Pyrazinamide

Pyrazinamide Recall

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Side Effects & Adverse Reactions

Patients started on pyrazinamide should have baseline serum uric acid and liver function determinations. Those patients with preexisting liver disease or those at increased risk for drug related hepatitis (e.g., alcohol abusers) should be followed closely.

Pyrazinamide should be discontinued and not be resumed if signs of hepatocellular damage or hyperuricemia accompanied by an acute gouty arthritis appear.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous 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 recommendations 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 antituberculous agents.

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

History

There is currently no drug history available for this drug.

Other Information

Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula:

C5H5N3O M.W. 123.11

Each Pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: Corn Starch, Magnesium Stearate, Pregelatinized Starch and Stearic Acid.

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Pyrazinamide Recall

Side Effects & Adverse Reactions

Legal Issues

FDA Safety Alerts

Manufacturer Warnings

Pyrazinamide Manufacturers

Remedyrepack Inc.
No Recall
Pyrazinamide | Remedyrepack Inc.

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 to 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 70 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.

The 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*

Maximal Daily

Dose in

Children

and Adults

Twice Weekly Dose

Drug

Children

Adults

Children

Adults

Isoniazid

10 to 20 mg/kg

PO or IM

5 mg/kg

PO or IM

300 mg

20 to 40 mg/kg

Max. 900 mg

15 mg/kg

Max. 900 mg

Rifampin

10 to 20 mg/kg

PO

10 mg/kg

PO

600 mg

10 to 20 mg/kg

Max. 600 mg

10 mg/kg

Max. 600 mg

Pyrazinamide

15 to 30 mg/kg

PO

15 to 30 mg/kg

PO

2 g

50 to 70 mg/kg

50 to 70 mg/kg

Streptomycin

20 to 40 mg/kg

IM

15 mg/kg**

IM

1 g**

25 to 30 mg/kg

IM

25 to 30 mg/kg

IM

Ethambutol

15 to 25 mg/kg

PO

15 to 25 mg/kg

PO

2.5 g

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 than 60 yrs of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.
Mikart, Inc.
No Recall
Pyrazinamide | Mikart, Inc.
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 evaluation 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 Definition of abbreviations: PO = perorally; IM = intramuscularly. * Doses based on weight should be adjusted as weight changes. ** In persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg..
Daily Dose*

Maximal Daily Dose in Children and Adults

Twice Weekly Dose

Drug

Children

Adults

Children

Adults

Isoniazid

10 to 20 mg/kg

PO or IM

5 mg/kg

PO or IM

300 mg

20 to 40 mg/kg

Max. 900 mg

15 mg/kg

Max. 900 mg

Rifampin

10 to 20 mg/kg

PO

10 mg/kg

PO

600 mg

10 to 20 mg/kg

Max. 600 mg

10 mg/kg

Max. 600 mg

Pyrazinamide

15 to 30 mg/kg

PO

15 to 30 mg/kg

PO

2 g

50 to 70 mg/kg

50 to 70 mg/kg

Streptomycin

20 to 40 mg/kg

IM

15 mg/kg**

IM

1 g**

25 to 30 mg/kg

IM

25 to 30 mg/kg

IM

Ethambutol

15 to 25 mg/kg

PO

15 to 25 mg/kg

PO

2.5 g

50 mg/kg

50 mg/kg
Remedyrepack Inc.
No Recall
Pyrazinamide | Remedyrepack Inc.
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 evaluation 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
*Doses based on weight should be adjusted as weight changes. In persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.Daily Dose *DrugChildrenAdultsIsoniazid10 to 20 mg/kg PO or IM5 mg/kg PO or IMRifampin10 to 20 mg/kg PO10 mg/kg POPyrazinamide15 to 30 mg/kg PO15 to 30 mg/kg POStreptomycin20 to 40 mg/kg IM15 mg/kg IMEthambutol15 to 25 mg/kg PO15 to 25 mg/kg PO
*In persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.Maximal Daily Dose in Children and AdultsDrugIsoniazid300 mgRifampin600 mgPyrazinamide2 gStreptomycin1 g *Ethambutol2.5 g
Twice Weekly DoseDrugChildrenAdultsIsoniazid20 to 40 mg/kg Max. 900 mg15 mg/kg Max. 900 mgRifampin10 to 20 mg/kg Max. 600 mg10 mg/kg Max. 600 mgPyrazinamide50 to 70 mg/kg50 to 70 mg/kgStreptomycin25 to 30 mg/kg IM25 to 30 mg/kg IMEthambutol50 mg/kg50 mg/kg
Versapharm Incorporated
No Recall
Pyrazinamide | Versapharm Incorporated
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 evaluation 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 * Doses based on weight should be adjusted as weight changes. † In persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg. 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 30 mg/kg
PO
15 to 30 mg/kg
PO Streptomycin
20 to 40 mg/kg
IM
15 mg/kg†
IM Ethambutol
15 to 25 mg/kg
PO
15 to 25 mg/kg
PO * In persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg. 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 = per-orally; IM = intramuscularly.
Remedyrepack Inc.
No Recall
Pyrazinamide | Remedyrepack Inc.

