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,...
Mechanism of Action
CLINICAL PHARMACOLOGY Absorption: Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin. Absolute oral bioavailability under fasting conditions is 37%. After a single 3-gram dose of fosfomycin tromethamine, the mean (± 1 SD) maximum serum concentration (C max ) achieved was 26.1 (± 9.1) mcg/mL within 2 hours. The oral bioavailability of fosfomycin is reduced to 30% under fed conditions. Following a single 3-gram oral dose of fosfomycin tromethamine with a high-fat meal, the mean C max achieved was 17.6 (± 4.4) mcg/mL within 4 hours. Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with fosfomycin tromethamine.
Indications
- INDICATIONS & USAGE Fosfomycin tromethamine granules for oral solution 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 granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)
Common Doses
- Refer to label
Dosage
DOSAGE & 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.) PREPARATION Fosfomycin tromethamine granules for oral solution should be taken orally.
Contraindications
- CONTRAINDICATIONS Fosfomycin tromethamine is contraindicated in patients with known hypersensitivity to the drug.
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 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.
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.