Fosfomycin Trometamol is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women caused by susceptible strains of Escherichia coli and Enterococcus faecalis.

Fosfomycin has in vitro activity against a broad range of gram-positive and gram-negative aerobic microorganisms associated with uncomplicated urinary tract infections. Fosfomycin Trometamol is a phosphonic acid derivative. It is a synthetic, broad-spectrum, bactericidal antibiotic intended for oral administration. Its bactericidal effect is due to inactivation of the enzyme enolpyruvyl transferase, which irreversibly blocks the condensation of uridine diphosphate N-acetylglucosamine with p-enolpyruvate, an early step in bacterial cell wall synthesis.

The recommended dosage for women 18 years of age and older for acute cystitis is one sachet of Fosfomycin with or without food. This medicine should not used in children.

Preparation: At first pour the 100 ml purified water in a glass. Then add full contents of one Fosfomycin sachet into purified water and stir to dissolve completely. Drink full mixture immediately after preparation.

When Fosfomycin is co-administered with metoclopramide, which increases gastrointestinal motility, the serum concentration and urinary excretion of fosfomycin may be reduced. Other medicines that increase gastrointestinal motility may produce similar effects.

Fosfomycin is contraindicated in patients with known hypersensitivity to the drug, in patients with severe renal insufficiency, and in patients undergoing haemodialysis.

In clinical trials, the most frequently reported adverse events occurring in more than 1% of the study population, regardless of relationship to the drug, were: diarrhea (10.4%), headache (10.3%), vaginitis (7.6%), nausea (5.2%), rhinitis (4.5%), back pain (3.0%), dysmenorrhea (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 relationship to the drug: abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder, fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy, menstrual disorder, migraine, myalgia, nervousness, paresthesia, pruritus, increased SGPT, skin disorder, somnolence, and vomiting.

Fosfomycin is classified as pregnancy category B. This drug should not be used during pregnancy unless the potential benefit outweighs the possible risk. A decision should be made either to discontinue breastfeeding or to avoid administering the drug, taking into account the importance of the medicine to the mother.

Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including Fosfomycin. Treatment with antibacterial agents may alter the normal flora of the colon, leading to overgrowth of C. difficile.
More than one single dose of Fosfomycin should not be used to treat a single episode of acute cystitis. Repeated daily doses of Fosfomycin did not improve clinical success or microbiological eradication rates compared with single-dose therapy, but they did increase the incidence of adverse events.

When Fosfomycin is co-administered with metoclopramide, which increases gastrointestinal motility, the serum concentration and urinary excretion of fosfomycin may be reduced. Other medicines that increase gastrointestinal motility may produce similar effects.

Intracellular antibiotic

Keep out of the reach of children. Store in a dry place below 25°C and protect from light.