Bexitrol-F 25/250

Inhaler:

This is indicated in the regular treatment of asthma where use of a combination product (long-acting ß2-agonist and inhaled corticosteroid) is appropriate:

• patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting ß2-agonist or
• patients already adequately controlled on both inhaled corticosteroid and long-acting ß2-agonist.

Inhalation Powder in Capsule:

Treatment of asthma: Fluticasone Propionate & Salmeterol Xinafoate combination is indicated for the treatment of asthma in patients aged 4 years and older. It is indicated for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. It is not indicated for the relief of acute bronchospasm.

Maintenance treatment of chronic obstructive pulmonary disease: Fluticasone Propionate & Salmeterol Xinafoate combination is indicated for the maintenance treatment of airflow obstruction and to reduce exacerbations in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.

Long-acting selective β2-adrenoceptor stimulants, Respiratory corticosteroids

Salmeterol & Fluticasone Propionate HFA inhaler is a combination of Salmeterol and Fluticasone Propionate. Salmeterol is a selective, long acting ß2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate is corticosteroid with potent anti-inflammatory activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systemic effects at usual dose.

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.

Inhalation Powder in Capsule (For Asthma):

Adult and Adolescent (12 Years and Older): Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart).

The recommended starting dosages for Salmeterol 50 µg & Fluticasone 100 µg & Salmeterol 50 µg & Fluticasone 250 µg for patients aged 12 years and older are based upon patients asthma severity.

The maximum recommended dosage is Salmeterol 50 µg & Fluticasone 500 µg twice daily.

Pediatric Patients (4 to 11 Years): For patients with asthma who are not controlled on an inhaled corticosteroid, the dosage is Salmeterol 50 µg & Fluticasone 100 µg twice daily (morning and evening, approximately 12 hours apart).

Chronic obstructive pulmonary disease: Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart). Rinsing the mouth after each inhalation is advised.

The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Fluticasone Propionate & Salmeterol Xinafoate combination is contraindicated because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. Ketoconazole, beta-adrenergic receptor blocking agents and nonpotassium-sparing diuretics are also contraindicated.

The use of Fluticasone Propionate & Salmeterol Xinafoate combination is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
• Severe hypersensitivity to milk proteins.

The common side effects experienced are oral candidiasis, pneumonia, immunosuppression hypercorticism, adrenal suppression, growth retardation, glaucoma and cataracts etc. The few side effects have been reported infrequently like ear signs and symptoms; nasal signs and symptoms; nasal sinus disorders; keratitis and conjunctivitis; dental discomfort and pain; gastrointestinal signs and symptoms; oral ulcerations; oral discomfort and pain; lower respiratory signs and symptoms; muscle stiffness, tightness, and rigidity; bone and cartilage disorders; sleep disorders; compressed nerve syndromes; chest symptoms; fluid retention; unusual taste; viral skin infections; disorders of sweat and sebum.

Pregnancy category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of Fluticasone Propionate & Salmeterol Xinafoate combination to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.