Monurol (Fosfomycin Tromethamine) - Indications and Dosage

INDICATIONS AND USAGE

MONUROL is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia 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 STUDIES section.)

DOSAGE AND ADMINISTRATION

The recommended dosage for women 18 years of age and older for uncomplicated urinary tract infection (acute cystitis) is one sachet of MONUROL. MONUROL may be taken with or without food.

MONUROL should not be taken in its dry form. Always mix MONUROL with water before ingesting. (See PREPARATION section.)

PREPARATION

MONUROL should be taken orally. Pour the entire contents of a single-dose sachet of MONUROL into 3 to 4 ounces of water (1/2 cup) and stir to dissolve. Do not use hot water. MONUROL should be taken immediately after dissolving in water.

HOW SUPPLIED

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

NDC # 0456-4300-08

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Keep this and all drugs out of the reach of children.

Manufactured by:
Zambon Switzerland Ltd.
Division of Zambon Group, SpA
Via Industria 13
6814 Cadempino, Switzerland

Made in Switzerland

Distributed by:
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045