(fos foe MYE sin)
- Fosfomycin Tromethamine
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Monurol: 3 g (1 ea, 3 ea [DSC]) [orange flavor]
Brand Names: U.S.
- Antibiotic, Miscellaneous
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
Vd: 90 to 180 L
Urine (38% as unchanged drug); feces (18% as unchanged drug)
Time to Peak
Serum: 2 hours; within 4 hours with high-fat meal
3 to 8 hours; CrCl <54 mL/minute: 50 hours
Special Populations: Renal Function Impairment
Urinary excretion decreases to 11% in patients with CrCl 7 to 54 mL/minute.
Use: Labeled Indications
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.
Off Label Uses
Urinary tract infections, complicated (in men)
One case report described the successful treatment of complicated vancomycin-resistant enterococcal urinary tract infection (UTI) in a male patient with repeated doses of fosfomycin [Shrestha 2000]. Subsequently, a retrospective chart review of patients (n=52) with extended-spectrum beta-lactamase- (ESBL-) producing E.coli UTIs described clinical and microbiological success in 94.3% and 78.5%, respectively, after 3 doses of fosfomycin 3 g every other night [Pullukcu 2007]. Another retrospective chart review of patients (n=41) with UTIs due to multidrug-resistant pathogens who were treated with fosfomycin demonstrated an overall microbiological cure of 59% [Neuner 2012]. Additional trials may be necessary to further define the role of fosfomycin in the treatment of complicated urinary tract infections in men.
Hypersensitivity to fosfomycin or any component of the formulation
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)
Refer to adult dosing.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
Pour contents of envelope into 3 to 4 oz (90 to 120 mL) of water (not hot), stir to dissolve, and take immediately.
Always mix with cool water before ingesting; do not administer in its dry form. May be administered without regard to meals.
Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. 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. 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. Consider therapy modification
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% (Limited to important or life-threatening): 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
Concerns related to adverse effects:
• 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
Signs and symptoms of urinary tract infection; urine culture plus sensitivity
Pregnancy Risk Factor
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).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, vaginitis, nausea, or diarrhea. Have patient report immediately to prescriber signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about fosfomycin
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Support Group
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- Drug class: miscellaneous antibiotics
Other brands: Monurol