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Clarinex-D 12hr

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Clarinex-D 12hr

CLARINEX-D® 12 HOUR Extended Release Tablets
(desloratadine/pseudoephedrine sulfate)

Clarinex-D 12hr

DRUG DESCRIPTION

CLARINEX-D 12 HOUR Extended Release Tablets are oval-shaped blue and white bilayer tablets containing 2.5 mg desloratadine in the blue immediate-release layer and 120 mg of pseudoephedrine sulfate USP in the white extended-release layer which is released slowly, allowing for twicedaily administration.

The inactive ingredients contained in CLARINEX-D 12 HOUR Extended Release Tablets are hypromellose USP, microcrystalline cellulose NF, povidone USP, silicon dioxide NF, magnesium stearate NF, corn starch NF, edetate disodium USP, citric acid anhydrous USP, stearic acid NF, and FD&C Blue No. 2 aluminum lake dye.

Desloratadine, 1 of the 2 active ingredients of CLARINEX-D 12 HOUR Extended Release Tablets, is a white to off-white powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. It has an empirical formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6] cyclohepta [1,2-b]pyridine and has the following structure:

Desloratadine - Structural Formula Illustration

Pseudoephedrine sulfate, the other active ingredient of CLARINEX-D 12 HOUR Extended Release Tablets, is the synthetic salt of one of the naturally occurring dextrorotatory diastereomers of ephedrine and is classified as an indirect sympathomimetic amine. Pseudoephedrine sulfate is a colorless hygroscopic crystal or white, hygroscopic crystalline powder, practically odorless, with a bitter taste. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in ether. The empirical formula for pseudoephedrine sulfate is (C10H15NO)2•H2SO4; the chemical name is benzenemethanol, α-[1-(methylamino) ethyl]-,[S-(R*,R*)]-, sulfate (2:1)(salt); and the chemical structure is:

Pseudoephedrine sulfate - Structural Formula Illustration

What are the possible side effects of desloratadine and pseudoephedrine (Clarinex-D 12 Hour, Clarinex-D 24 Hour)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your...

Read All Potential Side Effects and See Pictures of Clarinex-D 12hr »

What are the precautions when taking desloratadine and pseudoephedrine sulfate (Clarinex-D 12hr)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to desloratadine or pseudoephedrine; or to loratadine; or if you have any other allergies. Also, tell your doctor if you have had serious side effects from similar medications (such as other decongestants, including phenylephrine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, difficulty urinating (such as due to an enlarged prostate), high blood pressure (hypertension), heart/blood vessel disease (such as coronary artery disease), overactive thyroid (hyperthyroidism), diabetes, kidney disease,...

Read All Potential Precautions of Clarinex-D 12hr »

Last reviewed on RxList: 5/5/2014
This monograph has been modified to include the generic and brand name in many instances.

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Clarinex-D 12hr - User Reviews

Clarinex-D 12hr User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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