Monurol - Pharmaceutical Information, Clinical Trials, Detailed Pharmacology, Toxicology
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Monurol - Scientific Information

Manufacture: Forest Laboratories, Inc.
Country: United States
Condition: Bladder Infection, Transurethral Prostatectomy
Class: Miscellaneous antibiotics, Urinary anti-infectives
Form: Powder
Ingredients: fosfomycin tromethamine, mandarin flavor, orange flavor, saccharin, sucrose

Clinical Studies

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 (See table below). 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

Treatment Arm Treatment Duration (days) Microbiologic Eradication Rate Clinical Success Rate Outcome (based on difference in microbiologic eradication rates 5-11 days post therapy)
5-11 days post therapy Study day 12-21
Fosfomycin 1 630/771 (82%) 591/771 (77%) 542/771 (70%)  
Ciprofloxacin 7 219/222(98%) 219/222 (98%) 213/222 (96%) Fosfomycin inferior to ciprofloxacin
Trimethoprim/
sulfamethoxazole
10 194/197(98%) 194/197(98%) 186/197(94%) Fosfomycin inferior to trimethoprim/ sulfamethoxazole
Nitrofurantoin 7 180/238(76%) 180/238(76%) 183/238(77%) Fosfomycin equivalent to nitrofurantoin
Pathogen Fosfomycin 3 gm single dose Ciprofloxacin 250 mg bid x 7d Trimethoprim/sulfamethoxazole 160 mg/ 800 mg bid x 10 d Nitrofurantoin 100mg bid x 7d
E. coli 509/644 (79%) 184/187 (98%) 171/174 (98%) 146/187 (78%)
E. faecalis 10/10 (100%) 0/0 4/4 (100%) 1/2 (50%)