Pyrazinamide (Page 2 of 3)

OVERDOSAGE

Overdosage experience is limited. In one case report of overdose, abnormal liver function tests developed. These spontaneously reverted to normal when the drug was stopped. Clinical monitoring and supportive therapy should be employed. Pyrazinamide is dialyzable. 13

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 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

HOW SUPPLIED

Pyrazinamide Tablets, USP 500 mg are round, white, scored tablets, debossed S above the score, 660 below the score.
Unit dose packages of 100 (10 x 10) NDC 60687-138-01

Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

REFERENCES

  1. Drug Information, American Hospital Formulary Service. American Society of Hospital Pharmacists. Bethesda, MD. 1991.
  2. USPDI, Drug Information for the Health Care Professional. United States Pharmacopeial Convention, Inc. Rockville, MD. 1991:1B:2226-2227.
  3. Goodman-Gilman A, Rall TW, Nies AS, Taylor P. The Pharmacological Basis of Therapeutics , ed 8. New York, Pergamon Press. 1990;1154.
  4. Treatment of tuberculosis and tuberculosis infection in adults and children. Am Rev Respir Dis. 1986;134:363-368.
  5. Reynolds JEF, Parfitt K, Parsons AV, Sweetman-SC. Martindale The Extra Pharmacopoeia , ed 29. London, The Pharmaceutical Press. 1989;569-570.
  6. Bioassay of pyrazinamide for possible carcinogenicity. National Cancer Institute Carcinogenesis Technical Report Series No. 48, 1978.
  7. Zerger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W. Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals. Environ Mutagen. 1987;9 (Suppl 9):1-109.
  8. Roman IC, Georgian L. Cytogenetic effects of some antituberculosis drugs in vitro. Mutation Research. 1977;48:215-224.
  9. Holdiness M. Antituberculosis drugs and breast-feeding. Arch Intern Med. 1984;144:1888.
  10. Turcios N, Evans H. Preventing and managing tuberculosis in children. J Resp Dis. 1989;10(6)(Jun):23.
  11. Starke JR. Multidrug therapy for tuberculosis in children. Pediatr Infec Dis J. 1990;9:785-793.
  12. Specific requirements on content and format of labeling for human prescription drugs; proposed addition of “geriatric use” subsection in the labeling. Federal Register. 1990;55(212)(Nov 1):46134-46137.
  13. Stamathakis G, Montes C, Trouvin JH, et al. Pyrazinamide and pyrazinoic acid pharmacokinetics in patients with chronic renal failure. Clinical Nephrology. 1988;30:230-234.

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