GNH USA

USA — NDC

Breo Ellipta 25 ug/1

GNH USA supplies Breo Ellipta (Fluticasone/Vilanterol), a combination inhaled corticosteroid (ICS) and long-acting β2-agonist (LABA) for asthma and COPD

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

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1
Pack/s

What is Fluticasone Furoate and Vilanterol Trifenatate?

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

What is Fluticasone Furoate and Vilanterol Trifenatate used for?

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.

What are the side effects of Fluticasone Furoate and Vilanterol Trifenatate?

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.

What precautions apply to Fluticasone Furoate and Vilanterol Trifenatate?

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.

What does Fluticasone Furoate and Vilanterol Trifenatate interact with?

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

What is Breo Ellipta used for?+
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.
How does Fluticasone/Vilanterol work?+
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.
What is the usual dose of Breo Ellipta?+
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.
Is Breo Ellipta safe during pregnancy or breastfeeding?+
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.
How do I order Breo Ellipta from GNH USA?+
To order Breo Ellipta from GNH USA, submit an enquiry on the product page at gnh-usa.com with the required quantity. GNH USA 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.
How does Breo Ellipta compare to other asthma medications?+
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.
How should Breo Ellipta be stored and handled?+
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.
How is Breo Ellipta administered?+
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.
What are the most serious risks to watch for with Breo Ellipta?+
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.
Who should not use Breo Ellipta?+
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.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Fluticasone Furoate and Vilanterol Trifenatate
Brand
Breo Ellipta
Strength
25 ug/1
Form
POWDER
Route
RESPIRATORY (INHALATION)
Pack size
1 TRAY in 1 CARTON (0173-0882-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
Manufacturer
GlaxoSmithKline LLC
Origin
USA

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