Rofumil
Generic Name
Roflumilast
Manufacturer
Acme 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
Rofumil (Roflumilast) is an oral selective phosphodiesterase-4 (PDE4) inhibitor used to reduce the frequency of exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations.
Uses & Indications
Dosage
Adults
500 mcg once daily.
Elderly
No dosage adjustment is required for elderly patients.
Renal_impairment
No dosage adjustment is required for patients with renal impairment.
How to Take
Take orally once daily, with or without food. Swallow the tablet whole with water. Do not crush, chew, or break the tablet.
Mechanism of Action
Roflumilast and its active N-oxide metabolite work by selectively inhibiting phosphodiesterase-4 (PDE4), an enzyme responsible for breaking down cyclic adenosine monophosphate (cAMP). Inhibition of PDE4 leads to increased intracellular cAMP levels, which in turn reduces inflammatory cell activation and suppresses various inflammatory mediators, leading to anti-inflammatory effects in the lungs.
Pharmacokinetics
Onset
Not an acute bronchodilator; therapeutic effects (reduction in exacerbations) are typically observed over weeks of continuous treatment.
Excretion
Primarily excreted renally (approximately 70% as metabolites), with about 20% excreted via feces.
Half life
Roflumilast: approximately 17 hours. Roflumilast N-oxide (active metabolite): approximately 30 hours.
Absorption
Well absorbed after oral administration, with a mean absolute bioavailability of 80% for roflumilast. Peak plasma concentrations are reached in approximately 1 hour.
Metabolism
Extensively metabolized in the liver, primarily via cytochrome P450 (CYP) enzymes (CYP1A2 and CYP3A4) to its active N-oxide metabolite.
Side Effects
Contraindications
- •Hypersensitivity to roflumilast or any component of the formulation.
- •Moderate to severe hepatic impairment (Child-Pugh B or C).
Drug Interactions
Oral Contraceptives
Concomitant use with oral contraceptives may affect the efficacy of roflumilast or the contraceptive.
Combined P-gp and CYP3A4 Inhibitors (e.g., Erythromycin)
May increase roflumilast exposure.
Strong CYP450 Inducers (e.g., Rifampicin, Phenobarbital)
May decrease roflumilast exposure, potentially reducing efficacy.
Strong CYP450 Inhibitors (e.g., Ketoconazole, Fluvoxamine)
May increase roflumilast exposure and the risk of adverse effects. Dose adjustment may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptoms may include headache, nausea, diarrhea, dizziness, abdominal pain, and palpitations. Management is primarily supportive and symptomatic. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether roflumilast or its metabolites are excreted in human milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Pharmacies
Approval Status
FDA Approved
Patent Status
Off-patent (generic available)
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Global Brand Names
International brand names for this medicine
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