Sulfamethoxazole and Trimethoprim (Page 5 of 5)

HOW SUPPLIED

NDC:64725-0146-1 in a BOTTLE of 100 TABLETS

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

REFERENCES:

  1. Kremers P, Duvivier J, Heusghem C. Pharmacokinetic Studies of Co-Trimoxazole in Man after Single and Repeated Doses. . Feb-Mar 1974; 14:112–117. J Clin Pharmacol
  2. Kaplan SA, et al. Pharmacokinetic Profile of Trimethoprim-Sulfamethoxazole in Man. . Nov 1973; 128 (Suppl): S547–S555. J Infect Dis
  3. Varoquaux O, et al. Pharmacokinetics of the trimethoprim-sulfamethoxazole combination in the elderly. . 1985;20:575–581. Br J Clin Pharmacol
  4. Rudoy RC, Nelson JD, Haltalin KC. . May 1974;5:439–443. Antimicrobial Agents Chemother
  5. Clinical and Laboratory Standards Institute. . CLSI document M07–A9, CLSI, Wayne, PA, 2012. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – 9 ed th
  6. Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. . 1994 Oct;170(4):912-7. Pneumocystis carinii J Infect Dis
  7. Hardy DW, et al. A controlled trial of trimethoprim-sulfamethoxazole or aerosolized pentamidine for secondary prophylaxis of pneumonia in patients with the acquired immunodeficiency syndrome. . 1992; 327: 1842–1848. Pneumocystis carinii N Engl J Med
  8. Marinella Mark A. 1999. Trimethoprim-induced hyperkalemia: An analysis of reported cases. . 45:209–212. Gerontol
  9. Margassery, S. and B. Bastani. 2002. Life threatening hyperkalemia and acidosis secondary to trimethoprim-sulfamethoxazole treatment. . 14:410–414. J. Nephrol
  10. Brumfitt W, Pursell R. Trimethoprim/Sulfamethoxazole in the Treatment of Bacteriuria in Women. . Nov 1973; 128 (Suppl):S657–S663. J Infect Dis
  11. Masur H. Prevention and treatment of pneumonia. . 1992; 327: 1853–1880. Pneumocystis N Engl J Med
  12. Recommendations for prophylaxis against pneumonia for adults and adolescents infected with human immunodeficiency virus. 1992; 41(RR-4):1–11. Pneumocystis carinii MMWR.
  13. CDC Guidelines for prophylaxis against pneumonia for children infected with human immunodeficiency virus. . 1991; 40(RR-2):1–13. Pneumocystis carinii MMWR
  14. Clinical and Laboratory Standards Institute. . CLSI document M02–A11, CLSI, Wayne, PA, 2012. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard – 11 ed th
  15. Clinical and Laboratory Standards Institute (CLSI). , CLSI document M100–S23. CLSI document M100–S23, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement

Manufactured by: MUTUAL PHARMACEUTICAL COMPANY, INC. Philadelphia, PA 19124 USA

Rev 05, July 2013

Label Image
(click image for full-size original)
SULFAMETHOXAZOLE AND TRIMETHOPRIM
sulfamethoxazole and trimethoprim tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-0146(NDC:53489-146)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sulfamethoxazole (Sulfamethoxazole) Sulfamethoxazole 800 mg
Trimethoprim (Trimethoprim) Trimethoprim 160 mg
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM
SODIUM BENZOATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code MP;85
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64725-0146-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071017 08/25/1986
Labeler — TYA Pharmaceuticals (938389038)
Registrant — TYA Pharmaceuticals (938389038)
Establishment
Name Address ID/FEI Operations
TYA Pharmaceuticals 938389038 RELABEL (64725-0146), REPACK (64725-0146)

Revised: 08/2013 TYA Pharmaceuticals

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