Clarinex-D 24 Hour

Do not use desloratadine and pseudoephedrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of this medication.

Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Antihistamines and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Clarinex-D 24 Hour Extended Release Tablets are oval-shaped, light blue coated tablets with "D 24" branded in black on one side. Each tablet contains 5 mg desloratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate USP in an extended release core.

Seasonal Allergic Rhinitis

The clinical efficacy and safety of Clarinex-D 24 Hour Extended Release Tablets was evaluated in two 2-week multicenter, randomized parallel group clinical trials involving 2852 subjects 12 to 78 years of age with seasonal allergic rhinitis, 708 of whom received Clarinex-D 24 Hour Extended Release Tablets. In the 2 trials, subjects were randomized to receive Clarinex-D 24 Hour Extended Release Tablets once daily, CLARINEX Tablets 5 mg once daily, or sustained-release pseudoephedrine tablet 240 mg once daily for two weeks. The majority of patients were between 18 and <65 years of age with a mean age of 34.3 years and were predominantly women (63%). Patient ethnicity was 79% Caucasian, 10% Black, 8% Hispanic and 3% Asian/other ethnicity. Primary efficacy variable was twice-daily reflective patient scoring of 4 nasal symptoms (rhinorrhea, nasal stuffiness/congestion, nasal itching, and sneezing) and 4 non-nasal symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears/palate) on a four point scale (0=none, 1=mild, 2=moderate, and 3=severe). In both trials, the antihistaminic efficacy of Clarinex-D 24 Hour Extended Release Tablets, as measured by total symptom score excluding nasal congestion, was significantly greater than pseudoephedrine alone over the 2-week treatment period; and the decongestant efficacy of Clarinex-D 24 Hour Extended Release Tablets, as measured by nasal stuffiness/congestion, was significantly greater than CLARINEX (desloratadine alone) over the 2-week treatment period. Primary efficacy variable results from 1 of 2 trials are shown in Table 3.

There were no significant differences in the efficacy of Clarinex-D 24 Hour Extended Release Tablets across subgroups of subjects defined by gender, age, or race.

Clarinex-D 24 Hour Extended Release Tablets are oval-shaped, light blue coated tablets with "D24" branded in black on one side containing 5 mg desloratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate USP in an extended release core. Clarinex-D 24 Hour Extended Release Tablets are supplied in high-density polyethylene bottles of 100 (NDC 0085-1317-01).

Storage:

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Heat Sensitive. Avoid exposure at or above 30°C (86°F). Protect from excessive moisture. Protect from light.

Clarinex-D 24 Hour contains a combination of desloratadine and pseudoephedrine. Desloratadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Clarinex-D 24 Hour is used to treat sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Clarinex-D 24 Hour is for use in adults and children who are at least 12 years old.

Clarinex-D 24 Hour may also be used for purposes not listed in this medication guide.

Since cold or allergy medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction to Clarinex-D 24 Hour: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Clarinex-D 24 Hour and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out;

• seizure (convulsions); or

• severe dizziness, anxiety, restless feeling, tremors, or nervousness.

Common Clarinex-D 24 Hour side effects may include:

• weakness, mild dizziness;

• sleep problems (insomnia); or

• dry mouth, nose, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.