Monural granules for preparation of oral solution 3g sachets, 2pcs

Composition

Active ingredient:

fosfomycin trometamol;

Auxiliary substances:

tangerine flavor;

orange flavor;

saccharin;

sucrose

Pharmacological action

Monural – broad-spectrum antibacterial, bactericidal.

Inhibits the first stage of bacterial cell wall synthesis. It also has a specific effect-it inhibits enolpyruvyltransferase, which ensures the absence of cross-resistance and the possibility of synergism with other antibacterial agents (in vitro, synergism with amoxicillin, cephalexin, pipemidic acid is noted).

Pharmacodynamics

The antibacterial spectrum of action of fosfomycin trometamol in vitro includes most common gram-positive (Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus spp. ) and Gram-negative (Escherichia coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp. ) pathogens. In vitro fosfomycin trometamol reduces the adhesion of a number of bacteria to the urinary tract epithelium.

Pharmacokinetics

It is rapidly absorbed from the gastrointestinal tract when taken orally. In the body, it dissociates into fosfomycin and trometamol. Trometamol does not have antibacterial properties. The bioavailability of a single oral dose of 3 g is from 34 to 65%. Cmax in plasma is reached 2-2.5 hours after oral use and is 22-32 mcg / ml. T1 / 2-4 hours

Fosfomycin does not bind to plasma proteins, is not metabolized, and mainly accumulates in the urine. When a single dose of 3 g is taken orally, a high concentration (from 1053 to 4415 mg/l) is achieved in the urine, which is 99% bactericidal for most common pathogens of urinary tract infections. The minimum inhibitory concentration of fosfomycin for these pathogens is 128 mg/l. It is maintained in the urine for 24-48 hours, which implies a single-dose course of treatment. It is excreted unchanged by the kidneys. About 18-28% of the dose taken is excreted unchanged in the feces.

Indications

• Acute bacterial cystitis, acute attacks of recurrent bacterial cystitis; bacterial nonspecific urethritis;
• asymptomatic massive bacteriuria in pregnant women;
• postoperative urinary tract infections;
• prevention of urinary tract infection during surgery and transurethral diagnostic studies.

Contraindications

Individual hypersensitivity to fosfomycin trometamol, severe renal insufficiency (creatinine clearance

Side effects

Possible disorders of the gastrointestinal tract (nausea, heartburn, diarrhea), skin rash.

Interaction

Concomitant use with metoclopramide should be avoided, as this may lead to a decrease in the concentration of Monural in serum and urine.

How to take, course of use and dosage

Inside, on an empty stomach,2 hours before or after meals, preferably before bedtime, after emptying the bladder, pre-dissolved in 1/3 cup of water,1 packet (3 g); children over 5 years-2 g only 1 time. The course of treatment is 1 day.

In more severe cases (elderly, recurrent infections), take another 1 packet after 24 hours.

In order to prevent urinary tract infection during surgical intervention, transurethral diagnostic procedures — 1 package 3 hours before the intervention and 1 package 24 hours after the first dose.

In case of renal failure, the dose is reduced and the intervals between injections are extended.

Overdose

Treatment:  it is recommended to increase the diuresis by oral fluid intake.

Special instructions

Simultaneous food intake slows down the absorption of Monural, so it is necessary to use the drug 2 hours before or after a meal.

Patients with diabetes should take into account that in 1 package of Monural 2 g contains 2.1 g of sucrose, and in a package of Monural 3 g-2.213 g of sucrose.

Form of production

Granules for the preparation of an oral solution

Shelf life

3 years

Active ingredient

Fosfomycin

Conditions of release from pharmacies

By prescription

Dosage form

solution for oral use

Description

For pregnant women as prescribed by a doctor, For adults as prescribed by a doctor, For Nursing mothers as prescribed by a doctor

Indications

Urethritis, Urinary Tract Infections