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Fosfomycin: Pediatric drug information

Fosfomycin: Pediatric drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Fosfomycin: Drug information" and "Fosfomycin: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Monurol [DSC]
Brand Names: Canada
  • Ivozfo;
  • JAMP-Fosfomycin;
  • Monurol
Therapeutic Category
  • Antibiotic, Miscellaneous
Dosing: Neonatal

Note: Dosing is for an intravenous product not available in the US.

General dosing, susceptible infections: Fosfomycin sodium (Ref):

PMA <40 weeks: IV: 100 mg/kg/day in 2 divided doses.

PMA 40 to 44 weeks: IV: 200 mg/kg/day in 3 divided doses.

Dosing adjustment in renal impairment: Term and preterm neonates: There are no neonatal-specific recommendations; based on experience in adult patients, dosage adjustment suggested.

Dosing adjustment in hepatic impairment: Term and preterm neonates: No dosage adjustment necessary.

Dosing: Pediatric

Fosfomycin tromethamine (Monurol):

Urinary tract infection, uncomplicated

Urinary tract infection, uncomplicated: Limited data available: Note: Oral formulation should not be used for pyelonephritis or perinephric abscess.

Children <12 years: Oral: 2,000 mg as a single dose (Ref).

Children ≥12 years and Adolescents: Oral: 3,000 mg as a single dose (Ref).

Fosfomycin sodium (Ivozfo [Canadian product]): Note: High-dose regimens (>300 mg/kg/day for ≤40 kg and >16 g/day for >40 kg) may be considered for severe infections known or suspected to be caused by organisms with moderate susceptibility. Data is limited for doses >16 g/day, monitor closely.

Meningitis, bacterial

Meningitis, bacterial: Infants, Children, and Adolescents: IV:

<10 kg: 200 to 300 mg/kg/day in 3 divided doses.

10 to 40 kg: 200 to 400 mg/kg/day in 3 to 4 divided doses.

>40 kg: 16 to 24 g/day in 3 to 4 divided doses; maximum dose: 8 g/dose.

Osteomyelitis

Osteomyelitis: Infants, Children, and Adolescents: IV:

<10 kg: 200 to 300 mg/kg/day in 3 divided doses.

10 to 40 kg: 200 to 400 mg/kg/day in 3 to 4 divided doses.

>40 kg: 12 to 24 g/day in 2 to 3 divided doses; maximum dose: 8 g/dose.

Respiratory tract infection, nosocomial

Respiratory tract infection (lower), nosocomial: Infants, Children, and Adolescents: IV:

<10 kg: 200 to 300 mg/kg/day in 3 divided doses.

10 to 40 kg: 200 to 400 mg/kg/day in 3 to 4 divided doses.

>40 kg: 12 to 24 g/day in 2 to 3 divided doses; maximum dose: 8 g/dose.

Urinary tract infection, complicated

Urinary tract infection, complicated: Infants, Children, and Adolescents: IV:

<10 kg: 200 to 300 mg/kg/day in 3 divided doses.

10 to 40 kg: 200 to 400 mg/kg/day in 3 to 4 divided doses.

>40 kg: 12 to 16 g/day in 2 to 3 divided doses; maximum dose: 8 g/dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Oral: Fosfomycin tromethamine (Monurol): There are no dosage adjustments provided in the manufacturer's labeling; however, in adults with renal impairment (CrCl 7 to 54 mL/minute) the amount of fosfomycin recovered in the urine was lower, suggesting decreased renal excretion.

IV: Fosfomycin sodium (Ivozfo [Canadian product]):

Infants and Children <12 years: There are no pediatric-specific recommendations; based on experience in adult patients, dosage adjustment suggested.

Children ≥12 years and Adolescents:

CrCl >80 mL/minute: No dosage adjustment necessary.

CrCl >40 to 80 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; use with caution at recommended doses (especially the higher end of the recommended range).

CrCl 40 mL/minute: Administer 70% of the recommended daily dose (based on indication) in 2 to 3 divided doses; first dose (loading dose) should be doubled but should not exceed 8 g.

CrCl 30 mL/minute: Administer 60% of the recommended daily dose (based on indication) in 2 to 3 divided doses; first dose (loading dose) should be doubled but should not exceed 8 g.

