Sulfamethoxazole and Trimethoprim (Page 6 of 6)

Traveler’s Diarrhea in Adults


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

HOW SUPPLIED


Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg are white to off-white circular, beveled edge uncoated tablets, debossed with “H 48” on one side and deep break line on the other side.
Bottles of 100 NDC 69043-010-01
Bottles of 500 NDC 69043-010-05
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg are white to off-white oval, beveled edge uncoated tablets, debossed with “H 49” on one side and deep break line on other side.
Bottles of 100 NDC 69043-011-01
Bottles of 500 NDC 69043-011-05

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°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. 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.
  5. Marinella Mark A. 1999. Trimethoprim-induced hyperkalemia: An analysis of reported cases. Gerontol. 45:209–212.
  6. Margassery, S. and B. Bastani. 2002. Life threatening hyperkalemia and acidosis secondary to trimethoprim-sulfamethoxazole treatment. J. Nephrol. 14:410–414.
  7. Moh R, et al. Haematological changes in adults receiving a zidovudine-containing HAART regimen in combination with cotrimoxazole in Côte d’Ivoire. Antivir Ther. 2005;10(5):615-24.
  8. Al-Khatib SM, LaPointe N, Kramer JM, Califf RM. What Clinicians Should Know About the QT Interval. JAMA. 2003;289(16):2120-2127.
  9. Boyer EW, Stork C, Wang RY. Review: The Pharmacology and Toxicology of Dofetilide. Int J Med Toxicol. 2001;4(2):16.
  10. Kosoglou T, Rocci ML Jr, Vlasses PH. Trimethoprim alters the disposition of procainamide and N -acetylprocainamide. Clin Pharmacol Ther. Oct 1988;44(4):467-77.
  11. Brumfitt W, Pursell R. Trimethoprim/Sulfamethoxazole in the Treatment of Bacteriuria in Women. J Infect Dis. Nov 1973; 128 (Suppl): S657–S663.
  12. Masur H. Prevention and treatment of Pneumocystis pneumonia. N Engl J Med. 1992; 327: 1853–1880.
  13. Recommendations for prophylaxis against Pneumocystis carinii pneumonia for adults and adolescents infected with human immunodeficiency virus. MMWR. 1992; 41(RR-4):1–11.
  14. CDC Guidelines for prophylaxis against Pneumocystis carinii pneumonia for children infected with human immunodeficiency virus. MMWR. 1991; 40(RR-2):1–13.

Manufactured for:
CRONUS PHARMA LLC
2 Tower Center Blvd, Suite — 1101A
East Brunswick, NJ 08816
USA
Made in India
Code: TS/DRUGS/22/2009
Revised: 06/2021

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 400 mg/80 mg (100 Tablet Bottle)

NDC 69043-010-01

Sulfamethoxazole
and Trimethoprim
Tablets, USP
400 mg/80 mg

Rx only 100 Tablets

Cronus Pharma

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 400 mg/80 mg (100 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 800 mg/160 mg (100 Tablet Bottle)

NDC 69043-011-01

Sulfamethoxazole
and Trimethoprim
Tablets, USP
800 mg/160 mg
DOUBLE STRENGTH

Rx only 100 Tablets

Cronus Pharma

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 800 mg/160 mg (100 Tablet Bottle)
(click image for full-size original)

SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole and trimethoprim tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69043-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFAMETHOXAZOLE (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE 400 mg
TRIMETHOPRIM (TRIMETHOPRIM) TRIMETHOPRIM 80 mg
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM
MAGNESIUM STEARATE
STARCH, CORN
SODIUM BENZOATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape ROUND (Beveled Edge) Size 11mm
Flavor Imprint Code H;48
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69043-010-01 100 TABLET in 1 BOTTLE None
2 NDC:69043-010-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090624 02/16/2010
SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole and trimethoprim tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69043-011
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
MAGNESIUM STEARATE
STARCH, CORN
SODIUM BENZOATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape OVAL (Beveled Edge) Size 19mm
Flavor Imprint Code H;49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69043-011-01 100 TABLET in 1 BOTTLE None
2 NDC:69043-011-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090624 02/16/2010
Labeler — Cronus Pharma LLC (079421067)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
APL HEALTHCARE LIMITED 650844777 ANALYSIS (69043-010), ANALYSIS (69043-011), MANUFACTURE (69043-010), MANUFACTURE (69043-011)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (69043-010), ANALYSIS (69043-011), MANUFACTURE (69043-010), MANUFACTURE (69043-011)

Revised: 07/2021 Cronus Pharma LLC

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