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|PediaCare Infants" Oral Decongestant Drops

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 relieve nasal or sinus congestion caused by the common cold, sinusitis, and hay fever and other respiratory allergies. It is also used to relieve ear congestion caused 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 have special instructions on the proper dose of pseudoephedrine for your medical condition.

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 medicine without 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 or allergic reaction to pseudoephedrine or similar medicines, such as albuterol, amphetamines, ephedrine, epinephrine, isoproterenol, metaproterenol, norepinephrine, phenylephrine, phenylpropanolamine, or terbutaline. Also tell your health care 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 reduction in average weight, length, and rate of bone formation in the animal fetus.

Breast-feeding—Pseudoephedrine passes into breast milk and may cause unwanted effects in nursing babies (especially newborn and premature babies).

Children—Pseudoephedrine may be more likely to cause side effects in infants, especially newborn and premature infants, than in older children and adults.

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 or if they cause different side effects or problems in older people. There is no specific information comparing use of pseudoephedrine in the elderly with use in other age groups.

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 pseudoephedrine, it is especially important that your health care professional know 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 these medicines; also, taking pseudoephedrine with beta-blockers may increase the chance of side effects

• Cocaine—Using cocaine with pseudoephedrine may increase the effects of either one of these medicines on the heart and increase the chance of 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 pseudoephedrine while you are taking or within 2 weeks of taking monoamine oxidase (MAO) inhibitors may increase the chance of serious side effects

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

• Type 2 diabetes mellitus—Use of pseudoephedrine may 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 condition worse

• Overactive thyroid—Use of pseudoephedrine may make the condition worse

Proper Use of This Medicine

For patients taking pseudoephedrine extended-release capsules :

• Swallow the capsule whole. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.
• Do not crush or chew before swallowing.

For patients taking pseudoephedrine extended-release tablets :

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

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

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

Dosing—The dose of pseudoephedrine 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 pseudoephedrine. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For nasal or sinus congestion:
  • For regular (short-acting) oral dosage form (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-four hours.
    • 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 determined by your doctor
    • Children up to 4 months of age—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (extended-release capsules or extended-release tablets):
    • Adults and children 12 years of age and older—120 mg every 12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in twenty-four hours.
    • Children up to 12 years of age—Use is not recommended.

Missed dose—If you miss a dose of this medicine and you remember within an hour or so of the missed dose, take it right away. However, if you do not remember until later, 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 the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that 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 have a high fever, check with your doctor since these signs may mean that you 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 may need medical attention.

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

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 health care professional if any of the following side effects continue or are bothersome:

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

Revised: 12/14/1998

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