Sulfamethoxazole and Trimethoprim (Page 5 of 5)

HOW SUPPLIED

Product: 63739-228

NDC: 63739-228-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

REFERENCES:

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

Distributed by: Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Rev 06, October 2014

Sulfamethoxazole and Trimethoprim

Label Image
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SULFAMETHOXAZOLE AND TRIMETHOPRIM
sulfamethoxazole and trimethoprim tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-228(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:63739-228-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-228-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071017 08/25/1986
Labeler — McKesson Corporation (140529962)
Establishment
Name Address ID/FEI Operations
McKesson Corporation 140529962 REPACK (63739-228)

Revised: 03/2018 McKesson Corporation

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