Desloratadine; Pseudoephedrine Extended-Release Tablets

What are Desloratadine; Pseudoephedrine Extended-Release Tablets?

DESLORATADINE; PSEUDOEPHEDRINNE (Clarinex-D® 24 Hour, Clarinex-D® 12 Hour) is a combination of an antihistamine and decongestant. It relieves the symptoms of allergies like hay fever (seasonal rhinitis) including nasal and sinus congestion. A generic extended-release tablet is not yet available.

What should my health care professional know before I receive Desloratadine; Pseudoephedrine Extended-Release Tablets)?

They need to know if you have any of these conditions:

• asthma

• blood vessel disease

• diabetes

• difficulty swallowing

• glaucoma

• heart disease or a fast heart rate

• high or low blood pressure

• kidney disease

• liver disease

• over active thyroid

• seizures (convulsions)

• stomach ulcer or stomach obstruction (blockage)

• urinary tract or prostate trouble

• an unusual reaction to Desloratadine, Loratadine, Pseudoephedrine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

Take this medicine by mouth. Follow the directions on the prescription label. Swallow the tablets whole with water. Do not break or chew the tablets. Take your doses at regular intervals. Do not take your medicine more often than directed.

Older patients (> 60 years of age) may have a stronger reaction to this medicine, especially if they have kidney disease. Your health care provider may adjust your dose.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If it is almost time for your next dose, take only that dose. Do not take double doses and do not split tablets in half.

What drug(s) may interact with Desloratadine; Pseudoephedrine Extended-Release Tablets?

• alcohol or illicit drugs such as cocaine

• barbiturate medicines for inducing sleep or treating seizures (convulsions), like phenobarbital

• bromocriptine

• caffeine (excessive use)

• furazolidone

• linezolid

• MAO inhibitors (examples: Eldepryl®, Marplan®, Nardil® and Parnate®)

• mecamylamine

• medicines for anxiety or sleeping problems, such as alprazolam, diazepam or temazepam

• medicines for breathing difficulties, such as theophylline or for weight loss, such as ephedra

• medicines for hay fever and other allergies such as antihistamines

• medicines for heart disease such as digoxin or beta-blockers

• medicines for mental problems, including anxiety, depression and psychotic disturbances

• medicines for migraine headaches such as dihydroergotamine or ergotamine

• medicines for nasal congestion or colds, such as more pseudoephedrine

• medicines for pain such as codeine or morphine

• procarbazine

• reserpine

• sodium bicarbonate

• St. John's Wort (an herbal products or dietary supplement)

• thyroid hormones, such as levothyroxine

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Desloratadine; Pseudoephedrine Extended-Release Tablets?

Do not drive, use machinery, or do anything that needs mental alertness until you know how Desloratadine; Pseudoephedrine (Clarinex-D®) will affect you. To reduce the risk of dizzy or fainting spells, do not stand or sit up quickly, especially if you are an older patient. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Many over the counter (OTC) products you might buy for coughs, colds or allergies may contain the same or similar ingredients as found in Desloratadine; Pseudoephedrine (Clarinex-D®). For example, Pseudoephedrine is found in a decongestant product called Sudafed®. You should not take additional antihistamines or decongestants if you have been prescribed Clarinex-D®. If you are not sure of the ingredients in OTC products ask your pharmacist or other health care provider.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

What side effects may I notice from receiving Desloratadine; Pseudoephedrine Extended-Release Tablets?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• abdominal pain or rectal bleeding

• chest pain

• confusion

• convulsions (seizures)

• difficulty breathing or wheezing, shortness of breath

• difficulty swallowing or enlarged tongue

• difficulty urinating

• dizziness or fainting spells

• fast or irregular heartbeat, palpitations

• hallucinations (seeing or hearing things that are not there)

• high blood pressure

• numbness or tingling in the hands or feet

• rash

• severe, persistent, or worsening headache

• tremor, muscle contractions

• visual changes

• vomiting

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• dry mouth

• headache (mild)

• loss of appetite or nausea

• nervousness, agitation, or difficulty sleeping

• tiredness

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature or between 15 to 25 degrees C (59 to 77 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.