Roflumilast

Bronchodilator & Anti-asthma Preps: Orals/Parenterals · Phosphodiesterase type-4 inhibitor

Indications

As an add-on to bronchodilator therapy in the maintenance therapy in the maintenance treatment of severe COPD (post-bronchodilator FEV1, <50% predicted) associated with chronic bronchitits and frequent exacerbations.

Dosage

Adults: 500 mcg once daily. Children: Not recommended.

Adverse Effects

GI upset, weight loss, anorexia, insomnia, headache.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Severe immune disease or severe acute infection, cancer. Moderate to severe hepatic impairment. CHF. History of depression associated with suicidal ideation or behavior. Ensure contraception in women. Precautions: Latent infections. Do not use for relief of acute symptoms. Mild hepatic impairment. Monitor body wt. Risk of psychiatric disorders especially in patients with history of psychiatric symptoms or taking other medications associated with psychiatric reaction; advise patients to report suicidal ideation or changes in behaviour or mood (discontinue if occur).

Interactions

CYP3A4 or CYP1A2 inhibitors (e.g. cimetidine, fluvoxamine). Strong CYP inducers (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin). Immunosuppressants, oral corticosteroids.

Advice to Patient

Take with or without meals.

Pharmacokinetics

Metabolism: Hepatic. Bioavailability: Absolute: 80%. Half-life elimination: Oral: Roflumilast: 17 hrs. Roflumilast N-oxide: 30 hrs. Time to peak, plasma: Roflumilast: 0.5-2 hrs. Roflumilast N-oxide: 4-13 hrs. Excretion: Faeces (20%). Urine (70%).

Brands with this active ingredient

• Milast
• Raspro
• Raxus
• Rofluzon
• Romast
• Romilast
• Suntra

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.