Monurol sachet contains 3 grams of Fosfomycin (as fosfomycin trometamol). Monurol pediatric sachet contains 2 gram of fosfomycin (as fosfomycin trometamol). Each sachet contains granules which when dissolved in water make an orange flavored suspension for oral administration. Monurol and Monurol Paediatric also contain saccharin, sucrose, mandarin flavor, and orange flavor.
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| Monurol Sachets 3g |
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. Monurol may also be used for prophylaxis in diagnostic and surgical transurethral procedures.Mode of Action:
The antibiotic activity of Monurol is due to an inhibition of bacterial cell wall synthesis. Its particular mechanism of action, the specific inhibition of enol pyruvyl transferase, results in a lack of cross-resistance with other classes of antibiotics and the possibility of synergism with other antibiotics.Microbiology:
It has a broad spectrum of antibacterial activity against Gram-positive and Gram-negative organisms, including beta-lactamase producing strains and the pathogens most frequently isolated in urinary tract infections (E. coli, Proteus, Klebsiella, Enterobacter, Staphylococcus).Pharmacokinetics:
It is rapidly absorbed from the gastrointestinal track giving peak plasma concentrations after 2 hours. Monurol is eliminated mainly unchanged through the kidneys and this result is very high concentrations in the urine of approximately 3000 mg/ liter within 2-4 hours. Therapeutic concentrations are maintained for periods of 36 or more hours from a single dose.Dosage and Administration
Monurol and Monurol Paediatric should be taken on an empty stomach 1 hour before or 2 hours after meals. Ideally, Monurol or Monurol pediatric should be taken before bedtime after emptying the bladder. The contents of the 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 tract infections a single 3-gram dose of Monurol should be administered.Prophylaxis of Transurethral surgical Procedures:
In prophylaxis associated with transurethral surgical and diagnostic procedures, two 3 gram doses of Monurol should be given. The first dose should be taken three hours before and the second 24 hors after surgery.
Children (over 5 years of age):
Urinary tract infections:
In uncomplicated lower urinary tract infections, Monurol pediatric should be administered as a single 2-gram dose. Monurol Paediatric is not recommended for children under 5 years of age.Elderly patients over 75 years:
Renal impairment may result in sub-therapeutic concentration and this sachet is not recommended in these patients.Contra-Indications and Warnings
Contraindications:
Hypersensitivity to another drug. Severe renal insufficiency (creatinine clearance less than 10 ml/min) and patients undergoing hemodialysis. Fosfomycin sachets are contraindicated for children under 5 years.Precautions
Food delays and reduces the absorption of fosfomycin trometamol resulting in reduced blood and urine concentrations; however it is unlikely that efficacy in track infection would be seriously affected. In patients with moderately reduced renal function, including the physiological reduction in the elderly, the half-life of fosfomycin trometamol is slightly prolonged but urinary concentrations remain therapeutically adequate.In severe renal insufficiency and patients undergoing haemodialysis, therapeutic concentrations in the urine would not be achieved.
