Rofumil

N/A

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.

N/A

Hypersensitivity to Roflumilast or to any of the excipients. Moderate to severe liver impairment.

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.

A major step in Roflumilast metabolism is the N-oxidation of Roflumilast to Roflumilast N-oxide by CYP3A4 and CYP1A2. Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with Roflumilast is not recommended. The co-administration of Roflumilast with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase Roflumilast systemic exposure and may result in increased adverse reactions. The co-administration of Roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased 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.

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.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Roflumilast should not be used during pregnancy & lactation.

Not as emergency treatment for relief of acute brochospasm. Monitor body wt regularly. Severe immunological disease, severe acute infections, cancers (except basal cell carcinoma) or patients on immunosuppressants; CHF (NYHA grades III & IV). History of depression associated with suicidal ideation or behavior. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Pregnancy & lactation.

Geriatrics ( 65 years of age): There were no overall differences in safety and effectiveness of Roflumilast in the elderly compared to younger patients with COPD. Therefore, no dose adjustment is necessary.Pediatrics (<18 years of age): Safety and effectiveness of Roflumilast in children and adolescents below 18 years of age have not been established.Hepatic Impairment: Roflumilast is not recommended for use in patients with moderate or severe liver impairment.Renal impairment: No dosage adjustment is necessary for patients with renal impairment