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Advair HFA (fluticasone-salmeterol)

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Advair HFA may cause heart palpitations (irregular rapid beating or pulsations of the heart) (common).

This drug may also cause the following symptoms that are related to heart palpitations:

Medical Source Information
Yellow highlights indicate symptoms related to heart palpitations.

Cardiovascular side effects of salmeterol have included palpitations and peripheral vasodilation, commonly resulting in reflex tachycardia. Blood pressure has been increased and decreased. Higher doses have rarely aggravated angina, myocardial ischemia, or caused atrial or ventricular arrhythmias.

Changes in heart rate of approximately 8 to 16 beats per minute may be produced by 0.2 mg of salmeterol given by MDI. At an inhaled dose of 0.4 mg, two subjects have experienced nonspecific T-wave changes, and one subject experienced QT prolongation. Higher doses of salmeterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension. All of these effects are dose-related and lower doses may be tolerated.

Hypersensitivity side effects of fluticasone have included rare cases of immediate and delayed reactions including rash, angioedema and bronchospasm. Hypersensitivity side effects have also included postmarketing reports of a systemic eosinophilic condition. Clinical features of this condition have included a vasculitis consistent with Churg-Strauss syndrome, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy. These events have usually been associated with a reduction and/or discontinuation of oral corticosteroid therapy following introduction of fluticasone. Hypersensitivity reactions to salmeterol have presented as rash or urticaria.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: bronchospasm (wheezing, chest tightness, trouble breathing); fast or uneven heart beats, restless feeling, tremor; fever, chills, stabbing chest pain, cough with yellow or green mucus; blurred vision, eye pain, or seeing halos around lights; white patches or sores inside your mouth or on your lips; or worsening asthma symptoms. Less serious side effects include: headache, dizziness; nausea, vomiting, diarrhea; dry mouth, nose, or throat; stuffy nose, sinus pain, cough, sore throat; or hoarseness or deepened voice. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Nervous system side effects of fluticasone have included headache, dizziness, giddiness, fatigue, and insomnia. The nervous system has been adversely affected by salmeterol resulting in headache, restlessness, anxiety, nervousness, irritability, and insomnia.

Metabolic side effects associated with salmeterol have included hypokalemia, and less commonly hyperglycemia.

Fluticasone-salmeterol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.

Cardiovascular and central nervous system effects seen with all sympathomimetic drugs (e.g., increased blood pressure, heart rate, excitement) can occur after use of salmeterol. Like all medications containing sympathomimetic amines, fluticasone-salmeterol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.

Side Effects to Watch
Watch closely for the following side effects and notify your physician immediately should any of these develop:

Abnormal heart rate, fluttering in the chest, weakness, faintness, dizziness or loss of consciousness (signs of a serious condition called "torsade de pointe or QT prolongation" in which irregular heartbeats occur)
chickenpox

Lab and Diagnostic Tests
If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them):

EKG - if abnormal heartbeats (rapid slow or irregular) develop

References

Salmeterol xinafoate as maintenance therapy compared with albuterol in patients with asthma. D'Alonzo GE, Nathan RA, Henochowicz S, Morris RJ, Ratner P, Rennard SI JAMA 1994;271:1412-6.
Product Information. Severent (salmeterol). Anonymous Glaxo Wellcome, Research Triangle Park, NC. PROD;
Product Information. Advair Diskus (fluticasone-salmeterol) Anonymous Glaxo Wellcome, Research Triangle Pk, NC. PROD;
Salmeterol. Anonymous Med Lett Drugs Ther 1994;36:37-9.
A twelve month comparison of salmeterol with salbutamol in asthmatic patients. European Study Group [published erratum appears in Eur Respir J 1993;6(1):150]. Britton MG, Earnshaw JS, Palmer JB Eur Respir J 1992;5:1062-7.
Salmeterol comparison with salbutamol in adult asthmatic patients. Ullman A, Svedmyr N Thorax 1988;43:674-8.
Salmeterol xinafoate. A review of its pharmacological properties and therapeutic potential in reversible obstructive airways disease. Brogden RN, Faulds D Drugs 1991;42:895-912.
Salmeterol: a study by prescription-event monitoring in a UK cohort of 15,407 patients. Mann RD, Kubota K, Pearce G, Wilton L J Clin Epidemiol 1996;49:247-50.
Dose-response study with high-dose inhaled salmeterol in healthy subjects. Maconochie JG, Forster JK Br J Clin Pharmacol 1992;33:342-5.
Does tachyphylaxis occur to the non-pulmonary effects of salmeterol? Maconochie JG, Minton NA, Chilton JE, Keene ON Br J Clin Pharmacol 1994;37:199-204.
Salmeterol: a novel, long-acting beta 2-agonist. Meyer JM, Wenzel CL, Kradjan WA Ann Pharmacother 1993;27:1478-87.
Short-term cardiovascular effects of salmeterol. Tranfa CME, Pelaia G, Grembiale RD, Naty S, Durante S, Borrello G Chest 1998;113:1272-6.
Dose-response study of inhaled salmeterol in asthmatic patients with 24-hour spirometry and Holter monitoring. Kemp JP, Bierman CW, Cocchetto DM Ann Allergy 1993;70:316-22.
A comparison of salmeterol with albuterol in the treatment of mild-to- moderate asthma. Pearlman DS, Chervinsky P, LaForce C, Seltzer JM, Southern DL, Kemp JP, Dockhorn RJ, Grossman J, Liddle RF, Yancey SW, et al N Engl J Med 1992;327:1420-5.

Multum version: 154.0 (Jun 16, 2010)

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