Brezofil
Generic Name
Budesonide + Formoterol Fumarate Dihydrate
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| brezofil 100 mg syrup | ৳ 100.00 | N/A |
| brezofil 200 mg tablet | ৳ 8.00 | ৳ 80.00 |
| brezofil 400 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Brezofil is a combination inhaler containing Budesonide (a corticosteroid) and Formoterol (a long-acting beta2-agonist). It is used for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD) to improve breathing and reduce symptoms.
Uses & Indications
Dosage
Adults
Asthma: Usually 1-2 inhalations twice daily. COPD: 2 inhalations twice daily.
Elderly
No special dosage adjustment is required for elderly patients. However, if severe hepatic impairment is present, dosage adjustment may be needed.
Renal_impairment
No specific dosage adjustment is recommended for patients with renal impairment.
How to Take
Brezofil is for inhalation use only. Shake the inhaler well before each use. After inhaling the dose, rinse your mouth with water and spit it out to prevent oral candidiasis.
Mechanism of Action
Budesonide reduces inflammation in the airways by inhibiting inflammatory cells and mediators. Formoterol acts as a selective long-acting beta2-adrenergic agonist, causing bronchodilation by relaxing the smooth muscles of the airways.
Pharmacokinetics
Onset
Formoterol: 1-3 minutes. Budesonide: Initial effect in 2-3 hours, full therapeutic effect within 1-2 weeks.
Excretion
Formoterol is primarily excreted renally. Budesonide metabolites are excreted via urine and feces.
Half life
Formoterol: Approximately 8-10 hours. Budesonide: Approximately 2-4 hours.
Absorption
Budesonide has high first-pass metabolism after systemic absorption. Formoterol is rapidly absorbed after inhalation, with peak plasma concentrations occurring within 10 minutes.
Metabolism
Both budesonide and formoterol are extensively metabolized in the liver, primarily via CYP450 enzymes (CYP3A4 for budesonide).
Side Effects
Contraindications
- Hypersensitivity to budesonide, formoterol, or any excipients.
- Not for the relief of acute bronchospasm (should not be used as a rescue inhaler).
Drug Interactions
Beta-blockers
May reduce the effect of formoterol and cause bronchospasm in patients with asthma or COPD.
Diuretics (e.g., thiazide, loop diuretics)
May potentiate the hypokalemic effect of beta2-agonists.
Strong CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir)
May significantly increase systemic exposure to budesonide, potentially leading to systemic corticosteroid effects.
Storage
Store below 30°C. Protect from direct sunlight and frost. Do not puncture or incinerate the canister. Keep out of reach of children.
Overdose
Overdose of formoterol may lead to exaggerated beta2-adrenergic effects such as tachycardia, tremor, palpitations, headache, and hypokalemia. Overdose of budesonide can lead to systemic corticosteroid effects such as adrenal suppression. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether budesonide or formoterol passes into breast milk in amounts that could affect the infant. Use with caution during lactation and only if clearly needed.
Side Effects
Contraindications
- Hypersensitivity to budesonide, formoterol, or any excipients.
- Not for the relief of acute bronchospasm (should not be used as a rescue inhaler).
Drug Interactions
Beta-blockers
May reduce the effect of formoterol and cause bronchospasm in patients with asthma or COPD.
Diuretics (e.g., thiazide, loop diuretics)
May potentiate the hypokalemic effect of beta2-agonists.
Strong CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir)
May significantly increase systemic exposure to budesonide, potentially leading to systemic corticosteroid effects.
Storage
Store below 30°C. Protect from direct sunlight and frost. Do not puncture or incinerate the canister. Keep out of reach of children.
Overdose
Overdose of formoterol may lead to exaggerated beta2-adrenergic effects such as tachycardia, tremor, palpitations, headache, and hypokalemia. Overdose of budesonide can lead to systemic corticosteroid effects such as adrenal suppression. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether budesonide or formoterol passes into breast milk in amounts that could affect the infant. Use with caution during lactation and only if clearly needed.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date, refer to product packaging for exact date.
Availability
Pharmacies, hospitals
Approval Status
Approved by DGDA/FDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Budesonide/formoterol combination has been extensively studied in numerous clinical trials demonstrating its efficacy and safety in the management of asthma and COPD.
Lab Monitoring
- Monitor serum potassium levels, especially in patients with severe asthma and those receiving concomitant diuretics.
- Monitor blood glucose levels in diabetic patients.
- Consider monitoring adrenal function with long-term, high-dose use.
Doctor Notes
- Educate patients thoroughly on the correct inhaler technique and the importance of rinsing the mouth after use.
- Emphasize that this medication is for maintenance therapy and not for acute relief of bronchospasm.
- Monitor patients for signs of systemic corticosteroid effects and potassium levels, especially during periods of stress or concomitant use of other medications.
Patient Guidelines
- Always use Brezofil exactly as prescribed by your doctor.
- Do not use Brezofil to relieve sudden breathing problems; it is a maintenance treatment.
- Rinse your mouth thoroughly with water and spit it out after each dose to reduce the risk of oral thrush.
- If you use a spacer device, ensure proper technique.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed one.
Driving Precautions
Brezofil is unlikely to affect your ability to drive or operate machinery. However, if you experience side effects like dizziness or blurred vision, avoid driving or operating machinery until these symptoms resolve.
Lifestyle Advice
- Avoid known asthma triggers (e.g., dust mites, pollen, pet dander, smoke).
- If you smoke, consider quitting as it can worsen COPD and asthma.
- Maintain a healthy lifestyle with regular exercise and a balanced diet.
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