Bexitrol F HFA 25/125 Inhaler — Salmeterol 25mcg + Fluticasone 125mcg by Beximco

Indications

Bexitrol F is indicated in the regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate: - Patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting β2-agonist or - Patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist.

Pharmacology

Salmeterol Xinafoate is a selective, long-acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airway obstruction. Salmeterol is a selective long-acting (12-hour) beta-2-adrenoceptor agonist. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma. Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations.

Dosage & Administration

Adults and adolescents 12 years and older: 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone twice daily, or 2 puffs of 25 µg+125 µg twice daily, or 2 puffs of 25 µg+250 µg twice daily. Children (4-12 years): 2 puffs of 25 µg+50 µg twice daily. Rinsing the mouth after each inhalation is advised.

Side Effects

Salmeterol: tremor, subjective palpitations, headache, cardiac arrhythmia, arthralgia, hypersensitivity reactions including rash, oedema and angioedema. Fluticasone Propionate: hoarseness and candidiasis of the mouth and throat, cutaneous hypersensitivity reactions, rare cases of facial and oropharyngeal oedema.

Precautions & Warnings

Should not be initiated in patients during an exacerbation or if they have unstable or acutely deteriorating asthma. Not for relief of acute symptoms — a fast and short-acting bronchodilator is required for that purpose. Patients should be advised to have relief medication available at all times. In COPD patients, increased reporting of pneumonia has been observed.

Contraindications

Contraindicated in patients with a history of hypersensitivity to salmeterol xinafoate, fluticasone propionate or any of the excipients. Contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma.

Pregnancy & Lactation

Should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus or child. Insufficient experience of use in human pregnancy and lactation. Plasma concentrations after inhaled therapeutic doses are very low.

Storage Conditions

Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from eyes and children.

Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult your physician or pharmacist before starting any medication.