Clarinex-D (Oral)

Desloratadine and pseudoephedrine is a combination of two medicines used to treat nasal congestion (a stuffy nose), sneezing, and a runny nose caused by hay fever.

Desloratadine works by blocking the effects of a substance called histamine, which the body produces. Histamine can lead to itching, sneezing, a runny nose, and watery eyes.

Pseudoephedrine narrows blood vessels. This helps clear nasal congestion, but it may also raise blood pressure in patients who have high blood pressure.

This medicine is available only with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

Desloratadine can make your mouth, nose, and throat feel dry. To help with this temporarily, you can try sugarless candy or gum, let bits of ice melt in your mouth, or use a saliva substitute. If your mouth stays dry for more than 2 weeks, talk to your dentist. Ongoing dryness in your mouth may raise the risk of dental problems, such as tooth decay, gum disease, and fungal infections.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against the benefits it may provide. The following factors should be considered for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Desloratadine and pseudoephedrine combination is not recommended for children under 12 years of age.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children could cause serious or potentially life-threatening side effects.

Geriatric

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

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative to this medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might happen. In these cases, your doctor may need to adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below while using this medicine. The following interactions are significant and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or may change some of the other medicines you take.

• Dihydroergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both of the medicines.

• Abiraterone Acetate
• Guanethidine
• Iobenguane I 123
• Iobenguane I 131
• Methyldopa
• Midodrine
• Pitolisant

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are significant and are not necessarily all-inclusive.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Diabetes mellitus (sugar diabetes)—The decongestant in this medicine may increase the risk of heart or blood vessel disease in diabetic patients.

• Enlarged prostate or
• Urinary tract blockage or difficulty urinating—Some effects of antihistamines may worsen urinary problems.

• Glaucoma—There may be a slight increase in inner eye pressure.

• Heart or blood vessel disease or
• High blood pressure—The decongestant in this medicine may raise blood pressure and may also increase heart rate.

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

• Liver disease—Higher blood levels of desloratadine may occur, increasing the chance of side effects. This medicine should generally be avoided if you have liver disease.

• Overactive thyroid—If an overactive thyroid has caused a fast heart rate, desloratadine in this medicine may further increase heart rate.

• Urinary retention—This condition may worsen with the use of pseudoephedrine.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away 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 right away if any of the following symptoms of overdose occur:

• Increased heart rate
• sleepiness or unusual drowsiness

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Clarinex-D

Available Dosage Forms:

• Tablet, Extended Release, 12 HR
• Tablet, Extended Release, 24 HR

Therapeutic Class: Antihistamine, Less-Sedating/Decongestant Combination

Pharmacologic Class: Antihistamine, Less-Sedating

Chemical Class: Piperidine

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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 a meal Children 4 years of age and older—Use and dose must be determined by your doctor. Children and infants up to 4 years of age—Use is not recommended.

• 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 4 years of age and older—Use and dose must be determined by your doctor. Children and infants up to 4 years of age—Use is not recommended.

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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.