Монурал®

General characteristics. Structure:

Active ingredient: 3,754 g or 5,631 g of a fosfomitsin of a trometamol (2,0 g or 3,0 g of a fosfomitsin are equivalent).

Excipients: fragrance tangerine, fragrance orange, saccharin, sucrose.

Pharmacological properties:

Pharmacodynamics. Active agent of Monural - a fosfomitsin трометамол - an antibiotic of a wide range, derivative phosphonew acid. Monural possesses bactericidal action. The mechanism of action is connected with suppression of the first stage of synthesis of a cell wall of bacteria. Being a structural analog of phosphoenol of pyruvate, also the possibility of a synergism with other antibiotics enters competitive interaction with N-ацетил-глюкозамино-3-о-энолпирувил-трансферазой enzyme therefore there is specific, selective and irreversible inhibition of this enzyme that provides lack of cross resistance with other classes of antibiotics (in vitro note a synergism with amoxicillin, cefalexin, pipemidinovy acid).

The antibacterial range of action of a fosfomitsin of a trometamol of in vitro includes the majority usual gram-positive (Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyt., Staphylococcus spp.) and gram-negative (Е. coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp.) activators. In vitro of a fosfomitsin трометамол reduces adhesion of a number of bacteria on an epithelium of urinary tract.

Pharmacokinetics. Absorption: Monural is quickly soaked up from digestive tract at oral administration.

In an organism dissociates on фосфомицин and трометамол. The last has no antibacterial properties. Bioavailability at a single dose in a dose of 3 g makes from 34 to 65%. The maximum concentration in plasma is observed in 2-2,5 hours after oral administration and makes 22-32 mg/l. Plasma elimination half-life is equal to 4 hours.

Distribution: Monural does not contact proteins of plasma, is not metabolized, preferential collects in urine. At oral administration of a single dose of 3 g in urine high concentration (from 1053 to 4415 mg/l), for 99% bactericidal for the majority of ordinary causative agents of infections of urinary tract is reached. The minimum inhibiting Monural's concentration for these activators makes 128 mg/l. She is supported in urine for 24-48 hours that assumes a one-dose course of treatment. Monural's concentration in urine above the minimum overwhelming concentration for E. coli remains at least within 80 hours.

Removal: Monural is brought by kidneys in an invariable view with creation of high concentration in urine to 90%. About 10% of the accepted dose are removed through intestines in an invariable look. At patients with moderate decrease in renal function (the clearance of creatinine <80 is lovely / mines), including its physiological decrease at elderly people, the elimination half-life of a fosfomitsin is a little extended, but concentration in urine remains at the therapeutic level.

Indications to use:

• acute bacterial cystitis, bad attacks of recurrent bacterial cystitis;
• bacterial nonspecific urethritis;
• an asymptomatic massive bacteriuria at pregnant women;
• postoperative infections of uric ways;
• prevention of an infection of urinary tract at surgical intervention and transurethral diagnostic testings.

Route of administration and doses:

Inside. Granules dissolve in 1/3 glasses of water. Monural apply once a day inside on an empty stomach in 2 hours prior to or after food, preferably before going to bed, previously having emptied a bladder. The adult appoint on 1 package (3 g) once a day.

For the purpose of prevention of infection of urinary tract at surgical intervention, transurethral diagnostic procedures accept Monural twice in the doses stated above: in 3 hours prior to intervention and in 24 hours after intervention.

To children from 5 to 18 years appoint in a daily dose 2 g once a day.

The course of treatment makes 1 day. In more hard cases (the elderly patients recuring infections) accept 1 more package in 24 hours.

At a renal failure reduce a dose and extend intervals between introductions.

Features of use:

Use at pregnancy and a lactation. At pregnancy drug is appointed only when the potential advantage for mother exceeds potential risk for a fruit. In need of purpose of drug in the period of a lactation it is necessary to stop breastfeeding for the period of treatment.

Write a concomitant use slows down Monural's absorption - it is necessary to use drug in 2 hours prior to or after food.

Sick diabetes mellitus it is necessary to consider that 1 package of Monural of a dosage of 2 g or 3 g of a fosfomitsin contains 2,100 g or 2,213 g of sucrose, respectively.

Side effects:

Frustration from digestive tract (nausea, heartburn, diarrhea) are possible, skin rash, allergic reactions.

Interaction with other medicines:

It is necessary to avoid a concomitant use with Metoclopramidum as it can lead to decrease in concentration of Monural in blood serum and in urine.

Contraindications:

Individual hypersensitivity to a fosfomitsin to a trometamol, a heavy renal failure (clearance of creatinine <10 ml/min.), children's age up to 5 years.

Overdose:

Overdose symptoms: diarrhea. When developing persistent diarrhea the symptomatic treatment is recommended.

The risk of overdose is minimum as Monural is issued in packaging on 1 or 2 packages. In case of overdose liquid reception inside for the purpose of increase in a diuresis is recommended.

Storage conditions:

List B. To store at a temperature not above 30 °C. To store in the places unavailable to children. A period of validity - 3 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Granules for preparation of solution for intake of 2 g and 3 g. On 6 g or 8 g of drug place in packages from the 4-layer laminated foil (paper-polyethylene-aluminum-polyethylene). 1 or 2 packages place in a cardboard pack together with the application instruction.