Salmeterol + Fluticasone


Generic Medicine Info
Indications and Dosage
Inhalation/Respiratory
Chronic obstructive pulmonary disease
Adult: Dosage is individualised based on the severity of the disease.

Powder for inhalation:
Salmeterol 50 mcg and fluticasone 250 mcg per dose or blister
Salmeterol 50 mcg and fluticasone 500 mcg per dose or blister

1 inhalation bid.

Inhalation/Respiratory
Asthma
Adult: Dosage is individualised based on the severity of the disease and adjusted according to patient response and tolerance. Titrate to the lowest effective dose once control is achieved. Treatment guidelines must be considered.

Aerosol for inhalation:
Salmeterol 21 mcg and fluticasone 45 mcg per actuation
Salmeterol 21 mcg and fluticasone 115 mcg per actuation
Salmeterol 21 mcg and fluticasone 230 mcg per actuation
Salmeterol 25 mcg and fluticasone 50 mcg per metered dose or actuation
Salmeterol 25 mcg and fluticasone 125 mcg per metered dose or actuation
Salmeterol 25 mcg and fluticasone 250 mcg per metered dose or actuation

2 inhalations bid.

Powder for inhalation:
Salmeterol 14 mcg and fluticasone 55 mcg per dose
Salmeterol 14 mcg and fluticasone 113 mcg per dose
Salmeterol 14 mcg and fluticasone 232 mcg per dose
Salmeterol 50 mcg and fluticasone 100 mcg per dose or blister
Salmeterol 50 mcg and fluticasone 250 mcg per dose or blister
Salmeterol 50 mcg and fluticasone 500 mcg per dose or blister

1 inhalation bid.
Child: Aerosol for inhalation:
Salmeterol 25 mcg and fluticasone 50 mcg per metered dose or actuation

4-11 years 2 inhalations bid. Use of spacer device is recommended in patients who have or most likely to have difficulties in administration.

Salmeterol 21 mcg and fluticasone 45 mcg per actuation
Salmeterol 21 mcg and fluticasone 115 mcg per actuation
Salmeterol 21 mcg and fluticasone 230 mcg per actuation
Salmeterol 25 mcg and fluticasone 50 mcg per metered dose or actuation
Salmeterol 25 mcg and fluticasone 125 mcg per metered dose or actuation
Salmeterol 25 mcg and fluticasone 250 mcg per metered dose or actuation

≥12 years Same as adult dose.

Powder for inhalation:
Salmeterol 50 mcg and fluticasone 100 mcg per dose or blister

4-11 years 1 inhalation bid.

Salmeterol 14 mcg and fluticasone 55 mcg per dose
Salmeterol 14 mcg and fluticasone 113 mcg per dose
Salmeterol 14 mcg and fluticasone 232 mcg per dose
Salmeterol 50 mcg and fluticasone 100 mcg per dose or blister
Salmeterol 50 mcg and fluticasone 250 mcg per dose or blister
Salmeterol 50 mcg and fluticasone 500 mcg per dose or blister

