Fexofenadine and Pseudoephedrine (Systemic)
Fexofenadine and Pseudoephedrine (Systemic)
US Brand Names
Fexofenadine (fex-oh-FEN-a-deen) is an antihistamine and pseudoephedrine (soo-doe-e-FED-rin) is a decongestant. The combination of these two medicines is used to treat the nasal congestion (stuffy nose), sneezing, and runny nose caused by hay fever.
This medicine is available only with your doctor's prescription, in the following dosage form:
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 fexofenadine and pseudoephedrine combination, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to fexofenadine or pseudoephedrine, or to amphetamine, dextroamphetamine (e.g., Dexedrine), ephedrine (e.g., Ephed II), epinephrine (e.g., Adrenalin), isoproterenol (e.g., Isuprel), metaproterenol (e.g., Alupent), methamphetamine (e.g., Desoxyn), norepinephrine (e.g., Levophed), phenylephrine (e.g., Neo-Synephrine), Phenylpropanolamine (e.g., Dexatrim), or terbutaline (e.g., Brethine). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
In animal studies, this medicine did not cause birth defects but did cause a decrease in weight of newborn and bone formation in the ribs. Discuss with your doctor whether or not you should continue to use this medicine if you become pregnant.
It is not known whether fexofenadine passes into breast milk, but pseudoephedrine does pass into breast milk. Discuss with your doctor the risks of breast-feeding while taking this medicine.
Use is not recommended in infants and children up to 12 years of age. In children 12 years of age and older, this medicine is not expected to cause different side effects or problems than it does in adults.
Some side effects may be more likely to occur in elderly patients, who are usually more sensitive to the effects of this medicine.
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 this medicine, it is especially important that your health care professional know if you are taking any of the following:
• Monoamine oxidase (MAO) inhibitor activity (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 pseudoephedrine 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
• Diabetes mellitus (sugar diabetes)-Use of this medicine may cause an increase in blood glucose levels
• Enlarged prostate or
• Urinary tract blockage or difficult urination-Use of this medicine may cause urination to be more difficult
• Glaucoma or
• Increased pressure in the eye-Use of this medicine may make the condition worse
• Heart or blood vessel disease or
• High blood pressure-Use of this medicine may make the condition worse
• Kidney disease-Effects may be increased because of slower removal of the medicine from the body
• Overactive thyroid-Serious effects on the heart may occur
Swallow the extended-release tablet whole. Do not crush, break, or chew it before swallowing.
This medicine is best taken on an empty stomach (either one hour before or two hours after a meal).
The dose of this medicine may 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.
• For oral dosage form (extended-release tablets):
o For symptoms of hay fever:
§ Adults-1 tablet two times a day.
§ Children-Use and dose must be determined by your doctor.
If you miss a dose of this medicine, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
To store this medicine:
• Keep out of the reach of children.
• Store away from heat and direct light in a tightly closed container.
• 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. Be sure that any discarded medicine is out of the reach of children.
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 as soon as possible if any of the following side effects occur:
Trouble in sleeping.
Cough; dizziness; irregular heartbeat; nervousness; sore throat.
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:
Abdominal or stomach pain; agitation; anxiety; back pain; dry mouth; heartburn.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
August 12, 1998