Aroflo (25 mcg+125 mcg)/puff

Description

Indications
Aroflo is indicated for the regular treatment of asthma where the use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate. It is particularly used in:

• Patients who are not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2-agonists, or
• Patients who are already adequately controlled on both inhaled corticosteroids and long-acting β2-agonists.
  This medication should be taken as advised by a registered healthcare professional.

Pharmacology
Aroflo combines Salmeterol Xinafoate and Fluticasone Propionate to provide effective asthma control.

• Salmeterol Xinafoate is a selective, long-acting beta-2 agonist (12-hour duration) that helps relax the muscles of the airways and provides relief from asthma symptoms and other forms of airway obstruction.
• Fluticasone Propionate is a corticosteroid with strong anti-inflammatory properties that target the lungs when inhaled. It reduces symptoms, improves lung function, and prevents exacerbations without the systemic effects associated with oral corticosteroids.

Together, Salmeterol helps protect against symptoms, while Fluticasone improves lung function and prevents exacerbations. This combination offers a more convenient treatment regimen for patients who need both a beta-agonist and corticosteroid.

Dosage

Inhaler:

• Adults and adolescents (12 years and older):

  • 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily
  • 2 puffs of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily
  • 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 Capsule (for Asthma):

• Adults and Adolescents (12 years and older):

  • Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, 12 hours apart)
  • The maximum recommended dosage is Salmeterol 50 µg & Fluticasone 500 µg twice daily.

• Pediatric Patients (4-11 years):

  • Salmeterol 50 µg & Fluticasone 100 µg twice daily (morning and evening, 12 hours apart) for asthma not controlled with inhaled corticosteroids.

Inhaler for COPD:

• Adults:
  • Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, 12 hours apart)

Maxhaler (For Asthma):

• Adults and Adolescents (12 years and older):

  • 50/100 inhaler: One inhalation twice daily
  • 50/250 inhaler: One inhalation twice daily
  • 50/500 inhaler: One inhalation twice daily

• Children (4 years and older):

  • 50/100 inhaler: One inhalation twice daily (maximum 100 µg of Fluticasone Propionate twice daily for children)

Maxhaler (For COPD):

• Adults:
  • One inhalation twice daily

Special Patient Groups:

• No dose adjustment is necessary for elderly patients or those with renal impairment.
• There are no data available for use in patients with hepatic impairment.

This medicine should be used as directed by a registered healthcare professional.

Administration
Using an inhaler correctly is essential for effective asthma control. If used incorrectly, less medication may reach the lungs. Follow these steps for optimal use:

1. Remove the cap from the inhaler.
2. Shake the inhaler vigorously at least six times before each use.
3. If the inhaler is new or hasn’t been used for a week or more, shake well and release one puff into the air to check its function.
4. Exhale fully, hold the inhaler upright, and place the mouthpiece between your teeth, closing your lips around it.
5. While breathing in deeply and slowly, press down firmly on the canister to release the medicine.
6. Remove the inhaler from your mouth and hold your breath for at least 10 seconds, or as long as comfortable.
7. If you are prescribed multiple puffs, wait for 1 minute between doses and repeat steps 4-7.
8. After use, replace the cap and rinse your mouth with water.

Cleaning the Inhaler:

• Clean your inhaler at least once a week by removing the canister and rinsing the plastic actuator and cap with warm water. Do not submerge the metal canister. Thoroughly dry the actuator and cap before reassembling.

This medicine should be used as prescribed by a registered healthcare professional.

Interaction

• β-blockers: Non-selective and selective β-blockers should be avoided in asthma patients unless absolutely necessary.
• CYP3A4 inhibitors: Strong inhibitors (e.g., ketoconazole, ritonavir) can increase the systemic exposure of Fluticasone Propionate.

Contraindications
Aroflo is contraindicated in patients with known hypersensitivity to Salmeterol Xinafoate, Fluticasone Propionate, or any excipients. It should not be used for the primary treatment of status asthmaticus or other acute asthma episodes requiring intensive measures.

Side Effects
Common side effects include:

• Salmeterol: Tremors, palpitations, headache, arrhythmia, and muscle cramps. Hypersensitivity reactions such as rash and edema have also been reported.
• Fluticasone Propionate: Hoarseness, oral thrush (candidiasis), skin reactions, and, rarely, facial or oropharyngeal edema. Gargling with water after use may reduce these effects.

Pregnancy & Lactation

• Pregnancy: The use of Aroflo during pregnancy should be considered only if the benefits to the mother outweigh the potential risks to the fetus.
• Lactation: The inhaled doses of Salmeterol and Fluticasone are very low, making the risk to the breastfeeding child minimal. However, caution is advised, and it should only be used if the benefits outweigh the risks.

Precautions & Warnings

• Asthma Patients: Aroflo should not be initiated during an asthma exacerbation or if asthma is unstable. It is not for immediate relief of acute symptoms. Always keep a fast-acting bronchodilator available.
• Paradoxical Bronchospasm: In rare cases, paradoxical bronchospasm may occur. If this happens, use a short-acting bronchodilator and discontinue Aroflo.
• COPD Patients: Use with caution as there have been reports of pneumonia in COPD patients.

Overdose Effects

• Salmeterol Overdose: Symptoms may include seizures, palpitations, headache, tremor, muscle cramps, and arrhythmias. Treatment involves discontinuing Salmeterol and using cardioselective β-blockers.
• Fluticasone Propionate Overdose: Acute overdose may suppress adrenal function temporarily, but no emergency action is needed. Chronic overdose may require monitoring of adrenal function.

Therapeutic Class
Long-acting selective β-adrenoceptor stimulants and respiratory corticosteroids.

Storage Conditions

• Store in a cool, dry place below 30°C.
• Keep away from direct sunlight and heat.
• Keep out of reach of children. Do not puncture or incinerate the canister, even if it appears empty.
• Keep away from eyes.