Indications

Bexitrol F HFA 25/250 Inhaler is indicated in the regular treatment of asthma where the 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. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at the usual dose.

Dosage & Administration

Inhalation Aerosol:

Adults and adolescents 12 years and older: 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 250 µg Fluticasone Propionate twice daily.

Children (4-12 years): 2 puffs of 25 µg salmeterol and 50 µg Fluticasone Propionate twice daily.

Interaction

Both non-selective and selective β-blockers should be avoided in patients with asthma unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.

Contraindications

This is contraindicated in patients with a history of hypersensitivity to any of the ingredients.

Side Effects

As this preparation contains Salmeterol and Fluticasone Propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following the concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below.

Pregnancy & Lactation

Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus or child. There is an insufficient experience in the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk.

Precautions & Warnings

Consideration should be given to additional corticosteroid therapies, and include the administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, this preparation should be administered with caution in patients with active or quiescent pulmonary tuberculosis. This preparation should be administered with caution in patients with thyrotoxicosis.

Therapeutic Class

Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids

Storage Conditions

Protect from light and moisture by storing in a cool, dry place below 30°C. Keep out of children’s reach.

Pharmaceutical Name

Beximco Pharmaceuticals Ltd

Generic

Salmeterol + Fluticasone Propionate