CrCl 20 mL/minute: Administer 40% of the usual recommended daily dose (based on indication) in 2 to 3 divided doses; first dose (loading dose) should be doubled but should not exceed 8 g.

CrCl 10 mL/minute: Administer 20% of the usual recommended daily dose (based on indication) in 1 to 2 divided doses; first dose (loading dose) should be doubled but should not exceed 8 g.

Hemodialysis, intermittent: Patients undergoing hemodialysis every 48 hours should receive fosfomycin 2 g at the end of dialysis.

CVVH (post dilution): No dosage adjustment necessary in patients undergoing postdilution CVVH; there are no dosage adjustments provided in the manufacturer's labeling (has not been studied) for patients undergoing predilution CVVH.

Dosing: Hepatic Impairment: Pediatric

Oral: Fosfomycin tromethamine (Monurol): There are no dosage adjustments provided in the manufacturer's labeling.

IV: Fosfomycin sodium (Ivozfo [Canadian product]): Infants, Children, and Adolescents: No dosage adjustment necessary.

Dosing: Adult

(For additional information see "Fosfomycin: Drug information")

Bloodstream infection

Bloodstream infection: IV [Canadian product]: 12 to 24 g/day in 2 to 3 divided doses (maximum: 8 g/dose). Reserve high-dose regimens (>16 g/day) for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin.

Bone and joint infection

Bone and joint infection: IV [Canadian product]: 12 to 24 g/day in 2 to 3 divided doses (maximum: 8 g/dose). Reserve high-dose regimens (>16 g/day) for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin.

Endocarditis, infective

Endocarditis, infective: IV [Canadian product]: 12 to 24 g/day in 2 to 3 divided doses (maximum: 8 g/dose). Reserve high-dose regimens (>16 g/day) for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin.

Intra-abdominal infection, complicated

Intra-abdominal infection, complicated: IV [Canadian product]: 12 to 24 g/day in 2 to 3 divided doses (maximum: 8 g/dose). Reserve high-dose regimens (>16 g/day) for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin.

Meningitis, bacterial

Meningitis, bacterial: IV [Canadian product]: 16 to 24 g/day in 3 to 4 divided doses (maximum: 8 g/dose). Reserve high-dose regimens (>16 g/day) for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin.

Pneumonia, hospital-acquired or ventilator-associated

Pneumonia, hospital-acquired or ventilator-associated: IV [Canadian product]: 12 to 24 g/day in 2 to 3 divided doses (maximum: 8 g/dose). Reserve high-dose regimens (>16 g/day) for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin.

Prostatitis, chronic bacterial

Prostatitis, chronic bacterial (alternative agent) (off-label use): Note: Reserve for use when other options are not appropriate because of resistance or intolerance. The optimal dose has not been established; the following are some suggested dosing regimens:

Oral: 3 g every 2 to 3 days (Ref) or 3 g once daily for 1 week followed by 3 g once every 48 hours (Ref). Duration is ≥6 weeks (Ref).

Skin and soft tissue infection, complicated

Skin and soft tissue infection, complicated: IV [Canadian product]: 12 to 24 g/day in 2 to 3 divided doses (maximum: 8 g/dose). Reserve high-dose regimens (>16 g/day) for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin.

Urinary tract infection

Urinary tract infection:

Asymptomatic bacteriuria (≥105 CFU per mL) in pregnancy: Oral: 3 g as a single dose (Ref).

Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder without signs/symptoms of upper tract, prostate, or systemic infection), treatment: Oral: 3 g as a single dose (Ref). Note: Multidose regimens (eg, 3 g once every 2 to 3 days for 3 doses) have been described, particularly for multidrug-resistant UTIs; however, it is unknown whether these have greater efficacy than single-dose therapy (Ref). Fosfomycin may be less effective than other first-line agents, although data are conflicting (Ref).

Cystitis, prophylaxis for recurrent infection (alternative agent): Note: May be considered in nonpregnant women with bothersome, frequently recurrent cystitis despite nonantimicrobial preventive measures. The optimal duration has not been established; duration ranges from 3 to 12 months, with periodic reassessment (Ref).

Continuous prophylaxis: Oral: 3 g once every 7 to 10 days (Ref). Note: Some experts use a shorter dosing interval (eg, every 3 to 4 days), but there is no clinical evidence that this is more effective (Ref).

