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Drug overview for FOSFOMYCIN TROMETHAMINE (fosfomycin tromethamine):
Generic name: FOSFOMYCIN TROMETHAMINE (FOS-foe-MYE-sin troe-METH-a-meen)
Drug class: Urinary Tract Anti-Infectives
Therapeutic class: Genitourinary Therapy
Fosfomycin tromethamine, a phosphonic acid derivative, is a synthetic urinary antibacterial agent.
No enhanced Uses information available for this drug.
Generic name: FOSFOMYCIN TROMETHAMINE (FOS-foe-MYE-sin troe-METH-a-meen)
Drug class: Urinary Tract Anti-Infectives
Therapeutic class: Genitourinary Therapy
Fosfomycin tromethamine, a phosphonic acid derivative, is a synthetic urinary antibacterial agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for FOSFOMYCIN TROMETHAMINE (fosfomycin tromethamine) have been approved by the FDA:
Indications:
Bacterial urinary tract infection
E. coli urinary tract infection
Enterococcus urinary tract infection
Professional Synonyms:
E. coli UTI
Urinary tract infection due to Enterococcus species
Urinary tract infection due to Escherichia coli
UTI due to Enterococcus species
Indications:
Bacterial urinary tract infection
E. coli urinary tract infection
Enterococcus urinary tract infection
Professional Synonyms:
E. coli UTI
Urinary tract infection due to Enterococcus species
Urinary tract infection due to Escherichia coli
UTI due to Enterococcus species
The following dosing information is available for FOSFOMYCIN TROMETHAMINE (fosfomycin tromethamine):
Dosage of fosfomycin tromethamine is expressed in terms of fosfomycin.
Fosfomycin tromethamine is administered orally. Although fosfomycin has been administered IV+ as the disodium salt, a parenteral formulation of the drug is not commercially available in the US. Fosfomycin tromethamine for oral administration is available as granules for oral solution that must be dissolved in water prior to administration.
The drug should not be ingested as dry granules. The oral solution should be prepared by pouring the entire contents of a single-dose packet (sachet) containing 3 g of fosfomycin into 90-120 mL (3-4 ounces) of water and stirring until the granules dissolve. The entire oral solution should be ingested immediately after preparation.
Hot water should not be used to dissolve fosfomycin tromethamine granules. Although food decreases oral bioavailability of fosfomycin tromethamine, the manufacturer states that the drug may be administered without regard to food since the cumulative amount of fosfomycin excreted in urine is similar whether the drug is given with or without food. (See Pharmacokinetics.)
The drug should not be ingested as dry granules. The oral solution should be prepared by pouring the entire contents of a single-dose packet (sachet) containing 3 g of fosfomycin into 90-120 mL (3-4 ounces) of water and stirring until the granules dissolve. The entire oral solution should be ingested immediately after preparation.
Hot water should not be used to dissolve fosfomycin tromethamine granules. Although food decreases oral bioavailability of fosfomycin tromethamine, the manufacturer states that the drug may be administered without regard to food since the cumulative amount of fosfomycin excreted in urine is similar whether the drug is given with or without food. (See Pharmacokinetics.)
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
FOSFOMYCIN 3 GM SACHET | Maintenance | Adults take 1 sachet (3 gram) dissolved in 3 to 4 ounces (1/2 cup) of water by oral route as a single dose |
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
FOSFOMYCIN 3 GM SACHET | Maintenance | Adults take 1 sachet (3 gram) dissolved in 3 to 4 ounces (1/2 cup) of water by oral route as a single dose |
The following drug interaction information is available for FOSFOMYCIN TROMETHAMINE (fosfomycin tromethamine):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
Drug Interaction | Drug Names |
---|---|
Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3) |
VIVOTIF |
Fosfomycin, Oral/Metoclopramide SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Metoclopramide may decrease the amount of fosfomycin absorbed.(1) CLINICAL EFFECTS: The concurrent use of metoclopramide may result in reduced levels of fosfomycin and treatment failure.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Fosfomycin should not be used in patients receiving metoclopramide.(1) Consider the use of alternative urinary tract anti-infectives in patients maintained on metoclopramide. If concurrent use is warranted, monitor patients for fosfomycin treatment failure. DISCUSSION: Metoclopramide has been shown to reduce fosfomycin levels. Urinary levels of fosfomycin may not exceed required bactericidal levels for a long enough period of time to result in microbiological cure.(1) |
GIMOTI, METOCLOPRAMIDE HCL, REGLAN |
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
Drug Interaction | Drug Names |
---|---|
Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores. |
VOWST |
There are 0 moderate interactions.
The following contraindication information is available for FOSFOMYCIN TROMETHAMINE (fosfomycin tromethamine):
Drug contraindication overview.
Fosfomycin tromethamine is contraindicated in patients with known hypersensitivity to the drug.
Fosfomycin tromethamine is contraindicated in patients with known hypersensitivity to the drug.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
Severe List |
---|
Clostridioides difficile infection |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
Moderate List |
---|
Kidney disease with reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for FOSFOMYCIN TROMETHAMINE (fosfomycin tromethamine):
Adverse reaction overview.
