Monurol® [Fosfomycin]

Brand Zambon

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Clinical Pharmacology

The broad-spectrum antibiotic, a derivative of phosphonic acid, has a bactericidal effect, the mechanism of which is associated with the suppression of the first stage of the synthesis of the bacterial cell wall. It is a structural analogue of phosphoenol pyruvate, enters into a competitive interaction with the enzyme N-acetyl-glucosamino-3-o-enolpyruvil transferase. As a result, specific, selective and irreversible inhibition of this enzyme occurs, which ensures the absence of cross-resistance with other classes of antibiotics and the possibility of synergism with other antibiotics (synergism with amoxicillin, cephalexin, pimemidic acid is noted in vitro).

Active in vitro against most gram-positive microorganisms: Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus spp .; Gram-negative microorganisms: Essherichia coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp. In vitro fosfomycin reduces the adhesion of a number of bacteria on the urinary tract epithelium.

Indications

- acute bacterial cystitis;

- acute attacks of recurrent bacterial cystitis;

- bacterial non-specific urethritis;

- Asymptomatic massive bacteriuria in pregnant women;

- postoperative urinary tract infections;

- prevention of urinary tract infections during surgery and transurethral diagnostic studies.

Composition

Fosfomycin trometamol 5.631 g, incl. fosfomycin 3g

Auxiliary substances: tangerine flavoring, orange flavoring, saccharin, sucrose.

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Dosage and Administration

Adults take the drug 3 g 1 time / day. The course of treatment is 1 day. If necessary (for severe or recurrent infections, the elderly), it is possible to re-take the drug in a dose of 3 g after 24 hours.

In order to prevent infection of the urinary tract during surgery, transurethral diagnostic procedures, the drug is taken at a dose of 3 g 3 hours before the intervention and 3 g 24 hours after the first dose.

Children over the age of 5 years, the drug is prescribed in a dose of 2 g only once.

In appointing the drug to patients with renal insufficiency, reduce the dose and increase the interval between doses.

Before taking the granules dissolved in 1/3 cup of water. The drug is taken 1 time per day on an empty stomach 2 hours before or after meals (preferably before bedtime), after emptying the bladder.

Adverse reactions

Co side of the digestive system: nausea, heartburn, diarrhea.

Other: skin rash, allergic reactions.

Contraindications

- severe renal failure (QC

- children's age is younger than 5 years;

- Hypersensitivity to the drug.

Drug interactions

With simultaneous use with metoclopramide, a decrease in the concentration of fosfomycin in the serum and in the urine is possible (this combination is not recommended).

Pregnancy and Lactation

Use of the drug during pregnancy and lactation is possible only if the intended benefit of therapy for the mother outweighs the potential risk of teratogenic action.

Special instructions

In appointing Monurol® to patients with diabetes mellitus, it should be borne in mind that 1 bag containing 2 g of fosfomycin contains 2.1 g of sucrose, and 1 bag containing 3 g of fosfomycin contains 2. 213 g of sucrose.