Romilast 500 mcg (Tablet)

Unit Price: ৳ 10.00 (3 x 10: ৳ 300.00)
Strip Price: ৳ 100.00

Medicine Details

Category Details
Generic Roflumilast tablet
Company Labaid pharma ltd

Indications

  • Maintenance treatment of severe chronic obstructive pulmonary disease (COPD)
  • Associated with chronic bronchitis
  • Adult patients with a history of frequent exacerbations
  • Add on to bronchodilator treatment

Pharmacology

  • Phosphodiesterase-4 (PDE-4) inhibitor
  • Selective inhibition of the PDE4 isoenzyme
  • Potential anti-inflammatory and antimodulatory effects in the pulmonary system
  • Increased levels of intracellular cyclic AMP responsible for therapeutic actions

Dosage & Administration

Recommended adult dose: one 500 micrograms tablet once daily, may need several weeks to achieve effect, studied in clinical trials for up to one year, no dose adjustment for elderly or renal impairment

Interaction

  • No proven cases of hazardous interactions
  • Case report of interaction with ethanol and a compound containing pyrimethamine with dapsone
  • Potentiation of betahistine with salbutamol

Contraindications

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

Side Effects

  • Adverse reactions experienced by approximately 16% of patients in clinical COPD studies
  • Most commonly reported adverse reactions include diarrhea, weight decrease, nausea, abdominal pain, and headache
  • Majority of adverse reactions were mild or moderate, occurred within first weeks of therapy, and mostly resolved on continued treatment
  • Adverse reactions ranked under MedDRA frequency classification

Pregnancy & Lactation

  • Limited data in pregnant women
  • Reproductive toxicity shown in animal studies
  • Not recommended during pregnancy and in women of childbearing potential not using contraception
  • Crosses the placenta in pregnant rats
  • Excretion of Roflumilast or its metabolites in milk
  • Risk to the suckling child cannot be excluded
  • Should not be used during breastfeeding

Precautions & Warnings

  • Not indicated as rescue medicinal product for acute bronchospasms
  • Weight decrease occurred more frequently in patients treated with Romilast
  • Special clinical conditions for which treatment with Romilast should not be initiated or should be stopped
  • Increased risk of psychiatric disorders such as insomnia, anxiety, nervousness, and depression
  • Risk of suicidal ideation and behavior, including completed suicide
  • Reassessment of treatment in case of persistent intolerability
  • Concomitant treatment with theophylline not recommended
  • Romilast tablets contain lactose, not suitable for patients with rare hereditary problems of galactose intolerance

Overdose Effects

  • Symptoms observed at increased rate after single oral doses of 2,500 and 5,000 micrograms
  • Appropriate supportive medical care recommended in case of overdose
  • Haemodialysis not likely to efficiently remove Romilast
  • Dialysability by peritoneal dialysis is not known

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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