Product image of Miflonid Breezhaler (Budesonide) supplied by GNH India

Miflonid Breezhaler

Active Ingredient:
Budesonide
Origin:
EU

Miflonid Breezhaler (Budesonide)

Budesonide, the active ingredient in Miflonid Breezhaler, is a glucocorticoid corticosteroid presented as an inhalation powder for inhalation use. It reduces airway inflammation and is indicated for the long‑term management of asthma and chronic obstructive pulmonary disease (COPD) in adults and children when prescribed by a healthcare professional.

GNH India supplies Miflonid Breezhaler as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑assured products that meet EU regulatory standards with reliable logistics and regulatory support for cross‑border distribution.

Manufacturer / TM Owner

Novartis S.R.O.,

1
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Indications & Clinical Uses

Miflonid Breezhaler (budesonide) is a glucocorticoid inhaled to control airway inflammation in respiratory disease.

  • Asthma: improves symptom control and reduces frequency of exacerbations.
  • Chronic obstructive pulmonary disease (COPD): decreases airway inflammation and helps maintain lung function.
  • Bronchial hyperresponsiveness: reduces airway reactivity to triggers.

How It Works

  • Budesonide binds to intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus and modulates gene transcription. This suppresses the production of pro‑inflammatory cytokines, chemokines, and adhesion molecules while enhancing anti‑inflammatory proteins such as lipocortin‑1. The net effect is reduced inflammatory cell infiltration, mucus secretion, airway edema, and hyperresponsiveness.

Side Effects

Inhaled budesonide may cause a range of adverse reactions, most of which are mild and related to the local airway or systemic exposure.

Common Side Effects

  • Hoarseness or voice change.
  • Oral thrush (candidiasis).
  • Cough or throat irritation.
  • Headache.

Serious or Rare Side Effects

  • Paradoxical bronchospasm.
  • Adrenal suppression with long‑term high‑dose use.
  • Severe allergic reaction (anaphylaxis, angioedema).

Precautions & Warnings

Before prescribing Miflonid Breezhaler, clinicians should consider several safety precautions.

  • Assess infection: screen for active respiratory infections before initiating therapy.
  • Monitor growth: children on long‑term inhaled corticosteroids should have growth monitored regularly.
  • Evaluate bone health: prolonged high‑dose use may affect bone mineral density; consider calcium/vitamin D supplementation.
  • Use spacer: recommend a spacer device and mouth rinsing after inhalation to reduce oral candidiasis.
  • Review drug interactions: check for concomitant use of strong CYP3A4 inhibitors that may increase systemic exposure.
  • Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Budesonide can interact with other medicines that affect its metabolism or enhance corticosteroid effects.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) may markedly increase systemic budesonide levels, raising risk of adrenal suppression.
  • Systemic corticosteroids: concurrent use can lead to additive glucocorticoid effects and increased side‑effect risk.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles (e.g., fluconazole) may modestly raise budesonide exposure.
  • Protease inhibitors such as ritonavir can increase plasma concentrations.
  • Diuretics (e.g., furosemide) may potentiate hypokalemia when combined with systemic corticosteroid effects.

Frequently Asked Questions

Miflonid Breezhaler contains budesonide, an inhaled corticosteroid that is used to control and prevent symptoms of asthma and chronic obstructive pulmonary disease (COPD). It works by reducing airway inflammation, helping patients maintain better breathing function and decreasing the frequency of disease exacerbations.

Budesonide binds to glucocorticoid receptors inside airway cells, altering gene expression to suppress the production of inflammatory mediators such as cytokines and chemokines. This reduces swelling, mucus production, and immune‑cell infiltration, leading to less airway narrowing and improved airflow.

The dose of Miflonid Breezhaler is individualized by a qualified prescriber based on the severity of the patient’s asthma or COPD, age, and response to therapy. The prescribing clinician determines the number of inhalations per day and any necessary adjustments over time.

Safety data for budesonide inhalation during pregnancy and lactation are limited. The product should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss use with their healthcare provider.

To request Miflonid Breezhaler, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and the necessary import documentation.

Miflonid Breezhaler delivers budesonide, which has a high topical potency and low systemic bioavailability, similar to other inhaled corticosteroids such as fluticasone propionate. Differences lie mainly in device design, particle size distribution, and specific pharmacokinetic profiles, which can affect patient preference and adherence.

Store the Breezhaler device and its inhalation powder at ambient temperature, preferably below 25 °C. Keep it in the original packaging, protect it from moisture, heat, and direct sunlight. Do not expose the inhaler to freezing conditions, and ensure the device is kept out of reach of children.

The patient removes a capsule from the Breezhaler device, inserts it, and inhales through the mouthpiece with a steady, deep breath. After inhalation, the patient should hold their breath for about 10 seconds, then rinse the mouth with water and spit to reduce the risk of oral candidiasis.

Serious risks include paradoxical bronchospasm, adrenal suppression with prolonged high‑dose use, and severe allergic reactions such as anaphylaxis or angioedema. Patients should be instructed to seek immediate medical attention if they experience sudden worsening of breathing, severe swelling, or signs of systemic corticosteroid excess.

Miflonid Breezhaler is contraindicated in individuals with a known hypersensitivity to budesonide or any component of the inhaler device. It should also be avoided in patients with untreated active infections of the respiratory tract until the infection is resolved, and in those for whom systemic corticosteroid therapy is contraindicated.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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