Generic

Salmeterol + Fluticasone Propionate

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.

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 & 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 patients 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 moulded 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 take them. Clinically significant medication interactions are unlikely due to the relatively low plasma concentrations attained after inhalation treatment. Co-administering Fluticasone Propionate with known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) should be done with caution, since there is a risk of increased systemic exposure to Fluticasone Propionate.

Contraindications

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

Side Effects

Because this product contains Salmeterol and Fluticasone Propionate, the kind and intensity of adverse events associated with each component is possible. There have been no reports of increased 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 adverse effects of beta-2 agonist medication, including as tremor, subjective palpitations, and headache, have been recorded, but they are usually temporary and fade away with continued treatment. Arrhythmias of the heart, such as atrial fibrillation, supraventricular tachycardia, and extra systoles, can arise in vulnerable patients. Arthralgia and hypersensitivity reactions, such as rash, oedema, and angioedema, have been reported. There has been some oropharyngeal irritation reported. Muscle cramps have been reported on a few occasions.

Fluticasone propionate can cause hoarseness and mouth and throat candidiasis (thrush) in some persons. There have been reports of cutaneous hypersensitivity responses. There have been a few reports of face and oropharyngeal oedema. 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 predicted benefit to the mother outweighs any potential danger to the foetus or child. Salmeterol Xinafoate and Fluticasone Propionate have insufficient expertise in human pregnancy and lactation. There is no information about human breast milk.

Precautions & Warnings

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

Therapeutic Class

Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids

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.

Pharmaceutical Name

ACME Laboratories Ltd.