Aroflo (25 mcg+250 mcg)/puff

Description

Indications

Aroflo is indicated for the regular treatment of asthma where a combination therapy (long-acting β2-agonist and inhaled corticosteroid) is appropriate:

• Patients not adequately controlled with inhaled corticosteroids and ‘as-needed’ short-acting β2-agonists.
• Patients already stabilized on both an inhaled corticosteroid and a long-acting β2-agonist.

Use as directed by a registered physician.

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Pharmacology

Aroflo combines two active ingredients: Salmeterol Xinafoate and Fluticasone Propionate.

• Salmeterol Xinafoate: A selective, long-acting beta-2 agonist that helps prevent asthma symptoms by relaxing the airway muscles, providing bronchodilation for up to 12 hours.
• Fluticasone Propionate: A corticosteroid with potent anti-inflammatory effects that improves lung function and reduces exacerbations without significant systemic effects.

This combination offers a more convenient treatment regimen for patients requiring both medications.

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Dosage & Administration

Inhaler Dosage:

Adults & Adolescents (12 years and older):

• 25 µg Salmeterol + 50 µg Fluticasone Propionate: 2 puffs twice daily.
• 25 µg Salmeterol + 125 µg Fluticasone Propionate: 2 puffs twice daily.
• 25 µg Salmeterol + 250 µg Fluticasone Propionate: 2 puffs twice daily.

Children (4-12 years):

• 25 µg Salmeterol + 50 µg Fluticasone Propionate: 2 puffs twice daily.

Inhalation Capsule (For Asthma & COPD):

Adults & Adolescents (12 years and older):

• Salmeterol 50 µg & Fluticasone 100 µg or 250 µg: Twice daily (morning & evening, 12 hours apart).
• Maximum dose: Salmeterol 50 µg & Fluticasone 500 µg twice daily.

Children (4-11 years):

• Salmeterol 50 µg & Fluticasone 100 µg: Twice daily.

For COPD:

• Salmeterol 50 µg & Fluticasone 250 µg: Twice daily.

Maxhaler (For Asthma & COPD):

A user-friendly inhaler with a foil strip containing 60 doses of pre-dispensed inhalation powder.

Adults & Adolescents (12 years and older):

• 50/100 inhaler: 1 inhalation twice daily.
• 50/250 inhaler: 1 inhalation twice daily.
• 50/500 inhaler: 1 inhalation twice daily.

Children (4 years and older):

• 50/100 inhaler: 1 inhalation twice daily.

For COPD:

• 1 inhalation twice daily.

There is no need for dose adjustment in elderly patients or those with renal impairment.

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How to Use the Inhaler

Proper inhaler technique ensures effective medication delivery. Follow these steps:

1. Remove the cap and shake the inhaler at least six times.
2. If unused for a week or more, release one test spray.
3. Exhale fully, then place the mouthpiece between your teeth and seal your lips around it.
4. Inhale deeply while pressing down on the canister.
5. Remove the inhaler and hold your breath for at least 10 seconds.
6. If a second dose is needed, wait 1 minute and repeat.
7. Rinse your mouth with water after use.

Cleaning Instructions:

• Clean the inhaler at least once a week.
• Remove the canister, rinse the plastic actuator and cap in warm water, and dry thoroughly.
• Do not put the metal canister in water.

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Drug Interactions

• Avoid non-selective and selective β-blockers in asthma patients unless essential.
• Caution is needed when using strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) as they may increase Fluticasone systemic exposure.

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Contraindications

• Hypersensitivity to Salmeterol, Fluticasone Propionate, or any excipients.
• Not for the primary treatment of status asthmaticus or acute asthma attacks.

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Side Effects

Salmeterol-related:

• Tremor, palpitations, headache.
• Cardiac arrhythmias (atrial fibrillation, tachycardia).
• Muscle cramps, rash, oropharyngeal irritation.

Fluticasone Propionate-related:

• Hoarseness, oral thrush (candidiasis).
• Facial/oropharyngeal swelling, hypersensitivity reactions.
• Possible adrenal suppression with long-term use.

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Pregnancy & Lactation

• Pregnancy: Use only if the benefit outweighs the potential risk to the fetus.
• Lactation: Limited data suggest low drug levels in breast milk; consult a physician before use.

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Precautions & Warnings

• Not for acute asthma attacks; a fast-acting bronchodilator should be used instead.
• Serious asthma exacerbations may occur; seek medical attention if symptoms worsen.
• Paradoxical bronchospasm may occur; discontinue use if wheezing worsens after inhalation.
• Patients with COPD are at higher risk of pneumonia; monitor for symptoms.
• Corticosteroid effects: Long-term use may lead to Cushing’s syndrome, adrenal suppression, bone mineral loss, and growth retardation in children.

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Overdose Effects

Salmeterol Overdose:

• Symptoms: Seizures, hypertension, tachycardia, arrhythmias, tremors, nausea, dizziness.
• Treatment: Discontinue use and manage symptoms with cardioselective beta-blockers if necessary.

Fluticasone Propionate Overdose:

• Acute overdose: Temporary adrenal suppression; no emergency action needed.
• Chronic overdose: May lead to adrenal suppression; monitor adrenal function.

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Therapeutic Class

• Long-acting selective β2-agonists.
• Respiratory corticosteroids.

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Storage Conditions

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