Fosfomycin Tromethamine
Generic Name: fosfomycin tromethamine
Brand Names:
Fosfomycin Tromethamine
DESCRIPTION Fosfomycin Tromethamine Granules for Oral Solution contains Fosfomycin Tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single dose sachet which contains white granules consisting of 5.631 grams of Fosfomycin Tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: orange flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water.
Overview
DESCRIPTION Fosfomycin Tromethamine Granules for Oral Solution contains Fosfomycin Tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single dose sachet which contains white granules consisting of 5.631 grams of Fosfomycin Tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: orange flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water.
Uses
INDICATIONS AND USAGE 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 Granules for Oral Solution 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.)
Dosage
DOSAGE AND ADMINISTRATION The recommended dosage for women 18 years of age and older for uncomplicated urinary tract infection (acute cystitis) is one sachet of Fosfomycin Tromethamine Granules for Oral Solution. Fosfomycin Tromethamine Granules for Oral Solution may be taken with or without food. Fosfomycin Tromethamine Granules for Oral Solution should not be taken in its dry form. Always mix Fosfomycin Tromethamine Granules for Oral Solution with water before ingesting. (See PREPARATION section.)
Side Effects
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 Ciprofloxacin 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...
Interactions
Drug Interactions Metoclopramide When coadministered with Fosfomycin Tromethamine Granules for Oral Solution, 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 Granules for Oral Solution.
Warnings
WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Fosfomycin Tromethamine Granules for Oral Solution, 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. CONTRAINDICATIONS Fosfomycin Tromethamine Granules for Oral Solution is contraindicated in patients with known hypersensitivity to the drug.
Pregnancy
Pregnancy Teratogenic Effects When administered intramuscularly as the sodium salt at a dose of 1 gram to pregnant women, fosfomycin crosses the placental barrier. Fosfomycin Tromethamine Granules for Oral Solution crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1000 mg/kg/day (approximately 9 and 1.4 times the human dose based on body weight and mg/m 2 , respectively).
Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep this and all drugs out of the reach of children.
Frequently Asked Questions
What is Fosfomycin Tromethamine used for?▼
INDICATIONS AND USAGE 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 Granules for Oral Solution 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.)
What are the side effects of Fosfomycin Tromethamine?▼
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 Ciprofloxacin 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...
Can I take Fosfomycin Tromethamine during pregnancy?▼
Pregnancy Teratogenic Effects When administered intramuscularly as the sodium salt at a dose of 1 gram to pregnant women, fosfomycin crosses the placental barrier. Fosfomycin Tromethamine Granules for Oral Solution crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1000 mg/kg/day (approximately 9 and 1.4 times the human dose based on body weight and mg/m 2 , respectively).
What are the important warnings for Fosfomycin Tromethamine?▼
WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Fosfomycin Tromethamine Granules for Oral Solution, 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. CONTRAINDICATIONS Fosfomycin Tromethamine Granules for Oral Solution is contraindicated in patients with known hypersensitivity to the drug.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.