Salmeterol + Fluticasone


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : Inhalation Asthma Per powd inhalation dose contains salmeterol 50 mcg and fluticasone propionate 100/250/500 mcg: 1 inhalation twice daily. Per pressurised inhalation contains salmeterol 25 mcg and fluticasone propionate 50/125/250 mcg: 2 inhalations twice daily. COPD Per powd inhalation dose contains salmeterol 50 mcg and fluticasone propionate 500 mcg: 1 inhalation twice daily.
Dosage Details
Inhalation/Respiratory
Chronic obstructive pulmonary disease
Adult: As combination containing salmeterol 50 mcg and fluticasone propionate 500 mcg/dose of inhalation powder: 1 inhalation bid.

Inhalation/Respiratory
Asthma
Adult: As combination containing salmeterol 50 mcg and fluticasone propionate 100/250/500 mcg/dose of inhalation powder: 1 inhalation bid. As combination containing salmeterol 25 mcg and fluticasone propionate 50/125/250 mcg/dose of pressurised inhalation: 2 inhalation bid.
Child: 4-12 yr: As combination containing salmeterol 50 mcg and fluticasone propionate 100 mcg/ dose of inhalation powder: 1 inhalation bid; as combination containing salmeterol 25 mcg and fluticasone propionate 50 mcg/dose of pressurised inhalation: 2 inhalation bid. ≥12 yr: As combination containing salmeterol 50 mcg and fluticasone propionate 100/250/500 mcg/dose of inhalation powder: 1 inhalation bid; as combination containing salmeterol 50/125/250 mcg and fluticasone propionate 50 mcg/dose of pressurised inhalation: 2 inhalation bid.
Contraindications
Not for primary treatment of status asthmaticus or other acute attacks of asthma.
Special Precautions
Pulmonary TB, severe cardiovascular disorders, heart rhythm abnormalities, DM, thyrotoxicosis, hypokalaemia. Patients at risk of decreased bone mineral content (e.g. smoking, old age, sedentary lifestyle, poor nutrition, family history of osteoporosis or long term use of drugs that may decrease bone mass (e.g. anticonvulsants and corticosteroids). Do not stop therapy abruptly; therapy should be down titrated. Advise patient to rinse mouth after inhalation. Monitor height of children on prolonged therapy. Pregnancy, lactation.
Adverse Reactions
Mouth and throat candidiasis, throat irritation, hoarseness/dysphonia, nasopharyngitis, lower respiratory tract infections (e.g. pneumonia and bronchitis), hypokalaemia, headache, tremors, palpitation, muscle cramps. Prolonged high dose use may cause Cushing's syndrome, Cushingoid features, adrenal suppression, retardation of growth in children and adolescents, bone mineral density decrease, cataract and glaucoma.
Potentially Fatal: Paradoxical bronchospasm.
Inhalation/Respiratory: C
Drug Interactions
Increased fluticasone levels with CYP 3A4 inhibitors e.g ritonavir, ketoconazole, itraconazole. Additive effects with other β-agonist.
Action
Description: Salmeterol, a long acting β2-agonist which acts locally in the lung to mediate bronchodilation. Fluticasone, a corticosteroid with mainly glucocorticoid activity, reduce symptoms and exacerbations of asthma.
Onset: Bronchodilation: 10-20 minutes.
Duration: Bronchodilation: 12 hr
Pharmacokinetics:
Absorption: Salmeterol: Negligible absorption after inhalation. Fluticasone: Poorly absorbed from the GI tract; oral bioavailability <1%; absolute bioavailability of inhaled fluticasone: 5-11% (depending on device used).
Distribution: Salmeterol: Protein binding: 96%. Fluticasone: Protein binding: 91%.
Metabolism: Salmeterol: Extensive hepatic metabolism by hydroxylation; terminal elimination half-lives: 5.5 hr. Fluticasone: Extensive first-pass metabolism by cytochrome CYP3A4.
Excretion: Salmeterol: Eliminated mainly in faeces; negligible amounts of unchanged salmeterol are detectable in urine or faeces. Fluticasone: Mainly excreted in faeces as metabolites and unchanged drug; <5% excreted in urine.
Storage
Inhalation:
Chronic obstructive pulmonary disease: Do not store >30 °C.
Asthma: Powder inhaler: Do not store >30°C. Pressurised inhaler: Do not store >25°C.
Disclaimer: This information is independently developed by MIMS based on Salmeterol + Fluticasone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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