Roxair 500 mcg (Tablet)
Unit Price: ৳ 15.00 (3 x 10: ৳ 450.00)
Strip Price: ৳ 150.00
Medicine Details
Category | Details |
---|---|
Generic | Roflumilast tablet |
Company | Incepta pharmaceuticals 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
- 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