Monural granules for preparation of oral solution 3g, No. 2

Infectious and inflammatory diseases caused by microorganisms sensitive to fosfomycin:

• acute bacterial cystitis, acute attacks of recurrent bacterial cystitis;

• bacterial nonspecific urethritis;

• asymptomatic massive bacteriuria in pregnant women;

• postoperative urinary tract infections;

Prevention of infections during surgery on the urinary tract and during transurethral diagnostic studies.

Inside.
Dissolve the granules in 1/2 glass of water (50-75 ml) or another drink, stir until complete dissolution, take immediately after dissolution. MonuralЃ is used once a day by mouth on an empty stomach 1 hour before or 2-3 hours after a meal, preferably at bedtime, having previously emptied the bladder.

Adults and children from 12 to 18 years old: 1 packet (3 g) once a day, once.
In order to prevent urinary tract infection during surgery, transurethral diagnostic procedures, MonuralЃ is taken 2 times, 3 g each: 3 hours before the intervention and 24 hours after the intervention.

Children from 5 to 12 years old: 1 packet (2 g) once a day, once. In order to prevent infection of the urinary tract during surgery, transurethral diagnostic procedures, MonuralЃ is taken 2 times, 2 g each: 3 hours before the intervention and 24 hours after the intervention.
In more severe cases (elderly patients, recurrent infections), take another 1 packet after 24 hours.

No dose adjustment is required in patients with mild or moderate renal impairment. In patients with severe renal impairment or on hemodialysis, the use of the drug is contraindicated. No dose adjustment is required in patients with hepatic impairment.

1 packet of 8 g contains:
active substance - fosfomycin trometamol 5.631 g (equivalent to 3.0 g of fosfomycin);
excipients: tangerine flavor 0.07 g, orange flavor 0.07 g, saccharin 0.016 g, sucrose 2.213 g.

• Hypersensitivity to fosfomycin, other components of the drug;

• severe renal impairment (creatinine clearance <10 ml / min),

• children under 12 years of age (for a dosage of 3 g);

• children under 5 years of age (for a dosage of 2 g);

• hemodialysis,

• deficiency of sucrase / isomaltase,

• intolerance to fructose,

• glucose-galactose malabsorption.

Tradename:

MonuralЃ

International non-proprietary name.

Fosfomycin

Dosage form:

granules for preparation of oral solution.

Composition

1 package of 6 g contains:
active substance - fosfomycin trometamol 3.754 g (equivalent to 2.0 g of fosfomycin);
excipients: tangerine flavor 0.07 g, orange flavor 0.06 g, saccharin 0.016 g, sucrose 2.100 g.

1 packet of 8 g contains:
active substance - fosfomycin trometamol 5.631 g (equivalent to 3.0 g of fosfomycin);
excipients: tangerine flavor 0.07 g, orange flavor 0.07 g, saccharin 0.016 g, sucrose 2.213 g.

Description.

White granules with a tangerine scent.

Pharmacotherapeutic group

antibiotic

ATX code

J01XX01.

Pharmacological properties

Pharmacodynamics.
MonuralЃ contains fosfomycin [mono (2-ammonium-2-hydroxymethyl-1,3-propanediol) (2R-cis) - (3-methyloxyranyl) phosphonate] - a broad-spectrum antibacterial agent, a phosphonic acid derivative, intended for the treatment of urinary infections ways. The mechanism of action is associated with the suppression of the first stage of the synthesis of the bacterial cell wall. Being a structural analogue of phosphoenolpyruvate, competitively irreversibly inhibits the enzyme UDP-N-acetylglucosamienolpyruvyltransferase, which catalyzes the formation reaction of UDP-N-acetyl-3-O- (1-carboxyvinyl) -B-glucosamine from phosphoenolpyruvate and acetyl-D-N-glucose ... Also, the drug is able to reduce the adhesion of bacteria to the mucous membranes of the bladder, which can play the role of a predisposing factor for recurrent infections.The mechanism of action of the drug explains the absence of cross-resistance with other antibiotics and mutual enhancement of action with antibiotics of other classes, for example, with beta-lactam antibiotics.

