Indications

Aroflo HFA inhaler is indicated in the regular treatment of asthma where the use of a combination product (long-acting ß2-agonist and inhaled corticosteroid) is appropriate:

1. patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting ß2-agonist or
2. patients already adequately controlled on both inhaled corticosteroid and long-acting ß2-agonist.

Pharmacology

Salmeterol Xinafoate is a long-acting, selective beta-2 agonist that is used to treat asthma and other types of diffuse airway obstruction. Fluticasone Propionate is a corticosteroid that primarily acts as a glucocorticoid. At normal doses, Fluticasone Propionate is said to have a topical effect on the lungs but no systemic effects.

Fluticasone Propionate improves lung function and prevents exacerbations of the illness, while Salmeterol protects against symptoms. For patients using -agonists and inhaled corticosteroids at the same time, this preparation may provide a more convenient regimen. Both medications’ respective methods of action are detailed below:

Salmeterol is a long-acting (12-hour) selective beta-2-adrenoceptor agonist with a lengthy side chain that binds to the receptor’s exo-site.

Fluticasone Propionate: Fluticasone Propionate, when inhaled at approved levels, has a significant glucocorticoid anti-inflammatory impact within the lungs, resulting in reduced asthma symptoms and exacerbations without the side effects seen with systemic corticosteroids.

Dosage and Administration

Inhalation Aerosol:

Adults and adolescents 12 years and older: 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily or 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 Powder in Capsule (For Asthma):

Adult and Adolescent (12 Years and Older): Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart).

The recommended starting dosages for Salmeterol 50 µg & Fluticasone 100 µg & Salmeterol 50 µg & Fluticasone 250 µg for patients aged 12 years and older are based upon patient’s asthma severity.

The maximum recommended dosage is Salmeterol 50 µg & Fluticasone 500 µg twice daily.

Pediatric Patients (4 to 11 Years): For patients with asthma who are not controlled on an inhaled corticosteroid, the dosage is Salmeterol 50 µg & Fluticasone 100 µg twice daily (morning and evening, approximately 12 hours apart).

Inhalation Powder in Capsule (For COPD): Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart). Rinsing the mouth after each inhalation is advised.

Inhalation Powder in Maxhaler (For Asthma): This is a molded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.

Adults and Adolescents (12 years and older)-

50/100 Maxhaler: One Inhalation twice daily

50/250 Maxhaler: One Inhalation twice daily

50/500 Maxhaler: One Inhalation twice daily

Children (4 years and older)-

50/100 Maxhaler: One Inhalation twice daily. The maximum licensed dose of fluticasone propionate delivered by this Maxhaler in children is 100 ug twice daily. There are no data available for use of this Maxhaler in children aged under 4 years.

Inhalation Powder in Maxhaler (For COPD):

Maxhaler: One Inhalation twice daily

Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of this in patients with hepatic impairment.

Using the Maxhaler: This is a patient-friendly, ready-to-use, and easy-to-grip device. Use as per instructions for use.

Interaction

Both non-selective and selective ß-blockers should be avoided in patients with asthma unless there are compelling reasons for their use. Care should be taken while co-administering of CYP3A4 inhibitors (i.e. Ketoconazole, Ritonavir) & Salmeterol-Fluticasone as there is an increased risk of systemic side effects of individual components.

Contraindications

Aroflo HFA inhaler is contraindicated in patients with hypersensitivity to any of the active substances or to the excipient of this preparation.

Side Effects

As the Aroflo HFA inhaler contains Salmeterol and Fluticasone Propionate, the type, and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following the concurrent administration of the two compounds. The pharmacological side effects of ß2-agonist treatment, such as tremors, palpitations, and headaches have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia may occur. There have been reports of arthralgia and hypersensitivity reactions, including rash, edema, and angioedema. There have been reports of oropharyngeal irritation.

Due to the Fluticasone Propionate component, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after using the product. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Aroflo HFA inhaler. Possible systemic effects in children include adrenal suppression, growth retardation, decrease in bone mineral density.

Pregnancy & Lactation

Use in pregnancy: There are insufficient data on the use of Salmeterol & Fluticasone Propionate during pregnancy. Administration of drugs to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.

Use in lactation: There are no data available for human breast milk. Administration of Salmeterol & Fluticasone Propionate to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

Precautions & Warnings

Aroflo HFA inhaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Aroflo HFA inhaler should not be stopped abruptly. It should be administered with caution in patients with pulmonary tuberculosis. Aroflo HFA inhaler should be used with caution in patients with severe cardiovascular disorders, heart rhythm abnormalities, diabetes mellitus, thyrotoxicosis, uncorrected hypokalemia, or patients predisposed to low levels of serum potassium. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

Therapeutic Class

Respiratory corticosteroids, long-acting selective-adrenoceptor stimulants

Storage Conditions

Even if the canister appears to be empty, it should not be punctured, broken, or incinerated. Avoid storing in direct sunlight or in a hot environment. Keep it below 30°C. Keep your distance from the eyes. Keep your distance from youngsters.

Generic

Salmeterol + Fluticasone Propionate

Pharmaceutical Name

Aristopharma Ltd.