Decomit Plus
Generic Name
Budesonide 200 mcg + Formoterol Fumarate Dihydrate 6 mcg
Manufacturer
ACI Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| decomit plus 200 mcg inhaler | ৳ 550.00 | N/A |
Description
Overview of the medicine
Decomit Plus 200 mcg Inhaler is a combination medicine containing an inhaled corticosteroid (Budesonide) and a long-acting beta2-agonist (Formoterol). It is used for the regular maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It helps to open up the airways and reduce inflammation in the lungs.
Uses & Indications
Dosage
Adults
Asthma: Usually 1-2 inhalations twice daily. COPD: 2 inhalations twice daily. Adjust dose to minimum effective dose. Not for acute relief.
Elderly
No specific dose adjustment is required, but use with caution and monitor for side effects.
Renal_impairment
No specific dose adjustment is required as these drugs are primarily metabolized by the liver. Use with caution.
How to Take
For inhalation use only. Shake the inhaler well before each use. Prime the inhaler by spraying into the air 2-3 times if new or not used for more than a week. Inhale slowly and deeply through the mouthpiece while pressing down on the canister. Hold your breath for about 10 seconds, then exhale slowly. Rinse your mouth with water and spit it out after each dose to prevent oral thrush.
Mechanism of Action
Budesonide is an anti-inflammatory corticosteroid that reduces swelling and irritation in the airways. Formoterol is a long-acting beta2-adrenergic agonist that relaxes the smooth muscles in the airways, causing them to widen and making breathing easier.
Pharmacokinetics
Onset
Formoterol: Bronchodilation starts within 1-3 minutes. Budesonide: Full therapeutic effect develops over several days to weeks.
Excretion
Mainly excreted via urine, with a small portion in feces.
Half life
Formoterol: Approximately 10 hours. Budesonide: Approximately 2-3 hours.
Absorption
Budesonide is well absorbed after inhalation, with systemic bioavailability of about 39%. Formoterol is rapidly absorbed after inhalation, reaching peak plasma concentrations within 10-30 minutes.
Metabolism
Both budesonide and formoterol are extensively metabolized in the liver, primarily by CYP3A4 enzymes.
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.
- Patients with severe milk protein allergy (for some DPI formulations containing lactose).
Drug Interactions
Non-selective beta-blockers (e.g., propranolol)
May antagonize the effect of formoterol. Concomitant use should be avoided unless compelling reasons exist.
Diuretics (e.g., furosemide, hydrochlorothiazide)
May potentiate hypokalemia and ECG changes, especially at higher doses of formoterol.
Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs)
May potentiate the effect of formoterol on the cardiovascular system. Use with extreme caution.
Potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin)
May increase systemic exposure to budesonide, potentially leading to Cushing's syndrome and adrenal suppression. Avoid concomitant use.
Storage
Store below 30°C. Protect from direct sunlight and freezing. Keep out of reach of children. Do not puncture or burn the canister.
Overdose
Symptoms of budesonide overdose include adrenal suppression. Symptoms of formoterol overdose include tachycardia, tremors, palpitations, headache, nausea, and hypokalemia. 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 considered the preferred inhaled corticosteroid during pregnancy. Formoterol has shown reproductive toxicity in animal studies. Exercise caution when administered to a nursing mother. Consult your 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.
- Patients with severe milk protein allergy (for some DPI formulations containing lactose).
Drug Interactions
Non-selective beta-blockers (e.g., propranolol)
May antagonize the effect of formoterol. Concomitant use should be avoided unless compelling reasons exist.
Diuretics (e.g., furosemide, hydrochlorothiazide)
May potentiate hypokalemia and ECG changes, especially at higher doses of formoterol.
Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs)
May potentiate the effect of formoterol on the cardiovascular system. Use with extreme caution.
Potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin)
May increase systemic exposure to budesonide, potentially leading to Cushing's syndrome and adrenal suppression. Avoid concomitant use.
Storage
Store below 30°C. Protect from direct sunlight and freezing. Keep out of reach of children. Do not puncture or burn the canister.
Overdose
Symptoms of budesonide overdose include adrenal suppression. Symptoms of formoterol overdose include tachycardia, tremors, palpitations, headache, nausea, and hypokalemia. 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 considered the preferred inhaled corticosteroid during pregnancy. Formoterol has shown reproductive toxicity in animal studies. Exercise caution when administered to a nursing mother. Consult your doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 years from the date of manufacture when stored correctly.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Budesonide/Formoterol combinations in the treatment of asthma and COPD, showing improved lung function, reduced exacerbations, and improved quality of life.
Lab Monitoring
- Potassium levels: Monitor in patients with hypokalemia or those on diuretics.
- Adrenal function: Consider monitoring in patients on high doses for prolonged periods or transitioning from systemic corticosteroids.
Doctor Notes
- Emphasize proper inhaler technique to ensure optimal drug delivery and minimize local side effects.
- Instruct patients that this is a controller medication and not to be used for acute symptoms. They should always carry a separate rescue inhaler.
- Monitor for signs of oral candidiasis and advise patients to rinse their mouth after each use.
- Be aware of potential drug interactions, especially with CYP3A4 inhibitors and beta-blockers.
Patient Guidelines
- This inhaler is for daily maintenance treatment, not for sudden asthma attacks.
- Rinse your mouth thoroughly with water and spit it out after each dose to prevent oral thrush.
- Do not exceed the prescribed dose. Seek medical attention if your symptoms worsen or if your rescue inhaler use increases.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Decomit Plus is generally not expected to affect the ability to drive or operate machinery. However, if you experience side effects like dizziness or tremor, avoid driving or operating machinery.
Lifestyle Advice
- Identify and avoid asthma/COPD triggers (e.g., allergens, irritants, smoking).
- Maintain a healthy lifestyle, including regular exercise and a balanced diet.
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