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.

Pharmaceutical Name

ACI Limited

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.

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 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 take them. Clinically significant medication interactions are unlikely due to the relatively low plasma concentrations attained after inhalation treatment. Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.

Contraindications

Because this product contains Salmeterol and Fluticasone Propionate, the kind and intensity of adverse events associated with each component are 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 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.

Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal edema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after the use of a Salmeterol/ Fluticasone Propionate Inhaler.

Side Effects

Headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth are the most common side effects reported with Lamotrigine. When compared to short-term treatment, there is no difference in the categories of linked adverse events noticed with maintenance treatment up to 12 months.

Pregnancy & Lactation

Drugs should only be administered during pregnancy and lactation if the predicted benefit to the mother outweighs any potential danger to the fetus 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

Consideration should be given to additional corticosteroid therapies, and to include the administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, this preparation should be administered with caution in patients with active or quiescent pulmonary tuberculosis. This preparation should be administered with caution in patients with thyrotoxicosis.

Therapeutic Class

Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids

Storage Conditions

Do not store at temperatures above 30°C. Keep out of children’s reach.

Generic

Salmeterol and Fluticasone Propionate