Source: FDA, National Drug Code (US) Revision Year: 2019
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 sections.)
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.)
MONUROL should be taken orally. Pour the entire contents of a single-dose sachet of MONUROL into 3 to 4 ounces of water (½ cup) and stir to dissolve. Do not use hot water. MONUROL should be taken immediately after dissolving in water.
In acute toxicology studies, oral administration of high doses of MONUROL up to 5 g/kg were well-tolerated in mice and rats, produced transient and minor incidences of watery stools in rabbits, and produced diarrhea with anorexia in dogs occurring 2-3 days after single dose administration. These doses represent 50-125 times the human therapeutic dose.
The following events have been observed in patients who have taken MONUROL in overdose: vestibular loss, impaired hearing, metallic taste, and general decline in taste perception. In the event of overdosage, treatment should be symptomatic and supportive.
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.
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