Renafor-B
Generic Name
Budesonide + Formoterol Fumarate
Manufacturer
Renata Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| renafor b 160 mcg inhaler | ৳ 980.00 | N/A |
Description
Overview of the medicine
Renafor-B 160 mcg Inhaler is a combination medication containing Budesonide, an inhaled corticosteroid (ICS), and Formoterol Fumarate, a long-acting beta-2 adrenergic agonist (LABA). It is used for the regular treatment of asthma and for the symptomatic treatment of patients with severe chronic obstructive pulmonary disease (COPD) who have repeated exacerbations and significant symptoms despite regular therapy with long-acting bronchodilators.
Uses & Indications
Dosage
Adults
Asthma: 1-2 inhalations twice daily. COPD: 2 inhalations twice daily.
Elderly
No dosage adjustment required.
Renal_impairment
No specific dosage adjustment recommended for renal impairment. Caution advised.
How to Take
For inhalation use only. Shake the inhaler well before each use. Follow the instructions for proper inhaler technique provided by your doctor or pharmacist to ensure the medication reaches your lungs effectively. Rinse your mouth with water and spit it out after each dose to reduce the risk of oral thrush.
Mechanism of Action
Budesonide is an anti-inflammatory corticosteroid that reduces inflammation in the airways, while Formoterol is a selective long-acting beta-2 adrenergic agonist that relaxes the smooth muscles of the airways, leading to bronchodilation. Together, they improve lung function and reduce symptoms of asthma and COPD.
Pharmacokinetics
Onset
Formoterol: 1-3 minutes. Budesonide: Full therapeutic effect may take several days.
Excretion
Budesonide: Excreted primarily via urine and feces as metabolites. Formoterol: Excreted mainly via urine, both as unchanged drug and metabolites.
Half life
Budesonide: Approximately 2-4 hours. Formoterol: Approximately 8-10 hours.
Absorption
Budesonide: Well absorbed after inhalation, with systemic bioavailability of about 10-25%. Formoterol: Rapidly absorbed after inhalation, reaching peak plasma concentrations within 10-30 minutes.
Metabolism
Budesonide: Extensive first-pass metabolism in the liver by CYP3A4. Formoterol: Primarily metabolized by direct glucuronidation and O-demethylation.
Side Effects
Contraindications
- Hypersensitivity to Budesonide, Formoterol, or any excipients.
- Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
Drug Interactions
Diuretics (e.g., furosemide)
May potentiate hypokalemia associated with beta-agonists. Monitor potassium levels.
Tricyclic antidepressants, MAO inhibitors
May potentiate the effect of formoterol on the cardiovascular system. Use with caution.
Beta-adrenergic blockers (e.g., propranolol)
May antagonize the effect of formoterol. Non-cardioselective beta-blockers should generally be avoided.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
May increase systemic exposure to budesonide, potentially leading to corticosteroid side effects. Avoid concomitant use or monitor closely.
Storage
Store below 30°C. Protect from direct sunlight, heat, and freezing. Do not puncture or burn the canister. Keep out of reach of children.
Overdose
Overdose of formoterol may lead to exaggerated beta-adrenergic effects (e.g., tachycardia, palpitations, tremor, headache, nausea). Overdose of budesonide may lead to systemic corticosteroid effects (e.g., adrenal suppression, Cushingoid features) over time. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is excreted in breast milk; however, at therapeutic doses, effects on the infant are unlikely. Consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to Budesonide, Formoterol, or any excipients.
- Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
Drug Interactions
Diuretics (e.g., furosemide)
May potentiate hypokalemia associated with beta-agonists. Monitor potassium levels.
Tricyclic antidepressants, MAO inhibitors
May potentiate the effect of formoterol on the cardiovascular system. Use with caution.
Beta-adrenergic blockers (e.g., propranolol)
May antagonize the effect of formoterol. Non-cardioselective beta-blockers should generally be avoided.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
May increase systemic exposure to budesonide, potentially leading to corticosteroid side effects. Avoid concomitant use or monitor closely.
Storage
Store below 30°C. Protect from direct sunlight, heat, and freezing. Do not puncture or burn the canister. Keep out of reach of children.
Overdose
Overdose of formoterol may lead to exaggerated beta-adrenergic effects (e.g., tachycardia, palpitations, tremor, headache, nausea). Overdose of budesonide may lead to systemic corticosteroid effects (e.g., adrenal suppression, Cushingoid features) over time. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is excreted in breast milk; however, at therapeutic doses, effects on the infant are unlikely. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 months (2 years) from the date of manufacture when unopened. Discard 3 months after opening or when the dose counter reaches zero, whichever comes first.
Availability
Available in pharmacies and hospitals
Approval Status
Approved in various countries for asthma and COPD management
Patent Status
Off-patent (generic versions available)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Budesonide/Formoterol combination in the management of asthma and COPD, showing improved lung function, reduced exacerbations, and better symptom control compared to monotherapy.
Lab Monitoring
- Monitor serum potassium levels (especially in patients prone to hypokalemia).
- Monitor bone mineral density in patients on long-term high-dose inhaled corticosteroids.
Doctor Notes
- Emphasize proper inhaler technique and adherence to the dosing schedule for optimal therapeutic benefit.
- Counsel patients that this is a controller medication and not for acute relief; ensure they have a separate rescue inhaler.
- Advise patients to rinse their mouth after each use to minimize the risk of oral candidiasis.
Patient Guidelines
- This inhaler is for maintenance treatment; it is not for acute asthma attacks or acute COPD exacerbations.
- Rinse your mouth thoroughly with water and spit it out after each dose to prevent oral thrush.
- Follow your doctor's instructions for the correct inhaler technique and dosage schedule.
- Do not stop using this medication suddenly without consulting your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine is unlikely to affect your ability to drive or operate machinery. However, if you experience side effects like dizziness or tremor, avoid such activities.
Lifestyle Advice
- Avoid smoking and exposure to environmental irritants (e.g., dust, pollen) that can worsen respiratory conditions.
- Maintain a healthy lifestyle, including regular exercise and a balanced diet.
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