Clinical Information
Gen. Code and Des.
21871 fosfomycin tromethamine ORAL PACKET 3 G
GCN and Des.
55389 fosfomycin tromethamine ORAL PACKET 3 G
Strength
3GM
Dose Form
PACKET (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8360000 URINARY ANTI-INFECTIVES
Active Ingredients
4468 fosfomycin tromethamine 78964859
Inactive Ingredients
2598 sucrose 57501
2600 saccharin 81072
MONUROL- fosfomycin tromethamine powder
Forest Laboratories
R x only
DESCRIPTION
MONUROL (fosfomycin tromethamine) sachet 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 C3 H7 O4 P.C4 H11 NO3
Absorption: Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin. Absolute oral bioavailability under fasting conditions is 37%. After a single 3-gm dose of MONUROL, the mean (� 1 SD) maximum serum concentration (Cmax ) achieved was 26.1 (� 9.1) μg/mL within 2 hours. The oral bioavailability of fosfomycin is reduced to 30% under fed conditions. Following a single 3-gm oral dose of MONUROL with a high-fat meal, the mean Cmax achieved was 17.6 (� 4.4) μg/mL within 4 hours.
Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with MONUROL. Metoclopramide lowers the serum concentrations and urinary excretion of fosfomycin when coadministered with MONUROL. (See PRECAUTIONS, Drug Interactions)
Distribution: The mean apparent steady-state volume of distribution (Vss ) is 136.1 (�44.1) L following oral administration of MONUROL. Fosfomycin is not bound to plasma proteins.
Fosfomycin is distributed to the kidneys, bladder wall, prostate, and seminal vesicles. Following a 50 mg/Kg dose of fosfomycin to patients undergoing urological surgery for bladder carcinoma, the mean concentration of fosfomycin in the bladder, taken at a distance from the neoplastic site, was 18.0 μg per gram of tissue at 3 hours after dosing. Fosfomycin has been shown to cross the placental barrier in animals and man.
INDICATIONS AND USAGE
MONUROL is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains ofEscherichia coli and Enterococcus faecalis. MONUROL is not indicated for the treatment of pyelonephritis or perinephric abscess.
If persistence or reappearance of bacteriuria occurs after treatment with MONUROL, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIESsection)
