Monural powder for solution pack 3g N2
Condition: New product
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Active ingredients
Fosfomycin
Release form
Powder
Composition
Package 1 contains: fosfomycin trometamol 5.631 g, incl. Fosfomycin 3 g Auxiliary substances: tangerine flavoring, orange flavoring, saccharin, sucrose.
Pharmacological effect
A broad-spectrum antibiotic, a derivative of phosphonic acid, has a bactericidal effect, the mechanism of which is associated with the suppression of the first stage of the synthesis of the bacterial cell wall. It is a structural analogue of phosphoenol pyruvate, enters into a competitive interaction with the enzyme N-acetyl-glucosamino-3-o-enolpyruvil transferase. As a result, specific, selective and irreversible inhibition of this enzyme occurs, which ensures the absence of cross-resistance with other classes of antibiotics and the possibility of synergism with other antibiotics (synergism with amoxicillin, cephalexin, pimemidic acid is noted in vitro). Active in vitro against most gram-positive microorganisms: Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus spp .; Gram-negative microorganisms: Essherichia coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp. In vitro fosfomycin reduces the adhesion of a number of bacteria on the epithelium of the urinary tract.
Pharmacokinetics
Absorption: After ingestion is rapidly absorbed from the gastrointestinal tract. Bioavailability with a single dose of 3 g is 34-65%. Cmax is reached in 2-2.5 hours and is 22-32 mcg / ml. Distribution and metabolism: Phosphomycin trometamol does not bind to plasma proteins, dissociates in the body into fosfomycin and trometamol (does not have antibacterial properties) and is no longer metabolized, it mainly accumulates in the urine. When taken in a single dose of 3 g in the urine is reached a high concentration (from 1053 to 4415 mg / l), 99% bactericidal for most common pathogens of urinary tract infections. BMD (128 mg / l) is maintained in the urine for 24-48 hours (which suggests a single-dose course of treatment). Excretion: T1 / 2 from plasma - 4 hours. Excreted unchanged by the kidneys (up to 95%) with the creation of high concentrations in the urine; about 5% - with bile. Pharmacokinetics in special clinical situations In patients with moderately reduced renal function (CC> 80 ml / min), including its physiological decline in the elderly, T1 / 2 fosfomycin is slightly lengthened, but the concentration in the urine remains at a therapeutic level.
Indications
Acute bacterial cystitis. Acute attacks of recurrent bacterial cystitis. Bacterial nonspecific urethritis. Asymptomatic massive bacteriuria in pregnant women. Post-operative urinary tract infections. Prevention of urinary tract infection during surgical intervention and transurethral diagnostic studies.
Contraindications
Hypersensitivity to fosfomycin or other components of the drug. Severe renal failure (kk <10 ml / min). Children's age up to 5 years. Surase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Precautionary measures
In appointing the drug to patients with renal insufficiency, reduce the dose and increase the interval between doses.
Use during pregnancy and lactation
Use of the drug during pregnancy and lactation is possible only if the intended benefit of therapy for the mother outweighs the potential risk of teratogenic action.
Dosage and administration
Adults drug is prescribed 3 g 1 time / day. The course of treatment is 1 day. If necessary (for severe or recurrent infections, the elderly), it is possible to re-take the drug at a dose of 3 g after 24 hours. With the aim of preventing infection of the urinary tract during surgery, transurethral diagnostic procedures, the drug is taken at a dose of 3 g 3 hours before the intervention and 3 g 24 h after the first dose. In appointing the drug to patients with renal insufficiency, reduce the dose and increase the interval between doses. Before taking the granules dissolved in 1/3 cup of water. The drug is taken 1 time per day on an empty stomach 2 hours before or after meals (preferably before bedtime), after emptying the bladder.
Side effects
Co side of the digestive system nausea, heartburn, diarrhea. Other skin rash, allergic reactions.
Overdose
The risk of overdose is minimal. Treatment: forced diuresis.
Interaction with other drugs
With simultaneous use with metoclopramide, a reduction in the concentration of fosfomycin in the serum and in the urine is possible (this combination is not recommended).
special instructions
When prescribing Monural for patients with diabetes mellitus, it should be borne in mind that 1 bag containing 2 g of fosfomycin contains 2.1 g of sucrose, and 1 bag containing 3 g of fosfomycin contains 2. 213 g of sucrose.