Renabec-FG
Generic Name
Beclomethasone Dipropionate and Formoterol Fumarate Dihydrate Inhaler
Manufacturer
ACI Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| renabec fg 100 mcg inhaler | ৳ 1,200.00 | N/A |
Description
Overview of the medicine
Renabec-FG 100 mcg Inhaler is a combination medication containing Beclomethasone Dipropionate (an inhaled corticosteroid) and Formoterol Fumarate Dihydrate (a long-acting beta-2 agonist). It is used for the regular treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and adolescents where a combination therapy is appropriate.
Uses & Indications
Dosage
Adults
Asthma: 1-2 inhalations twice daily. COPD: 2 inhalations twice daily. Maximum 4 inhalations per day.
Elderly
No dosage adjustment is generally required in elderly patients.
Renal_impairment
No specific dosage adjustment recommended for patients with renal impairment, but caution is advised due to potential systemic exposure.
How to Take
For oral inhalation only. Shake the inhaler well before each use. Inhale slowly and deeply through the mouthpiece while pressing down on the canister. Hold breath for 5-10 seconds, then exhale slowly. Rinse mouth with water after use to reduce the risk of oral thrush.
Mechanism of Action
Beclomethasone Dipropionate is an inhaled corticosteroid that reduces inflammation in the airways, decreasing swelling and mucus production. Formoterol Fumarate is a long-acting beta-2 adrenergic agonist that causes bronchodilation by relaxing the smooth muscles in the airways, making breathing easier. The combination provides both anti-inflammatory and bronchodilator effects.
Pharmacokinetics
Onset
Formoterol: 1-3 minutes; Beclomethasone: Several days to weeks for full anti-inflammatory effect.
Excretion
Beclomethasone: Excreted mainly in the faeces (60%) and urine (12-15%) as metabolites. Formoterol: Excreted predominantly via the kidneys (approx. 60% as metabolites, 10% as unchanged drug) and faeces.
Half life
Beclomethasone (active metabolite): Approximately 2.8 hours; Formoterol: Approximately 10 hours.
Absorption
Beclomethasone: Rapidly absorbed, significant first-pass metabolism. Formoterol: Rapidly absorbed after inhalation, systemic bioavailability is about 10% of the delivered dose.
Metabolism
Beclomethasone: Hydrolysed to its active metabolite, beclomethasone-17-monopropionate (B-17-MP), in the lungs and liver. Formoterol: Primarily metabolized by direct glucuronidation and O-demethylation.
Side Effects
Contraindications
- Hypersensitivity to the active substances or to any of the excipients.
- Not for use in the acute symptoms of asthma or COPD (requires a rapid-acting bronchodilator).
Drug Interactions
Beta-blockers
May reduce the effect of formoterol. Non-selective beta-blockers should generally be avoided.
Other sympathomimetics
May potentiate adverse effects.
Diuretics/Xanthine derivatives/Steroids
May potentiate hypokalemia.
Quinidine/Disopyramide/Procainamide/Phenothiazines/Antihistamines/MAOIs/TCAs
May prolong QTc interval and increase risk of ventricular arrhythmias.
Storage
Store below 30°C. Do not freeze. Protect from direct sunlight and heat. Keep out of reach of children.
Overdose
Symptoms of overdose include tremor, headache, palpitations, tachycardia, hyperglycemia, and hypokalemia (due to formoterol), and systemic corticosteroid effects like adrenal suppression (due to beclomethasone). Treatment is supportive and symptomatic. Medical attention is required.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beclomethasone and formoterol are excreted in human milk; use with caution in breastfeeding mothers. Consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to the active substances or to any of the excipients.
- Not for use in the acute symptoms of asthma or COPD (requires a rapid-acting bronchodilator).
Drug Interactions
Beta-blockers
May reduce the effect of formoterol. Non-selective beta-blockers should generally be avoided.
Other sympathomimetics
May potentiate adverse effects.
Diuretics/Xanthine derivatives/Steroids
May potentiate hypokalemia.
Quinidine/Disopyramide/Procainamide/Phenothiazines/Antihistamines/MAOIs/TCAs
May prolong QTc interval and increase risk of ventricular arrhythmias.
Storage
Store below 30°C. Do not freeze. Protect from direct sunlight and heat. Keep out of reach of children.
Overdose
Symptoms of overdose include tremor, headache, palpitations, tachycardia, hyperglycemia, and hypokalemia (due to formoterol), and systemic corticosteroid effects like adrenal suppression (due to beclomethasone). Treatment is supportive and symptomatic. Medical attention is required.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beclomethasone and formoterol are excreted in human milk; use with caution in breastfeeding mothers. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 months, refer to product packaging for specific dates.
Availability
Pharmacies, hospitals, and licensed drug stores
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA in Bangladesh)
Patent Status
Generic versions available, original patent expired
Clinical Trials
Numerous clinical trials have demonstrated the efficacy and safety of beclomethasone/formoterol combination in asthma and COPD management, showing superior lung function improvement and exacerbation reduction compared to monotherapy.
Lab Monitoring
- Regular monitoring of lung function (FEV1, peak flow)
- Monitor for signs of oral candidiasis
- Periodic blood potassium and glucose levels (especially in susceptible patients)
Doctor Notes
- Emphasize proper inhalation technique and rinsing mouth after use.
- Regularly assess patient's asthma/COPD control and adjust therapy as needed.
- Monitor for systemic corticosteroid side effects, especially in patients on high doses or long-term therapy.
Patient Guidelines
- Always use exactly as prescribed by your doctor.
- Rinse your mouth with water after each use to prevent fungal infections.
- Do not use this inhaler for sudden breathing problems; use a rescue inhaler instead.
- Do not stop using this medicine abruptly without consulting your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, 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
Generally no effect on ability to drive or use machines. However, if you experience dizziness or tremor, avoid driving or operating machinery.
Lifestyle Advice
- Avoid triggers that worsen your asthma or COPD (e.g., smoke, allergens, air pollution).
- Maintain a healthy lifestyle, including regular exercise (as tolerated) and a balanced diet.
- Quit smoking if you smoke.
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