Applies to the following strength(s): 500 mg
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Tuberculosis - Active
15 to 30 mg/kg (up to 2 g) orally once a day in combination with three other antituberculous drugs for the initial 2 months of a 6-month or 9-month treatment regimen, until drug susceptibility tests are known. An alternate dosing regimen of 50 to 75 mg/kg (up to 3 g) orally twice a week may be used after 2 weeks of daily therapy to increase patient compliance.
Alternatively, the CDC, The American Thoracic Society, and the Infectious Diseases Society of America suggest the following dosing based on estimated lean body weight:
40 to 45 kg: 1000 mg
56 to 75 kg: 1500 mg
76 to 90 kg: 2000 mg
Twice weekly dosing:
40 to 55 kg: 2000 mg
56 to 75 kg: 3000 mg
76 to 90 kg: 4000 mg
Thrice weekly dosing:
40 to 55 kg: 1500 mg
56 to 75 kg: 2500 mg
76 to 90 kg: 3000 mg
Usual Adult Dose for Tuberculosis - Latent
A public health expert should be consulted prior to the use of the combination regimen with rifampin.
15 to 20 mg/kg, based on actual body weight (lean), orally once daily (maximum 2 g) for 2 months. Alternatively, a dosage of 50 mg/kg may be administered orally twice-weekly (maximum 4 g).
Usual Pediatric Dose for Tuberculosis - Active
(Used as part of a multidrug regimen. Treatment regimens consist of an initial 2-month phase, followed by a continuation phase of 4 or 7 additional months. Frequency of dosing may differ depending on phase of therapy)
Infants, Children less than 40 kg and Adolescents 14 years and younger and less than 40 kg:
Daily therapy: 15 to 30 mg/kg/dose (maximum: 2 g/dose) once daily
Directly observed therapy (DOT): 50 mg/kg/dose (maximum: 2 g/dose) twice weekly
Daily therapy: 20 to 40 mg/kg/dose once daily (maximum: 2 g/day)
Renal Dose Adjustments
The manufacturer recommends to start therapy at low end of dosage range and monitor patient closely.
For the treatment of active tuberculosis, the CDC, ATS, and IDSA recommend against daily dosing. For patients with CrCl less than 30 mL/min or patients receiving hemodialysis the recommended dose is 25 to 35 mg/kg per dose three times per week.
Liver Dose Adjustments
Monitor patients closely.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic or renal function, and of concomitant disease or other drug therapy.
If organism is susceptible to isoniazid and rifampin, pyrazinamide is continued for the first 2 months of a 6-month course of therapy (9-months if HIV positive). If primary drug resistance is shown, drug regimens should be adjusted as needed and continued for at least 6 months, or 3 months beyond culture conversion (9 months, or 6 months beyond culture conversion if HIV positive). If multiple-drug resistance is demonstrated, therapy should be continued for 12 to 24 months following culture conversion.
Pyrazinamide is contraindicated in patients with severe hepatic disease and with acute gout.
Patients started on pyrazinamide should have baseline serum uric acid and liver function test results. Liver function should be monitored closely during therapy. Patients with preexisting liver disease or those at increased risk of drug related hepatitis should be monitored closely.
Pyrazinamide should be discontinued and not restarted if signs of hepatocellular damage or hyperuricemia with an acute gouty arthritis appear.
Polyarthralgias have been reported in patients. The pain may respond to aspirin or other nonsteroidal anti-inflammatory agents.
Caution should be used in patients with a history of diabetes mellitus, as management of the disease may be more difficult.
Primary resistance of Mycobacterium tuberculosis to pyrazinamide is not common. In cases with known or suspected drug resistance, in vitro susceptibility tests with recent cultures of Mycobacterium tuberculosis against pyrazinamide and the usual primary drugs should be conducted. There are few reliable in vitro tests for pyrazinamide resistance. A reference laboratory capable of performing these tests must be utilized.
Clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal or hepatic function, and of concomitant disease or other drug therapy.
Extensively dialyzed and should be dosed after hemodialysis.
Most cases of tuberculosis (TB) should be empirically treated with 4 anti-TB agents, including rifampin, isoniazid, pyrazinamide, and either ethambutol or streptomycin. Therapy may be adjusted when drug susceptibility is known. If a patient has a significant risk for multi-drug resistant TB, a 5 drug regimen may be used.
The Joint Statement of the American Thoracic Society (ATS), the Center for Disease Control and Prevention (CDC), and the Council of the Infectious Diseases society of America (IDSA) advises that all intermittent dosing should be administered by directly observed therapy.
Clinical monitoring should be performed at weeks 2, 4, and 8.
The treatment of latent tuberculosis infection with pyrazinamide is considered complete when at least 60 doses have been administered within a 3 month period.