Fosfomycin is active against a wide range of gram-positive and gram-negative microorganisms commonly isolated in urinary tract infections, such as Escherichia coli, Citrobacter spp., Klebsiella spp., Proteus spp., Serratia spp., Pseudomonas aeruginosa, Enterrococcus faecalis. The emergence of resistance in vitro is explained by mutations in the gIpT and uhp genes, which control the transport of L-alpha-glycerophosphates and glucose-phosphates, respectively.

Pharmacokinetics.
Absorption: When taken orally, fosfomycin is well absorbed from the intestine and reaches a bioavailability of the order of 50%. The maximum plasma concentration is observed 2-2.5 hours after oral administration and is 22-32 mg / l. The plasma half-life is 4 hours.

Taking with food slows down absorption without affecting the concentration in the urine.

Distribution: Fosfomycin is distributed in the kidneys, bladder walls, prostate and seminal glands. A constant concentration of fosfomycin in urine, exceeding the Minimum Bacteriostatic Concentration (MBC), is achieved within 24-48 hours after oral administration.

Fosfomycin does not bind to plasma proteins and crosses the placental barrier.

After a single injection, fosfomycin is excreted in breast milk in small amounts.

Excretion: Fosfomycin is excreted unchanged, mainly by the kidneys by glomerular filtration (40-50% of the dose taken is found in urine), and the half-life is about 4 hours, and to a lesser extent - with feces (18-28% of the dose). The emergence of a second peak serum concentration 6 and 10 hours after ingestion of the drug suggests that the drug is susceptible to intestinal hepatic recirculation.

The pharmacokinetic properties of fosfomycin do not depend on age and pregnancy. The drug is cumulated in patients with renal insufficiency; a linear relationship was established between the pharmacokinetic parameters of fosfomycin and the glomerular filtration rate.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to fosfomycin:

• acute bacterial cystitis, acute attacks of recurrent bacterial cystitis;

• bacterial nonspecific urethritis;

• asymptomatic massive bacteriuria in pregnant women;

• postoperative urinary tract infections;

Prevention of infections during surgery on the urinary tract and during transurethral diagnostic studies.

Contraindications

• Hypersensitivity to fosfomycin, other components of the drug;

• severe renal impairment (creatinine clearance <10 ml / min),

• children under 12 years of age (for a dosage of 3 g);

• children under 5 years of age (for a dosage of 2 g);

• hemodialysis,

• deficiency of sucrase / isomaltase,

• intolerance to fructose,

• glucose-galactose malabsorption.

Application during pregnancy and lactation

During pregnancy, the drug is prescribed only when the potential benefit to the mother outweighs the potential risk to the fetus.
If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued for the duration of treatment

Method of administration and dosage

Inside.
Dissolve the granules in 1/2 glass of water (50-75 ml) or another drink, stir until complete dissolution, take immediately after dissolution. MonuralЃ is used once a day by mouth on an empty stomach 1 hour before or 2-3 hours after a meal, preferably at bedtime, having previously emptied the bladder.

Adults and children from 12 to 18 years old: 1 packet (3 g) once a day, once.
In order to prevent urinary tract infection during surgery, transurethral diagnostic procedures, MonuralЃ is taken 2 times, 3 g each: 3 hours before the intervention and 24 hours after the intervention.

Children from 5 to 12 years old: 1 packet (2 g) once a day, once. In order to prevent infection of the urinary tract during surgery, transurethral diagnostic procedures, MonuralЃ is taken 2 times, 2 g each: 3 hours before the intervention and 24 hours after the intervention.
In more severe cases (elderly patients, recurrent infections), take another 1 packet after 24 hours.

No dose adjustment is required in patients with mild or moderate renal impairment. In patients with severe renal impairment or on hemodialysis, the use of the drug is contraindicated. No dose adjustment is required in patients with hepatic impairment.