Adverse effects reported in more than 1% of patients receiving oral fosfomycin in clinical studies include adverse GI effects (diarrhea, nausea, dyspepsia), headache, dizziness, asthenia, and vaginitis.
Adverse effects reported in more than 1% of patients receiving oral fosfomycin in clinical studies include adverse GI effects (diarrhea, nausea, dyspepsia), headache, dizziness, asthenia, and vaginitis.
There are 2 severe adverse reactions.
More Frequent | Less Frequent |
---|---|
Vaginitis |
None. |
Rare/Very Rare |
---|
Clostridioides difficile infection |
There are 13 less severe adverse reactions.
More Frequent | Less Frequent |
---|---|
Diarrhea Headache disorder Nausea |
Abdominal pain with cramps Back pain Dizziness Dysmenorrhea Dyspepsia General weakness Pain Pharyngitis Rhinitis Skin rash |
Rare/Very Rare |
---|
None. |
The following precautions are available for FOSFOMYCIN TROMETHAMINE (fosfomycin tromethamine):
Safety and efficacy of fosfomycin have not been established in children 12 years of age or younger.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
None |
Severe Precaution
None |
Management or Monitoring Precaution
None |
There are no adequate and well-controlled studies using fosfomycin in pregnant women. Fosfomycin should be used during pregnancy only if clearly needed.
It is not known whether fosfomycin is distributed into milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or not administer fosfomycin, taking into account the importance of the drug to the woman.
Clinical studies of fosfomycin did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger patients. Although other clinical experience has not identified age-related differences in response or tolerance, dosage for geriatric patients should be selected with caution and the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in this age group should be considered.
The following prioritized warning is available for FOSFOMYCIN TROMETHAMINE (fosfomycin tromethamine):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for FOSFOMYCIN TROMETHAMINE (fosfomycin tromethamine)'s list of indications:
Bacterial urinary tract infection | |
N30.0 | Acute cystitis |
N30.00 | Acute cystitis without hematuria |
N30.01 | Acute cystitis with hematuria |
N30.9 | Cystitis, unspecified |
N30.90 | Cystitis, unspecified without hematuria |
N30.91 | Cystitis, unspecified with hematuria |
N39.0 | Urinary tract infection, site not specified |
O23.0 | Infections of kidney in pregnancy |
O23.00 | Infections of kidney in pregnancy, unspecified trimester |
O23.01 | Infections of kidney in pregnancy, first trimester |
O23.02 | Infections of kidney in pregnancy, second trimester |
O23.03 | Infections of kidney in pregnancy, third trimester |
O23.1 | Infections of bladder in pregnancy |
O23.10 | Infections of bladder in pregnancy, unspecified trimester |
O23.11 | Infections of bladder in pregnancy, first trimester |
O23.12 | Infections of bladder in pregnancy, second trimester |
O23.13 | Infections of bladder in pregnancy, third trimester |
O23.2 | Infections of urethra in pregnancy |
O23.20 | Infections of urethra in pregnancy, unspecified trimester |
O23.21 | Infections of urethra in pregnancy, first trimester |
O23.22 | Infections of urethra in pregnancy, second trimester |
O23.23 | Infections of urethra in pregnancy, third trimester |
O23.3 | Infections of other parts of urinary tract in pregnancy |
O23.30 | Infections of other parts of urinary tract in pregnancy, unspecified trimester |
O23.31 | Infections of other parts of urinary tract in pregnancy, first trimester |
O23.32 | Infections of other parts of urinary tract in pregnancy, second trimester |
O23.33 | Infections of other parts of urinary tract in pregnancy, third trimester |
O23.4 | Unspecified infection of urinary tract in pregnancy |
O23.40 | Unspecified infection of urinary tract in pregnancy, unspecified trimester |
O23.41 | Unspecified infection of urinary tract in pregnancy, first trimester |
O23.42 | Unspecified infection of urinary tract in pregnancy, second trimester |
O23.43 | Unspecified infection of urinary tract in pregnancy, third trimester |
O23.90 | Unspecified genitourinary tract infection in pregnancy, unspecified trimester |
O23.91 | Unspecified genitourinary tract infection in pregnancy, first trimester |
O23.92 | Unspecified genitourinary tract infection in pregnancy, second trimester |
O23.93 | Unspecified genitourinary tract infection in pregnancy, third trimester |
P39.3 | Neonatal urinary tract infection |
T83 | Complications of genitourinary prosthetic devices, implants and grafts |
T83.5 | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
T83.51 | Infection and inflammatory reaction due to urinary catheter |
T83.59 | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
T83.6 | Infection and inflammatory reaction due to prosthetic device, implant and graft in genital tract |
E. coli urinary tract infection | |
B96.2 | Escherichia coli [e. coli ] as the cause of diseases classified elsewhere |
