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.