Roflu 500 mcg (Tablet)
Unit Price: ৳ 15.00 (3 x 10: ৳ 450.00)
Strip Price: ৳ 150.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Roflumilast tablet |
| Company | Eskayef pharmaceuticals ltd |
Indications
- Severe chronic obstructive pulmonary disease (COPD) maintenance treatment
- Associated with chronic bronchitis
- History of frequent exacerbations
- Add on to bronchodilator treatment
Pharmacology
- Phosphodiesterase-4 (PDE-4) inhibitor
- Selective inhibition of the PDE4 isoenzyme
- Anti-inflammatory effects
- Antimodulatory effects in the pulmonary system
- Increased levels of intracellular cyclic AMP
Dosage & Administration
- Recommended adult dose: 500 micrograms Roflumilast once daily
- Need for several weeks to achieve 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
- Patients with moderate or severe hepatic impairment must not take Roflumilast
- No relevant use in the pediatric population
- Tablet should be swallowed with water
- Taken at the same time every day
- Can be taken with or without food
Interaction
- No proven hazardous interactions
- Case report of interaction with ethanol
- Potentiation of betahistine with salbutamol
Contraindications
- Hypersensitivity to Roflumilast or its excipients
- Moderate or severe hepatic impairment
Side Effects
- Adverse reactions in approximately 16% of patients in clinical COPD studies
- Most commonly reported adverse reactions: diarrhea, weight decreased, nausea, abdominal pain, headache
- Majority of adverse reactions were mild or moderate
- Occur within the first weeks of therapy
- Resolved on continued treatment
- Range of adverse reactions across various body systems
Pregnancy & Lactation
- Limited data from use in pregnant women
- Reproductive toxicity observed in animal studies
- Not recommended during pregnancy
- Crosses 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
- Informing patients about the risks and precautions
- Not indicated for relief of acute bronchospasms
- Monitoring of body weight due to potential decrease
- Caution with specific clinical conditions
- Increased risk of psychiatric disorders
- Assessment of risks and benefits for patients with psychiatric symptoms
- Consideration for reassessment in case of persistent intolerability
- Concomitant treatment with theophylline not recommended
- Contains lactose
Overdose Effects
- Symptoms observed after increased oral doses
- Appropriate supportive medical care recommended
- Limited efficiency of haemodialysis for 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