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Aminosalicylic Acid Dosage

Applies to the following strengths: 4 g

Usual Adult Dose for Tuberculosis - Resistant

4 grams orally 3 times a day

Comment: If this drug is used in patients with proven/suspected drug resistance, it should be used with at least 1 other agent to which the organism is susceptible.

Uses:

  • Treatment of tuberculosis in combination with other active agents
  • Treatment of multi-drug resistant tuberculosis (MDR-TB), or in situations when therapy with isoniazid or rifampin is not possible due to a combination of resistance and/or intolerance

American Thoracic Society (ATS), US Centers for Disease Control and Prevention (US CDC), and Infectious Diseases Society of America (IDSA) Recommendations:
4000 mg orally 2 to 3 times a day
  • Maximum dose: 12 grams/day

Comment: There are inadequate data to support intermittent dosing.

Use: Second-line treatment of drug-susceptible tuberculosis caused by susceptible organisms

Usual Adult Dose for Tuberculosis - Active

4 grams orally 3 times a day

Comment: If this drug is used in patients with proven/suspected drug resistance, it should be used with at least 1 other agent to which the organism is susceptible.

Uses:

  • Treatment of tuberculosis in combination with other active agents
  • Treatment of multi-drug resistant tuberculosis (MDR-TB), or in situations when therapy with isoniazid or rifampin is not possible due to a combination of resistance and/or intolerance

American Thoracic Society (ATS), US Centers for Disease Control and Prevention (US CDC), and Infectious Diseases Society of America (IDSA) Recommendations:
4000 mg orally 2 to 3 times a day
  • Maximum dose: 12 grams/day

Comment: There are inadequate data to support intermittent dosing.

Use: Second-line treatment of drug-susceptible tuberculosis caused by susceptible organisms

Usual Pediatric Dose for Tuberculosis - Resistant

ATS, US CDC, and IDSA Recommendations:
Children: 100 mg/kg orally 2 to 3 times a day

  • Maximum dose: 300 mg/kg/day

Comment: There are inadequate data to support intermittent dosing.

Use: Second-line treatment of drug-susceptible tuberculosis caused by susceptible organisms

American Academy of Pediatrics (AAP) Recommendations:
Infants, Children, and Adolescents: 200 to 300 mg/kg orally per day, given in 2 to 4 divided doses
  • Maximum dose: 10 grams/day

Use: Treatment of drug-resistant tuberculosis

Usual Pediatric Dose for Tuberculosis - Active

ATS, US CDC, and IDSA Recommendations:
Children: 100 mg/kg orally 2 to 3 times a day

  • Maximum dose: 300 mg/kg/day

Comment: There are inadequate data to support intermittent dosing.

Use: Second-line treatment of drug-susceptible tuberculosis caused by susceptible organisms

American Academy of Pediatrics (AAP) Recommendations:
Infants, Children, and Adolescents: 200 to 300 mg/kg orally per day, given in 2 to 4 divided doses
  • Maximum dose: 10 grams/day

Use: Treatment of drug-resistant tuberculosis

Renal Dose Adjustments

Mild to moderate renal dysfunction: Data not available
Severe renal dysfunction: Contraindicated
End-stage renal disease receiving dialysis: Use should be avoided.

Liver Dose Adjustments

Liver dysfunction: Data not available

Signs/symptoms of drug-induced hepatitis: Treatment should be stopped immediately.

Dose Adjustments

Liver dysfunction: Data not available

Signs/symptoms of drug-induced hepatitis: Treatment should be stopped immediately.

Precautions

CONTRAINDICATIONS:

  • Hypersensitivity to the active component or any of the ingredients
  • Severe renal dysfunction

Consult WARNINGS section for additional precautions.

Dialysis

Patients with end-stage renal disease receiving dialysis: Use should be avoided.

Other Comments

Administration advice:

  • Granules should not be crushed or chewed.
  • Packets and granules should be visually inspected before use.

Storage requirements:
  • Store below 15C (in a refrigerator or freezer)

Reconstitution/preparation techniques:
  • Suspend in an acidic drink or food with a pH of less than 5 (e.g., apple sauce, yogurt, tomato or orange juice) immediately prior to administration

General:
  • This drug is not active against Mycobacterium avium.

Monitoring:
  • Endocrine: Thyroid function in patients with HIV prior to starting and regularly during treatment, especially when given with ethionamide/prothionamide
  • Hepatic: Regular hepatic function tests, especially during the first 3 months of treatment
  • Hypersensitivity: Signs/symptoms of intolerance, especially during the first 3 months of treatment

Patient advice:
  • Patients should be advised to avoid using swollen packets or granules that have changed color (e.g., dark brown or purple) or lost their tan coloring.
  • Patients should be warned that granule skeletons may appear in feces.
  • Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.