Indications

This is indicated in the regular treatment of asthma when a combination product (long-acting 2-agonist and inhaled corticosteroid) is appropriate: patients who are not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting 2-agonist or patients who are already adequately controlled on both inhaled corticosteroid and long-acting 2-agonist.Fluticasone Propionate: Fluticasone Propionate, when inhaled at recommended doses, has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced asthma symptoms and exacerbations without the side effects seen with systemic corticosteroids.

Generic

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. Salmeterol ensures against side effects, and Fluticasone Propionate progresses lung work and anticipates exacerbations of the condition. This arrangement can offer a more helpful administration for patients on concurrent β-agonist and breathed-in corticosteroid treatment. The particular instruments of activity of both drugs are talked about below: Salmeterol: Salmeterol may be a specific long-acting (12-hour) beta-2-adrenoceptor agonist with a long side chain that ties to the exo-site of the receptor. Fluticasone Propionate: Fluticasone Propionate, when inhaled at recommended doses, has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced asthma symptoms and exacerbations without the side effects seen with systemic corticosteroids.

Dosage & 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 the 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

In patients with asthma, both non-selective and selective -blockers should be avoided unless there are compelling reasons to use them. Clinically significant drug interactions are unlikely due to the very low plasma concentrations achieved after inhaled dosing. When co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), caution should be exercised.

Contraindications

Patients with a history of hypersensitivity to any of the ingredients should avoid this.

Side Effects

Because this product contains Salmeterol and Fluticasone Propionate, the type and severity of adverse reactions associated with each compound is possible. There have been no reports of additional side effects from taking the two drugs at the same time. The following are side effects that have been linked to Salmeterol or Fluticasone Propionate. Salmeterol: Pharmacological side effects of beta-2 agonist treatment, such as tremors, subjective palpitations, and headaches, have been reported, but they are usually transient and fade away with continued treatment. Arrhythmias of the heart, such as atrial fibrillation, supraventricular tachycardia, and extrasystoles, can occur in susceptible patients. Fluticasone propionate can cause hoarseness and mouth and throat candidiasis (thrush) in some patients. There have been reports of cutaneous hypersensitivity reactions. There have been a few reports of facial and oropharyngeal edema. Gargling with water after using the Salmeterol/ Fluticasone Propionate Inhaler can help with hoarseness and candidiasis.

Pregnancy & Lactation

Drugs should only be administered during pregnancy and lactation if the expected benefit to the mother outweighs any potential risk to the fetus or child. Salmeterol Xinafoate and Fluticasone Propionate have insufficient experience in human pregnancy and lactation. There is no information on human breast milk.

Precautions & Warnings

Additional corticosteroid therapies should be considered, as well as the administration of antibiotics if an infection is present. This preparation, like all inhaled corticosteroid medications, should be used with caution in patients with active or dormant pulmonary tuberculosis. In patients with thyrotoxicosis, this medication should be used with caution.

Therapeutic Class

Respiratory corticosteroids, long-acting selective-adrenoceptor stimulants

Storage Conditions

Protect from light and moisture by storing in a cool, dry place below 30°C. Keep out of children’s reach.

Pharmaceutical Name

Square Pharmaceuticals Ltd.