Zotrim

DRUG DESCRIPTION

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:

Inactive Ingredients: Each trimethoprim/sulfamethoxazole double strength tablet contains magnesium stearate, pregelatinized starch and sodium starch glycolate.

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.