Medicine Information

Budetrol

Name: Budetrol
Brand: Budetrol
Rating: 4.5 (117 reviews)

Inhalation Capsule (for use with inhaler device)Budesonide 200 mcg + Formoterol 6 mcgAnti-asthmatic & COPD preparations, Combinations (Corticosteroids & LABAs)ATC: R03AK07

Generic Name

Budesonide + Formoterol Fumarate Dihydrate

Manufacturer

Square Pharmaceuticals Ltd.

Country

Bangladesh

Loading images...

Price Details

Current market pricing information

Variant	Unit Price	Strip Price
budetrol 200 mcg inhalation capsule	৳ 9.00	৳ 90.00

Description

Overview of the medicine

Budetrol 200 mcg Inhalation Capsule is a combination medicine containing Budesonide (an inhaled corticosteroid) and Formoterol Fumarate Dihydrate (a long-acting beta2-agonist). It is used to manage asthma and chronic obstructive pulmonary disease (COPD) by reducing airway inflammation and relaxing airway muscles, making breathing easier.

Uses & Indications

Regular treatment of asthma where a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate

Symptomatic treatment of patients with severe chronic obstructive pulmonary disease (COPD) with a history of repeated exacerbations and who have significant symptoms despite regular therapy with long-acting bronchodilators

Dosage

Adults

1 capsule (Budesonide 200 mcg + Formoterol 6 mcg) inhaled twice daily.

Elderly

No specific dose adjustment generally required, but monitor for adverse effects.

Renal_impairment

No specific dose adjustment required.

How to Take

For inhalation use only. Do not swallow the capsule. The capsule should be placed in a suitable inhalation device (e.g., Rotahaler, Revolizer) and the contents inhaled through the mouth. Rinse mouth with water after use to minimize risk of oral thrush.

Mechanism of Action

Budesonide acts as an anti-inflammatory agent, reducing swelling and irritation in the airways by inhibiting the release of inflammatory mediators. Formoterol acts as a long-acting beta2-agonist, relaxing the smooth muscles of the airways and causing bronchodilation, which helps to widen the air passages and improve airflow.

Pharmacokinetics

Onset

Bronchodilation within 1-3 minutes (Formoterol). Anti-inflammatory effects of Budesonide develop over days to weeks.

Excretion

Primarily renal excretion for metabolites, some fecal excretion.

Half life

Budesonide: approximately 2-2.8 hours. Formoterol: approximately 8-10 hours.

Absorption

Budesonide: rapidly absorbed after inhalation, systemic bioavailability 10-20%. Formoterol: rapidly absorbed, systemic bioavailability approx. 10%.

Metabolism

Primarily hepatic metabolism via CYP3A4 for both.

Side Effects

Contraindications

Hypersensitivity to budesonide, formoterol, or any excipients
Acute asthma attacks or acute exacerbation of COPD requiring intensive care
Patients with uncorrected hypokalemia

Drug Interactions

Beta-blockers (non-selective)

May reduce the effect of formoterol. Avoid concurrent use unless compelling reasons.

Ketoconazole, Itraconazole, Ritonavir

May increase systemic exposure to budesonide. Use with caution.

Diuretics, Xanthine derivatives, Steroids

May potentiate hypokalemic effect of formoterol. Monitor potassium levels.

Tricyclic antidepressants, MAO inhibitors

May potentiate cardiovascular effects of formoterol. Use with caution.

Storage

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.

Overdose

Symptoms may include tremor, headache, palpitations, tachycardia, metabolic acidosis, hypokalemia, hyperglycemia, and possibly systemic corticosteroid effects like adrenal suppression. Treatment is supportive and symptomatic.

Pregnancy & Lactation

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is generally considered safe. Formoterol has shown reproductive toxicity in animal studies. Consult a doctor. Small amounts of budesonide and formoterol pass into breast milk; caution advised.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

Pack of 10 capsulesPack of 30 capsules

Shelf Life

Typically 24-36 months from manufacturing date, check specific packaging.

Availability

Pharmacies, Hospitals

Approval Status

Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)

Patent Status

Generic versions available, original patent expired

WHO Essential Medicine

Yes

Clinical Trials

Extensive clinical trials have demonstrated the efficacy and safety of budesonide/formoterol combination in asthma and COPD management, showing superior control compared to monotherapy.

Lab Monitoring

Serum potassium levels (especially in patients with severe asthma or on concomitant therapies)
Blood glucose levels (especially in diabetics)
Adrenal function (in patients switching from oral corticosteroids or on high doses for long periods)

Doctor Notes

Emphasize proper inhalation technique to optimize drug delivery.
Patients should be instructed on the difference between maintenance and rescue inhalers.
Monitor for systemic corticosteroid side effects, especially in patients on high doses or those with risk factors.

Patient Guidelines

Use regularly as prescribed, even when feeling well.
Do not use for sudden breathing problems; use a rapid-acting 'rescue' inhaler for acute symptoms.
Rinse your mouth with water after each dose to prevent oral thrush.
If your symptoms worsen or you need your rescue inhaler more often, contact your doctor immediately.

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 resume your regular dosing schedule. Do not double the dose.

Driving Precautions

Generally, this medicine does not affect the 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 respiratory irritants.
Stay hydrated and maintain a healthy diet.
Regular exercise, as tolerated, can improve lung function and overall well-being.