Urinary tract infection, complicated (including pyelonephritis): Note: Some experts reserve use for multidrug-resistant infections when other options are not appropriate because of resistance or intolerance (Ref).

IV [Canadian product]: 12 to 24 g/day in 2 to 3 divided doses (maximum: 8 g/dose) (manufacturer's labeling). Total duration of therapy ranges from 5 to 14 days; for patients with symptomatic improvement within the first 48 to 72 hours of therapy, some experts recommend shorter courses of 5 to 10 days (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

Oral: No dosage adjustment necessary for any degree of kidney dysfunction (Ref). However, elimination is significantly prolonged in patients with CrCl <50 mL/minute; monitor closely for adverse effects and tolerability, particularly with prolonged therapy.

IV [Canadian product]: Note: Dose recommendations are based on expert opinion derived from pharmacokinetic modeling and limited clinical data (Ref); safety and efficacy of dose adjustments have not been fully evaluated in clinical trials.

Fosfomycin Dose Adjustments for Altered Kidney Function

CrCla

% of indication-specific recommended daily dose to be administered

Frequency

a Estimated using the Cockcroft-Gault formula (manufacturer’s labeling).

b The initial (loading) dose should be increased to twice the maintenance dose; not to exceed 8 g (manufacturer’s labeling). For example, if the maintenance dose is 4 g then the loading dose should be 8 g.

c Reserve dose regimens in the higher part of the range for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin (ie, where higher dosages [>16 g/day] would be considered in patients with normal kidney function) (expert opinion).

40 to 130 mL/minute

100%

2 to 4 divided doses

30 to <40 mL/minuteb

~75% (range: 70% to 80%c)

2 to 3 divided doses

20 to <30 mL/minuteb

~60% (range: 50% to 70%c)

2 to 3 divided doses

10 to <20 mL/minuteb

~40% (range: 30% to 50%c)

2 to 3 divided doses

<10 mL/minuteb

~20% (range: 20% to 30%c)

1 to 2 divided doses

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2):

Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Young patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

IV: Administer maximum indication-specific doses (usually 24 g/day in 3 to 4 divided doses except for urinary tract infections) (expert opinion derived from limited clinical data) (Ref).

Hemodialysis, intermittent (thrice weekly): Dialyzable (extensively removed) (Ref):

Oral: No dosage adjustment necessary. However, elimination is significantly prolonged in patients on dialysis (Ref); monitor closely for adverse effects and tolerability, particularly with prolonged therapy. When scheduled dose falls on a dialysis day, administer after dialysis (Ref).

IV: Initial: 2 to 4 g, then 2 to 4 g three times weekly post hemodialysis (expert opinion derived from (Ref)). Reserve higher-dose regimens for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin (ie, where higher dosages [>16 g/day] would be considered in patients with normal kidney function) (Ref).

Peritoneal dialysis:

Oral: No dosage adjustment necessary. However, elimination is significantly prolonged in patients on dialysis (Ref); monitor closely for toxicity and tolerability, particularly with prolonged therapy (Ref).

IV: 2 to 4 g every 48 hours (expert opinion derived from (Ref)). Reserve higher-dose regimens for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin (ie, where higher dosages [>16 g/day] would be considered in patients with normal kidney function) (Ref).

CRRT:

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection) and consideration of initial loading doses. Close monitoring of response and adverse reactions due to drug accumulation is important. Note: Very little clinical data.

Oral: No dosage adjustment necessary (Ref).

IV: 6 to 8 g every 12 hours (Ref). Reserve higher-dose regimens for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin (ie, where higher dosages [>16 g/day] would be considered in patients with normal kidney function) (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration):

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection) and consideration of initial loading doses. Close monitoring of response and adverse reactions due to drug accumulation is important.

Oral: No dosage adjustment necessary (Ref).

IV: 4 to 6 g once daily followed by a 4 to 6 g supplemental dose after each PIRRT session (expert opinion derived from limited clinical data (Ref)). Reserve higher-dose regimens for severe infections known or suspected to be caused by organisms with decreased susceptibility to fosfomycin (ie, where higher dosages [>16 g/day] would be considered in patients with normal kidney function) (Ref).

Dosing: Hepatic Impairment: Adult

Oral: There are no dosage adjustments provided in the manufacturer's labeling.

IV [Canadian product]: No dosage adjustment necessary.

