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DESLORATADINE AND PSEUDOEPHEDRINE (Systemic)†

Some commonly used brand names are:

In the U.S.—

Clarinex-D
Clarinex-D 12 Hour

† Not commercially available in Canada.

Description

Desloratadine and Pseudoephedrine ((des-LOR-at-a-deen and soo-doe-e-FED-rin)) is a combination of two medicines used to treat nasal congestion (stuffy nose), sneezing, and runny nose caused by hay fever.

Desloratadine works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes.

The pseudoephedrine causes narrowing of blood vessels. This leads to clearing of nasal congestion, but it may also cause an increase in blood pressure in patients who have high blood pressure.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

Oral
Extended-release tablets [12 hour] (U.S.)
Extended-release tablets [24 hour] (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For desloratadine and pseudoephedrine combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to desloratadine or pseudoephedrine or to loratadine. Also tell your doctor and pharmacist if you are allergic to any other substances, such as adrenergic agents, foods, preservatives, or dyes.

Pregnancy—Desloratadine and pseudoephedrine combinations have not been studied in pregnant women. However, studies in animals have shown that desloratadine causes unwanted problems in the fetus. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Desloratadine passes into breast milk and may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Desloratadine and pseudoephedrine combination is not recommended for use in pediatric patients under 12 years of age.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of desloratadine and pseudoephedrine combination in the elderly with use in other age groups, elderly patients are more likely to be sensitive to the effects of this drug.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking desloratadine and pseudoephedrine combination, it is especially important that your doctor and pharmacist know if you are taking any of the following:

Digitalis (e.g., Digoxin)—Use of this medicine may affect heartbeats.

Monoamine oxidase inhibitor (MAO) (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—If you are now taking, or have taken within the past 2 weeks, any of the MAO inhibitors, the side effects of the MAO inhibitors may become more severe; these medicines should not be used together.

Other medical problems—The presence of other medical problems may affect the use of desloratadine and pseudoephedrine combination. Make sure you tell your doctor if you have any other medical problems, especially:

Diabetes mellitus (sugar diabetes)—The decongestant in this medicine may put diabetic patients at a greater risk of having heart or blood vessel disease.

Enlarged prostate or
Urinary tract blockage or difficult urination—Some of the effects of antihistamines may make urinary problems worse.

Glaucoma—A slight increase in inner eye pressure may occur.

Heart or blood vessel disease or
High blood pressure—The decongestant in this medicine may cause blood pressure to increase and may also speed up the heart rate.

Kidney disease—Higher blood levels of desloratadine may result, which may increase the chance of side effects. If you are taking the 24 hour extended-release tablets, the dosage may need to be reduced. The 12 hour extended-release tablets should generally be avoided if you have kidney disease.

Liver disease—Higher blood levels of desloratadine may result, which may increase the chance of side effects. This medicine should generally be avoided if you liver disease

Overactive thyroid—If an overactive thyroid has caused a fast heart rate, desloratadine in this medicine may cause the heart rate to speed up further.

Urinary retention—Condition may be worsened with use of pseudoephedrine

Proper Use of This Medicine

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects .

Not taking over-the-counter antihistamines and decongestants while taking desloratadine and pseudoephedrine combination.

When taking desloratadine and pseudoephedrine extended-release tablet :

Swallow it whole.
Do not crush, break, or chew before swallowing.

Dosing—The dose of desloratadine and pseudoephedrine combination will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of desloratadine and pseudoephedrine combination. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (extended-release tablets [12 hour]):
- For nasal congestion or rhinorrhea:
  - Adults and teenagers—Oral, one tablet (2.5 milligrams desloratadine, 120 milligrams pseudoephedrine) two times a day 12 hours apart, taken with or without meals.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (extended-release tablets [24 hour]):
- For nasal congestion or rhinorrhea:
  - Adults and teenagers—Oral, one tablet (5 milligrams desloratadine, 240 milligrams pseudoephedrine) daily, taken with or without a meal
  - Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

Keep out of the reach of children.
Store away from heat and direct light.
Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Desloratadine may cause dryness of the mouth, nose, and throat. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Observed during clinical practice

Abdominal or stomach pain area; chills; clay-colored stools; cough; dark urine; difficult or labored breathing; difficulty swallowing; dizziness; elevated liver enzymes; fast heartbeat; fast, pounding, or irregular heartbeat or pulse; fever; general tiredness and weakness; headache; hives; irregular heartbeat; itching; light-colored stools; loss of appetite; nausea; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; rash; redness of skin; shortness of breath; skin rash; swelling; tightness in chest; unpleasant breath odor; unusual tiredness or weakness; upper right abdominal pain; vomiting of blood; vomiting; welts; wheezing; yellow eyes or skin

Symptoms of overdose

Get emergency help immediately if any of the following symptoms of overdose occur

Increased heart rate; sleepiness or unusual drowsiness

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Dry mouth; sleeplessness; trouble sleeping; unable to sleep

Less common

Body aches or pain; congestion; dryness or soreness of throat; hoarseness; nervousness; restlessness; runny nose; sleepiness or unusual drowsiness; tender, swollen glands in neck; trouble sitting still; voice changes; weight loss

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 04/13/2005
Revised: 02/15/2006

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