Monural - instructions for use, dose, side effects, contraindications

1 pack of 6 g contains: active substance - phosphomycin trometamol 3.754 g (equivalent to 2.0 g phosphomycin); auxiliary substances: mandarin flavor 0.07 g, orange flavoring 0.06 g, saccharin 0.016 g, sucrose 2,100 g.

1 pack of 8 g contains: active substance - fosfomycin trometamol 5.61 g (equivalent to 3.0 g of phosphomycin); auxiliary substances: mandarin flavoring 0.07 g, orange flavoring 0.07 g, saccharin 0.016 g, sucrose 2.213 g.

Description:

Granules of white color with a tangerine smell.

Pharmacotherapeutic group:antibiotic

ATX: & nbsp

J.01.X.X.01 Phosphomycin

Pharmacodynamics:

Active substance Monuralan - phosphomycin trometamol - broad spectrum antibiotic, phosphonic acid derivative.

Monural® has a bactericidal effect. The mechanism of action is associated with the suppression of the first stage of bacterial cell wall synthesis. Being a structural analogue of pyruvate phosphoenol, it competes with the enzyme N-acetyl-glucosamine-3-o-enolpyruvyl transferase, resulting in a specific, selective and irreversible inhibition of this enzyme, which ensures that there is no cross-resistance to other classes of antibiotics and the possibility of synergism with other antibiotics (in vitro note synergism with amoxicillin, cephalexin, pipemidinic acid). Antibacterial spectrum of the action of fosfomycin trometamol in vitro includes most of the usual Gram-positive (Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyt., Staphylococcus spp.) and gram-negative (E. coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp.) pathogens. In vitro phosphomycin trometamol reduces the adhesion of a number of bacteria to the epithelium of the urinary tract.

Pharmacokinetics:

Suction: Monural® is rapidly absorbed from the gastrointestinal tract by oral ingestion.

In the body dissociates into phosphomycin and trometamol. The latter does not have antibacterial properties. Bioavailability with a single oral dose of 3 g is from 34 to 65%. The maximum concentration in plasma is observed after 2-2,5 hours after oral administration and is 22-32 mg / l. The half-life of the plasma is 4 hours.

Distribution: Monural® does not bind to plasma proteins, not

metabolized, mainly accumulated in the urine. With oral intake of a single dose of 3 g in urine is achieved high concentration (from 1053 to 4415 mg / l), 99% bactericidal for most common pathogens of urinary tract infections. The minimum inhibitory concentration of Monural® for these pathogens is 128 mg / l. It is maintained in the urine for 24-48 hours, which involves a one-day course of treatment. The concentration of Monural in the urine is above the minimum inhibitory concentration for E. coli remains for at least 80 hours.

Excretion: Monural® is 90% excreted by the kidneys in an unchanged form with the creation of high concentrations in the urine. About 10% of the dose taken is removed through the intestines in an unchanged form.In patients with a moderate decrease in renal function (creatinine clearance <80 mil / min), including its physiological decline in the elderly, the half-life of phosphomycin slightly lengthens, but the concentration in the urine remains at the therapeutic level.

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 failure (creatinine clearance <10 ml / min), children under 5 years.

Pregnancy and lactation:

In pregnancy the drug is prescribed only when the potential benefit to the mother exceeds the potential risk to the fetus.

If necessary, the drug during lactation should stop breastfeeding for the duration of treatment

Dosing and Administration:

Inside.

The granules are dissolved in 1/3 cup of water. Monural is applied once a day inward on an empty stomach 2 hours before or after eating, preferably before going to bed, pre-emptying the bladder.

Adults prescribe 1 package (3 g) 1 time per day.

To prevent infection of the urinary tract during surgery, transurethral diagnostic procedures take Monural twice at the doses indicated above: 3 hours before the intervention and 24 hours after the intervention.

Children from 5 years to 18 years appoint a daily dose of 2 grams 1 time per day.

The course of treatment is 1 day.

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

With renal failure reduce the dose and extend the intervals between the administrations.

Side effects:

Possible disorders of the gastrointestinal tract (nausea, heartburn, diarrhea), skin rashes, allergic reactions.

Overdose:

Symptoms of an overdose: diarrhea. If persistent diarrhea occurs, symptomatic treatment is recommended.

The risk of overdose is minimal, since Monural® is available in packs of 1 or 2 packs.In case of an overdose, it is recommended to take the liquid inside to increase diuresis.

Interaction:

Simultaneous reception with metoclopramide should be avoided, as this can lead to a decrease in the concentration of Monural® in the serum and urine.

Special instructions:

Simultaneous food intake slows the absorption of Monural® - it is necessary to apply the drug 2 hours before or after eating.

Patients with diabetes should take into account that in 1 package Monurala® with a dosage of 2 g or 3 g of phosphomycin contains 2,100 g or 2,213 g of sucrose, respectively.

Form release / dosage:

Granules for solution for oral administration 2 g and 3 g.

Packaging:For 6 g or 8 g of the drug is placed in packages of 4-layer laminated foil (paper-polyethylene-aluminum-polyethylene). 1 or 2 bags are placed in a cardboard box together with an instruction for use.

Storage conditions:

List B. Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012976 / 01

Date of registration:11.07.2007

The owner of the registration certificate:Zambon Switzerland Co., Ltd.Zambon Switzerland Co., Ltd. Switzerland

Manufacturer: & nbsp

ZAMBON SWITZERLAND, Ltd. Switzerland

Representation: & nbspZAMBON SpA ZAMBON SpA Italy

Information update date: & nbsp29.10.2015

Illustrated instructions

Instructions

Monural® (Monural®)