SPL Set ID: aacd04a4-f2d5-45a2-b9e7-0e92244a5880

Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a white to off-white powder in a single-dose sachet. Each 8 grams granules per sachet contains 5.631 grams of fosfomycin tromethamine, USP (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1 R ,2 S )-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). Fosfomycin tromethamine, USP is a white or almost white powder. It is very soluble in water, slightly soluble in ethanol (96 %) and in methanol, practically insoluble in acetone. The molecular weight of fosfomycin tromethamine is 259.2 g/mol, molecular formula is C 3 H 7 O 4 P.C 4 H 11 NO 3 , and its chemical structure is as follows: 1