Other antibacterials

Fosfomycin Tromethamine

Approved 6 Oct 2020OralFor solution

The FDA lists this product in 7 strengths and forms.

Indications

Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis . Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected.

(See PRECAUTIONS and CLINICAL STUDIES sections.)

Contraindications

Fosfomycin Tromethamine is contraindicated in patients with known hypersensitivity to the drug.

Warnings and precautions

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Fosfomycin Tromethamine, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

Interactions

Drug Interactions Metoclopramide: When coadministered with Fosfomycin Tromethamine, metoclopramide, a drug which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects. Cimetidine: Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with Fosfomycin Tromethamine.

Indications

(See PRECAUTIONS and CLINICAL STUDIES sections.)

Warnings and precautions

Interactions

Adverse reactions

Clinical Trials: In clinical studies, drug related adverse events which were reported in greater than 1% of the fosfomycin-treated study population are listed below: Drug-Related Adverse Events (%) in Fosfomycin and Comparator Populations Adverse Events Fosfomycin N=1233 Nitrofurantoin N=374 Trimethoprim/ sulfamethoxazole N=428 Ciprofoxacin N=455 Diarrhea 9.0 6.4 2.3

3.1 Vaginitis 5.5 5.3 4.7

6.3 Nausea 4.1 7.2 8.6

3.4 Headache 3.9 5.9 5.4

3.4 Dizziness 1.3 1.9 2.3

2.2 Asthenia 1.1 0.3 0.5

0.0 Dyspepsia 1.1 2.1 0.7

1.1 In clinical trials, the most frequently reported adverse events occurring in > 1% of the study population regardless of drug relationship were: diarrhea 10.4%, headache 10.3%, vaginitis 7.6%, nausea 5.2%, rhinitis 4.5%, back pain 3.0%, dysmenorrheal 2.6%, pharyngitis 2.5%, dizziness 2.3%, abdominal pain 2.2%, pain 2.2%, dyspepsia 1.8%, asthenia 1.7%, and rash 1.4%. The following adverse events occurred in clinical trials at a rate of less than 1%, regardless of drug relationship: abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder, fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy, menstrual disorder, migraine, myalgia, nervousness, paresthesia, pruritus, SGPT increased, skin disorder, somnolence, and vomiting.

One patient developed unilateral optic neuritis, an event considered possibly related to Fosfomycin Tromethamine therapy. Post-marketing Experience: Serious adverse events from the marketing experience with Fosfomycin Tromethamine outside of the United States have been rarely reported and include: angioedema, aplastic anemia, asthma (exacerbation), cholestatic jaundice, hepatic necrosis, and toxic megacolon. Although causality has not been established, during post marketing surveillance, the following events have occurred in patients prescribed Fosfomycin Tromethamine: anaphylaxis and hearing loss.

Laboratory Changes: Significant laboratory changes reported in U.S. clinical trials of Fosfomycin Tromethamine without regard to drug relationship include: increased eosinophil count, increased or decreased WBC count, increased bilirubin, increased SGPT, increased SGOT, increased alkaline phosphatase, decreased hematocrit, decreased hemoglobin, increased and decreased platelet count. The changes were generally transient and were not clinically significant.

Fosfomycin Tromethamine

Indications

Contraindications

Warnings and precautions

Interactions

Two medicines in one question?

Fosfomycin Tromethamine

Indications

Contraindications

Warnings and precautions

Interactions

Two medicines in one question?

Pregnancy and breastfeeding

Adverse reactions

Composition

Strengths and forms

Official product information

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