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AIRDUO DIGIHALER (fluticasone propionate and salmeterol)inhalation powder(九)
ism and adrenal suppression(including adrenal crisis) may appear in a small number of patients who are sensitive to theseeffects. If such effects occur, AirDuo Digihaler should be reduced slowly, consistent withaccepted procedures for reducing systemic corticosteroids, and for management of asthmasymptoms.
5.8 Drug Interactions with Strong Cytochrome P450 3A4 InhibitorsThe use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir,clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole,telithromycin) with AirDuo Digihaler is not recommended because increased systemic
corticosteroid and increased cardiovascular adverse effects may occur [see DrugInteractions (7.1) and, Clinical Pharmacology (12.3)].
5.9 Paradoxical Bronchospasm and Upper Airway Symptoms
As with other inhaled medicines, AirDuo Digihaler can produce paradoxical bronchospasm,which may be life-threatening. If paradoxical bronchospasm occurs following dosing withinhaled fluticasone propionate/salmeterol medicines, it should be treated immediately with aninhaled, short-acting bronchodilator; inhaled fluticasone propionate/salmeterol medicines shouldbe discontinued immediately; and alternative therapy should be instituted. Upper airwaysymptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have beenreported in patients receiving inhaled fluticasone propionate/salmeterol medicines.
5.10 Hypersensitivity Reactions, Including Anaphylaxis
Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm,hypotension), including anaphylaxis, may occur after administration of AirDuo Digihaler. There
have been reports of anaphylactic reactions in patients with severe milk protein allergy afterinhalation of other powder products containing lactose; therefore, patients with severe milkprotein allergy should not use AirDuo Digihaler [see Contraindications (4)].
5.11 Cardiovascular and Central Nervous System Effects
Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension orhypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache,tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia [see Overdosage (10.2)].
Therefore, AirDuo Digihaler, like all products containing sympathomimetic amines, should beused with caution in patients with cardiovascular disorders, especially coronary insufficiency,cardiac arrhythmias, and hypertension.
Salmeterol, a component of AirDuo Digihaler, can produce a clinically significant cardiovasculareffect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Althoughsuch effects are uncommon after administration of salmeterol at recommended doses, if theyoccur, the drug may need to be discontinued. In addition, beta-agonists have been reported toproduce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown.
Large doses of inhaled or oral salmeterol (12 to 20 times the recommended dose) have beenassociated with clinically significant prolongation of the QTc interval, which has the potential forproducing ventricular arrhythmias. Fatalities have been reported in association with excessiveuse of inha |
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