Ecofomural granules for the preparation of a solution for oral administration of 3 g
Condition: New product
999 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Fosfomycin
Release form
Granules
Composition
Package 1 contains: fosfomycin trometamol 5.629 g, which corresponds to the content of fosfomycin 3 g. Excipients: lactulose - 1.5 g, sodium saccharinate - 0.016 g, strawberry flavoring - 0.07 g, maltitol - up to a weight of 8 g.
Pharmacological effect
Ecofomural (active substance: fosfomycin) is a broad-spectrum antibiotic derived from phosphonic acid. Fosfomycin being a structural analogue fosfoenola pyruvate to inactivate the enzyme N-acetyl-glucosamine-3-o-enolpiruvil transferase irreversibly blocks the condensation of uridine diphosphate-N-acetyl-glucosamine with fosfoenola pyruvate inhibits the synthesis of UDP-N-acetylmuramic acid, whereby the initial stage of formation of the peptidoglycan of the bacterial cell wall is suppressed and, as a result, the microbial cell is killed (bactericidal action). Inactivation of the enzyme N-acetyl-glucosamino-3-o-enolpyruvil-transferase reduces the likelihood of cross-resistance to antibiotics with a similar mechanism of action and creates conditions for synergism (in vitro experiments revealed a synergistic effect with amoxicillin, cephalexin, pimemidic acid). In vitro, phosphomitsin-sensitive gram-positive (Staphylococcus saprophyticus, Enterococcus faecalis) and gram-negative (Escherichia coli, Klebsiella pneumonia, Citrobacter spp., Enterobacter spp., Proteus mirabilis) microorganisms. In vitro fosfomycin reduces the adhesion of a number of bacteria on the epithelium of the urinary tract.
Pharmacokinetics
Absorption: Fosfomycin is rapidly absorbed from the gastrointestinal tract by oral administration. In the body it dissociates into fosfomycin and trometamol. The latter does not possess antibacterial properties. The bioavailability of a single oral dose of 3.0 g ranges from 34% to 65%. Cmax in plasma is observed after 2-2.5 h (Tmax) after oral administration and is 22-32 mg / l. Distribution and metabolism: Phosphomycin does not bind to plasma proteins, is not metabolized in the body, accumulates in the urine. Oral administration of a single dose of 3.0 g in the urine results in a high concentration of the antibiotic (from 1053 to 4415 mg / l), 99% bactericidal for most common pathogens of urinary tract infections. The minimum inhibitory concentration of fosfomycin for these pathogens is 128 mg / l and is maintained in the urine for 24-48 hours, which suggests a one-day course of treatment with a single injection of the drug. Withdrawal: T1 / 2 from plasma is 4 hours.90% of fosfomycin is excreted by the kidneys unchanged, creating high concentrations in the urine. About 10% of the accepted dose of the drug is excreted through the intestine unchanged. Pharmacokinetics in special clinical situations: In patients with moderately reduced kidney function (CC less than 80 ml / min), including age-related physiological decreases in kidney function (the elderly), T1 / 2 phosphomycin is prolonged, but the concentration in the urine remains at a therapeutic level.
Indications
Bacterial infections of the urinary tract of various localization caused by microorganisms sensitive to fosfomycin: Acute uncomplicated urinary tract infections. Asymptomatic bacteriuria. Prevention of urinary tract infections after surgical intervention and transurethral diagnostic studies.
Contraindications
Hypersensitivity to fosfomycin or other components of the drug. Severe renal failure (kk less than 10 ml / min). Children's age up to 5 years. Surase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Precautionary measures
On the part of the digestive system: nausea, heartburn, diarrhea, vomiting, dyspepsia, pseudomembranous colitis, abdominal pain, increased activity of hepatic transaminases. Since the cardiovascular system: tachycardia, lower blood pressure. On the part of the nervous system: headache, dizziness, asthenia, paresthesia (feeling of numbness of the skin, crawling), optic neuritis.
Use during pregnancy and lactation
In pregnancy, the drug is used only if the intended benefit to the mother outweighs the potential risk to the fetus. When prescribing the drug during lactation, you must stop breastfeeding for the duration of therapy.
Dosage and administration
Apply once, on an empty stomach, 2-3 hours before or after a meal, preferably before bedtime, after emptying the bladder. Package contents are dissolved in 1/4 cup of water. Adults and children over 12 years old are prescribed a daily dose of 3.0 g, children aged 5 to 12 years old - at a daily dose of 2.0 g. The treatment course is 1 day. For the prevention of urinary tract infections during surgery, diagnostic procedures, the above dose is taken 2 times - 3 hours before the intervention and 24 hours after it.
Side effects
On the part of the digestive system, nausea, heartburn, diarrhea, vomiting, dyspepsia, pseudomembranous colitis, abdominal pain, increased activity of hepatic transaminases. From the side of the cardiovascular system, tachycardia, decreased blood pressure. From the nervous system headache, dizziness, asthenia, paresthesia ( skin numbness, crawling), optic neuritis. Allergic reactions, skin rash, allergic reactions, pruritus, asthma, angioedema, urticaria, anaphylactic shock. Other vulvovaginitis , thrombocytosis, leukopenia.
Overdose
Symptoms: diarrhea, vestibular syndrome, hearing loss, metallic taste and general taste disorders. Treatment: for persistent diarrhea, symptomatic treatment is prescribed. In case of overdose, it is recommended to increase diuresis by ingestion of liquid.
Interaction with other drugs
Concurrent use with metoclopramide, antacids or drugs containing calcium salts should be avoided, since This may lead to a decrease in serum and urine phosphomycin concentrations. Simultaneous use with other drugs that enhance the motility of the gastrointestinal tract, can also lead to a decrease in the concentration of fosfomycin in serum and urine.
special instructions
Taking Ekofomural with food during a meal slows down its absorption, and therefore, it is recommended to take the drug 2-3 hours before or after a meal. During or after treatment with fosfomycin, diarrhea may occur, in this case the diagnosis of pseudomembranous colitis should be excluded, which requires appropriate treatment. The use of drugs that suppress intestinal peristalsis is contraindicated. Patients with diabetes should be aware that maltitol is a part of the drug. Insulin is necessary for the metabolism of maltitol, but because of its slow and poor absorption from the gastrointestinal tract, maltitol does not significantly affect the concentration of glucose in plasma, so dose adjustment of hypoglycemic drugs is not required. Due to the content of maltitol, Ecofomural is not recommended for patients with hereditary fructose intolerance. Impact on the ability to drive motor vehicles and control mechanisms Patients should be warned about the possibility of dizziness.If dizziness occurs, you should refrain from performing these types of activities.