Monuril Special Precautions

Do not use >1 single dose of Monuril to treat a single episode of acute cystitis. Repeated daily doses of Monuril did not improve the clinical success or microbiological eradication rates compared to single-dose therapy, but did increase the incidence of adverse events. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy.
Use in pregnancy & lactation: Clinical experience in human pregnancy with fosfomycin trometamol is limited; however, fosfomycin, in 3 different forms, has been in wide use in other countries for many years without apparent ill consequences. Animal studies with fosfomycin trometamol (the form used in Monuril) have shown no hazard to the fetus. Previous animal studies with the calcium and sodium salt of fosfomycin in rats showed signs of fetal toxicity at the highest doses tested (approximately 25 times the therapeutic dose), but studies at lower doses and in rabbits showed no hazard. Although animal studies with fosfomycin trometamol have shown no hazard, it should only be used in pregnancy when the expected benefit outweighs the risk.
Fosfomycin has been shown to cross into breast milk. Therefore, Monuril should not be given to lactating women except when absolutely necessary.
Use in children: Safety and effectiveness in children ≤12 years have not been established in adequate and well-controlled studies.