Expiration dates: 05/2022
Structure and Composition:
Granules for oral solution. 1 pack contains fosfomycin trometamol 3.754 or 5.631 g (Equivalent to 2 g of fosfomycin, or 3)
Excipients: flavor mandarin orange flavor saccharin, sucrose,
bags made of paper laminated with polyethylene, 2 or 3 g packet or carton 1 packet.
Description pharmaceutical form:
Granules of white color with a characteristic odor.
Characteristic:
Active ingredient monural - fosfomycin trometamol - broad-spectrum antibiotic, a phosphonic acid derivative.
Pharmachologic effect:
Suppress the first stage of bacterial cell wall synthesis. It has also specific action - inhibits enolpiruvil-trasferazu that ensures the absence of cross-resistance and the possibility of synergism with other anti-infective agents (in vitro synergism noted with amoxicillin, cephalexin, pipemidinovoy acid).
Pharmacokinetics:
Rapidly absorbed from the gastrointestinal tract if swallowed. In the body and dissociates into fosfomycin trometamol. Trometamol possesses no antibacterial properties. The bioavailability of a single oral dose of 3 g is from 34 to 65%. Cmax in plasma attained 2-2.5 hours after oral administration and is 22-32 mg / ml. T1 / 2 - 4 hours.
Fosfomycin is not bound to plasma proteins, not metabolized, predominantly accumulates in the urine. When administered orally, a single dose of 3 grams of urine, a high concentration (from 1053 to 4415 mg / L), 99% for most of bactericidal agents conventional urinary tract infections. The minimum inhibitory concentration of fosfomycin for these agents is 128 mg / l. It is supported in the urine for 24-48 hours, suggesting a single-dose treatment. Excreted by the kidneys unchanged. Approximately 18-28% of the dose is excreted in the feces unchanged.
Description of the pharmacological actions:
Antibacterial spectrum of fosfomycin trometamol in vitro action includes the most common gram-positive (Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus spp.) And gram negative (Escherichia coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp.) pathogens. In vitro fosfomycin trometamol reduces the adhesion of a number of bacteria on urinary tract epithelium.
Testimony:
Acute bacterial cystitis, acute episodes of recurrent bacterial cystitis bacterial nonspecific urethritis massive asymptomatic bacteriuria in pregnant women post-operative prophylaxis of urinary tract infection urinary tract infection during surgery and transurethral diagnostic tests.
Contraindications:
Individual hypersensitivity to fosfomycin trometamol, severe renal impairment (Cl creatinine <10 ml / min), children under 5 years.
Side effect:
There are disorders of the gastrointestinal tract (nausea, heartburn, diarrhea), skin rash.
Drug Interactions:
Avoid simultaneous reception with metoclopramide, as This may reduce monural in serum and urine.
Dosage and administration:
Inside, on an empty stomach 2 hours before or after meals, preferably at bedtime, after emptying the bladder, previously dissolved in 1/3 cup water, 1 package (3 g) for children older than 5 years - 2 g 1 time only. The course of treatment - 1 day.
In more severe cases (older age, recurrent infections) take another 1 pack within 24 hours.
In order to prevent urinary tract infection during surgery, transurethral diagnostic procedures - 1 package for 3 hours before the intervention and 1 package of 24 hours after the first dose.
In renal failure, reduce the dose, and lengthen the intervals between doses.
Overdose:
Treatment: It is recommended to increase diuresis by oral fluid.
Special instructions:
Simultaneous food intake delays absorption monural, so you need to use the drug 2 hours before or after a meal.
Patients with diabetes should be aware that monural 2 g contains 2.1 g of sucrose in 1 package, and the package monural 3 g - 2,213 g of sucrose.
