Roflumilast

Indications

Roflumilast is used for: Chronic obstructive pulmonary disease

Adult Dose

Chronic Obstructive Pulmonary Disease Reduction of frequency of exacerbations or worsening of symptoms 500 mcg PO once daily

Child Dose

Safety and efficacy not established

Renal Dose

Administration

Contra Indications

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.

Precautions

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. Lactation: Probable that roflumilast, its metabolites, or both are excreted into milk; avoid use

Pregnancy-Lactation

Pregnancy Data are not available regarding use in pregnant women Lactation Probable that roflumilast, its metabolites, or both are excreted into milk; avoid use

Interactions

Erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine; rifampicin, phenobarb, carbamazepine, phenytoin, theophylline, OC.

Adverse Effects

Side effects of Roflumilast : 1-10% Diarrhea (9.5%), Weight loss (7.5%), Nausea (4.7%), Headache (4.4%), Back pain (3.2%), Insomnia (2.4%), Decreased appetite (2.1%), Dizziness (2.1%) 1-10% Abdominal pain (1-2%), Anxiety (1-2%), Depression (1-2%), Dyspepsia (1-2%), Gastritis (1-2%), Muscle spasms (1-2%), Rhinitis (1-2%), Sinusitis (1-2%), Tremor (1-2%), Urinary tract infection (1-2%), Vomiting (1-2%) Frequency Not Defined Suicidality

Mechanism of Action

Selective phosphodiesterase (PDE)-4 inhibitor; PDE-4 inhibition leads to accumulation of intracellular cyclic adenosine monophosphate (cAMP) in lung tissue and is thought to be underlying mechanism of action.