Fosfomycin

Fosfomycin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

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Overview

Fosfomycin is an anti-bacterial agent that is FDA approved for the treatment of uncomplicated urinary tract infection. Common adverse reactions include diarrhea,vaginitis,nausea,headache,dizziness,asthenia,dyspepsia and elevation of eosinophil and WBC counts, bilirubin,ALT, AST, alkaline phosphatase and decrease in hematocrit, hemoglobin and plateletcount.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1

• Dosing Information

• Dosage

Condition2

• Dosing Information

• Dosage

Condition3

• Dosing Information

• Dosage

Condition4

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Fosfomycin in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fosfomycin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Fosfomycin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Fosfomycin in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fosfomycin in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Fosfomycin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Fosfomycin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• 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

Structure

File:Fosfomycin01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Fosfomycin in the drug label.

Pharmacokinetics

Absorption

• Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin. Absolute oral bioavailability under fasting conditions is 37%. After a single 3-gm dose of MONUROL, the mean (± 1 SD) maximum serum concentration (Cmax) achieved was 26.1 (± 9.1) μg/mL within 2 hours. The oral bioavailability of fosfomycin is reduced to 30% under fed conditions. Following a single 3-gm oral dose of MONUROL with a high-fat meal, the mean Cmaxachieved was 17.6 (± 4.4) μg/mL within 4 hours.

• Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with MONUROL. Metoclopramide lowers the serum concentrations and urinary excretion of fosfomycin when coadministered with MONUROL. (SeePRECAUTIONS, DRUG INTERACTIONS)

Distribution

• The mean apparent steady-state volume of distribution (Vss) is 136.1 (±44.1) L following oral administration of MONUROL. Fosfomycin is not bound to plasma proteins.

• Fosfomycin is distributed to the kidneys, bladder wall, prostate, and seminal vesicles. Following a 50 mg/Kg dose of fosfomycin to patients undergoing urological surgery for bladder carcinoma, the mean concentration of fosfomycin in the bladder, taken at a distance from the neoplastic site, was 18.0 μg per gram of tissue at 3 hours after dosing. Fosfomycin has been shown to cross the placental barrier in animals and man.

Excretion

• Fosfomycin is excreted unchanged in both urine and feces. Following oral administration of MONUROL, the mean total body clearance (CLTB) and mean renal clearance (CLR) of fosfomycin were 16.9 (± 3.5) L/hr and 6.3 (± 1.7) L/hr, respectively. Approximately 38% of a 3-gm dose of MONUROL is recovered from urine, and 18% is recovered from feces. Following intravenous administration, the mean CLTBand mean CLRof fosfomycin were 6.1 (± 1.0) L/hr and 5.5 (±1.2) L/hr, respectively.

• A mean urine fosfomycin concentration of 706 (± 466) μg/mL was attained within 2-4 hours after a single oral 3-gm dose of MONUROL under fasting conditions. The mean urinary concentration of fosfomycin was 10 μg/mL in samples collected 72-84 hours following a single oral dose of MONUROL.

• Following a 3-gm dose of MONUROL administered with a high fat meal, a mean urine fosfomycin concentration of 537 (± 252) μg/mL was attained within 6-8 hours. Although the rate of urinary excretion of fosfomycin was reduced under fed conditions, the cumulative amount of fosfomycin excreted in the urine was the same, 1118 (± 201) mg (fed) vs. 1140 mg (± 238) (fasting). Further, urinary concentrations equal to or greaterthan 100 μg/mL were maintained for the same duration, 26 hours, indicating that MONUROL can be taken without regard to food.

• Following oral administration of MONUROL, the mean half-life for elimination (t1/2) is 5.7 (± 2.8) hours.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Fosfomycin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Fosfomycin in the drug label.

How Supplied

Storage

There is limited information regarding Fosfomycin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Fosfomycin in the drug label.

Precautions with Alcohol

• Alcohol-Fosfomycin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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