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 evaluation 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 30 mg/kg
PO
15 to 30 mg/kg
PO Streptomycin
20 to 40 mg/kg
IM
15 mg/kg†
IM Ethambutol
15 to 25 mg/kg
PO
15 to 25 mg/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 = per-orally; IM = intramuscularly.

1 Doses based on weight should be adjusted as weight changes. 2 In persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg. 3 In persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.
Remedyrepack Inc.
No Recall
Pyrazinamide | Remedyrepack Inc.

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 to 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 70 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.

The 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*

Maximal Daily

Dose in

Children

and Adults

Twice Weekly Dose

Drug

Children

Adults

Children

Adults

Isoniazid

10 to 20 mg/kg

PO or IM

5 mg/kg

PO or IM

300 mg

20 to 40 mg/kg

Max. 900 mg

15 mg/kg

Max. 900 mg

Rifampin

10 to 20 mg/kg

PO

10 mg/kg

PO

600 mg

10 to 20 mg/kg

Max. 600 mg

10 mg/kg

Max. 600 mg

Pyrazinamide

15 to 30 mg/kg

PO

15 to 30 mg/kg

PO

2 g

50 to 70 mg/kg

50 to 70 mg/kg

Streptomycin

20 to 40 mg/kg

IM

15 mg/kg**

IM

1 g**

25 to 30 mg/kg

IM

25 to 30 mg/kg

IM

Ethambutol

15 to 25 mg/kg

PO

15 to 25 mg/kg

PO

2.5 g

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 than 60 yrs of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.
Dava Pharmaceuticals, Inc.
No Recall
Pyrazinamide | Dava Pharmaceuticals, Inc.
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 to 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 70 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.

The 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*

Maximal Daily

Dose in

Children

and Adults

Twice Weekly Dose

Drug

Children

Adults

Children

Adults

Isoniazid

10 to 20 mg/kg

PO or IM

5 mg/kg

PO or IM

300 mg

20 to 40 mg/kg

Max. 900 mg

15 mg/kg

Max. 900 mg

Rifampin

10 to 20 mg/kg

PO

10 mg/kg

PO

600 mg

10 to 20 mg/kg

Max. 600 mg

10 mg/kg

Max. 600 mg

Pyrazinamide

15 to 30 mg/kg

PO

15 to 30 mg/kg

PO

2 g

50 to 70 mg/kg

50 to 70 mg/kg

Streptomycin

20 to 40 mg/kg

IM

15 mg/kg**

IM

1 g**

25 to 30 mg/kg

IM

25 to 30 mg/kg

IM

Ethambutol

15 to 25 mg/kg

PO

15 to 25 mg/kg

PO

2.5 g

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 than 60 yrs of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.
American Health Packaging
No Recall
Pyrazinamide | American Health Packaging
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 to 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 70 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.
Definition of abbreviations: PO = perorally; IM = intramuscularly.
* Doses based on weight should be adjusted as weight changes.
**In persons older than 60 yrs of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.
The 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*

Maximal Daily

Dose in

Children

and Adults

     Twice Weekly Dose

   Drug

   Children

   Adults

    Children

    Adults

Isoniazid

10 to 20 mg/kg

PO or IM

5 mg/kg

PO or IM

300 mg

20 to 40 mg/kg

Max. 900 mg

15 mg/kg

Max. 900 mg

Rifampin

10 to 20 mg/kg

PO

10 mg/kg

PO

600 mg

10 to 20 mg/kg

Max. 600 mg

10 mg/kg

Max. 600 mg

Pyrazinamide

15 to 30 mg/kg

PO

15 to 30 mg/kg

PO

2 g

50 to 70 mg/kg

50 to 70 mg/kg

Streptomycin

20 to 40 mg/kg

IM

15 mg/kg**

IM

1 g**

25 to 30 mg/kg

IM

25 to 30 mg/kg

IM

Ethambutol

15 to 25 mg/kg

PO

15 to 25 mg/kg

PO

2.5 g

50 mg/kg

50 mg/kg

Pyrazinamide

Pyrazinamide Recall

Side Effects & Adverse Reactions

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Uses

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