Sulfamethoxazole and Trimethoprim (Page 4 of 4)

HOW SUPPLIED

Sulfamethoxazole and Trimethoprim Tablets, USP are supplied as follows:

Sulfamethoxazole and Trimethoprim DS (double strength) Tablets USP, 800 mg/160 mg, are supplied as white, oval, bisected tablets debossed “IP” bisect “272” on one side.

They are available as follows:

Bottles of 10: NDC 65162-272-01

Bottles of 24: NDC 65162-272-24

Bottles of 100: NDC 65162-272-10

Bottles of 250: NDC 65162-272-25

Bottles of 500: NDC 65162-272-50

Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg, are supplied as white, round, bisected tablets debossed “IP” over “271” on one side.

They are available as follows:

Bottles of 50: NDC 65162-271-05

Bottles of 100: NDC 65162-271-10

Bottles of 500: NDC 65162-271-50

Bottles of 1000: NDC 65162-271-11

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. 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 by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev.07-2021-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65162-271-10

Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65162-272-10

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg

Rx only

100 Tablets

Amneal Pharmaceuticals LLC

SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole and trimethoprim tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-271 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 MAGNESIUM STEARATE POVIDONE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color white Score 2 pieces Shape ROUND Size 13mm Flavor Imprint Code IP;271 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65162-271-05 50 TABLET in 1 BOTTLE None 2 NDC:65162-271-10 100 TABLET in 1 BOTTLE None 3 NDC:65162-271-50 500 TABLET in 1 BOTTLE None 4 NDC:65162-271-11 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076899 02/25/2010

SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole and trimethoprim tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-272 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 MAGNESIUM STEARATE POVIDONE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color white Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code IP;272 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65162-272-01 10 TABLET in 1 BOTTLE None 2 NDC:65162-272-24 24 TABLET in 1 BOTTLE None 3 NDC:65162-272-10 100 TABLET in 1 BOTTLE None 4 NDC:65162-272-25 250 TABLET in 1 BOTTLE None 5 NDC:65162-272-50 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076899 09/13/2010

Labeler — Amneal Pharmaceuticals LLC (123797875)

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals Private Limited		650762060	analysis (65162-271), analysis (65162-272), label (65162-271), label (65162-272), manufacture (65162-271), manufacture (65162-272), pack (65162-271), pack (65162-272)

Revised: 12/2022 Amneal Pharmaceuticals LLC