Clarinex-D 12 Hour

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 have an allergy to desloratadine, loratadine, pseudoephedrine, or any other part of Clarinex-D 12 Hour (desloratadine and pseudoephedrine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Glaucoma, heart disease, high blood pressure, or trouble passing urine.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Clarinex-D 12 Hour.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Clarinex-D 12 Hour. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine for longer than you were told by your doctor.
• Do not use on a child younger than 12 years of age.
• If you are 65 or older, use Clarinex-D 12 Hour with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.
• Dry mouth.
• Headache.
• Not hungry.
• Sore throat.
• Upset stomach.
• Feeling tired or weak.
• Restlessness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from heat.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Seasonal Allergic Rhinitis

CLARINEX-D® 12 HOUR Extended Release Tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. Clarinex-D 12 Hour Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired [see Clinical Pharmacology (12)].

No specific interaction studies have been conducted with Clarinex-D 12 Hour Extended Release Tablets.

Monoamine Oxidase Inhibitors

Clarinex-D 12 Hour Extended Release Tablets should not be used in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment because the action of pseudoephedrine a component of Clarinex-D 12 Hour Extended Release tablets on the vascular system may be potentiated by these agents [see Contraindications (4) and Warnings and Precautions (5.3)].

Beta-Adrenergic Blocking Agents

The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, and reserpine, may be reduced by sympathomimetics such as pseudoephedrine. Exercise caution when using Clarinex-D 12 Hour Extended Release Tablets with these agents.

Digitalis

Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis. Exercise caution when using Clarinex-D 12 Hour Extended Release Tablets with these agents.

Inhibitors of Cytochrome P450 3A4

In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3-hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine [see Clinical Pharmacology (12.3)].

Fluoxetine

In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3-hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine [see Clinical Pharmacology (12.3)].

Cimetidine

In controlled clinical studies co-administration of desloratadine with cimetidine a histamine H2-receptor antagonist resulted in increased plasma concentrations of desloratadine and 3-hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine [see Clinical Pharmacology (12.3)].

There is no information to indicate that abuse or dependency occurs with CLARINEX or Clarinex-D 12 Hour Extended Release Tablets.

Get emergency medical help if you have any of these signs of an allergic reaction to Clarinex-D 12 Hour: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Clarinex-D 12 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 12 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.