Adverse Reactions (Significant): Considerations
Clostridioides difficile infection

Clostridioides difficile infection has occurred with oral fosfomycin, including Clostridioides difficile -associated diarrhea (Ref).

Mechanism: Dose- and time-related; related to cumulative antibiotic exposure. Fosfomycin may cause disruption of the intestinal microbiota resulting in the overgrowth of pathogens, such as C. difficile (Ref).

Onset: Varied; may start on the first day of antibiotic therapy or up to 3 months postantibiotic (Ref). C. difficile has been reported within 30 days of fosfomycin therapy, including up to 14 days after the last dose (Ref).

Risk factors (general):

• Antibiotic exposure (highest risk factor) (Ref)

• Long durations in a hospital or other health care setting (recent or current) (Ref)

• Older adults (Ref)

• Immunocompromised conditions (Ref)

• A serious underlying condition (Ref)

• GI surgery/manipulation (Ref)

• Antiulcer medications (eg, proton pump inhibitors, H2 blockers) (Ref)

• Chemotherapy (Ref)

Electrolyte disturbances

IV fosfomycin [Canadian product] is associated with electrolyte abnormalities, including hypernatremia, hypokalemia, hypomagnesemia, and hypophosphatemia (Ref).

Hypernatremia and hypokalemia are the most common electrolyte disorders (Ref). Electrolyte abnormalities are typically mild; however, reports of severe hypernatremia have occurred (Ref). Electrolyte supplementation may be required in ~10% to 20% of patients receiving IV fosfomycin (Ref). Several cases of hypernatremia have been associated with the incorrect reconstitution of the drug (Ref).

Mechanism: Dose-related; each gram of IV fosfomycin contains ~0.32 g of sodium, creating a fluid and sodium imbalance (Ref). Fosfomycin may also increase the urinary excretion of potassium in the distal part of the renal tubules (Ref).

Onset: Rapid; electrolyte abnormalities often occur while receiving active therapy and hypokalemia has been reported within 4 days of exposure (Ref); however, the duration of therapy may impact the risk.

GI disturbances

Fosfomycin is associated with abdominal pain, dyspepsia, nausea, and non-Clostridioides difficile diarrhea. GI disturbances have been reported for both oral and IV [Canadian product] formulations (Ref). GI symptoms associated with oral fosfomycin are typically mild, self-limiting (within 1 to 2 days), and do not usually require discontinuation (Ref). Diarrhea is the most common GI adverse reaction with oral fosfomycin (Ref). Compared with ciprofloxacin for the treatment of urinary tract infections, daily oral fosfomycin caused more GI adverse reactions; however, there was not a greater rate of discontinuation (Ref).

Onset: Rapid; within approximately the first week after initiation (Ref).

Hypersensitivity reactions (immediate and delayed)

Hypersensitivity reactions (immediate and delayed) have been reported and range from skin rash to rare cases of anaphylaxis and anaphylactic shock (Ref). Delayed hypersensitivity reactions, including severe cutaneous adverse reactions (SCARs) (drug reaction with eosinophilia and systemic symptoms [DRESS], Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], and acute generalized exanthematous pustulosis [AGEP]), have been reported but may not have been the only implicated drug (Ref). Acute localized exanthematous pustulosis (ALEP) has also been reported (Ref).

Mechanism: Immediate hypersensitivity reactions (eg, anaphylaxis, urticaria) can be non–IgE-mediated or IgE-mediated. Delayed hypersensitivity reactions, including rash and SCARs, are commonly T-cell-mediated (Ref).

Onset: Immediate hypersensitivity reactions: Rapid; generally occur within 1 hour of administration, but may occur up to 6 hours after exposure (Ref). Delayed hypersensitivity reactions: Nonspecific rash: Intermediate; generally occur 7 to 10 days after initiation. Other reactions (including SCARs): Varied; typically occur a few days up to 2 months after initiation (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported with the oral formulation.

