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Formoterol 12 mcg with Budesonide 400 mcg – Asthma & COPD Maintenance

May 05, 2025

Introduction

BUDEPRESS FORTE 400 Capsules combine two potent agents – Budesonide, a corticosteroid, and Formoterol Fumarate, a long-acting beta-2 agonist (LABA). This fixed-dose combination is widely prescribed for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD), especially in moderate to severe cases.This formulation delivers targeted therapy via inhalation, offering anti-inflammatory and bronchodilatory benefits that improve lung function and reduce the frequency of exacerbations.

What Is Budesonide and Formoterol Fumarate?

  • Budesonide (400 mcg): An inhaled corticosteroid (ICS) that reduces inflammation, swelling, and mucus production in the lungs.

  • Formoterol Fumarate (12 mcg): A long-acting beta-agonist that relaxes bronchial smooth muscles, providing up to 12 hours of bronchodilation.

Together, they address both underlying airway inflammation and bronchoconstriction, offering comprehensive respiratory support.

Key Benefits of BUDEPRESS FORTE 400

Benefit Description
Dual-action relief Anti-inflammatory (Budesonide) + Bronchodilation (Formoterol)
Improves lung function Enhances FEV₁ and PEF scores
Reduces exacerbations Fewer asthma or COPD flare-ups
Quick onset, long duration Formoterol acts within minutes and lasts up to 12 hours
Convenient capsule form Designed for use with a dry powder inhaler (DPI)
Once or twice-daily use Based on disease severity and physician advice

Indications and Uses

BUDEPRESS FORTE 400 is indicated for:

  • Asthma (moderate to severe) not adequately controlled with ICS alone

  • Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema

  • Maintenance therapy to reduce the risk of exacerbations and improve quality of life

How to Use

  • Inhalation only. Use with a suitable Dry Powder Inhaler (DPI) device.

  • Do not swallow the capsule.

  • Insert one capsule into the inhaler, puncture, and inhale deeply through the mouth.

  • Rinse mouth after inhalation to avoid oral thrush.

Dosage Guidelines

Condition Dosage
Asthma (Adults & adolescents ≥12 yrs) 1 capsule twice daily or as prescribed
COPD 1 capsule twice daily
Max daily dose 800 mcg Budesonide + 24 mcg Formoterol (2 capsules/day)

Dosage may vary. Always follow your physician’s instructions.

Mechanism of Action

  • Formoterol Fumarate: Stimulates beta-2 receptors causing bronchodilation, easing airflow obstruction.

  • Budesonide: Suppresses inflammation by inhibiting multiple inflammatory cytokines and mediators in the lungs.

This combination controls both the symptoms and the progression of obstructive airway diseases.

Pharmacokinetics

  • Formoterol:

    • Onset: ~1–3 minutes

    • Duration: ~12 hours

    • Metabolism: Hepatic (CYP2D6, CYP2C19)

  • Budesonide:

    • Onset: ~2–6 hours

    • Duration: Depends on inflammation control

    • Metabolism: Hepatic (CYP3A4)

Side Effects

Common:

  • Cough or throat irritation

  • Headache

  • Hoarseness or voice changes

  • Oral candidiasis (thrush)

Rare but Serious:

  • Paradoxical bronchospasm

  • Hypokalemia

  • Adrenal suppression (with prolonged use)

  • Increased heart rate or palpitations

Tip: Rinse your mouth and gargle after each use to minimize oral infections.

Warnings & Precautions

  • Not for acute asthma attacks or rescue use – use a short-acting bronchodilator (SABA) like salbutamol in emergencies.

  • Monitor blood glucose in diabetics.

  • Use cautiously in patients with cardiovascular disease, seizure disorders, or hyperthyroidism.

  • Avoid abrupt discontinuation.

Contraindications

  • Hypersensitivity to budesonide or formoterol

  • Primary treatment of status asthmaticus

  • Children below 12 years (unless prescribed by a physician)

Drug Interactions

Drug Class Effect
Beta-blockers (e.g., atenolol) May reduce bronchodilation effect
Strong CYP3A4 inhibitors (e.g., ketoconazole) Increase systemic exposure to Budesonide
Diuretics Risk of hypokalemia
MAO inhibitors, tricyclics May enhance cardiovascular side effects

Storage Instructions

  • Store below 30°C

  • Keep capsules in blister until use

  • Protect from moisture and direct sunlight

  • Keep out of reach of children

Frequently Asked Questions (FAQs)

Q1. Can I use BUDEPRESS FORTE 400 during an asthma attack?
No, it is a maintenance medicine. Use a fast-acting bronchodilator like salbutamol during acute attacks.

Q2. How soon does it start working?
Formoterol begins working within 1–3 minutes, but full control of inflammation (from Budesonide) may take a few days.

Q3. Is BUDEPRESS FORTE 400 suitable for long-term use?
Yes, it is designed for long-term control of asthma and COPD under medical supervision.

Q4. What should I do if I miss a dose?
Take it as soon as you remember. If it’s close to the next dose, skip the missed one. Never double the dose.

Q5. Can it be used in children?
Use in children below 12 should only be under strict medical guidance.

Conclusion

BUDEPRESS FORTE 400 Capsules (Budesonide 400 mcg + Formoterol Fumarate 12 mcg) provide dual-action maintenance therapy for asthma and COPD. With effective control of both inflammation and bronchospasm, it significantly reduces exacerbations and improves lung function when used consistently.

About The Author

STERIS HEALTHCARE PVT LTD

Steris Healthcare Pvt Ltd, known as Sterispharma, was founded in February 2018 by a team of experienced professionals in the pharmaceutical industry. Headquartered in Navi Mumbai, the company holds certifications from WHO, GMP, and ISO, reflecting its dedication to maintaining high standards of quality and safety. Sterispharma’s mission is to provide affordable, high-quality medications across India, strictly adhering to WHO guidelines. With the convenience of an online pharmacy, customers can easily order medicines with home delivery options.

For further information 

Email: info@sterispharma.com / contact@sterispharma.com

Call/WhatsApp: 8209542042 , 8824175417

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