Source: FDA, National Drug Code (US) Revision Year: 2023
Sulfamethoxazole and trimethoprim injection, a sterile solution for intravenous infusion only, is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial. Each mL contains Sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as preservatives; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3%v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary.
Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:
C14H18N4O3 M.W. 290.3
Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:
C10H11N3O3S M.W. 253.28
| Dosage Forms and Strengths |
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Sulfamethoxazole and trimethoprim injection, USP is available as an injection containing 80 mg/mL of sulfamethoxazole and 16 mg/mL of trimethoprim in 5 mL single-dose, 10 mL and 30 mL multiple-dose vials. |
| How Supplied |
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Sulfamethoxazole and trimethoprim injection, USP is supplied as follows: 5 mL Single Dose Vial containing 80 mg trimethoprim (16 mg/mL) and 400 mg sulfamethoxazole (80 mg/mL) for infusion with 5% dextrose in water.
10 mL Multiple Dose Vial; Each 5 mL containing 80 mg trimethoprim (16 mg/mL) and 400 mg sulfamethoxazole (80 mg/mL) for infusion with 5% dextrose in water.
30 mL Multiple Dose Vial; Each 5 mL containing 80 mg trimethoprim (16 mg/mL) and 400 mg sulfamethoxazole (80 mg/mL) for infusion with 5% dextrose in water.
Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024 Made in India |
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