Rofumil
Generic Name
Roflumilast
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rofumil 500 mcg tablet | ৳ 10.05 | ৳ 100.50 |
Description
Overview of the medicine
Roflumil (Roflumilast) is used to reduce the risk of exacerbations in patients with severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis and a history of exacerbations. It is not a bronchodilator and should not be used for the relief of acute bronchospasm.
Uses & Indications
Dosage
Adults
500 mcg orally once daily.
Elderly
No specific dose adjustment required for elderly patients.
Renal_impairment
No dose adjustment required for patients with renal impairment.
How to Take
Take orally once daily, with or without food. Swallow the tablet whole; do not crush, break, or chew.
Mechanism of Action
Roflumilast and its active N-oxide metabolite work by selectively inhibiting phosphodiesterase-4 (PDE4), an enzyme found in inflammatory cells. Inhibition of PDE4 leads to increased intracellular cyclic AMP (cAMP) levels, which in turn reduces inflammation and suppresses immune responses relevant to COPD.
Pharmacokinetics
Onset
Clinical benefit may not be evident for several weeks or months of treatment.
Excretion
Primarily excreted in the urine as metabolites (approximately 70%) and a smaller extent in feces.
Half life
Roflumilast: approximately 17 hours. Roflumilast N-oxide (active metabolite): approximately 30 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations (Cmax) of roflumilast occurring within 1 hour. Food does not significantly affect absorption.
Metabolism
Extensively metabolized, primarily by CYP1A2 and CYP3A4 to its active N-oxide metabolite.
Side Effects
Contraindications
- •Moderate to severe hepatic impairment (Child-Pugh B or C)
- •Hypersensitivity to roflumilast or any component of the tablet
Drug Interactions
0
Strong CYP Inducers (e.g., Rifampicin, Phenobarbital): May decrease roflumilast exposure.
1
Strong CYP Inhibitors (e.g., Fluvoxamine, Ketoconazole, Erythromycin): May increase roflumilast exposure.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, provide supportive treatment. There is no specific antidote for roflumilast. Monitor vital signs and provide symptomatic and supportive care.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. It is unknown if roflumilast is excreted in human milk; use with caution in nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Available in pharmacies nationwide
Approval Status
FDA Approved (2011), DGDA Approved
Patent Status
Patent expired/Generic available
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Global Brand Names
International brand names for this medicine
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