Uronormin-F - Instructions For The Use Of The Powder, Reviews, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Uronormin-F

Uronormin-F: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Uronormin-F

ATX code: J01XX01

Active ingredient: fosfomycin (Fosfomycin)

Producer: Pharmstandard-Leksredstva, JSC (Russia)

Description and photo update: 28.11.2018

Prices in pharmacies: from 218 rubles.

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Uronormin-F is an antibacterial drug used to treat infectious and inflammatory diseases of the urinary tract.

Release form and composition

Dosage form - powder for the preparation of a solution for oral administration: granular, almost white or white, has a characteristic fruity odor (in a cardboard box there are 1-3 heat-sealable sachets made of Buflen material, containing 6 or 8 g of powder, and instructions for the use of Uronormin- F).

1 sachet of powder, 2 or 3 g each contains:

• active substance: trometamol fosfomycin - 3.754 or 5.631 g (in terms of pure fosfomycin - 2 or 3 g);
• additional components: sucrose - 2.1 or 2.213 g; orange flavor - 0.06 or 0.07 g; tangerine flavor - 0.07g; sodium saccharinate - 0.016 g.

Pharmacological properties

Pharmacodynamics

Uronormina-F contains fosfomycin [mono (2-ammonium-2-hydroxymethyl-1,3-propanediol) (2R-cis) - (3-methyloxyranyl) phosphonate], which is a broad-spectrum antibacterial agent derived from phosphonic acid, intended for the treatment of urinary tract infections.

The mechanism of action of the substance is based on the suppression of the first stage of the synthesis of the bacterial cell wall. Fosfomycin is a structural analogue of phosphoenolpyruvate and inhibits the enzyme UDP-N-acetylglucosamienolpyruvyltransferase irreversibly competitively. This enzyme catalyzes the formation reaction of UDP-N-acetyl-3-O- (1-carboxyvinyl) -D-glucosamine from UDP-N-acetyl-D-glucosamine and phosphoenolpyruvate.

Also fosfomycin is able to reduce the adhesion of bacteria to the mucous membranes of the bladder, which can act as a predisposing factor for recurrent infections. Due to this mechanism, cross-resistance of Uronormin-F does not develop with other classes of antibiotics and mutual enhancement of action when combined with antibiotics of other classes, for example, with β-lactam antibiotics.

Fosfomycin is active against a wide range of gram-negative and gram-positive microorganisms commonly isolated from urinary tract infections, including Escherichia coli, Citrobacter spp., Klebsiella spp., Serratia spp., Enterococcus faecalis, Pseudomonas aeruginosa, Proteus spp.

The resistance observed in vitro is associated with mutations in the uhp and glpT genes, which control the transport of glucose phosphates and L-alpha glycerophosphates, respectively.

Pharmacokinetics

After oral administration, fosfomycin is well absorbed from the intestine, the substance reaches a bioavailability of about 50%. The maximum plasma concentration is 22–32 mg / l and is reached in 2–2.5 hours. The plasma half-life is 4 hours. When taking fosfomycin with food, absorption slows down, but its concentration in the urine does not change.

The substance is distributed in the walls of the bladder, kidneys, seminal glands and prostate. Its constant concentration in urine, exceeding MBSK (Minimum Bacteriostatic Concentration), is reached within 24-48 hours after oral administration. Fosfomycin does not bind to plasma proteins and crosses the placental barrier. After a single dose, the substance is excreted in breast milk in small amounts.

Fosfomycin is excreted mainly by the kidneys unchanged by glomerular filtration (40-50% of the dose is found in the urine), and the half-life is approximately 4 hours, the substance is excreted in the feces to a lesser extent (from 18 to 28% of the dose).

Uronormin-F is presumably subject to enterohepatic recirculation as a second peak serum concentration occurs 6 and 10 hours after ingestion.

The pharmacokinetic properties of fosfomycin do not depend on age and pregnancy.

In renal failure, the substance accumulates; a linear relationship was found between the glomerular filtration rate and the pharmacokinetic parameters of fosfomycin.

Indications for use

Uronormin-F is prescribed for the treatment of infectious and inflammatory diseases caused by microorganisms that are sensitive to the action of fosfomycin:

• bacterial nonspecific urethritis;
• acute bacterial cystitis, acute attack of recurrent bacterial cystitis;
• postoperative urinary tract infections;
• asymptomatic massive bacteriuria in pregnant women.

When performing surgical interventions on the urinary tract and transurethral diagnostic studies, Uronormin-F is prescribed for prophylactic purposes.

Contraindications

• severe renal impairment (in patients with creatinine clearance <10 ml / min);
• hemodialysis;
• fructose intolerance, sucrase / isomaltase deficiency, glucose-galactose malabsorption;
• age up to 5 and 12 years (for a dosage of 2 and 3 g, respectively);
• lactation period;
• individual intolerance to the components of the drug.

Pregnant women are prescribed Uronormin-F under medical supervision after assessing the ratio of the expected benefit with the possible risk.

Uronormin-F, instructions for use: method and dosage

Uronormin-F is taken orally after emptying the bladder, on an empty stomach (1 hour before or 2–3 hours after a meal), preferably at bedtime.

A single dose should be diluted in 50–75 ml of water or another drink, mixed until completely dissolved, and taken immediately after preparation of the solution. Frequency rate of admission - 1 time per day.

Recommended single dose:

• children 5–12 years old: 1 sachet, 2 g each;
• children 12-18 years old and adults: 1 sachet of 3 g.

