Fosmural granules for oral suspension 3g. sachet №1

Description

Fosmural granules Composition
active ingredients: fosfomycin;

1 sachet contains 5.631 g of fosfomycin trometamol equivalent to fosfomycin 3 g

excipients: sucrose, sodium saccharin, tangerine flavor * orange flavor **.

* Tangerine flavoring additive: maltodextrin, flavorings, ascorbic acid, butylhydroxytoluene (E 321).

** Orange flavor additive: maltodextrin, flavorings, guar gum.

Fosmural granules Dosage form
Granules for oral solution.

Basic physical and chemical properties: white or almost white granules without lumps and impurities.

Fosmural granules Pharmacological group
Antimicrobial agents for systemic use. ATX code J01X X01.

Pharmacological properties

Pharmacodynamics.

The drug has a broad spectrum of antibacterial action. It is effective against strains of causative agents of urinary tract infections, most often isolated: E. coli, Klebsiella spp., Enterobacter spp., Pseudomonas spp., Staphylococcus spp., Even if they are resistant to other antibacterial drugs. The drug also acts on penicillinase-forming strains. Fosmural has an anti-adhesive effect on bacteria that adhere to the epithelium that lines the urinary tract.

Pharmacokinetics.

The drug is easily absorbed from the gastrointestinal tract, the maximum plasma concentration is reached after 2:00 and is 30-35 μg / ml, the half-life is 2:00. Fosmural is not metabolized in the body, it is excreted by glomerular filtration in a biologically active form. It accumulates mainly in the kidneys at a concentration of 2500-3500 μg / ml, and its minimum inhibitory concentration for E. coli is 128 μg / ml. Enterohepatic circulation of the drug makes it possible to maintain the therapeutic level of the drug for 48 hours, this time is enough for urine sterilization and recovery.

Indications
Treatment of acute uncomplicated urinary tract infections caused by microorganisms sensitive to fosfomycin.
Prevention during diagnostic procedures and surgical interventions.
Contraindications
Hypersensitivity to drug components, severe renal failure (creatinine clearance

Interaction with other medicinal products and other types of interactions
Simultaneous reception with metoclopramide reduces the absorption of Fosmural, which leads

to a decrease in the concentration of the drug in serum and urine.

Application features
Simultaneous food intake slows down the absorption of fosfomycin.

Patients with diabetes mellitus and those who need to follow a diet should take into account that

1 packet of Fosmural contains 2.213 g of sucrose.

A transient increase in the activity of hepatic transaminases is possible.

Application during pregnancy or lactation.

Application during pregnancy and lactation is possible only for health reasons or if the expected effect of therapy for the mother outweighs the potential risk to the fetus / child. There have been no adequate and well-controlled studies on use during pregnancy. Therefore, the ability of fosfomycin to cross the placenta should be taken into account.

For the period of treatment, breastfeeding should be stopped.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

There is no data to support the effect on the reaction rate.