Bexitrol F Maxhaler 50/500

Indications

This medication is designed for the ongoing management of asthma when a combination therapy (long-acting β2-agonist and inhaled corticosteroid) is deemed appropriate. It is beneficial for:

• Patients whose asthma is not sufficiently controlled with inhaled corticosteroids and occasional use of a short-acting β2-agonist.
• Patients who are currently managing their asthma effectively with both an inhaled corticosteroid and a long-acting β2-agonist.

Pharmacology

Salmeterol Xinafoate is a long-acting beta-2 agonist, providing extended relief from asthma symptoms and other airway obstructions. Fluticasone Propionate is a corticosteroid with potent glucocorticoid activity, targeting the lungs directly to minimize systemic effects. Together, Salmeterol helps to prevent symptoms, while Fluticasone improves lung function and reduces the risk of asthma exacerbations. This combination offers a convenient alternative for those already using separate β-agonist and corticosteroid treatments.

• Salmeterol: A long-acting beta-2-adrenoceptor agonist that binds to the exo-site of the receptor, providing relief for up to 12 hours.
• Fluticasone Propionate: An inhaled corticosteroid with strong anti-inflammatory properties, effectively managing asthma symptoms and reducing flare-ups without the systemic side effects associated with oral corticosteroids.

Dosage

Inhaler:

• Adults and Adolescents (12 years and older): 2 puffs of either 25 µg Salmeterol with 50 µg Fluticasone Propionate, 125 µg Fluticasone Propionate, or 250 µg Fluticasone Propionate, administered 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. The maximum dose is Salmeterol 50 µg & Fluticasone 500 µg twice daily.
• Children (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): One inhalation of either 50/100 µg, 50/250 µg, or 50/500 µg twice daily.
• Children (4 years and older): One inhalation of 50/100 µg twice daily, with a maximum dose of 100 µg of Fluticasone Propionate twice daily.

Maxhaler (for COPD):

• One inhalation twice daily.

Instructions for Use:

1. Remove the cap and shake the inhaler vigorously.
2. If the inhaler is new or hasn’t been used recently, release a puff into the air.
3. Exhale fully, hold the inhaler upright, and place it between your teeth with your lips sealed around the mouthpiece.
4. Inhale deeply and slowly while pressing down on the canister.
5. Hold your breath for 10 seconds or as long as comfortable, then exhale slowly.
6. If multiple puffs are prescribed, wait 1 minute between puffs. Shake the inhaler and repeat.
7. Rinse your mouth with water after use and replace the cap.

Cleaning: Clean the inhaler weekly by removing the canister and rinsing the actuator and cap in warm water. Dry thoroughly before reassembling.

Interaction

Avoid using non-selective and selective β-blockers in asthma patients unless absolutely necessary. Drug interactions are unlikely due to low plasma concentrations after inhalation, but caution is advised when using strong CYP3A4 inhibitors (e.g., ketoconazole).

Contraindications

This medication is contraindicated in patients with hypersensitivity to Salmeterol Xinafoate, Fluticasone Propionate, or any excipients. It is not suitable for the primary treatment of status asthmaticus or other acute asthma episodes requiring intensive measures.

Side Effects

Salmeterol: Common side effects include tremors, palpitations, headaches, and rare cases of muscle cramps or hypersensitivity reactions.

Fluticasone Propionate: May cause hoarseness, oral thrush, or skin hypersensitivity. Gargling with water post-use can alleviate these symptoms.

Pregnancy & Lactation

Pregnancy: Use only if the benefits to the mother outweigh potential risks to the fetus. Limited data is available on the use of these medications during pregnancy.

Lactation: Use only if the benefits to the mother outweigh potential risks to the breastfeeding child. Inhaled doses result in low plasma concentrations and minimal transfer to breast milk.

Precautions & Warnings

Do not initiate treatment during an asthma exacerbation or if asthma is unstable. This medication is not for immediate relief of acute symptoms. Monitor for worsening symptoms and discontinue if paradoxical bronchospasm occurs.

COPD Patients: Monitor for signs of pneumonia, which has been associated with this treatment in COPD patients.

Corticosteroids: Long-term use may lead to systemic effects like Cushing’s syndrome or growth retardation. Regular reviews and dose adjustments are recommended.

Use in Special Populations

Inhaled corticosteroids may reduce growth velocity in pediatric patients. Long-term effects on adult height are unknown.

Overdose Effects

Salmeterol: Overdose may result in symptoms such as seizures, hypertension, tachycardia, and muscle cramps. Treatment includes discontinuing Salmeterol and using cardioselective beta-blockers cautiously.

Fluticasone Propionate: Acute overdose may suppress adrenal function temporarily. Long-term overdose requires monitoring for adrenal suppression.

Therapeutic Class

Long-acting beta-2 adrenoceptor agonists, respiratory corticosteroids.

Storage Conditions

Store below 30°C, away from sunlight and heat. Do not puncture or incinerate the canister. Keep out of reach of children.