1% to 10%:

Dermatologic: Skin rash (1%)

Gastrointestinal: Abdominal pain (2%), diarrhea (9% to 10%) (table 1), dyspepsia (1% to 2%) (table 2), nausea (4% to 5%) (table 3)

Fosfomycin: Adverse Reaction: Diarrhea

Drug (Fosfomycin)

Comparator (Nitrofurantoin)

Comparator (Trimethoprim/Sulfamethoxazole)

Comparator (Ciprofloxacin)

Number of Patients (Fosfomycin)

Number of Patients (Nitrofurantoin)

Number of Patients (Trimethoprim/Sulfamethoxazole)

Number of Patients (Ciprofloxacin)

Comments

10%

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Reported regardless of drug relationship

9%

6%

2%

3%

1,233

374

428

455

Reported as drug-related

Fosfomycin: Adverse Reaction: Dyspepsia

Drug (Fosfomycin)

Comparator (Nitrofurantoin)

Comparator (Trimethoprim/Sulfamethoxazole)

Comparator (Ciprofloxacin)

Number of Patients (Fosfomycin)

Number of Patients (Nitrofurantoin)

Number of Patients (Trimethoprim/Sulfamethoxazole)

Number of Patients (Ciprofloxacin)

Comments

2%

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Reported regardless of drug relationship

1%

2%

0.7%

1%

1,233

374

428

455

Reported as drug-related

Fosfomycin: Adverse Reaction: Nausea

Drug (Fosfomycin)

Comparator (Nitrofurantoin)

Comparator (Trimethoprim/Sulfamethoxazole)

Comparator (Ciprofloxacin)

Number of Patients (Fosfomycin)

Number of Patients (Nitrofurantoin)

Number of Patients (Trimethoprim/Sulfamethoxazole)

Number of Patients (Ciprofloxacin)

Comments

5%

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Reported regardless of drug relationship

4%

7%

9%

3%

1,233

374

428

455

Reported as drug-related

Genitourinary: Dysmenorrhea (3%), vaginitis (6% to 8%)

Nervous system: Asthenia (1% to 2%), dizziness (1% to 2%), headache (4% to 10%), pain (2%)

Neuromuscular & skeletal: Back pain (3%)

Respiratory: Pharyngitis (3%), rhinitis (5%)

<1%:

Dermatologic: Pruritus

Gastrointestinal: Abnormal stools, anorexia, constipation, flatulence, vomiting, xerostomia

Genitourinary: Dysuria, hematuria

Hematologic & oncologic: Lymphadenopathy

Hepatic: Increased serum alanine aminotransferase

Nervous system: Drowsiness, insomnia, migraine, nervousness, paresthesia

Neuromuscular & skeletal: Myalgia

Ophthalmic: Optic neuritis

Respiratory: Flu-like symptoms

Miscellaneous: Fever

Postmarketing:

Dermatologic: Acute generalized exanthematous pustulosis (Iarikov 2015), Stevens-Johnson syndrome (Iarikov 2015), toxic epidermal necrolysis (Iarikov 2015)

Gastrointestinal: Clostridioides difficile-associated diarrhea (Wenzler 2018), toxic megacolon

Hematologic & oncologic: Aplastic anemia (Iarikov 2015)

Hepatic: Cholestatic jaundice, hepatic necrosis

Hypersensitivity: Anaphylactic shock (Iarikov 2015), anaphylaxis (Iarikov 2015), angioedema (Iarikov 2015), drug reaction with eosinophilia and systemic symptoms (Iarikov 2015)

Otic: Hearing loss

Respiratory: Exacerbation of asthma

Contraindications

Hypersensitivity to fosfomycin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hematologic effects: IV [Canadian product]: Agranulocytosis and neutropenia have been reported with use.

• Hepatic effects: Hepatic injury, including steatosis and hepatitis, has been reported; usually reversible upon discontinuation.

Disease-related concerns:

• Electrolyte disturbances: Electrolyte disturbances may occur. Use with caution in patients with cardiac insufficiency, hypertension, hyperaldosteronism, hypernatremia, hypoalbuminemia, nephrotic syndrome, pulmonary edema, or hepatic cirrhosis. Hypokalemia may cause cardiac arrhythmia, edema, hyporeflexia, muscle twitching, tiredness, and weakness.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Packet, Oral:

Monurol: 3 g (1 ea [DSC]) [orange flavor]

Generic: 3 g (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Pack (Fosfomycin Tromethamine Oral)

3 g (per each): $72.00 - $100.40

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral:

Monurol: 3 g (3 g) [contains saccharin]

Generic: 3 g (3 g)

Solution Reconstituted, Intravenous:

Ivozfo: 4 g (1 ea)

Additional Information

Each 1 g of fosfomycin IV (equivalent to 1.32 g fosfomycin sodium) contains 14 mmol (320 mg) sodium.

