PSEUDOEPHEDRINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Cenafed
• Chlor-Trimeton Non-Drowsy Decongestant 4 Hour
• Decofed
• Dimetapp Decongestant
• Dimetapp Decongestant Pediatric Drops
• Drixoral Nasal Decongestant
• Efidac/24
• Genaphed
• Myfedrine
• PediaCare Infants' Oral Decongestant Drops
• Pseudo 60's
• Sudafed
• Sudafed Children's Nasal Decongestant Liquid Medication
• Sudafed 12 Hour
• Triaminic AM Decongestant Formula
• Triaminic Infant Oral Decongestant Drops

In Canada?

• Balminil Decongestant Syrup
• Benylin Decongestant
• Drixoral N.D.
• Eltor 120
• Maxenal
• Robidrine
• Sudafed Decongestant
• Sudafed Decongestant Extra Strength
• Sudafed Decongestant 12 Hour

Generic name product may be available in the U.S. and Canada.

Category

• Decongestant, nasal, systemic

Description

Pseudoephedrine (soo-doe-e-FED-rin) is used to relievenasal or sinus congestion caused by the common cold, sinusitis, and hay feverand other respiratory allergies. It is also used to relieve ear congestioncaused by ear inflammation or infection.

Some of these preparations are available only with your doctor's prescription.Others are available without a prescription; however, your doctor may havespecial instructions on the proper dose of pseudoephedrine for your medicalcondition.

Pseudoephedrine is available in the following dosage forms:

Oral
• Capsules (U.S. and Canada)
• Extended-release capsules (Canada)
• Oral solution (U.S.)
• Syrup (U.S. and Canada)
• Tablets (U.S. and Canada)
• Extended-release tablets (U.S. and Canada)

Before Using This Medicine

If you are taking this medicinewithout a prescription, carefully read and follow any precautions on the label.For pseudoephedrine, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to pseudoephedrine or similar medicines, such as albuterol,amphetamines, ephedrine, epinephrine, isoproterenol, metaproterenol, norepinephrine,phenylephrine, phenylpropanolamine, or terbutaline. Also tell your healthcare professional if you are allergic to any other substances, such as foods,preservatives, or dyes.

Pregnancy?Studies on birth defects have not been done in humans.Pseudoephedrine has not been shown to cause birth defects in animal studies.However, studies in animals have shown that pseudoephedrine causes a reductionin average weight, length, and rate of bone formation in the animal fetus.

Breast-feeding?Pseudoephedrine passes into breast milk and maycause unwanted effects in nursing babies (especially newborn and prematurebabies).

Children?Pseudoephedrine may be more likely to cause sideeffects in infants, especially newborn and premature infants, than in olderchildren and adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof pseudoephedrine in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingpseudoephedrine, it is especially important that your health care professionalknow if you are taking any of the following:

• Beta-blockers (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin],betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol],labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g.,Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol[e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Sotacor], timolol[e.g., Blocadren])?Pseudoephedrine may decrease the effect of thesemedicines; also, taking pseudoephedrine with beta-blockers may increase thechance of side effects

• Cocaine?Using cocaine with pseudoephedrine may increase theeffects of either one of these medicines on the heart and increase the chanceof side effects

• 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])?Taking pseudoephedrinewhile you are taking or within 2 weeks of taking monoamine oxidase (MAO) inhibitorsmay increase the chance of serious side effects

Other medical problems?The presence of other medicalproblems may affect the use of pseudoephedrine. Make sure you tell your doctorif you have any other medical problems, especially:

• Type 2 diabetes mellitus?Use of pseudoephedrinemay cause an increase in blood glucose levels

• Enlarged prostate or
• Glaucoma, or a predisposition to glaucoma or
• Heart disease or blood vessel disease or
• High blood pressure?Pseudoephedrine may make the conditionworse

• Overactive thyroid?Use of pseudoephedrine may make the conditionworse

Proper Use of This Medicine

For patientstaking pseudoephedrine extended-release capsules:

• Swallow the capsule whole. However, if the capsule is too large toswallow, you may mix the contents of the capsule with jam or jelly and swallowwithout chewing.
• Do not crush or chew before swallowing.

For patients taking pseudoephedrine extended-releasetablets:

• Swallow the tablet whole.
• Do not break, crush, or chew before swallowing.

To help prevent trouble in sleeping, take the lastdose of pseudoephedrine for each day a few hours before bedtime. Ifyou have any questions about this, check with your doctor.

Take this medicine only as directed. Do nottake more of it, do not take it more often, and do not take it for a longerperiod of time than recommended on the label (usually 7 days), unless otherwisedirected by your doctor. To do so may increase the chance of side effects.

Dosing?The dose of pseudoephedrine will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of pseudoephedrine. If your dose isdifferent, do not change it unless your doctor tells you to do so.

The number of capsules, tablets, or teaspoonfuls of solution or syrup thatyou take each day depends on the strength of the medicine. Also, the timebetween doses depends on whether you are taking a short-acting or long-actingform of pseudoephedrine.

• For nasal or sinus congestion:
  • For regular (short-acting) oral dosageform (capsules, oral solution, syrup, or tablets):
    • Adults and children 12 years of age and older?60 milligrams(mg) every four to six hours. Do not take more than 240 mg in twenty-fourhours.
    • Children 6 to 12 years of age?30 mg every four to six hours.Do not take more than 120 mg in twenty-four hours.
    • Children 2 to 6 years of age?15 mg every four to six hours.Do not take more than 60 mg in twenty-four hours.
    • Children 4 months to 2 years of age?Dose must be determinedby your doctor
    • Children up to 4 months of age?Use and dose must be determinedby your doctor.
  • For long-acting oral dosage form (extended-releasecapsules or extended-release tablets):
    • Adults and children 12 years of age and older?120 mg every12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in twenty-fourhours.
    • Children up to 12 years of age?Use is not recommended.

Missed dose?If you miss a dose of this medicine and you rememberwithin an hour or so of the missed dose, take it right away. However, if youdo not remember until later, skip the missed dose and go back to your regulardosing 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 the capsule or tablet form of this medicine in the bathroom,near the kitchen sink, or in other damp places. Heat or moisture may causethe medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If symptoms do not improve within 7 days or if you also havea high fever, check with your doctor since these signs may mean thatyou have other medical problems.

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 mayneed medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Rare?more common with high doses

Convulsions (seizures); hallucinations(seeing, hearing, or feeling things that are not there); irregular or slow heartbeat; shortness of breathor troubled breathing

Symptoms of overdose

Convulsions (seizures); fast breathing; hallucinations (seeing, hearing, or feeling thingsthat are not there); increase in blood pressure; irregular heartbeat (continuing); shortnessof breath or troubled breathing (severe or continuing); slow or fast heartbeat (severe or continuing); unusualnervousness, restlessness, or excitement

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your health careprofessional if any of the following side effects continue or are bothersome:

More common

Nervousness; restlessness; trouble in sleeping

Less common

Difficult or painful urination; dizzinessor lightheadedness; fast or pounding heartbeat; headache; increased sweating; nausea or vomiting; trembling; unusual paleness; weakness

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour health care professional.