumilast should not be used during pregnancy & lactation.
Therapeutic
No case of overdose has been reported in clinical studies with Roflumilast. However, during the Phase I studies of Roflumilast, at an increased rate after a single oral dose of 2500 mcg and a single dose of 5000 mcg, The following symptoms were observed: headache, gastrointestinal disorders, dizziness, palpitations, lightheadedness, clamminess and arterial hypotension. Missed Dose: Patients should be advised that if they forget to take a tablet at the usual time, they should take the tablet as soon as they remember or continue on the next day with the next tablet at the usual time. Patients should not take a double dose to make up for a forgotten dose.
Storage Conditions
Antihistamines anti-allergies & hypo-sensitisation
Over The Counter Products
