Usual Adult Dose for Tuberculosis - Active

Initial dose regimen: 250 mg orally once a day for 1 to 2 days, then 250 mg orally 2 times a day for 1 to 2 days; the dose should be increased to 1000 mg orally in 3 to 4 divided doses
Maintenance dose: 500 to 1000 mg (OR 15 to 20 mg/kg/day) orally once a day
Maximum dose: 1000 mg/day

Comments:

• Additional drug/s should be given with this drug to treat patients with susceptible strains of tuberculosis.
• Maintenance doses may be administered in divided doses in patients who exhibit poor gastrointestinal tolerance.
• Duration of treatment should be based on clinical response, including permanent bacteriological conversion and maximal clinical improvement.

• Treatment of active tuberculosis in patients with Mycobacterium tuberculosis resistant to isoniazid or rifampin
• Treatment of active tuberculosis in patients infected with M tuberculosis when there is intolerance to other drugs

Usual Pediatric Dose for Tuberculosis - Active

10 to 20 mg/kg orally in 2 to 3 divided doses per day (after meals) OR 15 mg/kg orally once a day

• Maximum dose: 1000 mg/day

• Additional drug/s should be given with this drug to treat patients with susceptible strains of tuberculosis.
• Malabsorption syndrome may occur in patients who adhere to treatment but fail to appropriately respond, and may be present in patients with concurrent HIV infection. Therapeutic drug monitoring should be considered in patients with malabsorption syndrome.
• The duration of treatment should be based on clinical response, including permanent bacteriological conversion and maximal clinical improvement.
• The American Academy of Pediatrics (AAP) recommends once a day treatment with isoniazid, rifampin, and pyrazinamide for 2 months in patients with meningitis caused by M tuberculosis, and once a day treatment with isoniazid and rifampin for 9 to 12 months in patients with meningitis caused by Mycoplasma bovis.

• Treatment of active tuberculosis in patients with M tuberculosis resistant to isoniazid or rifampin
• Treatment of active tuberculosis in patients infected with M tuberculosis when there is intolerance to other drugs

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction: Data not available
Severe liver dysfunction: Contraindicated

Elevated transaminases during treatment: Temporarily discontinue this drug and the companion antituberculosis drug/s until levels resolve, then reintroduce the drug sequentially to determine which drug/s may be responsible for hepatotoxicity.

Precautions

CONTRAINDICATIONS:

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

Dialysis

Data not available

Other Comments

Administration advice:

• Gastrointestinal effects may be minimized with dose decreases, changing the time of administration, and/or with the addition of an antiemetic agent.
• Neurotoxic effects may be relieved or prevented by adding pyridoxine.
• Directly observed therapy should be considered in all patients treated for tuberculosis.

• Gastrointestinal side effects may diminish in severity with continued treatment.
• Limitation of use: This drug should be used only to treat infections that are proven/strongly suspected to be caused by bacteria.

• Endocrine: Thyroid function tests periodically during treatment
• Hepatic: Liver transaminases at baseline and monthly during treatment
• Metabolic: Blood glucose levels at baseline and periodically during treatment
• Ocular: Ophthalmic examinations at baseline and periodically during treatment

• Patients should be advised to avoid missing doses and to complete the entire course of therapy.
• Patients should be warned to avoid consuming excessive amounts of alcohol with this drug.
• Patients should be told to immediately contact their healthcare provider if any of the following signs/symptoms occur: change in vision.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.