20/3/2017 Fosfomycin: Drug information - UpToDate

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Fosfomycin: Drug information

Copyright 1978-2017 Lexicomp, Inc. All rights reserved.

(For additional information see "Fosfomycin: Patient drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)

Brand Names: US Monurol

Brand Names: Canada Monurol

Pharmacologic Category Antibiotic, Miscellaneous

Dosing: Adult
Urinary tract infections, uncomplicated: Oral: Females: Single dose of 3 g in 3 to 4 oz (90 to 120
mL) of water

Complicated UTI (off-label): Males: Oral: 3 g every 2 to 3 days for 3 doses (Neuner 2012; Pullukcu
2007)

Prostatitis (off-label): Males: Oral: 3 g every 3 days for a total of 21 days (Shrestha, 2000)

Dosing: Geriatric Refer to adult dosing.

Dosing: Renal Impairment There are no dosage adjustments provided in the manufacturers
labeling.

Dosing: Hepatic Impairment There are no dosage adjustments provided in the manufacturers
labeling.

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

Packet, Oral:

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

Generic Equivalent Available (US) No

Administration Always mix with cool water before ingesting; do not administer in its dry form. May be
administered without regard to meals.

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Use
Uncomplicated urinary tract infections: Treatment of uncomplicated urinary tract infections (acute
cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.

Limitations of use: Not indicated for the treatment of pyelonephritis or perinephric abscess. If
persistence or reappearance of bacteriuria occurs after treatment with fosfomycin, other therapeutic
agents should be selected.

Use: Off-Label
Urinary tract infections, complicated (in men)

Medication Safety Issues

Sound-alike/look-alike issues:

Monurol may be confused with Monopril

Adverse Reactions
1% to 10%:

Central nervous system: Headache (4% to 10%), pain (2%), dizziness (1% to 2%)

Dermatologic: Skin rash (1%)

Gastrointestinal: Diarrhea (9% to 10%), nausea (4% to 5%), abdominal pain (2%), dyspepsia (1%
to 2%)

Genitourinary: Vaginitis (6% to 8%), dysmenorrhea (3%)

Neuromuscular & skeletal: Back pain (3%), weakness (1% to 2%)

Respiratory: Rhinitis (5%), pharyngitis (3%)

<1%, postmarketing, and/or case reports: Abnormal stools, anaphylaxis, angioedema, anorexia,
aplastic anemia, cholestatic jaundice, constipation, dermatological disease, drowsiness, dysuria, ear
disease, exacerbation of asthma, fatigue, fever, flatulence, flu-like symptoms, hearing loss, hematuria,
hepatic necrosis, increased serum ALT, insomnia, lymphadenopathy, menstrual disease, migraine,
myalgia, nervousness, optic neuritis, paresthesia, pruritus, toxic megacolon, vomiting, xerostomia

Contraindications Hypersensitivity to fosfomycin or any component of the formulation

Warnings/Precautions
Concerns related to adverse effects:

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Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.

difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed
>2 months postantibiotic treatment.

Concurrent drug therapy issues:

Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency
adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug
interactions database for more detailed information

Metabolism/Transport Effects None known.

Drug Interactions

(For additional information: Launch drug interactions program)

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. Risk X: Avoid
combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol.
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: Vaccination with live attenuated typhoid vaccine
(Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this
vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Risk D:
Consider therapy modification

Pregnancy Risk Factor B (show table)

Pregnancy Implications Adverse events have not been observed in animal reproduction studies.
Fosfomycin crosses the placenta. Several studies have used a single dose therapy with fosfomycin for the
treatment of asymptomatic bacteriuria in pregnant women (Reeves, 1992). However, when treatment is
needed in pregnant women, an appropriate antibiotic with a 3 to 7 day regimen is currently recommended
(Nicolle, 2005).

Breast-Feeding Considerations Fosfomycin distributes into breast milk (Kirby, 1977). Due to

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the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision
be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of
treatment to the mother.

