Roxair 500 mcg (Tablet)

Unit Price: ৳ 15.00 (3 x 10: ৳ 450.00)
Strip Price: ৳ 150.00

Medicine Details

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
  • Potential antiinflammatory and antimodulatory effects in the pulmonary system
  • Increased levels of intracellular cyclic AMP responsible for therapeutic actions

Dosage & Administration

  • Recommended dose: one tablet of 500 micrograms Roflumilast once daily
  • May need to be taken for several weeks to achieve its effect
  • Studied in clinical trials for up to one year
  • No dose adjustment for elderly (65 years and older)
  • No dose adjustment for renal impairment
  • Caution in patients with mild hepatic impairment (Child-Pugh A)
  • Patients with moderate or severe hepatic impairment (Child-Pugh B or C) must not take

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
  • Concurrent administration of H1 antagonists may cause mutual attenuation of effect

Contraindications

  • Hypersensitivity to Roflumilast or to any of the excipients
  • Moderate or severe hepatic impairment

Side Effects

  • Adverse reactions experienced by approximately 16% of patients in clinical COPD studies
  • Common adverse reactions: diarrhoea, weight decreased, nausea, abdominal pain, headache
  • Mostly mild or moderate reactions
  • Adverse reactions mainly occurred within the first weeks of therapy and mostly resolved on continued treatment
  • Various adverse reactions under respective MedDRA frequency classification

Pregnancy & Lactation

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

Precautions & Warnings

  • Inform patients about risks and precautions for safe use
  • Not indicated as rescue medicinal product for the relief of acute bronchospasms
  • Weight decrease may occur and should be monitored
  • Roxair should not be initiated or continued in certain severe clinical conditions
  • Associated with an increased risk of psychiatric disorders
  • Treatment reassessment in case of persistent intolerability
  • Concomitant treatment with theophylline not recommended
  • Roxair tablets contain lactose, not suitable for patients with rare hereditary problems

Overdose Effects

  • Observed symptoms after single oral doses of 2,500 micrograms and one single dose of 5,000 micrograms
  • In case of overdose, appropriate supportive medical care is recommended
  • Haemodialysis not likely to be efficient 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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