Aroflo 125 HFA Inhaler

✔️ Dosage & Administration

Metered-Dose Inhaler – Asthma

Adults and adolescents 12 years and older:
Depending on the severity of asthma and the previous corticosteroid dose, the usual options include:

• 2 inhalations of 25 mcg Salmeterol + 50 mcg Fluticasone Propionate, twice daily
• 2 inhalations of 25 mcg + 125 mcg, twice daily
• 2 inhalations of 25 mcg + 250 mcg, twice daily

Children 4–12 years:
2 inhalations of 25 mcg Salmeterol + 50 mcg Fluticasone Propionate, twice daily.

✔️ Drug Interactions

Clinically significant interactions are generally unlikely because systemic exposure following inhalation is relatively low. However:

• Beta-blockers, including selective and non-selective agents, may reduce the bronchodilator effect of salmeterol and can potentially worsen bronchospasm.
• Strong CYP3A4 inhibitors, such as ketoconazole and ritonavir, may increase systemic exposure to fluticasone and increase the risk of corticosteroid-related adverse effects.
• Other medicines that affect cardiac rhythm or lower potassium levels should be used with caution.

✔️ Inhalation Capsule – COPD

The usual dose is 50 mcg Salmeterol + 250 mcg Fluticasone Propionate twice daily, approximately 12 hours apart.

Important: Rinse the mouth with water after each inhalation and spit out the water to reduce the risk of oral thrush.

Special populations: Routine dose adjustment is generally not required in elderly patients or those with renal impairment. Limited information is available regarding use in hepatic impairment.

✔️ Side Effects

Salmeterol-related effects may include:

• Tremor
• Headache
• Palpitations
• Muscle cramps
• Throat irritation
• Joint pain
• Nervousness
• Cardiac rhythm disturbances, particularly in susceptible individuals
• Hypersensitivity reactions such as rash, swelling, or angioedema

These effects are often mild and may decrease with continued treatment.

Fluticasone Propionate-related effects may include:

• Hoarseness or voice changes
• Oral or throat candidiasis (thrush)
• Throat irritation
• Hypersensitivity reactions
• Rare facial or oropharyngeal swelling

Rinsing the mouth with water after inhalation can help reduce the risk of oral thrush and throat irritation.

✔️ Overdose Effects

Salmeterol overdose may cause tremor, headache, palpitations, tachycardia, blood pressure changes, arrhythmias, muscle cramps, dizziness, insomnia, hypokalemia, or hyperglycemia.

Fluticasone Propionate overdose may temporarily suppress adrenal function after excessive exposure. Chronic excessive use may result in more prolonged adrenal suppression.

Treatment of overdose is generally supportive and should be managed by a healthcare professional.

✔️ Aroflo should not be used in patients with:

• Known hypersensitivity to salmeterol, fluticasone propionate, or any component of the formulation.
• Acute severe asthma or status asthmaticus requiring intensive treatment.

Aroflo should not be used as the primary treatment for an acute asthma attack.

✔️ Inhalation Capsule – Asthma

Adults and adolescents 12 years and older:
Depending on asthma severity, 50 mcg + 100 mcg or 50 mcg + 250 mcg, twice daily, approximately 12 hours apart.

The maximum recommended strength is 50 mcg + 500 mcg twice daily when specifically prescribed.

Children 4–11 years:
For children whose asthma is not adequately controlled with an inhaled corticosteroid, the recommended dose is 50 mcg + 100 mcg twice daily, approximately 12 hours apart.

✔️ Precautions & Warnings

• Aroflo should not be initiated during an acute asthma exacerbation or when asthma is unstable or rapidly worsening.
• It is not a rescue inhaler and does not provide rapid relief of sudden bronchospasm. Patients should keep an appropriate short-acting rescue bronchodilator available.
• If asthma symptoms remain uncontrolled or worsen after starting treatment, seek medical advice promptly.
• Paradoxical bronchospasm may rarely occur immediately after inhalation. If sudden worsening of wheezing occurs, discontinue the medicine and use a fast-acting bronchodilator as directed while seeking medical attention.
• Long-term or high-dose inhaled corticosteroid therapy may rarely cause systemic effects such as adrenal suppression, Cushingoid features, reduced bone mineral density, cataract, glaucoma, and growth suppression in children.
• The corticosteroid dose should be maintained at the lowest dose that effectively controls asthma.
• Patients with COPD receiving salmeterol/fluticasone should be monitored for signs of pneumonia.
• Patients with diabetes, cardiovascular disease, thyroid disorders, or a history of seizures should inform their doctor before treatment.
• Regular medical review is recommended to assess asthma control and inhaler technique.

✔️ Pregnancy & Lactation

Pregnancy: There are limited data regarding the use of salmeterol and fluticasone during pregnancy. Animal studies have shown fetal effects at high systemic exposures. Aroflo should be used during pregnancy only when the expected benefit to the mother outweighs the potential risk to the fetus and under medical supervision.

Breastfeeding: Systemic exposure following therapeutic inhalation is expected to be low, but adequate human data regarding excretion into breast milk are limited. Use during breastfeeding should be based on an appropriate benefit-risk assessment by a healthcare professional.

✔️ Storage:

• Store below 30°C.
• Protect from direct sunlight and excessive heat.
• The pressurized canister should not be punctured, broken, or incinerated, even when apparently empty.
• Keep away from children.
• Avoid spraying the medicine into or near the eyes.