Breon 100 Accucap

Indications

Breon Inhalation Capsules are prescribed for the following conditions:

• Chronic Obstructive Pulmonary Disease (COPD): For long-term, once-daily maintenance therapy to alleviate airflow obstruction and reduce exacerbations in adults with COPD.
• Asthma: For the once-daily management of asthma symptoms in adults aged 18 years and older.

Important Use Limitation: Not suitable for the immediate relief of acute bronchospasm.
Always use as directed by a registered healthcare professional.

Composition

Each inhalation capsule contains:

• 25/100 mcg formulation: Vilanterol 25 mcg (as Vilanterol Trifenatate) & Fluticasone Furoate 100 mcg
• 25/200 mcg formulation: Vilanterol 25 mcg (as Vilanterol Trifenatate) & Fluticasone Furoate 200 mcg

Description

• Vilanterol Trifenatate is a long-acting, selective beta-2 agonist (LABA) that helps relax bronchial muscles and improve airflow, making it effective in managing asthma and obstructive airway diseases.
• Fluticasone Furoate is a potent corticosteroid with primarily glucocorticoid effects, targeting inflammation directly in the lungs without significant systemic absorption at recommended doses.

Pharmacology

Breon combines two active ingredients—Vilanterol (LABA) and Fluticasone Furoate (ICS)—to target different aspects of airway inflammation and obstruction.

• Vilanterol, a beta-2 agonist, stimulates intracellular adenylate cyclase, increasing cyclic AMP levels, which leads to the relaxation of bronchial smooth muscles and reduces inflammation caused by mast cells.
• Fluticasone Furoate acts locally in the lungs to reduce inflammation, inhibiting various immune cells and mediators like eosinophils, histamine, leukotrienes, and cytokines that contribute to the symptoms of COPD and asthma. The exact mechanism of action for Fluticasone Furoate is not fully understood.

Dosage & Administration

This product is for oral inhalation only. Do not swallow the capsule. Always use the capsule with the provided inhaler device. Remove the capsule from the blister pack immediately before use. After inhalation, rinse your mouth with water (do not swallow) to reduce the risk of oral thrush.

• COPD Maintenance: Inhale 1 capsule (25/100 mcg) once daily.
• Asthma: Inhale 1 capsule (25/100 mcg or 25/200 mcg) once daily.
  Always follow your healthcare provider’s instructions.

Drug Interactions

• Strong CYP3A4 inhibitors (e.g., Ketoconazole): May increase the risk of side effects. Use with caution.
• Monoamine oxidase inhibitors & tricyclic antidepressants: May intensify the vascular effects of Vilanterol.
• Beta-blockers: May counteract the bronchodilatory effects of Vilanterol.
• Diuretics: May increase the risk of hypokalemia, especially with non-potassium-sparing diuretics.

Contraindications

• Not for the primary treatment of acute asthma or COPD exacerbations.
• Not suitable for individuals with severe hypersensitivity to milk proteins or any of the ingredients in the formulation.

Side Effects

• COPD: Common side effects (≥3% incidence) include nasopharyngitis, upper respiratory tract infections, headache, oral thrush, back pain, pneumonia, bronchitis, sinusitis, cough, oral pain, muscle aches, hypertension, flu, sore throat, and fever.
• Asthma: Common side effects (≥2% incidence) include nasopharyngitis, oral thrush, headache, flu, upper respiratory tract infections, bronchitis, sinusitis, oral pain, voice changes, and cough.

Pregnancy & Lactation

There is limited data on the use of Breon Inhalation Capsules during pregnancy and breastfeeding. Consult your healthcare provider before use.

Precautions & Warnings

• Increased Risk of Asthma Events: LABA monotherapy may increase the risk of serious asthma-related complications.
• Acute Symptoms: Do not use for treating acute COPD or asthma symptoms.
• Candida Infections: Inhaled corticosteroids may cause oral thrush. Rinse your mouth after use to reduce the risk.
• Pneumonia Risk: Patients with COPD are at higher risk of pneumonia. Monitor for symptoms.
• Infection Risks: Use with caution in patients with active or recent infections, such as tuberculosis, fungal, bacterial, or viral infections.
• Adrenal Suppression: When switching from oral corticosteroids, gradually taper the dosage to avoid adrenal insufficiency.
• Paradoxical Bronchospasm: If bronchospasm occurs, discontinue use immediately.
• Cardiovascular Concerns: Use with caution in patients with heart conditions due to beta-adrenergic stimulation.
• Ophthalmic Monitoring: Long-term ICS use may lead to cataracts or glaucoma. Refer to an ophthalmologist if symptoms occur.
• Bone Health: Monitor bone density periodically, especially in long-term users.

Use in Special Populations

• Children & Adolescents: Not recommended for children under 18 as safety and efficacy are not established.
• Hepatic Impairment: In patients with moderate to severe liver impairment, monitor for increased systemic corticosteroid effects.

Overdose

There are no available clinical data on overdose with Breon Inhalation Capsules. Seek immediate medical attention if an overdose is suspected.

Therapeutic Class

Respiratory corticosteroids

Storage Conditions

Store in a cool, dry place, away from direct sunlight and heat. Keep out of reach of children. Avoid contact with eyes.