≥12 years Same as adult dose.
Contraindications
Acute episodes of asthma or COPD; status asthmaticus.
Special Precautions
Patient with active or quiescent pulmonary tuberculosis, systemic fungal, viral, bacterial or parasitic infections; CV disease (e.g. arrhythmia, coronary insufficiency, heart failure, hypertension), diabetes mellitus, hypokalaemia or predisposition to hypokalaemia, thyrotoxicosis, predisposition to decreased bone mineral count (e.g. family history of osteoporosis, prolonged immobilisation, postmenopausal status, tobacco use), history of increased intraocular pressure, cataracts, glaucoma, seizure disorders, low BMI. Patient transferring from systemic corticosteroid to inhaled corticosteroid. Patient undergoing surgery or subjected to stress. Not for initiation in patient with significantly deteriorating asthma or COPD. Avoid abrupt withdrawal and dose reduction. Hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Adrenal suppression, acute adrenal crisis (prolonged use); laryngeal spasm, irritation and swelling; lower respiratory tract infections (e.g. pneumonia, bronchitis), oral candidiasis; decreased bone mineral density; elevated blood pressure and heart rate, QTc prolongation, hypokalaemia (high doses); increased intraocular pressure, glaucoma, cataracts, central serous chorioretinopathy; Cushing’s syndrome, Cushingoid features; growth retardation in children; hypersensitivity reactions (e.g. urticaria, angioedema, rash, hypotension, anaphylaxis). Rarely, cardiac arrhythmias (e.g. supraventricular tachycardia, extrasystoles, atrial fibrillation), increased serum glucose levels, systemic eosinophilic conditions (e.g. eosinophilic granulomatosis with polyangiitis); psychological or behavioural effects (e.g. psychomotor hyperactivity, depression, aggression) in children.
Cardiac disorders: Palpitation, angina pectoris.
Musculoskeletal and connective tissue disorders: Muscle cramps and spasms, arthralgia, myalgia, traumatic fractures.
Nervous system disorders: Headache, tremor.
Psychiatric disorders: Anxiety, sleep disorders.
Respiratory, thoracic and mediastinal disorders: Throat irritation, hoarseness or dysphonia, sinusitis, nasopharyngitis.
Skin and subcutaneous tissue disorders: Contusions.
Potentially Fatal: Paradoxical bronchospasm.
Inhalation/Respiratory: C
Patient Counseling Information
Do not switch between brands or types of inhalation devices including spacer devices unless instructed by your doctor. Rinse the mouth with water after using inhalation devices.
Monitoring Parameters
Perform pulmonary function tests (e.g. forced expiratory volume in 1 second [FEV1], peak flow). Monitor blood pressure, heart rate, CNS stimulation, bone mineral density (at baseline and periodically thereafter); serum K (in hypokalaemic patients); glucose (in diabetic patients). Assess for signs and symptoms of oral candidiasis, adrenal insufficiency, glaucoma or cataracts. Monitor growth in adolescents and children via stadiometry.
Overdosage
Symptoms: Dizziness, increased systolic blood pressure, tremor, headache, tachycardia, hypokalaemia, seizures, angina, hypotension, arrhythmias, nervousness, muscle cramps, dry mouth, palpitation, nausea, fatigue, dizziness, malaise, insomnia, metabolic acidosis, hyperglycaemia; temporary adrenal suppression (acute inhalation); prolongation of QTc interval. Rarely, adrenal crisis (particularly in children). Management: Supportive and symptomatic treatment. Monitor and correct K levels. In chronic cases, monitor adrenal reserve and give systemic corticosteroids as needed, continue with inhaled steroids at the recommended dose once stabilised.
Drug Interactions
Increased plasma concentration with strong CYP3A4 inhibitors (e.g. ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin).
Salmeterol: May have diminished or antagonised therapeutic effect with β-blockers. May increase the risk of hypokalaemia and ECG changes with loop or thiazide diuretics. May have enhanced adverse effect when used concomitantly with other β-adrenergic drugs. Effects on the vascular system may be potentiated with concomitant use or within 2 weeks of discontinuation of MAOIs or TCAs.
Action
Description: Salmeterol is a selective long-acting β2 receptor agonist that acts locally in the lungs. Its action is suspected to be mediated, at least in part, by the activation of intracellular adenyl cyclase resulting in increased cyclic adenosine monophosphate (cAMP) levels, thus causing relaxation of bronchial smooth muscle and prevention of release of mediators of immediate hypersensitivity from cells, particularly from mast cells.
Fluticasone is a corticosteroid that provides significantly potent vasoconstrictive and anti-inflammatory effects.
Onset: Salmeterol: 30-48 minutes (asthma); 2 hours (COPD).
Duration: Bronchodilation: Salmeterol: 12 hours.
Pharmacokinetics:
Absorption: Salmeterol: Minimal systemic absorption. Time to peak plasma concentration: Approx 20 minutes.
Fluticasone: Systemically absorbed via the lungs. Bioavailability: Approx 5-11%, depending on the inhalation device used. Time to peak plasma concentration: 0.5-1 hour.
Distribution: Salmeterol: Plasma protein binding: Approx 94-98%.
Fluticasone: Plasma protein binding: 91%.
Metabolism: Salmeterol: Extensively metabolised in the liver via hydroxylation and via aliphatic oxidation by CYP3A4 isoenzyme to α-hydroxysalmeterol.
Fluticasone: Metabolised in the liver by CYP3A4 isoenzyme to 17β-carboxylic acid (inactive metabolite).
Excretion: Salmeterol: Via faeces (60%); urine (25%). Elimination half-life: 5.5 hours.
Fluticasone: Via faeces (as unchanged drug and metabolites); urine (<5% primarily as metabolites). Elimination half-life: Approx 11.2 hours.
Chemical Structure

Chemical Structure Image
Salmeterol

Source: National Center for Biotechnology Information. PubChem Database. Salmeterol, CID=5152, https://pubchem.ncbi.nlm.nih.gov/compound/Salmeterol (accessed on Jan. 22, 2020)


Chemical Structure Image
Fluticasone propionate

Source: National Center for Biotechnology Information. PubChem Database. Fluticasone propionate, CID=444036, https://pubchem.ncbi.nlm.nih.gov/compound/Fluticasone-propionate (accessed on Jan. 21, 2020)

Storage
Store below 30°C. Aerosol for inhalation: Protect from direct sunlight. Storage recommendations may vary among individual products. Refer to specific product guideline.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03AK06 - salmeterol and fluticasone ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.
References
Advair Diskus (GlaxoSmithKline LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 11/11/2020.

Advair HFA- Aerosol Metered (GlaxoSmithKline LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 11/11/2020.

Airduo Digihaler (Teva Respiratory, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 11/11/2020.

Airduo Respiclick (Teva Respiratory, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 11/11/2020.

Anon. Fluticasone (Oral Inhalation). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/11/2020.

Anon. Fluticasone and Salmeterol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/11/2020.

Anon. Salmeterol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/11/2020.

Buckingham R (ed). Fluticasone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/11/2020.

Buckingham R (ed). Salmeterol Xinafoate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/11/2020.

Fluticasone; Salmeterol. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 13/11/2020.

Joint Formulary Committee. Fluticasone with Salmeterol. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/11/2020.

Seretide Accuhaler (GlaxoSmithKline LLC Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 11/11/2020.

Seretide Accuhaler 50 mcg/250 mcg/dose Inhalation Powder, Pre-dispensed (GlaxoSmithKline UK). MHRA. https://products.mhra.gov.uk. Accessed 11/03/2021.

Seretide Evohaler 25 mcg/125 mcg Per Metered Dose Pressurised Inhalation, Suspension (GlaxoSmithKline UK). MHRA. https://products.mhra.gov.uk. Accessed 11/03/2021.

Seretide Evohaler Dose Counter (Glaxo Wellcome S.A, Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 11/11/2020.

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 © 2021 MIMS. All rights reserved. Powered by MIMS.com
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