RACEMETHIONINE (Systemic)?

Some commonly used brand names are:

In the U.S.?

• M-Caps
• Pedameth
• Uracid

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

Other commonly used names are methionine and DL-methionine.

? Not commercially available in Canada.

Category

• Acidifier, urinary
• Antidote, to acetaminophen overdose

Description

Racemethionine (race-e-me-THYE-oh-neen) is used to make the urine more acidic.Making the urine more acidic helps to relieve skin irritation in incontinent(loss of bladder control) adults and diaper rash in infants. This medicinealso helps to control strong urine odor.

Racemethionine is available only with your doctor's prescription, in thefollowing dosage forms:

Oral
• Capsules (U.S.)
• Oral solution (U.S.)
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For racemethionine,the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to racemethionine. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Racemethionine has not been shown tocause birth defects or other problems in humans.

Breast-feeding?It is not known whether racemethionine passes intobreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are takingthis medicine and who wish to breast-feed should discuss this with their doctor.

Children?This medicine has been tested in children and, ineffective doses, has not been shown to cause different side effects or problemsthan it does in 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. Although there is no specific informationcomparing use of racemethionine in the elderly with use in other age groups,this medicine is not expected to cause different side effects or problemsin older people than it does in younger adults.

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. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

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

• Acidosis (metabolic) or
• Liver disease?Use of racemethionine may make these conditionsworse

Proper Use of This Medicine

You should not take more of this medicine, or take it more often, than yourdoctor ordered. You should also make sure that you get enough protein in yourdiet. This is especially important in infants. Infants who get toomuch racemethionine and not enough protein may not gain weight as they should.If you have any questions about this, ask your health care professional.

Take racemethionine with, or just after, meals.

For patients taking racemethionine capsules:

• If you are unable to swallow the capsule, the contents may be addedto juice, water, or warm milk or infant formula.

For patients taking racemethionine oral solution:

• Use a specially marked measuring spoon or other device to measureeach dose accurately. The average household teaspoon may not hold the rightamount of liquid.

Make certain your health care professional knows if you are on any specialdiet, such as a low-protein diet.

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

The number of capsules or tablets or teaspoonfuls of solution that youtake depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, andthe length of time you take the medicine depend on your medical condition.

• For making urine more acidic:
  • For oral dosage form (capsules):
    • Adults and teenagers?The usual dose is 200 milligrams (mg)three or four times a day.
    • Children?The usual dose is the contents of 1 capsule (200 mg)added to a warm bottle of milk or formula in the evening, or added to a glassof juice or water.
  • For oral dosage form (oral solution):
    • Adults and children older than 14 months of age?The usual doseis 22/3 teaspoonfuls (200 mg) three or four times a day.
    • Children 6 to 14 months of age?The usual dose is 1 teaspoonful(75 mg) four times a day for three to five days.
    • Children 2 to 6 months of age?The usual dose is 1 teaspoonful(75 mg) three times a day for three to five days.
    • Children up to 2 months of age?Dose must be determined by yourdoctor.
  • For oral dosage form (tablets):
    • Adults and teenagers?The usual dose is 500 mg three or fourtimes a day.
    • Children?The capsule or oral solution is the recommended dosageform for this age group.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed 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 causethe medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• 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 yourrash has not improved after 10 days, check with your doctor.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Side effects that may occur duringracemethionine therapy usually do not need medical attention. They may goaway during treatment as your body adjusts to the medicine. Check with yourdoctor if any of the following side effects continue or are bothersome:

More common

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although this use is not included in product labeling,racemethionine may be used to treat acetaminophen poisoning when the preferredmedicine for treatment is not available.

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.