MONURAL

Active material: Fosfomycin
When ATH: J01XX01
CCF: Antibiotic group of phosphonic acid derivatives. Uro antiseptic
ICD-10 codes (testimony): N30, N34, O23, Z29.2
When CSF: 06.14
Manufacturer: ZAMBON SWITZERLAND Ltd. (Switzerland)

Pharmaceutical form, composition and packaging

Granules for oral solution white, a tangerine scent.

Excipients: tangerine flavor, orange flavor, saxarin, sucrose.

Packages multilayered laminated (1) – packs cardboard.

Granules for oral solution white, a tangerine scent.

Excipients: tangerine flavor, orange flavor, saxarin, sucrose.

Packages multilayered laminated (1) – packs cardboard.

Pharmacological action

Broad-spectrum antibiotic, phosphonic acid derivative, It has a bactericidal effect, the mechanism of which is associated with the suppression of the first stage of synthesis of bacterial cell walls. It is a structural analog of pyruvate fosfoenola, enters into a competitive interaction with the enzyme N-acetyl-glucosamine-3-o-transferase enolpiruvil. As a result, the specific, selective and irreversible inhibition of this enzyme, that ensures that no cross-resistance with other classes of antibiotics and the possibility of synergism with other antibiotics (in vitro synergism noted with amoxicillin, cephalexin, pipemidic acid).

Active in vitro against most Gram-positive microorganisms: Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus spp.; Gram mikrorganizmov: Еsherichia coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus is wonderful, Pseudomonas spp., Serratia spp. In vitro fosfomycin reduces the adhesion of a number of bacteria on urinary tract epithelium.

Pharmacokinetics

Absorption

After intake of rapidly absorbed from the gastrointestinal tract. Bioavailability after a single oral dose 3 g of 34-65%. C_max achieved through 2-2.5 h and is 22-32 ug / ml.

Distribution and metabolism

Fosfomycin trometamol is not bound to plasma proteins, in the body and dissociates into fosfomycin trometamol (It lacks antibacterial properties) or more is not metabolized, predominantly accumulates in the urine. When receiving a single dose 3 g in urine, a high concentration (from 1053 to 4415 mg / l), on 99% bactericidal for most common causative agents of urinary tract infections. IGC (is 128 mg / l) supported in the urine over 24-48 no (which involves a single-dose treatment).

Deduction

T_1/2 plasma – 4 no. Excreted unchanged by the kidneys (to 95%) with the creation of high concentrations in the urine; about 5% – the bile.

Pharmacokinetics in special clinical situations

Patients with moderate reduction in renal function (CC>80 ml / min), including the physiological decline in the elderly, T_1/2 fosfomycin slightly lengthened, but the concentration in the urine remains at therapeutic levels.

Testimony

- Acute bacterial cystitis;

- Acute attacks of recurrent bacterial cystitis;

- Bacterial nonspecific urethritis;

- Massive asymptomatic bacteriuria in pregnant women;

- Postoperative urinary tract infection;

- Prevention of urinary tract infections during surgery and transurethral diagnostic tests.

Dosage regimen

Adults the drug is prescribed for 3 g 1 time / day. Course of treatment 1 day. If necessary, (in severe or recurrent infections, the elderly) possible re-taking the drug at a dose of 3 g in 24 no.

With the aim of prevention of urinary tract infections during surgery, transurethral diagnostic procedures The drug is taken at a dose of 3 d for 3 hours before the intervention, and 3 g in 24 hours after the first dose.

Children under the age of 5 years the drug is prescribed in a dose 2 r only once.

In appointing the drug patients with renal insufficiency It should reduce the dose and increase the interval between doses.

Before receiving the pellets were dissolved in 1/3 cup water. The drug is taken 1 times / day on an empty stomach 2 hours before or after meals (preferably at bedtime), pre-empty the bladder.

Side effect

Co of the digestive system: nausea, heartburn, diarrhea.

Other: skin rash, allergic reactions.

Contraindications

- Severe degree of renal insufficiency (CC<10 ml / min);

- Children under the age of 5 years;

- Hypersensitivity to the drug.

Pregnancy and lactation

Use of the drug during pregnancy and lactation is possible only in the case, if the expected benefit of therapy for the mother outweighs the potential risk of teratogenic effects.

Cautions

In appointing Monural^® patients with diabetes should be considered, what in 1 package, contains 2 g fosfomycin, contains 2.1 g sucrose, and 1 package, contains 3 g fosfomycin, – 2. 213 g sucrose.

Overdose

The risk of overdose is minimal.

Treatment: diurez.

Drug Interactions

While the use of metoclopramide may decrease the concentration of fosfomycin in serum and urine (this combination is not recommended).

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children. Shelf life – 3 year.