Bilexa 100/25

Indications

Neobloc-V is indicated for:

• • Chronic Obstructive Pulmonary Disease (COPD): Long-term, once-daily maintenance treatment to manage airflow obstruction and reduce exacerbations.
  • Asthma: Daily treatment for adults (18 years and older).

Important Note: Not suitable for acute bronchospasm relief.

Composition

• 25/100 Inhalation Capsule: Contains 25 mcg Vilanterol (as Vilanterol Trifenatate) and 100 mcg Fluticasone Furoate.
• 25/200 Inhalation Capsule: Contains 25 mcg Vilanterol and 200 mcg Fluticasone Furoate.

Description

• Vilanterol Trifenatate: A long-acting beta-2 agonist that helps manage asthma and airway obstruction by relaxing bronchial muscles and enhancing airflow.
• Fluticasone Furoate: A corticosteroid with glucocorticoid activity, targeting inflammation in the lungs without significant systemic effects.

Pharmacology

• Vilanterol: Stimulates beta-2 adrenergic receptors, increasing cyclic AMP levels, which relaxes bronchial smooth muscle and reduces mediator release.
• Fluticasone Furoate: Reduces inflammation by affecting various cell types and mediators involved in respiratory conditions.

Dosage & Administration

• Administration: Inhalation only. Do not swallow capsules. Use the inhaler device and rinse mouth with water after use to prevent oral candidiasis.
• COPD: 1 inhalation of 25/100 mcg daily.
• Asthma: 1 inhalation of either 25/100 mcg or 25/200 mcg daily.

Always follow your doctor’s instructions for use.

Interactions

• CYP2D6 Inhibitors: May increase Vilanterol levels.
• Reserpine/Clonidine: Caution advised due to potential excessive sympathetic activity reduction.
• Digitalis Glycosides: Risk of bradycardia.
• Calcium Channel Blockers (e.g., Verapamil, Diltiazem): May cause severe reductions in heart rate and blood pressure.
• Potassium-Sparing Diuretics/Supplements: Risk of elevated serum potassium.
• NSAIDs: May reduce antihypertensive efficacy and increase renal impairment risk.
• Dual Renin-Angiotensin System Inhibition: Risk of renal impairment, hypotension, and hyperkalemia.

Contraindications

• Not for primary treatment of severe asthma or acute COPD episodes.
• Contraindicated in severe hypersensitivity to milk proteins or any component.

Side Effects

• COPD: Nasopharyngitis, upper respiratory infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, and sinusitis.
• Asthma: Nasopharyngitis, oral candidiasis, headache, influenza, upper respiratory infection, and dysphonia.

Pregnancy & Lactation

• Pregnancy: Not recommended due to potential fetal harm.
• Lactation: Avoid breastfeeding while using this medication.

Precautions & Warnings

• Asthma/COPD Exacerbation: Avoid abrupt discontinuation.
• Diabetes: Monitor glucose levels as beta-blockers may mask hypoglycemia symptoms.
• Infections: Caution with existing infections and monitor for pneumonia in COPD patients.
• Adrenal Function: Taper off systemic corticosteroids gradually when switching to this medication.

Use in Special Populations

• Children & Adolescents: Not indicated for those under 18. Safety and efficacy in this group are not established.
• Hepatic Impairment: Increased systemic exposure in moderate to severe impairment; monitor for corticosteroid effects.

Overdose Effects

• Nebivolol: Provide supportive care; treat bradycardia, hypotension, and heart block with specific measures.
• Valsartan: May cause hypotension and tachycardia; not removed by hemodialysis.

Therapeutic Class

Respiratory Corticosteroids.

Storage Conditions

Store in a cool, dry place away from light. Avoid exposure to direct sunlight or heat. Keep out of reach of children.