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|Tubasal

AMINOSALICYLATE SODIUM (Systemic)

Some commonly used brand names are:

In the U.S.—

• Tubasal

In Canada—

• Nemasol Sodium

Another commonly used name is PAS .

Category

• Antibacterial, antimycobacterial

Description

Aminosalicylate sodium (a-mee-noe-sal-I-si-late soe-dee-um) belongs to the family of medicines called anti-infectives. It is used with other medicines, to help the body overcome tuberculosis (TB). It will not work for colds, flu, or other virus infections.

To help clear up your tuberculosis (TB) completely, you must keep taking this medicine for the full time of treatment, even if you begin to feel better. This is very important. It is also important that you do not miss any doses .

Aminosalicylate sodium is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets (U.S. and Canada)

Before Using This Medicine

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 aminosalicylate sodium, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to aminosalicylate sodium, aspirin or other salicylates, including methyl salicylate (oil of wintergreen), or to other related medicines such as sulfonamides (sulfa medicine). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—In one study where aminosalicylates were taken with other medicines for tuberculosis, there was an increase in birth defects. However, other studies have not shown aminosalicylates to cause birth defects.

Breast-feeding—Aminosalicylate sodium passes into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—There is no specific information comparing use of aminosalicylate sodium in children with use in other age groups.

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 aminosalicylate sodium 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 aminosalicylate sodium, it is especially important that your health care professional know if you are taking any of the following:

• Aminobenzoates (e.g., Potaba)—Use of aminosalicylate sodium with aminobenzoates may decrease the effectiveness of aminosalicylate sodium

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

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency—Aminosalicylate sodium may cause or worsen this blood problem

• Heart disease or other circulation problems—The sodium in aminosalicylate sodium may cause or worsen heart or circulation problems

• Kidney disease (severe)—Patients with kidney disease may have an increase in side effects

• Liver disease (severe)—Patients with severe liver disease may have an increase in side effects

• Stomach ulcer—Aminosalicylate sodium may cause stomach irritation

Proper Use of This Medicine

Aminosalicylate sodium may be taken with or after meals or with an antacid if it upsets your stomach.

To help clear up your tuberculosis (TB) completely, it is important that you keep taking this medicine for the full time of treatment even if you begin to feel better after a few weeks. Since TB may take a long time to clear up, you may have to take the medicine every day for as long as 1 to 2 years or more. If you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night . For example, if you are to take 3 doses a day, doses should be spaced about 8 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing—The dose of aminosalicylate sodium 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 aminosalicylate sodium. This medicine comes in tablets as aminosalicylate sodium (the salt form), but your doctor bases the dose on the amount of aminosalicylate acid (the acid form of the medicine) in the tablet. If your dose is different, do not change it unless your doctor tells you to do so.

• For the tablet dosage form:
  • For the treatment of tuberculosis:
    • Adults and children 12 years of age and older—3.3 to 4 grams (aminosalicylate acid) every eight hours, or 5 to 6 grams (aminosalicylate acid) every twelve hours. This medicine must be taken with other medicines used to treat tuberculosis (TB).
    • Younger children—The dose is based on body weight and must be determined by the doctor. Depending on the size of the dose, the medicine may be given every six or eight hours. This medicine must be taken with other medicines used to treat tuberculosis (TB).

Missed dose—If you do miss a dose of this medicine, take it as soon as possible. This will help to keep a constant amount of medicine in the blood. However, if it is almost time for your next dose, 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 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.

Precautions While Using This Medicine

If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.

Do not take aminosalicylate sodium within 6 hours of taking rifampin. Taking the 2 medicines too close together may keep rifampin from working properly.

For diabetic patients:

• This medicine may cause false test results with some urine sugar tests . Check with your doctor before changing your diet or the dosage of your diabetes medicine.

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 immediately if any of the following side effects occur:

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 doctor 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 doctor.

Revised: 05/02/1994

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