HS
ORALAIR tablets are available as follows:
ORALAIR 100 IR tablets are round and biconvex, slightly speckled white to beige with "100" engraved on both sides
ORALAIR 300 IR tablets are round and biconvex, slightly speckled white to beige with "300" engraved on both sides
4 CONTRAINDICATIONS
ORALAIR is contraindicated in patients with:
Severe, unstable or uncontrolled asthma
History of any severe systemic allergic reaction
History of any severe local reaction to sublingual allergen immunotherapy
A history of eosinophilic esophagitis
Hypersensitivity to any of the inactive ingredients (mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and lactose monohydrate) contained in this product [see Description (11)]
5 WARNINGS AND PRECAUTIONS
5.1 Severe Allergic Reactions
ORALAIR can cause systemic allergic reactions including anaphylaxis which may be life-threatening. In addition, ORALAIR can cause severe local reactions, including laryngopharyngeal swelling, which can compromise breathing and be life-threatening.
Patients who have a systemic allergic reaction to ORALAIR should stop taking ORALAIR.
Patients who have either escalating or persistent local reactions to ORALAIR should be reeva luated and considered for discontinuation of ORALAIR.
Administer the initial dose of ORALAIR in a healthcare setting under the supervision of a physician prepared to manage a severe systemic or a severe local allergic reaction. Observe patients in the office for at least 30 minutes following the initial dose of ORALAIR.
Severe and serious allergic reactions may require treatment with epinephrine [See Warnings and Precautions (5.2)].
5.2 Epinephrine
Prescribe auto-injectable epinephrine to patients receiving ORALAIR. Instruct patients to recognize the signs and symptoms of a severe allergic reaction and in the proper use of emergency self-injection of epinephrine, and instruct patients to seek immediate medical care upon its use [See Patient Counseling Information (17)].
ORALAIR may not be suitable for patients with certain medical conditions that may reduce the ability to survive a serious allergic reaction or increase the risk of adverse reactions after epinephrine administration. Examples of these medical conditions include but are not limited to: markedly compromised lung function (either chronic or acute), unstable angina, recent myocardial infarction, significant arrhythmia, and uncontrolled hypertension.
ORALAIR may not be suitable for patients who are taking medications that can potentiate or inhibit the effect of epinephrine. These medications include:
Βeta-adrenergic blockers: Patients taking beta-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, beta-adrenergic blockers antagonize the cardiostimulating and bronchodilating effects of epinephrine.
Alpha-adrenergic blockers, ergot alkaloids: Patients taking alpha-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, alpha-adrenergic blockers antagonize the vasoconstricting and hypertensive effects of epinephrine. Similarly, ergot alkaloids may reverse the pressor effects of epinephrine.
Tricyclic antidepr |