Administration: Pediatric

Oral: Oral packet: Do not administer in its dry form; must be mixed with water prior to administration. May be administered without regard to meals. Pour contents of 3 g packet into 3 to 4 oz (90 to 120 mL) of water (not hot) and stir to dissolve; the resultant concentration is 25 to 33.3 mg/mL. Measure appropriate volume for desired dose and take immediately. Discard any remaining solution.

IV [Canadian product]: Infuse 2 g dose over ≥15 minutes, 4 g dose over ≥30 minutes, or 8 g dose over ≥60 minutes. Consider extended infusion time (up to 4 hours for the 4 g or 8 g dose) in patients at high risk for hypokalemia.

Administration: Adult

Oral: Always mix with 3 to 4 oz (90 to 120 mL) cool water before ingesting; do not administer in its dry form or mix with hot water. May be administered without regard to meals.

IV [Canadian product]: Infuse 2 g dose over ≥15 minutes; 4 g dose over ≥30 minutes; and 8 g dose over ≥60 minutes. Consider extended infusion time (≤4 hours for the 4 or 8 g dose) or reduction in individual dose with more frequent administration in patients at high risk for hypokalemia.

Storage/Stability

IV [Canadian product]: Store intact vials at 15°C to 30°C (59°F to 86°F). Reconstituted solution may be stored at 2°C to 8°C (36°F to 46°F) for ≤48 hours. Diluted solution may be stored at 2°C to 8°C (36°F to 46°F) or 25°C (77°F) for ≤48 hours. Protect from light.

Oral packet: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Use

Oral granules packet: Treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus (FDA approved in adults).

Note: IV products are available in other countries (eg, Canada) and are used for treatment of bacterial meningitis, osteomyelitis, lower respiratory tract infection (nosocomial), and urinary tract infections (complicated) (and any associated bacteremia) in all ages.

Medication Safety Issues
Sound-alike/look-alike issues:

Monurol may be confused with Monopril

Older Adult: High-Risk Medication:

Fosfomycin is identified in the Screening Tool of Older Person's Prescriptions (STOPP) criteria as a potentially inappropriate medication in older adults (≥65 years of age) for use in asymptomatic bacteriuria (O’Mahony 2023).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Gastrointestinal Agents (Prokinetic): May decrease the serum concentration of Fosfomycin. Risk C: Monitor therapy

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Mycophenolate: Antibiotics may decrease serum concentrations of the active metabolite(s) of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Dietary Considerations

Some products may contain sodium.

Pregnancy Considerations

Fosfomycin crosses the placenta.

Outcome data following use of fosfomycin during pregnancy are available (Benevent 2023; Konwar 2022; Mannucci 2019; Philipps 2020).

Fosfomycin is approved for the treatment of urinary tract infections. Untreated asymptomatic bacteriuria may increase the risk of adverse pregnancy outcomes, including the risk of pyelonephritis, preterm labor, and delivery of low-birth-weight infants; treatment with an appropriate antibiotic is recommended (Nicolle [IDSA 2019]). Single dose fosfomycin is effective for the treatment of asymptomatic bacteriuria in pregnant patients (Nicolle [IDSA 2019]; Schulz 2022; Wang 2020). Additional studies are needed to evaluate the effect on outcomes, such as reducing the risk of preterm labor or preventing pyelonephritis (Nicolle [IDSA 2019]). Avoid use in patients at risk for preterm birth when treatment with prolonged antibiotic therapy may be indicated (Betschart 2020).

Monitoring Parameters

Observe for change in stool frequency.

IV [Canadian product]: Serum electrolytes (especially sodium, potassium, and phosphate) and fluid balance (in particular when using high dose regimens, for all doses in neonates and premature infants, and digitalized patients); renal function; liver function.

Mechanism of Action

As a phosphonic acid derivative, fosfomycin inhibits bacterial wall synthesis (bactericidal) by inactivating the enzyme, pyruvyl transferase, which is critical in the synthesis of cell walls by bacteria.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Oral: Rapidly absorbed.

Distribution:

Oral: Vd: 90 to 180 L.

IV [Canadian product]: 0.3 L/kg.

Protein binding: None.

Bioavailability: Oral: Fasting: 37%; With food: 30%.

