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Pyrazinamide

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Pyrazinamide

Indications
Dosage
How Supplied

INDICATIONS

Pyrazinamide is indicated for the initial treatment of active tubercuIosis in adults and children when combined with other antitubercu-lous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.*4)

(Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.)

(In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment.)

It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis.

Pyrazinamide should only be used in conjunction with other effective antituber-culous agents.

DOSAGE AND ADMINISTRATION

Pyrazinamide should always be administered with other effective antituberculous drugs. It is administered for the initial 2 months of a 6-month or longer treatment regimen for drug-susceptible patients. Patients who are known or suspected to have drug-resistant disease should be treated with regimens individualized to their situation.

Pyrazinamide frequently will be an important component of such therapy.

Patients with concomitant HIV infection may require longer courses of therapy. Physicians treating such patients should be alert to any revised recommendations from CDC for this group of patients.

Usual dose: Pyrazinamide is administered orally, 15 to 30 mg/kg once daily. Older regimens employed 3 or 4 divided doses daily, but most current recommendations are for once a day. Three grams per day should not be exceeded. The CDC recommendations do not exceed 2 g per day when given as a daily regimen (see table).

Alternatively, a twice weekly dosing regimen (50 to 75 mg/kg twice weekly based on lean body weight) has been developed to promote patient compliance with a regimen on an outpatient basis. In studies evaluating the twice weekly regimen, doses of pyrazinamide in excess of 3 g twice weekly have been administered. This exceeds the recommended maximum 3 g/daily dose. However, an increased incidence of adverse reactions has not been reported.

This table is taken from the CDC-American Thoracic Society joint recommendations.4

Recommended Drugs for the Initial Treatment of Tuberculosis in Children and Adults

  Daily Dose*
Drug Children Adults
Isoniazid 10 to 20 mg/kg
PO or IM
5 mg/kg
PO or IM
Rifampin 10 to 20 mg/kg
PO
10 mg/kg
PO
Pyrazinamide 15 to 30mg/kg
PO
15 to 30mg/kg
PO
Streptomycin 20 to 40mg/ kg
IM
15mg/kg**
IM
Ethambutol 15 to 25mg/kg
PO
15 to 25mg/kg
PO
Maximal Daily Dose in Children and Adults
Drug  
Isoniazid 300 mg
Rifampin 600 mg
Pyrazinamide 2 g
Streptomycin 1 g**
Ethambutol 2.5 g
Twice Weekly Dose
Drug Children Adults
Isoniazid 20 to 40 mg/kg
Max. 900 mg
15 mg/kg
Max. 900 mg
Rifampin 10 to 20 mg/kg
Max. 600 mg
10 mg/kg
Max. 600 mg
Pyrazinamide 50 to 70 mg/kg 50 to 70 mg/kg
Streptomycin 25 to 30 mg/kg
IM
25 to 30 mg/kg
IM
Ethambutol 50 mg/kg 50 mg/kg
Definition of abbreviations:
PO = perorally; IM = intramuscularly
*Doses based on weight should be adjusted as weight changes.
** In persons older then 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.

HOW SUPPLIED

Pyrazinamide Tablets USP contain pyrazinamide 500 mg. They are supplied as white, round, scored tablets debossed “VP/012”

in containers of 60 tablets NDC 61748-012-06,
in containers of 90 tablets NDC 61748-012-09,
in containers of 100 tablets NDC 61748-012-01,
in containers of 500 tablets NDC 61748-012-05,
and in hospital unit-dose cartons of 100 tablets (in strips of 10 tablets per strip) NDC 61748-012-11.

Storage: Store in a well-closed container at controlled room temperature, 15°C to 30°C (59°F to 86°F).

Dispense in a well-closed container with a child-resistant closure.

REFERENCES

*See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.4

4. Treatment of tuberculosis and tuberculosis infection in adults and children. Am Rev Respir Dis. 1986 ; 134 : 363-368.

Marketed by: VersaPharm Incorporated, Marietta, GA 30062. Manufactured by: MIKART INC., Atlanta, GA 30318. Rev. 04/01. FDA revision date: 8/13/2002

Last reviewed on RxList: 12/3/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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