Uronormin-F powder for solution inside 3g / 8g No. 2

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Uronormin-F powder for solution inside 3g / 8g No. 2

Active substance
Fosfomycin

Dosage Form:
powder for oral solution

Composition:

1 pack contains: for dosage 2 grams for dosage 3 grams
Active substance:

Fosfomycin trometamol - 3,754 g - 5,631 g
in terms of fosfomycin - 2.0 g - 3.0 g
Excipients:

Sucrose - 2,100 g - 2,213 g
Tangerine Flavor - 0,070 g - 0,070 g
Orange Flavor - 0.060 g - 0,070 g
Sodium saccharinate - 0,016 g - 0,016 g
Mass of package contents - 6,000 g - 8,000 g

Description:

The granulated powder is white or almost white in color, with a characteristic fruity odor.

Pharmacotherapeutic group:

Synthetic other antibacterial agents

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

The mechanism of action is associated with the suppression of the first stage of the synthesis of the bacterial cell wall. As a structural analog of phosphoenolpyruvate competitively irreversibly inhibits the enzyme UDP-N-atsetilglyukozamienolpiruviltransferazu that catalyzes the reaction for the formation of UDP-N-acetyl-3-O- (1-carboxyvinyl) -D-glucosamine from phosphoenolpyruvate and UDP-N-acetyl-D-glucosamine . Also, the drug can reduce the adhesion of bacteria to the mucous membranes of the bladder, which may play a role as a predisposing factor for recurrent infections. The mechanism of action of the drug explains the lack of cross-resistance with other classes of antibiotics and the mutual enhancement of action with antibiotics of other classes, for example with beta-lactam antibiotics.

Fosfomycin is active against a wide range of gram-positive and gram-negative microorganisms, usually secreted in urinary tract infections, such as Escherichia coli, Citrobacter spp., Klebsiella spp., Proteus spp., Serratia spp., Pseudomonas aeruginosa, Enterrococcus faerae.

The emergence of resistance in the laboratory is due to the mutation of the glpT and uhp genes that control the transport of L-alpha-glycerophosphates and glucose phosphates, respectively.

Pharmacokinetics:

Suction:
When ingested fosfomycin is well absorbed from the intestine and reaches a bioavailability of about 50%.The maximum plasma concentration is observed after 2-2.5 hours after oral administration and is 22-32 mg / l. The half-life of plasma is 4 hours. Food intake slows down absorption without affecting urine concentration.

Distribution:
Fosfomycin is distributed in the kidneys, walls of the bladder, prostate and seminal glands. A constant concentration of fosfomycin in the urine, exceeding the Minimum Bacteriostatic Concentration (IBSC), is achieved within 24-48 hours after oral administration. Fosfomycin does not bind to plasma proteins and overcomes the placental barrier. After a single injection, phosphomycin is excreted in breast milk in small quantities.

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

The occurrence of a second peak serum concentration at 6 and 10 hours after taking the drug suggests that the drug is susceptible to enterohepatic recirculation.
The pharmacokinetic properties of fosfomycin do not depend on age and pregnancy. The drug is cumulated in patients with renal insufficiency; a linear relationship was established between the pharmacokinetic parameters of fosfomycin and the glomerular filtration rate.

Indications:

Infectious and inflammatory diseases caused by microorganisms susceptible to fosfomycin:
- acute bacterial cystitis, acute attacks of recurrent bacterial cystitis;
- bacterial non-specific urethritis;
- Asymptomatic massive bacteriuria in pregnant women;
- postoperative urinary tract infections;

Prevention of infections during surgery on the urinary tract and in transurethral diagnostic studies.

Contraindications:

- Hypersensitivity to fosfomycin and other components of the drug;
- severe renal failure (creatinine clearance <10 ml / min);
- children's age up to 5 years (for a dosage of 2 g), children's age up to 12 years (for a dosage of 3 g);
- hemodialysis;
- deficiency of sucrase / isomaltase;
- fructose intolerance;
- glucose-galactose malabsorption.

Pregnancy and lactation:

During pregnancy, the drug is prescribed only when the potential benefit to the mother outweighs the potential risk to the fetus. Data from a limited number of pregnancies studied do not show adverse effects on the pregnancy, the fetus, or the health of the newborn.

If necessary, the appointment of the drug during breastfeeding should stop breastfeeding at the time of treatment.

Dosage and administration:

Inside
The powder is dissolved in 1/2 glass of water (50-75 ml) or another drink, stirred until complete dissolution, taken immediately after dissolution. URONORMIN-F is applied once a day, inside on an empty stomach 1 hour before or 2-3 hours after a meal, preferably before bedtime, after emptying the bladder.

