Regulatory Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
Therapeutic
Prescription Only
Formulation Information
GRANULE, FOR SUSPENSION
**Dosage and administration:** Monurol should be taken on an empty stomach one hour before or 2 hours after meals. Ideally, Monurol should be taken before bedtime after emptying the bladder. The contents of sachet should be dissolved in a glass of water and taken immediately after preparation. _Adults including elderly up to 75 years:_ _Urinary tract infections:_ In uncomplicated lower urinary a single 3g dose of Monurol should be administered. _Elderly patients over 75 years:_ Renal impairment may result in sub-therapeutic concentrations and Monurol is not recommended in these patients.
ORAL
Medical Information
**Uses:** Monurol is an anti-bacterial agent. Monurol contains fosfomycin trometamol, an orally well-absorbed salt of fosfomycin, which is a broad spectrum antibiotic derived from phosphonic acid. It is indicated for the treatment of acute uncomplicated lower urinary tract infections caused by pathogens sensitive to fosfomycin.
_Contraindications:_ Hypersensitivity to the drug. Severe renal insufficiency (creatinine clearance less than 10 ml/min) and patients undergoing haemodialysis.
J01XX01
fosfomycin
Manufacturer Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
ZAMBON SWITZERLAND LTD
Active Ingredients
Documents
Package Inserts
Monurol Sachet 3g per Sachet PI.pdf
Approved: March 21, 2005