Bexitrol F 25/125 HFA Inhaler, 1 Inhaler [Salmetrol 25mcg + Fluticasone 125mcg]

Bexitrol® -F HFA Inhalation Aerosol Salmeterol and Fluticasone Propionate Description

Bexitrol® -F metered dose inhaler is a combination of Salmeterol Xinafoate BP and Fluticasone Propionate BP. Salmeterol Xinafoate is a selective, long acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airways 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 usual dose.IndicationBexitrol® -F is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: – patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting beta-2-agonist or, – patients already adequately controlled on both inhaled corticosteroids and long-acting beta-2-agonist

Recommended Dosage

Adults and adolescents 12 years and olderTwo inhalations of 25 μg Salmeterol and 50 μg Fluticasone Propionate twice daily. or, Two inhalations of 25 μg Salmeterol and 125 μg Fluticasone Propionate twice daily. or, Two inhalations of 25 μg Salmeterol and 250 μg Fluticasone Propionate twice daily.

Contraindications

Bexitrol® -F is contraindicated in patients with a history of hypersensitivity to any of the ingredients.Special Warnings and Special PrecautionsConsideration should be given to additional corticosteroid therapies, and toincluding administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, Bexitrol®-F should be administered with caution in patients with active or quiescent pulmonary tuberculosis. Bexitrol® -F should be administered with caution in patients with thyrotoxicosis.

Precaution for Paediatric Use

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.

Drug 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.

Use During Pregnancy and 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 foetus or child. There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk.

Undesirable Effects

As Bexitrol® -F 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 concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below. Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps. Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler. Salmeterol/ Fluticasone Propionate clinical trials: The following undesirable effects were commonly reported: Hoarseness/dysphonia, throat irritation, headache, candidiasis of mouth and throat and palpitations.

Overdose

There are no data available from clinical trials on overdose with Bexitrol® -F.Pharmacodynamic PropertiesMechanism of action Bexitrol® -F contains Salmeterol and Fluticasone Propionate, which have different modes of action. Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. Bexitrol® -F can offer a more convenient regime for patients on concurrent βagonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below: Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor. Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.

Pharmaceutical Precautions

Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30oC. Keep away from eyes. Keep away from children.Commercial PackBexitrol® -F 25/250: Each canister contains 60 and 120 metered doses, each actuation delivers Salmeterol Xinafoate BP equivalent to 25 μg Salmeterol and Fluticasone Propionate BP 250 μg. Bexitrol® -F 25/125: Each canister contains 120 metered doses, each actuation delivers Salmeterol Xinafoate BP equivalent to 25 μg Salmeterol and Fluticasone Propionate BP 125 μg. Bexitrol® -F 25/50: Each canister contains 120 metered doses, each actuation delivers Salmeterol Xinafoate BP equivalent to 25 μg Salmeterol and Fluticasone Propionate BP 50 μg. Manufactured by BEXIMCO PHARMACEUTICALS LTD. Tongi, Bangladesh 5000100 050209 ® Bexitrol is a registered trademark of Beximco Pharmaceuticals Ltd.