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Congestion for Use of Clarinex-D 12 Hour cleared – FDA Gives the Nod

by Medindia Content Team on February 4, 2006 at 5:15 PM
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Congestion for Use of Clarinex-D 12 Hour cleared – FDA Gives the Nod

The FDA has given its consent for the novel version of the allergy medicine, Clarinex-D 12 Hour, to alleviate nasal, non nasal symptoms and nasal congestion occurring in adults and children above the age of 12. According to the researchers, this medicine will be in time for the spring allergy season.

It is estimated that about 36 million people in the U.S. are troubled by seasonal allergies with apparent runny nose, sneezing, nasal congestion, and itchy, watery eyes, symptoms.

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Clarinex (desloratadine) , used for treatment of seasonal allergy symptoms, is a nonsedating antihistamine procured only by prescription . Approval for Clarinex-D 24 Hour (containing 5 milligrams desloratadine and 240 milligrams pseudo ephedrine), prescribed only once a day was obtained last spring. Clarinex-D 12 hour, the recently approved medicine contains 2.5 milligrams desloratadine and 120 milligrams pseudo ephedrine, and can be consumed twice a day.

The FDA approval was close on the heels of two clinical trials involving 1,200 people or more who suffered seasonal allergies. The trails involved comparison of the treatment with Clarinex-D 12 HOUR extended-release tablets with pseudoephedrine alone and desloratadine alone. The results depicted that the extended-release-combined medication eased nasal congestion as well as provided immense relief compared to desloratadine alone, relieving other allergy symptoms better than pseudoephedrine alone.
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Insomnia, headache, dry mouth, and fatigue are some of the common side effects associated with Clarinex-D 12 Hour use. This medicine should not be taken by those suffering from narrow-angle glaucoma, severe high blood pressure or heart disease, urination difficulty, or by patients who may have taken a monoamine-oxidase inhibitor 14 days prior to the use of this drug. It also recommended that those with certain other medical conditions such as high blood pressure, diabetes, heart disease, thyroid, liver, or kidney problems, or enlarged prostate should seek the advice of a medical specialist before resorting to the use of Clarinex-D 12 hour or Clarinex-D 24 Hour.

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