Rhinocort® Allergy (Budesonide) — New Over-The-Counter Drug Approval

Rhinocort® Allergy (budesonide) — New Over-The-Counter Drug Approval

• The FDA approved the over-the-counter (OTC) use of AstraZeneca’s Rhinocort Allergy (budesonide) nasal spray, for the temporary relief of symptoms (nasal congestion, runny nose, itchy nose, and sneezing) of hay fever or other upper respiratory allergies in adults and children ages 6 years and older.

— Rhinocort Aqua® (budesonide) nasal spray is also generically available by prescription.

• Rhinocort Allergy contains a glucocorticosteroid (budesonide), which exhibits anti-inflammatory effects, thereby, reducing the symptoms associated with hay fever and upper respiratory allergies.

• Use of Rhinocort Allergy should be stopped and a doctor consulted in the following situations: contact with someone who has chickenpox, measles, or tuberculosis; symptoms of an infection such as persistent fever; any change in vision; and severe or frequent nosebleeds.

• The recommended dose of Rhinocort Allergy is as follows:

Age Dose Adults and children 12 • Spray 2 times into each nostril once daily while sniffing years of age and older gently. • Once allergy symptoms improve, reduce to 1 spray in each nostril per day. From 6 to under 12 years • Spray 1 time into each nostril once daily while sniffing of age gently. • If allergy symptoms do not improve, increase to 2 sprays in each nostril per day. • Once allergy symptoms improve, reduce to 1 spray in each nostril per day. Under 6 years of age • Do not use

— Prior to use, Rhinocort Allergy should be primed for 8 sprays. If not used for 2 consecutive days, Rhinocort Allergy should be reprimed until a fine mist appears.

• AstraZeneca’s launch plans for Rhinocort Allergy are pending. Rhinocort Allergy will be available in bottles containing 32 mcg of budesonide per spray.

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