Monitoring Parameters Signs and symptoms of urinary tract infection; urine culture plus
sensitivity

Mechanism of Action As a phosphoric 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

Pharmacodynamics/Kinetics
Absorption: Rapidly absorbed

Distribution: Vd: 90 to 180 L

Protein binding: None

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

Half-life elimination: 3 to 8 hours; CrCl <54 mL/minute: 50 hours; hemodialysis patients: 40 hours

Time to peak, serum: 2 hours; within 4 hours with high-fat meal

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

Pricing: US
Pack (Monurol Oral)

3 g (1): $86.99

Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single
manufacturer of the brand and/or generic product, respectively. The pricing data should be used for
benchmarking purposes only, and as such should not be used to set or adjudicate any prices for
reimbursement or purchasing functions. Pricing data is updated monthly.

International Brand Names Efomycin (PK); Fasapren (CR, DO, GT, HN, NI, PA, SV); Focin (PK);
Folsmycin (TW); Fomicyt (GB); Fosfocil (CR, DO, GT, HN, MX, NI, PA, PE, SV); Fosfocin (GR, IT);
Fosfocina (CU, EC, ES, GR); Fosfocine (FR, VN); Fosfomin (TH); Fosforal (IN); Fosfurol (PY); Fosmicin
(TH); Fosmicin-S (JP); Fosmicyn (AR); Fosmidex (ID); Fostren (CO); Fraxemicin-S Kit (KR); Fu An Xin (CN);
Infectofos (DE); Monural (BG, HU, PL, RO, RU, SK, UA); Monuril (AT, BE, BR, CH, CO, DE, FR, GB, ID, IE,
IT, LU, MT, NL, PT); Monurol (CN, DK, ES, FI, HK, HU, IL, KR, KW, LB, MY, PE, PH, PK, QA, SA, SE, SG,
TH, TR, TW, VN); Novellmycin (ID); Rapidnorm (CZ); Solufos (AR, ES); Sonomycin (PK); Ufo (TW); Uninex
(HR); Uridoz (FR); Urifos (CZ, HR); Urinex (HR); Urizone (ZA); Veramina (AR); Vnikon (CN)

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REFERENCES

1. Kirby WM, "Pharmacokinetics of Fosfomycin," Chemotherapy, 1977, 23(Suppl 1):141-51. [PubMed 832510]
2. Monurol (fosfomycin) [prescribing information]. St. Louis, MO: Forest Pharmaceuticals; September 2014.
3. Neuner EA, Sekeres J, Hall GS, van Duin D. Experience with fosfomycin for treatment of urinary tract infections due to
multidrug-resistant organisms. Antimicrob Agents Chemother. 2012;56(11):5744-5748. [PubMed 22926565]
4. Nicolle LE, Bradley S, Colgan R, et al. Infectious Diseases Society of America guidelines for the diagnosis and
treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40(5):643-654. [PubMed 15714408 ]
5. Patel SS, Balfour JA, and Bryson HM, Fosfomycin Tromethamine. A Review of Its Antibacterial Activity,
Pharmacokinetic Properties, and Therapeutic Efficacy as a Single-Dose Oral Treatment for Acute Uncomplicated
Lower Urinary Tract Infections, Drugs, 1997, 53(4):637-56. [PubMed 9098664]
6. Pullukcu H, Tasbakan M, Sipahi OR, Yamazhan T, Aydemir S, Ulusoy S. Fosfomycin in the treatment of extended
spectrum beta-lactamase-producing Escherichia coli-related lower urinary tract infections. Int J Antimicrob Agents.
2007;29(1):62-65. [PubMed 17189097]
7. Reeves DS, "Treatment of Bacteriuria in Pregnancy With Single Dose Fosfomycin Trometamol: A Review," Infection,
1992, 20(Suppl 4):S313-6. [PubMed 1294525]
8. Shrestha N, Amuh D, Goldman MP, et al, Treatment of a Complicated Vancomycin-Resistant Enterococcal Urinary
Tract Infection With Fosfomycin, Infectious Diseases in Clinical Practice, 2000, 9:368-71. [PubMed Shrestha.2000]

Topic 8477 Version 106.0

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