Rhinocort Aqua Available In The US For Adults And Children With Allergic Rhinitis
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Rhinocort Aqua Available In The US For Adults And Children With Allergic Rhinitis

WAYNE, PA -- February 7, 2000 -- AstraZeneca LP announced the nationwide availability of its new nasal allergy relief medication, Rhinocort Aqua(TM) (budesonide) Nasal Spray, for the treatment of seasonal and perennial allergic rhinitis in adults and children six years of age and older. Approved by the U.S. Food and Drug Administration in October 1999, Rhinocort Aqua is the first nasal steroid medication for children and adults with a recommended starting dose of only one spray per nostril, once-a-day. The active compound, budesonide, is in a fragrance-free, water-based formulation that contains no alcohol and no benzalkonium chloride preservative. Rhinocort Aqua uses potassium sorbate as a preservative.

"Rhinocort Aqua is a welcomed, patient-friendly treatment option that can be very beneficial for allergic rhinitis patients who suffer seasonally or live everyday with this bothersome disease," said Robert Overholt, MD, President of the Allergy, Asthma & Sinus Center in Knoxville, Tennessee. Approximately 20 to 40 million Americans suffer from allergic rhinitis. Sometimes known as hay fever, it is believed to be the most common chronic allergic disease in the U.S. Although not life-threatening, it can be serious enough to interfere with daily life. Symptoms, such as congestion, sneezing and runny nose, can often be mistaken for the common cold, but unlike a cold can last anywhere from a few weeks to all year.

Leading U.S. allergy specialists' organizations -- the American Academy of Allergy, Asthma and Immunology, the American College of Allergy, Asthma and Immunology and the Joint Council on Allergy, Asthma and Immunology -- consider nasal steroids to be the most effective medication class for controlling the nasal congestion associated with allergic rhinitis.

In some clinical trials Rhinocort Aqua was shown to be effective and well-tolerated in both adults and children suffering from allergic rhinitis. The medication can provide a significant reduction in the severity of nasal symptoms -- congestion, runny nose and sneezing -- in as few as 24 hours after initial therapy. Maximum benefit generally takes two weeks to achieve. Product effectiveness depends on use at regular intervals. The recommended once-daily starting dose regimen is one spray per nostril for adults and children. The maximum recommended once-daily regimen requires two sprays per nostril in children; four sprays per nostril in adults. Rhinocort Aqua is contained in a pocket-sized bottle with each dose delivered through a hand-held, wing-tipped applicator. The bottle contains 60 metered sprays. Each spray provides 32 mcg of budesonide mixed in water.

The safety and efficacy of Rhinocort Aqua were evaluated in seven placebo-controlled clinical trials, with over 1500 patients aged six years and older with allergic rhinitis. Overall, the medication significantly reduced the severity of the nasal symptoms -- runny nose, sneezing and congestion -- and showed a low incidence of side effects in clinical trials. The most commonly reported adverse events for Rhinocort Aqua and vehicle placebo (a mixture with no active drug) respectively were: epistaxis (nosebleed) - 8 percent vs 5 percent; pharyngitis (sore throat) - 4 percent vs 3 percent; bronchospasm - 2 percent vs 1 percent; nasal irritation - 2 percent vs <1 percent; and coughing - 2 percent vs <1 percent. Patients previously treated with oral steroids (e.g., pills) and transferred to nasal steroids should be carefully monitored for adrenal insufficiency. As with other nasal steroids, after symptomatic relief is achieved, the dose should be reduced to the least amount necessary to control symptoms. Physicians should routinely monitor the growth of children taking nasal steroids to any possible growth effects.

Related Links: Rhinocort Aqua (budesonide) Nasal Spray and AstraZeneca LP.

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