Rofumil 500 mcg (Tablet)

Unit Price: ৳ 10.05 (2 x 10: ৳ 201.00)
Strip Price: ৳ 100.50

Medicine Details

Category Details
Generic Roflumilast tablet
Company Drug international ltd

Indications

  • Maintenance treatment of severe COPD
  • Associated with chronic bronchitis
  • Add on to bronchodilator treatment
  • Adult patients with frequent exacerbations

Pharmacology

  • Phosphodiesterase-4 (PDE-4) inhibitor
  • Selective inhibition of PDE4 isoenzyme
  • Potential antiinflammatory effects
  • Antimodulatory effects
  • Increased levels of intracellular cyclic AMP

Dosage & Administration

  • Recommended dose 500 micrograms once daily
  • May take several weeks to achieve effect
  • Studied in clinical trials for up to one year
  • Swallow with water
  • Take at the same time every day

Interaction

  • No proven hazardous interactions
  • Case report of interaction with ethanol
  • Case report of potentiation with betahistine and salbutamol
  • Concurrent administration of H1 antagonists may cause mutual attenuation of effects

Contraindications

  • Hypersensitivity to Roflumilast or excipients
  • Moderate or severe hepatic impairment

Side Effects

  • Adverse reactions in approximately 16% of patients
  • Commonly reported: diarrhea, weight decreased, nausea, abdominal pain, headache
  • Majority of reactions were mild or moderate
  • Occur mainly within the first weeks of therapy

Pregnancy & Lactation

  • Not recommended during pregnancy
  • Has shown reproductive toxicity in animal studies
  • Crosses the placenta in pregnant rats
  • Not recommended during breastfeeding

Precautions & Warnings

  • Inform patients about risks and precautions
  • Not indicated as rescue medicinal product for acute bronchospasms
  • Weight decrease observed in patients
  • Special clinical conditions for use
  • Increased risk of psychiatric disorders and suicidal ideation
  • Reassessment in case of persistent intolerability
  • Concomitant treatment precautions

Overdose Effects

  • Observed symptoms at increased rate after overdose
  • Appropriate supportive medical care recommended
  • Haemodialysis not likely to be effective method of removal

Therapeutic Class

  • Antihistamines anti-allergies & hypo-sensitisation

Storage Conditions

  • Store below 30°C
  • Keep away from light and moisture
  • Keep out of the reach of children

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