Bexitrol F 25/250 HFA

Indications

Bexitrol F is prescribed for the regular management of asthma when a combination therapy of a long-acting β2-agonist and an inhaled corticosteroid is appropriate. This includes:

• Patients who are not adequately controlled with inhaled corticosteroids and short-acting β2-agonists used on an “as needed” basis.
• Patients already stabilized on both an inhaled corticosteroid and a long-acting β2-agonist.

Pharmacology

Salmeterol Xinafoate is a long-acting β2-agonist that specifically targets the treatment of asthma and other obstructive airway conditions. Fluticasone Propionate is a corticosteroid with potent anti-inflammatory effects, primarily acting on the lungs. At regular doses, Fluticasone minimizes systemic effects while improving lung function and reducing asthma flare-ups. Together, these drugs offer a more convenient treatment for patients already on separate β2-agonist and corticosteroid inhalers.

Mechanism of Action:

• Salmeterol: As a long-acting β2-agonist, Salmeterol provides up to 12 hours of bronchodilation, binding to receptors in the lungs to ease breathing.
• Fluticasone Propionate: When inhaled, this corticosteroid works directly in the lungs, helping to reduce inflammation, alleviate symptoms, and prevent asthma exacerbations, without the common systemic side effects.

Dosage
Inhaler:

• Adults and Adolescents (12+ years): 2 puffs of 25 µg Salmeterol + 50 µg Fluticasone Propionate, or 2 puffs of 25 µg Salmeterol + 125 µg Fluticasone Propionate, or 2 puffs of 25 µg Salmeterol + 250 µg Fluticasone Propionate, all taken twice daily.
• Children (4-12 years): 2 puffs of 25 µg Salmeterol + 50 µg Fluticasone Propionate twice daily.

Inhalation Capsule (Asthma):

• Adults and Adolescents (12+ years): Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily, approximately 12 hours apart.
• Children (4-11 years): 50 µg Salmeterol + 100 µg Fluticasone twice daily.

Inhalation Capsule (COPD):
Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening).

Maxhaler (Asthma):
Pre-loaded with 60 doses of inhalation powder for daily use:

• Adults & Adolescents (12+ years): 50/100, 50/250, or 50/500 inhaler, one inhalation twice daily.
• Children (4+ years): 50/100 inhaler, one inhalation twice daily.

Maxhaler (COPD):

• One inhalation twice daily.

Administration Instructions

Proper inhaler use is crucial to ensure effective treatment and prevent asthma attacks. Incorrect usage can reduce the medication’s impact. Follow these steps for best results:

1. Remove the cap.
2. Shake the inhaler vigorously (at least six times).
3. If unused for a week or more, release a puff into the air to ensure functionality.
4. Breathe out fully, then place the inhaler mouthpiece between your teeth, closing your lips around it.
5. Press down on the canister while breathing in slowly and deeply through your mouth.
6. Hold your breath for 10 seconds or as long as comfortable, then exhale.
7. If multiple puffs are prescribed, wait one minute before repeating the steps.
8. Replace the cap and rinse your mouth after use.

Cleaning the Inhaler:
Clean the inhaler once a week. Remove the metal canister, rinse the plastic parts in warm water, and dry thoroughly before reassembling.

Drug Interactions
Avoid both non-selective and selective β-blockers in asthma patients unless absolutely necessary. Strong CYP3A4 inhibitors, such as ketoconazole and ritonavir, may increase systemic exposure to Fluticasone Propionate.

Contraindications
Do not use Bexitrol F in patients with known hypersensitivity to Salmeterol, Fluticasone Propionate, or any excipients. It should also not be used for primary treatment of status asthmaticus or during acute asthma episodes.

Side Effects
Side effects may include:

• Salmeterol: Tremors, palpitations, headache, cardiac arrhythmias, and hypersensitivity reactions.
• Fluticasone Propionate: Hoarseness, oral candidiasis, and possible cutaneous hypersensitivity.

Pregnancy & Lactation

• Pregnancy: Only consider use if the benefits to the mother outweigh risks to the fetus.
• Lactation: Administer with caution as low concentrations of the drugs may pass into breast milk.

Precautions
This inhalation capsule should not be initiated during an acute asthma attack. Always keep fast-acting relief medication available.

Storage Conditions
Store below 30°C, away from heat and sunlight. Keep out of reach of children.