General Information

Monurol (fosfomycin tromethamine) is a synthetic, broad spectrum, bactericidal antibiotic for oral administration.

Monurol is specifically indicated for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.

Monurol is supplied as granules. 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.

Mechanism of Action

Monurol (fosfomycin tromethamine) is a synthetic, broad spectrum, bactericidal antibiotic. Fosfomycin (the active component of fosfomycin tromethamine) has in vitro activity against a broad range of gram-positive and gram-negative aerobic microorganisms which are associated with uncomplicated urinary tract infections. Fosfomycin is bactericidal in urine at therapeutic doses. The bactericidal action of fosfomycin is due to its inactivation of the enzyme enolpyruvyl transferase, thereby irreversibly blocking the condensation of uridine diphosphate-N-acetylglucosamine with p-enolpyruvate, one of the first steps in bacterial cell wall synthesis. It also reduces adherence of bacteria to uroepithelial cells.

Side Effects

Adverse effects associated with the use of Monurol may include, but are not limited to, the following:

• diarrhea
• headache
• vaginitis
• nausea
• rhinitis
• back pain
• dysmenorrheal
• pharyngitis
• dizziness
• abdominal pain
• pain
• dyspepsia
• asthenia
• rash

Clinical Trial Results

In controlled, double-blind studies of acute cystitis performed in the United States, a single-dose of Monurol was compared to three other oral antibiotics. The study population consisted of patients with symptoms and signs of acute cystitis of less than 4 days duration, no manifestations of upper tract infection (e.g., flank pain, chills, fever), no history of recurrent urinary tract infections (20% of patients in the clinical studies had a prior episode of acute cystitis within the preceding year), no known structural abnormalities, no clinical or laboratory evidence of hepatic dysfunction, and no known or suspected CNS disorders, such as epilepsy, or other factors which would predispose to seizures. In these studies, the following clinical success (resolution of symptoms) and microbiologic eradication rates were obtained:

Fosfomycin 1 day duration- clinical success rate of 70%

Ciprofloxacin 7 day duration - clinical success rate of 96%; Fosfomycin inferior to ciprofloxacin

Trimethoprim/ sulfamethoxazole 10 day duration - clinical success rate of 94%; Fosfomycin inferior to trimethoprim/ sulfamethoxazole

Nitrofurantoin 7 day duration - clinical success rate of 77%; Fosfomycin equivalent to nitrofurantoin