For prophylactic purposes of urinary tract infection during transurethral diagnostic procedures and surgery, a single dose of Uronormina-F is taken 2 hours (children 5-12 years old) or 3 hours (children 12-18 years old and adults) and 24 hours after the intervention).

In more severe cases (recurrent infections, elderly patients), another single dose is prescribed after 24 hours.

Side effects

Among the most common adverse reactions to a single dose of Uronormin-F are disorders of the digestive system, most often diarrhea. These violations are transient and short-term.

Possible adverse reactions [> 10% - very common; (> 1% and 0.1% and 0.01% and <0.1%) - rarely; <0.01% - very rare]:

• digestive system: infrequently - nausea, diarrhea, dyspepsia; rarely - vomiting, abdominal pain; with an unknown frequency - decreased appetite, antibiotic-associated colitis;
• lymphatic system: rarely - aplastic anemia; with an unknown frequency - thrombocytosis (petechiae), eosinophilia;
• nervous system: infrequently - dizziness, headache; rarely - paresthesia;
• respiratory system: with an unknown frequency - bronchospasm, asthma, shortness of breath;
• immune system: with unknown frequency - anaphylactic reactions, including hypersensitivity, anaphylactic shock;
• vessels: with an unknown frequency - petechiae, decreased blood pressure;
• heart: very rarely - tachycardia;
• liver and biliary tract: with an unknown frequency - a short increase in the activity of alkaline phosphatase and hepatic transaminases;
• skin and subcutaneous tissues: rarely - urticaria, rash, itching; with an unknown frequency - angioedema;
• infectious and parasitic diseases: infrequently - vulvovaginitis; rarely - superinfection;
• others: rarely - fatigue.

Overdose

Information regarding oral overdose of fosfomycin is limited.

The main symptoms are: hearing impairment, vestibular function, metallic taste in the mouth and a general decrease in taste perception.

Therapy: symptomatic and supportive. In order to increase urine output, oral fluid intake is recommended.

special instructions

If hypersensitivity reactions develop, including anaphylactic shock and anaphylaxis, Uronormin-F should be discontinued and adequate treatment should be carried out.

During the period of therapy, antibiotic-associated diarrhea may develop. Its severity can vary from mild to colitis, and the possibility of death cannot be ruled out. Diarrhea, especially persistent, severe and / or bloody, observed during the period of admission or after the end of the course of treatment with fosfomycin (including for several weeks after treatment), can be a sign of pseudomembranous colitis caused by Clostridium difficile. With a presumptive / confirmed diagnosis, therapy for pseudomembranous colitis is started immediately. In this clinical situation, drugs that suppress intestinal motility are contraindicated.

The concentration of fosfomycin in urine in renal failure, if the creatinine clearance is higher than 10 ml / min, after taking the usual dose, persists for 48 hours. Uronormin-F powder is contraindicated for patients undergoing hemodialysis.

In case of diabetes mellitus, it must be borne in mind that 1 package with a dosage of 2 or 3 g contains 2.1 or 2.213 g of sucrose, respectively.

Influence on the ability to drive vehicles and complex mechanisms

Patients, when driving vehicles during therapy, should take into account the likelihood of developing dizziness.

Application during pregnancy and lactation

During pregnancy, Uronormin-F can only be used in cases where the expected benefit is higher than the possible risk. In limited studies, no adverse effects on pregnancy, fetus, or newborn health have been identified.

During lactation, if it is necessary to use Uronormina-F, breastfeeding should be interrupted.

Pediatric use

The use of Uronormin-F powder at a dosage of 2 g is contraindicated in children under 5 years of age; at a dosage of 3 g - for children under 12 years old.

With impaired renal function

Uronormin-F is not prescribed for patients with creatinine clearance <10 ml / min (with severe renal failure).

Drug interactions

Possible interactions:

• metoclopramide: the concentration of fosfomycin in urine and serum decreases;
• antacids, calcium salts, drugs that increase the motility (motor activity) of the gastrointestinal tract: can reduce the concentration of fosfomycin in urine and blood plasma.

Against the background of antibiotic therapy, many cases of increased activity of antivitamin K antagonists have been reported. In patients with risk factors such as inflammation, severe infection, poor general health or age, a change in INR (international normalized ratio) may be due to an infectious disease or develop due to treatment. Such changes are presumably more characteristic of fluoroquinolones, macrolides, cyclins, Co-trimoxazole and some cephalosporins.

Analogs

The analogues of Uronormin-F are Fosforal Rompharm, Ekofomural, Monural, Ovea, Urofosfabol, Fosmicin, etc.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Uronormin-F

Reviews about Uronormin-F are mostly positive. Patients note that it is cheaper than analogs, while not inferior to them in efficiency. The preparation is indicated to have a pleasant taste and a convenient dosage form. The development of side effects is rarely reported.

Price for Uronormin-F in pharmacies

The approximate price for Uronormin-F is: 1 sachet 6 g - 250–271 rubles; 1 sachet 8 g - 338–369 rubles.

Uronormin-F: prices in online pharmacies

Drug name Price Pharmacy

Uronormin-F 2 g powder for solution for oral administration 1 pc. RUB 218 Buy

Uronormin-F 3 g powder for oral solution 1 pc. 230 RUB Buy

Uronormin-F powder for prig solution for internal approx. 2g 6g bag RUB 311 Buy

Uronormin-F powder for prig solution for internal approx. 3g 8g bag 446 r Buy

Uronormin-F 3 g powder for solution for oral administration 2 pcs. 495 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!