aminosalicylate sodium (Oral route)

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Available Dosage Forms:

• Tablet

Therapeutic Class: Antitubercular

Uses For aminosalicylate sodium

Aminosalicylate sodium 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 aminosalicylate sodium 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.

Before Using aminosalicylate sodium

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 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

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.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using aminosalicylate sodium.

Interactions with Medicines

Using aminosalicylate sodium with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin
• Isoniazid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 aminosalicylate sodium

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 aminosalicylate sodium 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 aminosalicylate sodium too soon, your symptoms may return.

aminosalicylate sodium 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. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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. aminosalicylate sodium 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. aminosalicylate sodium must be taken with other medicines used to treat tuberculosis (TB).

Missed Dose

If you miss a dose of aminosalicylate sodium, take it as soon as possible. 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using aminosalicylate sodium

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:

• aminosalicylate sodium 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.

aminosalicylate sodium Side Effects

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:

• Fever
• joint pains
• skin rash or itching
• unusual tiredness or weakness

• Abdominal pain (severe)
• backache
• headache
• lower back pain
• pain or burning while urinating
• paleness of skin
• sore throat
• yellow eyes or skin

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

• Changes in menstrual periods
• decreased sexual ability in males
• dry, puffy skin
• swelling of front part of neck
• weight gain (unusual)

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• loss of appetite
• nausea and vomiting
• stomach pain (mild)

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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