Bexitrol F Maxhaler 50/250

Indications

This medication is recommended for the ongoing management of asthma when a combination of a long-acting β2-agonist and an inhaled corticosteroid is appropriate. It is particularly useful for:

• Patients whose asthma is not sufficiently controlled by inhaled corticosteroids and ‘as needed’ short-acting β2-agonists.
• Patients who are already managing well with both inhaled corticosteroids and long-acting β2-agonists.

Pharmacology

Salmeterol Xinafoate is a selective, long-acting β2-agonist designed for asthma and other types of diffuse airway obstruction. Fluticasone Propionate is a corticosteroid with potent glucocorticoid properties, specifically targeting the lungs with minimal systemic effects at recommended doses. The combination of Salmeterol, which prevents symptoms, and Fluticasone Propionate, which enhances lung function and reduces exacerbations, offers a more streamlined treatment option for patients using both β-agonists and inhaled corticosteroids.

• Salmeterol: A selective, long-acting β2-adrenoceptor agonist with a 12-hour duration, featuring a long side chain that binds to the receptor’s exo-site.
• Fluticasone Propionate: When inhaled at recommended doses, provides a strong glucocorticoid anti-inflammatory effect in the lungs, reducing symptoms and preventing asthma exacerbations without systemic side effects.

Dosage

• Inhaler:
  • Adults and adolescents (12 years and older): 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate, or 125 µg, or 250 µg of Fluticasone Propionate twice daily.
  • Children (4-12 years): 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily.
• Inhalation Capsule (for Asthma):
  • Adults and Adolescents (12 years and older): Salmeterol 50 µg & Fluticasone 100 µg or 250 µg twice daily.
  • Pediatric Patients (4 to 11 years): Salmeterol 50 µg & Fluticasone 100 µg twice daily.
• Inhalation Capsule (for COPD): Salmeterol 50 µg & Fluticasone 250 µg twice daily.
• Maxhaler (for Asthma):
  • Adults and Adolescents (12 years and older): 50/100, 50/250, or 50/500 inhaler – One inhalation twice daily.
  • Children (4 years and older): 50/100 inhaler – One inhalation twice daily.
• Maxhaler (for COPD): One inhalation twice daily.

Administration

Proper inhaler use is crucial for effective treatment. Follow these steps for optimal results:

1. Remove the cap and shake the inhaler vigorously.
2. For new or unused inhalers, release a puff into the air to ensure proper operation.
3. Exhale fully, hold the inhaler upright, and place the mouthpiece between your teeth, closing your lips around it.
4. Inhale deeply and slowly while pressing down on the canister to release the medication.
5. Hold your breath for at least 10 seconds.
6. If multiple puffs are prescribed, wait 1 minute between them and repeat steps 4-7.
7. Replace the cap and rinse your mouth with water after use.

Interaction

Avoid non-selective and selective β-blockers in asthma patients unless absolutely necessary. Be cautious when combining with strong CYP3A4 inhibitors, as this may increase systemic exposure to Fluticasone Propionate.

Contraindications

Do not use in patients with a history of hypersensitivity to Salmeterol Xinafoate, Fluticasone Propionate, or any excipients. Not recommended for primary treatment of acute asthma episodes or status asthmaticus.

Side Effects

• Salmeterol: Potential side effects include tremors, palpitations, headache, and in rare cases, cardiac arrhythmias, rash, and muscle cramps.
• Fluticasone Propionate: May cause hoarseness, oral thrush, cutaneous hypersensitivity, and rarely, facial edema. Gargling with water post-use may alleviate some symptoms.

Pregnancy & Lactation

• Pregnancy: Use only if the benefit to the mother outweighs any risk to the fetus. Limited data available.
• Lactation: Use only if the benefit to the mother outweighs any risk to the child. Plasma levels of the drug are very low, but data on human milk are limited.

Precautions & Warnings

• Asthma Patients: Avoid initiation during an exacerbation. Not intended for immediate relief of acute symptoms.
• COPD Patients: Monitor for signs of pneumonia.
• Corticosteroids: Long-term use may lead to systemic effects such as adrenal suppression, Cushing’s syndrome, or decreased bone mineral density.

Storage Conditions

Store below 30°C, away from direct sunlight and heat. Do not puncture or incinerate the canister, even when empty. Keep away from children.