Icufos O (Fosfomycin)

• Composition :
  Each single dose sachet contains Fosfomycin trometamol3g.
• Indications :
  For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of E.Coli and Entreococcusfaecalis.
• Pharmacodynamics :
  The bactericidal action of fosfomycin is due to its inactivation of the enzyme enolpyruvyl transferase, thereby irreversibly blocking the condensation of uridine diphosphate-N-acetylglucosamine with p-enolpyruvate, one of the first steps in the bacterial cell wall synthesis. It also reduces adherence of bacteria to uroepithelial cells.
• 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 Icufos-O. Icufos-O may be taken with or without food. Icufos-O should not be taken in its dry form. Always mix Icufos-O with water before ingesting.
• Contraindications :
  Icufos-O is contraindicated in patients with known hypersensitivity to the drug or any other inactive constituents of the product and in patientswith severe renal insufficiency (CLcr<10ml/min) and those undergoing haemodialysis.
• Precautions and warnings :
  Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including Fosfomycin. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. More than one single dose of Icufos-Oshould not be used to treat a single episode of acute cystitis.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy category B: Teratogenic effects. Should be used in pregnancy only if clearly needed. It is not known whether fosfomycin is excreted into breast milk. a decision should be made whether to discontinue nursing or to not administer the drug, taking into account the importance of the drug to the mother.Safety and effectiveness in children age 12 years and under have not been established in adequate and well-controlled studies.
• Drug interactions :
  Concomitant administration of metoclopramide has been shown to lower serum and urinary concentrations and should be avoided.
• Adverse reactions :
  Common adverse effects of fosfomycin include: Headache, dizziness, nausea, diarrhoea and vaginitis.
• Therapy Area :
  Anti-Bacterials