Product image of Breo Ellipta 25 ug/1 (Fluticasone Furoate and Vilanterol Trifenatate) 25 ug/1 POWDER supplied by GNH India

Breo Ellipta 25 ug/1

Active Ingredient:
Fluticasone Furoate and Vilanterol Trifenatate
Form:
POWDER
Brand:
Breo Ellipta
Origin:
USA

Breo Ellipta 25 ug/1 (Fluticasone Furoate and Vilanterol Trifenatate POWDER) 25 ug/1

Fluticasone furoate and vilanterol, the active ingredient in Breo Ellipta, is a combination inhaled corticosteroid (ICS) and long-acting β2-agonist (LABA) presented as a 25 µg per inhalation powder for respiratory use. It is used for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD) in eligible patients.

GNH India supplies Breo Ellipta as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

Strength

25 ug/1

Pack Size

1 TRAY in 1 CARTON (0173-0882-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER

Manufacturer / TM Owner

GlaxoSmithKline LLC

1
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Indications & Clinical Uses

Breo Ellipta is a combination medication used to manage respiratory conditions. It is primarily prescribed for the following conditions:

  • Asthma: Helps control and prevent symptoms such as wheezing, shortness of breath, coughing, and chest tightness.
  • COPD: Reduces inflammation and improves airflow in the lungs to manage symptoms like chronic bronchitis and emphysema.

How It Works

  • Fluticasone furoate binds to glucocorticoid receptors, reducing airway inflammation. Vilanterol activates β2-adrenergic receptors, producing prolonged bronchodilation. Together, they help manage symptoms of asthma and COPD by reducing inflammation and opening airways.

Side Effects

Breo Ellipta may cause various side effects, ranging from common to serious.

Common Side Effects

  • Headache: Mild to moderate pain in the head.
  • Throat irritation: Soreness or discomfort in the throat.
  • Nasal congestion: Stuffy or runny nose.
  • Back pain: Discomfort or pain in the back.
  • Joint pain: Aching or discomfort in the joints.
  • Sinusitis: Inflammation of the sinuses.
  • Oral thrush: Fungal infection in the mouth.
  • Cough: Persistent coughing.

Serious or Rare Side Effects

  • Worsening of breathing problems: Severe asthma attacks or COPD exacerbations.
  • Pneumonia: Lung infection, especially in COPD patients.
  • Cardiovascular effects: Increased heart rate, palpitations, or changes in blood pressure.
  • Eye problems: Increased risk of glaucoma or cataracts.
  • Osteoporosis: Weakened bones.
  • Hypokalemia: Low potassium levels in the blood.
  • Allergic reactions: Hives, rash, or swelling of the face, lips, or tongue.

Precautions & Warnings

Breo Ellipta should be used with caution and under medical supervision. Important precautions include:

  • Not for rescue use: Do not use during sudden breathing problems; a rescue inhaler is required for acute symptoms.
  • Regular monitoring: Frequent eye exams and bone density tests may be needed due to the risk of glaucoma, cataracts, and osteoporosis.
  • Infections: Increased risk of pneumonia in COPD patients; monitor for signs of infection.
  • Cardiovascular conditions: Use cautiously in patients with heart conditions, hypertension, or arrhythmias.
  • Hypokalemia: Monitor potassium levels regularly, especially in high-risk patients.
  • Storage: Store at room temperature and away from sunlight, excess heat, and moisture. Keep in the foil tray and out of reach of children. Dispose of the inhaler 6 weeks after removing it from the foil overwrap or when the dose indicator reads 0, whichever comes first.

Avoid Interactions

Breo Ellipta may interact with other medications, potentially affecting its efficacy or increasing the risk of side effects.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors: Can increase the risk of systemic side effects of fluticasone and vilanterol.
  • Beta-blockers: May reduce the effectiveness of vilanterol and worsen breathing problems.
  • MAO inhibitors: Can increase the risk of cardiovascular side effects.
  • Tricyclic antidepressants: May enhance the cardiovascular effects of vilanterol.
  • Monoamine oxidase inhibitors: Can increase the risk of adverse cardiovascular effects.

Moderate Interactions (Monitor Closely)

  • Other corticosteroids: May increase the risk of systemic side effects.
  • Diuretics: Can increase the risk of hypokalemia.
  • Anticholinergics: May enhance the bronchodilator effects but also increase the risk of side effects.
  • Theophylline: Can increase the risk of cardiovascular side effects and hypokalemia.

Frequently Asked Questions

Breo Ellipta is used for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It helps control and prevent symptoms such as wheezing, shortness of breath, coughing, and chest tightness in asthma, and manages symptoms like chronic bronchitis and emphysema in COPD.

Fluticasone furoate is a corticosteroid that reduces inflammation in the airways by binding to glucocorticoid receptors. Vilanterol is a long-acting beta-agonist that relaxes the muscles around the airways, making it easier to breathe. Together, they help manage symptoms of asthma and COPD.

The usual dose of Breo Ellipta is determined by a healthcare provider based on the patient's condition and response to treatment. It is typically inhaled once a day, but the exact dosage should be prescribed by a doctor.

Breo Ellipta is classified as a Category C medication during pregnancy, meaning it should be used with caution. The safety of Breo Ellipta during breastfeeding has not been established. Patients should consult their healthcare provider before using this medication during pregnancy or breastfeeding.

To order Breo Ellipta from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will then provide pricing, availability, shipping, and the necessary import paperwork.

Breo Ellipta is a combination of an inhaled corticosteroid and a long-acting beta-agonist, which makes it effective for both reducing inflammation and opening airways. Compared to other asthma medications, it offers a dual-action approach, which can be beneficial for patients who need both anti-inflammatory and bronchodilator effects.

Breo Ellipta should be stored at room temperature and away from sunlight, excess heat, and moisture. Keep it in the foil tray and out of reach of children. Dispose of the inhaler 6 weeks after removing it from the foil overwrap or when the dose indicator reads 0, whichever comes first.

Breo Ellipta is administered via inhalation using a special inhaler. The medication comes as a powder and is usually inhaled once a day. Patients should follow the instructions provided by their healthcare provider and the inhaler's user guide.

The most serious risks associated with Breo Ellipta include severe asthma attacks or COPD exacerbations, pneumonia (especially in COPD patients), cardiovascular effects such as increased heart rate or changes in blood pressure, and eye problems like glaucoma or cataracts. Patients should monitor for these risks and consult their healthcare provider if any severe symptoms occur.

Breo Ellipta should not be used by individuals with severe hypersensitivity to its ingredients or those with a severe milk protein allergy. It is also not recommended for use during sudden COPD attacks. Patients with certain cardiovascular conditions, such as coronary insufficiency, cardiac arrhythmias, or hypertension, should use it with caution.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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