FDA Approves Clarinex-D 12 Hour

Extended-Release Treatment Approved for Seasonal Allergy Symptoms

From the WebMD Archives

Feb. 3, 2006 -- A newer version of the prescription allergy medicine Clarinex has been approved by the FDA to treat nasal and non-nasal symptoms of seasonal allergies including nasal congestion in adults and children over age 12.

Researchers say the new Clarinex-D 12 Hour should be available in time for the spring allergy season.

Clarinex (desloratadine) is a nonsedating antihistamine available by prescription for the treatment of seasonal allergy symptoms. Clarinex-D 24 Hour (containing 5 milligrams desloratadine and 240 milligrams pseudoephedrine) as a once-daily prescription was approved last spring.

The newly approved Clarinex-D 12 Hour contains 2.5 milligrams desloratadine and 120 milligrams pseudoephedrine. The recommended dosing would be twice a day.

The FDA based its approval on two clinical trials involving more than 1,200 people with seasonal allergies. The studies compared treatment of Clarinex-D 12 HOUR extended-release tablets with pseudoephedrine alone and desloratadine alone.

The results showed that the extended-release-combined medication effectively relieved nasal congestion as well as provided significantly greater relief than desloratadine alone and that it relieved other allergy symptoms (excluding nasal congestion) better than pseudoephedrine alone.

The most common side effects associated with Clarinex-D 12 Hour were insomnia, headache, dry mouth, and fatigue. It should not be taken by those with narrow-angle glaucoma, severe high blood pressure or heart disease, urination difficulty, or by patients who may have taken a monoamine-oxidase inhibitor within the past 14 days. Those with certain other medical conditions such as high blood pressure, diabetes, heart disease, thyroid, liver, or kidney problems, or enlarged prostate should check with their health care provider prior to using Clarinex-D 12 hour or Clarinex-D 24 Hour.

About 36 million people in the U.S. are affected by seasonal allergies. Symptoms include runny nose, sneezing, nasal congestion, and itchy, watery eyes.

WebMD Health News Reviewed by Louise Chang, MD on February 03, 2006

Sources

SOURCE: FDA. News release, Schering-Plough Corp.
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