Generics: Salmeterol + Fluticasone Propionate
Dosage Form: Inhaler.
This is indicated in the regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting β2-agonist or
- patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist.
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
Two times in daily.
Inhalation 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 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.
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 inhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
- 50/100 inhaler: One Inhalation twice daily
- 50/250 inhaler: One Inhalation twice daily
- 50/500 inhaler: One Inhalation twice daily
Children (4 years and older)-
- 50/100 inhaler: One Inhalation twice daily. The maximum licensed dose of fluticasone propionate delivered by this inhaler in children is 100 mcg twice daily. There are no data available for use of this inhaler in children aged under 4 years.
Maxhaler (For COPD):
- Inhaler: 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 inhaler: This is a patient friendly, ready to use and easy to grip device. Use as per instructions for use.
Route of administration: Orally.
Both non-selective and selective β-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. 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.
This is contraindicated in patients with a history of hypersensitivity to any of the ingredients.
As this preparation 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 concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
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 oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
Pregnancy & Lactation:
Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child. There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk.
Precautions & Warnings:
Consideration should be given to additional corticosteroid therapies, and to including 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.
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.
Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids
Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from eyes. Keep away from children.
Manufactured by: Beximco Pharmaceuticales Ltd.