Pyrazinamide (Page 3 of 3)

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: 1 B : 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) : 1109.

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: 785793.

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.

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Package Labeling:

PYRAZINAMIDE pyrazinamide tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55695-026(NDC:61748-012) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRAZINAMIDE (PYRAZINAMIDE) PYRAZINAMIDE 500 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE CELLULOSE, MICROCRYSTALLINE STEARIC ACID

Product Characteristics Color white (WHITE) Score 2 pieces Shape ROUND (ROUND) Size 13mm Flavor Imprint Code VP;012 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55695-026-00 90 TABLET in 1 CONTAINER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA081319 04/01/1995

Labeler — Department of State Health Services, Pharmacy Branch (781992540)

Revised: 02/2016 Department of State Health Services, Pharmacy Branch