Bactrim DS (Page 6 of 6)

Prophylaxis:

Adults:

The recommended dosage for prophylaxis in adults is 1 BACTRIM DS (double strength) tablet daily.14

Children:

For children, the recommended dose is 750 mg/m2 /day sulfamethoxazole with 150 mg/m2 /day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.15 The following table is a guideline for the attainment of this dosage in children:

Body Surface Area Dose–every 12 hours
(m2) Tablets
0.26
0.53 ½
1.06 1

Traveler’s Diarrhea in Adults:

For the treatment of traveler’s diarrhea, the usual adult dosage is 1 BACTRIM DS (double strength) tablet or 2 BACTRIM tablets every 12 hours for 5 days.

HOW SUPPLIED

BACTRIM™ TABLETS are supplied as follows:

BACTRIM™ DS (double strength) TABLETS (white, oval shaped, scored) containing 160 mg trimethoprim and 800 mg sulfamethoxazole –

bottles of 10 (NDC 54868-0337-3), bottles of 20 (NDC 54868-0337-0), bottles of 30 (NDC 54868-0337-1).

Imprint on tablets (debossed): (front) BACTRIM DS

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. 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. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically ; Approved Standard – Fourth Edition. NCCLS Document M7–A4, Vol.17, No. 2, NCCLS, Wayne, PA, January, 1997.
  6. Kaufman DW, Kelly JP, Johannes CB, Sandler A, Harmon D, Stolley PD, Shapiro S. Acute thrombocytopenic purpura in relation to the use of drugs. Blood 1993; 82: 2714–18.
  7. Aster RH, Curtis BR, McFarland JG, Bougie DW. Drug-induced immune thrombocytopenia: pathogenesis, diagnosis, and management. J Thromb Haemost 2009; 7: 911–8.
  8. 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.
  9. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests ; Approved Standard – Sixth Edition. NCCLS Document M2–A6, Vol.17, No.1, NCCLS, Wayne, PA, January, 1997.
  10. Marinella Mark A. 1999. Trimethoprim-induced hyperkalemia: An analysis of reported cases. Gerontol. 45:209–212.
  11. Margassery, S. and B. Bastani. 2002. Life threatening hyperkalemia and acidosis secondary to trimethoprim-sulfamethoxazole treatment. J. Nephrol. 14:410–414.
  12. Brumfitt W, Pursell R. Trimethoprim/Sulfamethoxazole in the Treatment of Bacteriuria in Women. J Infect Dis. Nov 1973; 128 (Suppl):S657–S663.
  13. Masur H. Prevention and treatment of Pneumocystis pneumonia. N Engl J Med. 1992; 327: 1853–1880.
  14. Recommendations for prophylaxis against Pneumocystis carinii pneumonia for adults and adolescents infected with human immunodeficiency virus. MMWR. 1992; 41(RR-4):1­–11.
  15. CDC Guidelines for prophylaxis against Pneumocystis carinii pneumonia for children infected with human immunodeficiency virus. MMWR. 1991; 40(RR-2):1–13.

BACTRIMTM and BACTRIMTM DS are trademarks of Hoffmann-La Roche Inc.

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

Rev 03, September 2009

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL — 800 mg/160 mg Label

Rx only

Bactrim™ DS

sulfamethoxazole and trimethoprim
(double strength) tablets USP

AR
SCIENTIFIC

800 mg/160 mg DOUBLE STRENGTH

Principal Display Panel -- 800 mg/160 mg Label
(click image for full-size original)
BACTRIM DS sulfamethoxazole and trimethoprim tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0337(NDC:13310-146)
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 BACTRIM;DS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0337-0 20 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-0337-1 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-0337-3 10 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017377 08/26/1997
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 09/2009 Physicians Total Care, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.