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Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fosfomycin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Fosfomycin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Fosfomycin with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Fosfomycin with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Fosfomycin with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Fosfomycin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Fosfomycin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Fosfomycin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Fosfomycin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Fosfomycin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Fosfomycin in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Fosfomycin in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Fosfomycin in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Fosfomycin in the drug label.
Pharmacology
There is limited information regarding Fosfomycin Pharmacology in the drug label.
Mechanism of Action
Fosfomycin (the active component of fosfomycin tromethamine) hasin vitroactivity 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.
There is generally no cross-resistance between fosfomycin and other classes of antibacterial agents such as beta-lactams and aminoglycosides.
Fosfomycin has been shown to be active against most strains of the following microorganisms, both in vitroand in clinical infections
Aerobic gram-positive microorganisms
Enterococcus faecalis
Aerobic gram-negative microorganisms
Escherichia coli
The followingin vitrodata are available,but their clinical significance is unknown.
Fosfomycin exhibitsin vitrominimum inhibitory concentrations (MIC's) of 64 μg/mL or less against most (≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of fosfomycin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials:
