Roxair 500Tablet

Generic

Roflumilast

Indications

• Roflumilast is prescribed as a supplement to bronchodilator therapy.
• In adult patients with a history of repeated exacerbations of severe Chronic Obstructive Pulmonary Disease (COPD) coupled with persistent bronchitis (i.e. individuals with a history of chronic cough and sputum).
• Roflumilast should never be used as a last resort.

Pharmacology

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor with potential antiinflammatory and antimodulatory effects in the pulmonary system due to its specific inhibition of the PDE4 isoenzyme. The therapeutic effects of Roflumilast are considered to be due to higher levels of intracellular cyclic AMP.

Dosage & Administration

The recommended dosage for patients with COPD is one 500 mcg tablet daily, with or without food.

Interaction

The N-oxidation of Roflumilast to Roflumilast N-oxide by CYP3A4 and CYP1A2 is a key step in Roflumilast metabolism. Strong cytochrome P450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin) should not be used with Roflumilast. Roflumilast co-administration with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase Roflumilast systemic exposure and cause more adverse events.

Contraindications

Roflumilast or any of the excipients cause hypersensitivity. Liver damage ranging from moderate to severe.

Side Effects

• Fatigue is a common ailment.
• Metabolism and nutrition problems include reduced appetite and weight loss.
• Back discomfort and muscle spasms are examples of musculoskeletal and connective tissue diseases.
• Dizziness, headaches, and tremors are examples of nervous system diseases.
• Anxiety, depression, and insomnia are psychiatric illnesses.

Pregnancy & Lactation

Pregnancy Classification C. In pregnant women, there are no appropriate and well-controlled trials. During pregnancy and breastfeeding, Roflumilast should be avoided.

Precautions & Warnings

Not as an emergency therapy for acute brochospasm relief. Regularly check your body weight. Patients with severe immunological illness, severe acute infections, malignancies (excluding basal cell carcinoma), or immunosuppressive drugs; CHF (NYHA grades III & IV). Suicidal ideation or action are linked to a history of depression. Galactose intolerance, Lapp-lactase insufficiency, or glucose-galactose malabsorption are all examples of glucose-galactose malabsorption. Hepatic dysfunction. Lactation and pregnancy.

Therapeutic Class

Antihistamines anti-allergies & hypo-sensitisation

Storage Conditions

Do not store above 30° C. Keep away from light and out of the reach of children.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.