Aroflo 50mcg+250mcg Arocap 1 Strip

✔️ Dosage & Administration

Inhalation Capsule – Asthma

Adults and adolescents 12 years and older:

• 50 mcg + 100 mcg or 50 mcg + 250 mcg, twice daily.
• Doses should preferably be taken in the morning and evening, approximately 12 hours apart.
• The starting strength should be selected according to asthma severity.
• The maximum recommended strength is 50 mcg salmeterol + 500 mcg fluticasone propionate twice daily.

Children 4–11 years:

• For asthma not adequately controlled with an inhaled corticosteroid: 50 mcg + 100 mcg twice daily, approximately 12 hours apart.

Inhalation Capsule – COPD

• 50 mcg salmeterol + 250 mcg fluticasone propionate twice daily, approximately 12 hours apart.
• Rinse the mouth with water after each inhalation.

Elderly patients:
No routine dosage adjustment is generally required.

Renal impairment:
Dose adjustment is generally not required.

Hepatic impairment:
There is limited information regarding use in patients with hepatic impairment. Medical supervision is recommended.

✔️ Drug Interactions

Although inhaled administration generally produces relatively low systemic concentrations, clinically important interactions can occur with certain medicines.

β-blockers:
Both non-selective and selective β-blockers may reduce the bronchodilating effect of salmeterol and can potentially trigger bronchospasm. They should generally be avoided in patients with asthma unless there is a compelling medical reason for their use.

Strong CYP3A4 inhibitors:
Medicines such as ketoconazole and ritonavir may increase systemic exposure to fluticasone propionate and potentially increase corticosteroid-related adverse effects. Concomitant use should be carefully evaluated by the physician.

Inform your doctor about all prescription medicines, over-the-counter medicines, and supplements you are taking.

✔️ Side Effects

Because Aroflo contains both salmeterol and fluticasone propionate, adverse effects associated with either component may occur.

Salmeterol-related effects may include:

• Tremor
• Palpitations
• Headache
• Muscle cramps
• Throat or oropharyngeal irritation
• Arthralgia
• Rash
• Edema
• Angioedema
• Cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, or extra-systoles

These β2-agonist-related effects are often temporary and may decrease with continued regular treatment.

Fluticasone propionate-related effects may include:

• Hoarseness
• Oral or throat candidiasis (thrush)
• Local irritation
• Skin hypersensitivity reactions
• Rare facial or oropharyngeal edema

Rinsing the mouth with water after inhalation can help reduce the risk of oral candidiasis and hoarseness.

✔️ Pregnancy & Lactation

Pregnancy:
Aroflo should be used during pregnancy only when the expected benefit to the mother outweighs any potential risk to the fetus. There is limited clinical experience with the combined use of salmeterol and fluticasone propionate during human pregnancy.

Lactation:
Use during breastfeeding should be considered only when the expected maternal benefit outweighs potential risk to the infant. Systemic concentrations after inhalation are generally low, and consequently exposure through breast milk is expected to be low. However, adequate human data regarding the presence of these medicines in breast milk are limited.

✔️ Aroflo should not be used in patients with:

• Known hypersensitivity to salmeterol xinafoate, fluticasone propionate, or any component of the formulation.
• Acute severe asthma or status asthmaticus requiring intensive treatment.
• Acute asthma symptoms requiring immediate bronchodilator therapy as the primary treatment.

✔️ Precautions & Warnings

Asthma

• Aroflo should not be initiated during an acute asthma exacerbation or when asthma is unstable or rapidly worsening.
• It should not be used as a rescue medicine for sudden breathing difficulty.
• Patients should have their prescribed short-acting rescue bronchodilator available.
• If symptoms remain uncontrolled or worsen after starting treatment, medical advice should be obtained promptly.
• Do not discontinue maintenance therapy without consulting the treating physician.

Paradoxical Bronchospasm

Inhaled medicines can rarely cause paradoxical bronchospasm, characterized by an immediate worsening of wheezing or breathing difficulty after inhalation. If this occurs, use the prescribed rapid-acting bronchodilator immediately, discontinue Aroflo, and seek medical evaluation for alternative treatment.

COPD

Patients with COPD receiving salmeterol/fluticasone therapy may have an increased risk of pneumonia. Symptoms of pneumonia and COPD exacerbation can be similar, so new or worsening respiratory symptoms, fever, or changes in sputum should be assessed by a healthcare professional.

Corticosteroid-related Effects

Although inhaled corticosteroids generally produce fewer systemic effects than oral corticosteroids, systemic effects may occur, especially with high doses or prolonged treatment.

Possible effects include:

• Adrenal suppression
• Cushingoid features or Cushing's syndrome
• Reduced bone mineral density
• Cataracts
• Glaucoma
• Growth retardation in children
• Very rarely, behavioral or psychological disturbances in children and adolescents

Treatment should therefore be reviewed regularly, with the corticosteroid dose maintained at the lowest dose that effectively controls symptoms.

Use in Children

Inhaled corticosteroids may temporarily reduce growth velocity in children. The long-term effect of this reduction on final adult height is not fully established. Children receiving prolonged corticosteroid treatment should have their growth monitored regularly.

✔️ Storage:

• Store below 30°C.
• Protect from direct sunlight and excessive heat.
• Do not puncture, break, or burn the pressurized canister, even when it appears empty.
• Keep away from moisture and extreme temperatures.
• Avoid contact of the medication with the eyes.
• Keep out of reach of children.