MONUROL Granules for oral solution Ref.[10878] Active ingredients: Fosfomycin

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

MONUROL (fosfomycin tromethamine) Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (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 (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2.

Its empirical formula is C3H7O4Pā€¢C4H11NO3, and its chemical structure is as follows:

How Supplied

MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.

NDC:

  • Single-dose sachet 0456-4300-08
  • One unit carton 0456-4300-01

Manufactured by: Zambon Switzerland Ltd., A Subsidiary of Zambon S.p.A, Via Industria 13, 6814 Cadempino, Switzerland

Distributed by: Allergan USA, Inc., Madison, NJ 07940

Drugs

Drug Countries
MONUROL Canada, Ecuador, Spain, Hong Kong, Israel, Singapore, Turkey, United States

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