Monural (Fosphomycin) 3 g

Zambon S.p.A., Italy

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$24 - $32
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Product Overview

Structure

Active substance:

 fosfomycin trometamol;

Excipients:

tangerine flavoring;

orange flavoring;

saccharin;

sucrose

pharmachologic effect

Monural - broad-spectrum antibacterial, bactericidal.

Suppresses the first stage of the synthesis of the bacterial cell wall. It also has a specific effect - it inhibits enolpiruvyl transferase, 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 in vitro antibacterial spectrum of action of fosfomycin trometamol includes most common gram-positive (Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus spp.) And gram-negative (Escherichia coli, Citrobacter spple. ,Pppp. Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp.) Pathogens. In vitro fosfomycin trometamol reduces the adhesion of a number of bacteria on the epithelium of the urinary tract.

Pharmacokinetics

Quickly absorbed from the digestive 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%. C max  in plasma is achieved 2–2.5 hours after oral administration and is 22–32 μg / ml. T 1/2  - 4 hours

Fosfomycin does not bind to plasma proteins, is not metabolized, mainly accumulates in the urine. With oral administration of a single dose of 3 g in urine, a high concentration is achieved (from 1053 to 4415 mg / l), which is 99% bactericidal for most common 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 suggests a single-dose course of treatment. It is excreted by the kidneys unchanged. About 18–28% of the dose taken is excreted unchanged in feces.

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.

Contraindications

Individual hypersensitivity to fosfomycin trometamol, severe renal failure (Cl creatinine

Side effects

Disorders from the gastrointestinal tract (nausea, heartburn, diarrhea), skin rash are possible.

Interaction

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

How to take, course of administration and dosage

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

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

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

In renal failure, the dose is reduced and the intervals between administrations are extended.

Overdose

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

Special instructions

Simultaneous eating 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 be aware that in 1 package of Monural 2 g contains 2.1 g of sucrose, and in the package of Monural 3 g - 2.213 g of sucrose.

Release form

Granules for oral solution

Storage conditions

The drug should be stored out of the reach of children.

Shelf life

3 years

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