B96.20 | Unspecified escherichia coli [e. coli] as the cause of diseases classified elsewhere |
B96.29 | Other escherichia coli [e. coli] as the cause of diseases classified elsewhere |
N30.0 | Acute cystitis |
N30.00 | Acute cystitis without hematuria |
N30.01 | Acute cystitis with hematuria |
N30.9 | Cystitis, unspecified |
N30.90 | Cystitis, unspecified without hematuria |
N30.91 | Cystitis, unspecified with hematuria |
N39.0 | Urinary tract infection, site not specified |
O23.0 | Infections of kidney in pregnancy |
O23.00 | Infections of kidney in pregnancy, unspecified trimester |
O23.01 | Infections of kidney in pregnancy, first trimester |
O23.02 | Infections of kidney in pregnancy, second trimester |
O23.03 | Infections of kidney in pregnancy, third trimester |
O23.1 | Infections of bladder in pregnancy |
O23.10 | Infections of bladder in pregnancy, unspecified trimester |
O23.11 | Infections of bladder in pregnancy, first trimester |
O23.12 | Infections of bladder in pregnancy, second trimester |
O23.13 | Infections of bladder in pregnancy, third trimester |
O23.2 | Infections of urethra in pregnancy |
O23.20 | Infections of urethra in pregnancy, unspecified trimester |
O23.21 | Infections of urethra in pregnancy, first trimester |
O23.22 | Infections of urethra in pregnancy, second trimester |
O23.23 | Infections of urethra in pregnancy, third trimester |
O23.3 | Infections of other parts of urinary tract in pregnancy |
O23.30 | Infections of other parts of urinary tract in pregnancy, unspecified trimester |
O23.31 | Infections of other parts of urinary tract in pregnancy, first trimester |
O23.32 | Infections of other parts of urinary tract in pregnancy, second trimester |
O23.33 | Infections of other parts of urinary tract in pregnancy, third trimester |
O23.4 | Unspecified infection of urinary tract in pregnancy |
O23.40 | Unspecified infection of urinary tract in pregnancy, unspecified trimester |
O23.41 | Unspecified infection of urinary tract in pregnancy, first trimester |
O23.42 | Unspecified infection of urinary tract in pregnancy, second trimester |
O23.43 | Unspecified infection of urinary tract in pregnancy, third trimester |
O23.9 | Unspecified genitourinary tract infection in pregnancy |
O23.90 | Unspecified genitourinary tract infection in pregnancy, unspecified trimester |
O23.91 | Unspecified genitourinary tract infection in pregnancy, first trimester |
O23.92 | Unspecified genitourinary tract infection in pregnancy, second trimester |
O23.93 | Unspecified genitourinary tract infection in pregnancy, third trimester |
Enterococcus urinary tract infection | |
B95.2 | Enterococcus as the cause of diseases classified elsewhere |
N30.0 | Acute cystitis |
N30.00 | Acute cystitis without hematuria |
N30.01 | Acute cystitis with hematuria |
N30.9 | Cystitis, unspecified |
N30.90 | Cystitis, unspecified without hematuria |
N30.91 | Cystitis, unspecified with hematuria |
N39.0 | Urinary tract infection, site not specified |
O23.0 | Infections of kidney in pregnancy |
O23.00 | Infections of kidney in pregnancy, unspecified trimester |
O23.01 | Infections of kidney in pregnancy, first trimester |
O23.02 | Infections of kidney in pregnancy, second trimester |
O23.03 | Infections of kidney in pregnancy, third trimester |
O23.1 | Infections of bladder in pregnancy |
O23.10 | Infections of bladder in pregnancy, unspecified trimester |
O23.11 | Infections of bladder in pregnancy, first trimester |
O23.12 | Infections of bladder in pregnancy, second trimester |
O23.13 | Infections of bladder in pregnancy, third trimester |
O23.2 | Infections of urethra in pregnancy |
O23.20 | Infections of urethra in pregnancy, unspecified trimester |
O23.21 | Infections of urethra in pregnancy, first trimester |
O23.22 | Infections of urethra in pregnancy, second trimester |
O23.23 | Infections of urethra in pregnancy, third trimester |
O23.3 | Infections of other parts of urinary tract in pregnancy |
O23.30 | Infections of other parts of urinary tract in pregnancy, unspecified trimester |
O23.31 | Infections of other parts of urinary tract in pregnancy, first trimester |
O23.32 | Infections of other parts of urinary tract in pregnancy, second trimester |
O23.33 | Infections of other parts of urinary tract in pregnancy, third trimester |
O23.4 | Unspecified infection of urinary tract in pregnancy |
O23.40 | Unspecified infection of urinary tract in pregnancy, unspecified trimester |
O23.41 | Unspecified infection of urinary tract in pregnancy, first trimester |
O23.42 | Unspecified infection of urinary tract in pregnancy, second trimester |
O23.43 | Unspecified infection of urinary tract in pregnancy, third trimester |
O23.9 | Unspecified genitourinary tract infection in pregnancy |
O23.90 | Unspecified genitourinary tract infection in pregnancy, unspecified trimester |
O23.91 | Unspecified genitourinary tract infection in pregnancy, first trimester |
O23.92 | Unspecified genitourinary tract infection in pregnancy, second trimester |
O23.93 | Unspecified genitourinary tract infection in pregnancy, third trimester |
Formulary Reference Tool