Half-life elimination:

Oral: 3 to 8 hours; CrCl <54 mL/minute: 50 hours; Hemodialysis patients: 40 hours.

IV [Canadian product]: ~2 hours; Elderly and/or critically ill patients: 3.6 to 3.8 hours; CVVHF: 12 hours.

Time to peak, serum: Oral: 2 hours; Within 4 hours with high-fat meal.

Excretion:

Oral: Urine (38% as unchanged drug); feces (18% as unchanged drug).

IV [Canadian product]: Urine (80% to 90% as unchanged drug); feces (<1% as unchanged drug).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Oral: Urinary excretion decreases to 11% in patients with CrCl 7 to 54 mL/minute.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Fosfomicina Luar | Veramina;
  • (AT) Austria: Fomicyt | Fosfomycin;
  • (BD) Bangladesh: Fosfomax;
  • (BE) Belgium: Fosfocin;
  • (BF) Burkina Faso: Monuril;
  • (CH) Switzerland: Monuril;
  • (CN) China: Fosfomycin dinatrium | Fosfomycin dinitri | Fu an xin | Fu mei xin | Li ke te | Monurol | Xin ya mai lin;
  • (CO) Colombia: Fomaxin;
  • (CZ) Czech Republic: Fomicyt;
  • (DE) Germany: Fosfomycin eberth | Infectofos;
  • (DO) Dominican Republic: Fosfocil | Fosfomicina sintesis | Fosmicin | Luxol | Uroprin;
  • (EC) Ecuador: Fosfocina | Fosfomicina | Fosfomicina sodica;
  • (EE) Estonia: Fosfocina;
  • (ES) Spain: Fosfocina;
  • (FI) Finland: Fosfomycin Infectopharm;
  • (FR) France: Fomicyt | Fosfocina | Fosfocine;
  • (GB) United Kingdom: Alexi | Fomicyt;
  • (GR) Greece: Fomicyt;
  • (HR) Croatia: Fomicyt;
  • (ID) Indonesia: Focyn | Fosfomycin | Fosmicin | Fosmidex;
  • (IE) Ireland: Fomicyt;
  • (IN) India: Bdfosfo | Crifos | Fonyl | Fosfocide | Fosfofic | Fosfojoy | Fosfotas | Fosjet | Fresofos | Icufos | Lupifos | Samfos;
  • (IT) Italy: Fosfocin | Infectofos;
  • (JP) Japan: Bluebacirin | Eukocin | Forocyle s | Foskoricin | Fosmicin | Frazemicin | Harosmin | Hoskarize | Hoskarize s | Isoramycin | Perexine;
  • (KR) Korea, Republic of: Fonfocin | Fonofos | Fosfocin | Fosfomycin | Frazemicin | Jw fosfomycin sodium;
  • (KW) Kuwait: Alexi;
  • (LT) Lithuania: Infectofos;
  • (LV) Latvia: Fosfocina;
  • (MX) Mexico: Fosfocil | Fosfomicina Antibioticos | Fosune;
  • (NL) Netherlands: Fomicyt;
  • (NO) Norway: Fosfomycin Infectopharm;
  • (NZ) New Zealand: Fosmicin;
  • (PE) Peru: Fosfobiotic | Fosfocil;
  • (PK) Pakistan: Focin | Fosfomycin | Fosforin | Fosomin;
  • (PL) Poland: Fomicyt | Infectofos;
  • (PR) Puerto Rico: Fosfomycin tromethamine;
  • (QA) Qatar: Fosfolag;
  • (RU) Russian Federation: Fosfomycin | Fosmicin | Urobactocin | Urofosfabol;
  • (SE) Sweden: Fosfocin | Fosfomycin Infectopharm;
  • (SI) Slovenia: Fosfocina intravenosa | Infectofos;
  • (SK) Slovakia: Fomicyt;
  • (TH) Thailand: Fosfomin | Fosmicin;
  • (TN) Tunisia: Fomicyt | Fosfocine;
  • (TR) Turkey: Fosit;
  • (TW) Taiwan: Fofocin | Fosfocina | Fosfomycin | Fosmicin s | Kinfomycin | Ufo;
  • (UA) Ukraine: Fosmicin | Phosphoral;
  • (UY) Uruguay: Fosfocina | Fosfomicina
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