Indications

Breon inhalation capsule is indicated in-
. Long-term, once-daily, maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
. Once-daily treatment of asthma in patients aged 18 years and older.
Important limitation of use: Not indicated for relief of acute bronchospasm.

Composition

25/50 inhalation capsule: Each dry powder inhaler capsule contains Vilanterol 25 mcg (as Vilanterol Trifenatate INN) & Fluticasone Furoate INN 50 mcg

25/100 inhalation capsule: Each dry powder inhaler capsule contains Vilanterol 25 mcg (as Vilanterol Trifenatate INN) & Fluticasone Furoate INN 100 mcg

25/200 inhalation capsule: Each dry powder inhaler capsule contains Vilanterol 25 mcg (as Vilanterol Trifenatate INN) & Fluticasone Furoate INN 200 mcg

Description

Vilanterol Trifenatate is a selective, long-acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airway obstruction. Fluticasone Furoate is a corticosteroid with mainly
glucocorticoid activity. Fluticasone Furoate is stated to exert a topical effect on the lungs without systematic effects at the usual dose.

Pharmacology

This preparation contains both futicasone furoate and vilanterol, the mechanisms of action described below for the individual components. These drugs represent 2 diferent classes of medications (a
synthetic corticosteroid and a LABA) that have diferent efects on clinical and physiological aspects. The pharmacologic efects of beta 2-adrenoceptor agonist drugs, including vilanterol, are at least in
part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3, 5-adenosine monophosphate (cyclic AMP).
Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. The precise
mechanism through which futicasone furoate afects COPD and asthma symptoms is not known. Infammation is an important component in the pathogenesis of COPD and asthma. Corticosteroids have
been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes,
cytokines) involved in infammation.

Dosage & Administration

This inhalation capsule must not be swallowed. Only to be used with the device. Remove the capsule from the blister pack only immediately before using it in the inhalation device. After inhalation, rinse
your mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis.

Route of administration: Oral inhalation.

Maintenance treatment of COPD: 1 inhalation of 25/100 mcg once daily.

Asthma: 1 inhalation of 25/100 mcg or 25/200 mcg once daily.

Interaction

. Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects.
. Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of vilanterol on vascular system.
. Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm.
. Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non-potassium-sparing diuretics may worsen with concomitant beta-agonists.

Contraindications

. Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures.
. Severe hypersensitivity to milk proteins or any ingredients.