"The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
(sulfamethoxazole and trimethoprim) Tablets, USP and (phenazopyridine Hydrochloride) Tablets, USP
THE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED. For use of the individual components when dispensed as medications outside this combination package for treating urinary tract infections (UTI), please see the package inserts for the individual products.
This product consists of trimethoprim/sulfamethoxazole double strength (160 mg/800 mg) tablets and phenazopyridine hydrochloride 200 mg tablets for oral administration.
Trimethoprim/sulfamethoxazole double strength tablets. Trimethoprim/sulfamethoxazole double strength is a synthetic antibacterial combination product. Each trimethoprim/sulfamethoxazole double strength tablet contains 160 mg trimethoprim and 800 mg sulfamethoxazole.
Trimethoprim is 2,4-pyrimidinediamine, 5-[(3,4,5-trimethoxyphenyl)methyl]. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32, the molecular formula C14H18N4O3. Its structual formula is:
Sulfamethoxazole is benzenesulfonamide, 4-amino-N-(5-methyl-3-isoxazolyl). It is an almost white, odorless, tasteless compound with a molecular weight of 253.28, the molecular formula C10H11N3O3S. Its structual formula is:
Phenazopyridine Hydrochloride tablets. Each round maroon tablet contains 200 mg phenazopyridine hydrochloride, USP for oral administration. Phenazopyridine Hydrochloride is chemically designated 2,6-pyridinediamine, 3-(phenylazo) monohydrochloride with a molecular weigth of 249.70, the molecular formula C11H11N5 ·HCl. Its structual formula is:
Inactive Ingredients: Each phenazopyridine hydrochloride tablet contains acacia, carnauba wax, confectioners sugar, corn starch powder, edible white ink, gelatin, hydrogenated vegetable oil, lactose, magnesium stearate, Opalux AS-3942 dark maroon, sodium starch glycolate, sucrose, talc powder and white bees wax.
Last reviewed on RxList: 1/28/2005
This monograph has been modified to include the generic and brand name in many instances.
Additional Zotrim Information
Report Problems to the Food and Drug Administration
Find out what women really need.