Adults and children from 12 to 18 years: 1 package (3 g) once a day once.
In order to prevent infection of the urinary tract during surgery, transurethral diagnostic procedures, fosfomycin is taken 1 time in 3 g: 3 hours before the intervention and 24 hours after the intervention.

Children from 5 to 12 years: 1 package (2 g) once a day once.
In order to prevent infection of the urinary tract during surgery, transurethral diagnostic procedures, fosfomycin is taken 2 times 2 g: 2 hours before the intervention and 24 hours after the intervention.
In more severe cases (elderly patients, recurrent infections), take another 1 packet in 24 hours.
In patients with mild or moderate severity of renal failure, dose adjustment is not required.
In patients with severe renal failure or on hemodialysis, the use of the drug is contraindicated. In patients with hepatic insufficiency, dose adjustment is not required.

Side effects:

The most common adverse reactions to a single dose of fosfomycin are disorders of the gastrointestinal tract, most often diarrhea. These reactions are short-lived and pass spontaneously.

The following are adverse side reactions that have been reported with the use of fosfomycin during clinical trials or post-registration follow-up.

The frequency of reactions is indicated as follows: very often (≥ 1/10); often (≥ 1/100 - <1/10); infrequently (≥ 1/1 000 - <1/100); rarely (≥ 1/10 000 - <1/1 000); very rarely (<1/10 000); unknown - the incidence of adverse reactions cannot be estimated based on available data.

In each group, adverse reactions are presented in descending order of severity.
Infectious and parasitic diseases:
Infrequently: vulvovaginitis
Seldom: superinfection

Immune system disorders:
Unknown: anaphylactic reactions, including anaphylactic shock, hypersensitivity
Nervous system disorders:
Infrequent: headache, dizziness
Rarely: paresthesias
Heart disorders:
Very rare: tachycardia
Disorders of the respiratory system, organs of the chest and mediastinum:
Unknown: asthma, bronchospasm, shortness of breath
Violations of the gastrointestinal tract:
Infrequently: diarrhea, nausea, dyspepsia
Rarely: abdominal pain, vomiting
Unknown: antibiotic-associated colitis, loss of appetite
Violations of the skin and subcutaneous tissues:
Seldom: rash, urticaria, itch
Unknown: angioedema
General disorders and disorders at the site of administration:
Seldom: fatigue
Vascular disorders:
Unknown: lower blood pressure, petechiae
Disorders of the liver and biliary tract:
Unknown: a short-term increase in the activity of alkaline phosphatase and "liver" transaminases
Violations of the blood and lymphatic system:
Seldom: aplastic anemia
Unknown: eosinophilia, thrombocytosis (petechiae).

Overdose:

Data regarding the overdose of fosfomycin when administered orally is limited. In patients who took an excessive dose of the drug, the following reactions were observed: dysfunction of the vestibular apparatus, hearing loss, "metallic" taste in the mouth, as well as an overall decrease in taste perception.

Overdose treatment is symptomatic and supportive.
In the case of overdose, it is recommended to take the liquid inside to increase diuresis.

Interaction:

When combined with fosfomycin, metoclopramide reduces the concentration of fosfomycin in serum and urine.
The simultaneous use of antacids or calcium salts leads to a decrease in the concentration of fosfomycin in the blood plasma and urine.
Drugs that increase the motor activity (motility) of the gastrointestinal tract can cause a similar effect (decrease in the concentration of fosfomycin in the blood plasma and urine).
There are specific problems associated with a change in the international normalized attitude (INR). In patients receiving antibiotics, numerous cases of increased activity of antivitamin antagonists K have been reported. With the presence of such risk factors as severe infection, inflammation, age or poor general health, a change in INR may be due to both an infectious disease and the result of its treatment. Such changes are considered more characteristic of the following classes of antibiotics: fluoroquinolones, macrolides, cyclins, cotrimoxazole, and some cephalosporins.

Special instructions:

During treatment with fosfomycin, hypersensitivity reactions may occur, including anaphylaxis and anaphylactic shock, which are life-threatening. In such cases, it is necessary to exclude repeated intake of fosfomycin and conduct adequate treatment.
The use of virtually all antibacterial agents, including fosfomycin, can lead to antibiotic-associated diarrhea. Its severity can range from mild diarrhea to fatal colitis. Diarrhea, especially severe, persistent and / or mixed with blood, observed during or after treatment with fosfomycin (including for several weeks after treatment) may be a symptom of pseudomembranous colitis caused by Clostridium difficile. With an alleged or confirmed diagnosis of pseudomembranous colitis, treatment should be initiated immediately. Drugs that suppress intestinal motility, in this clinical situation is contraindicated.

Use in case of kidney failure: the concentration of fosfomycin in the urine is maintained for 48 hours after taking the usual dose, if the creatinine clearance is above 10 ml / min. The drug is contraindicated in patients undergoing hemodialysis.
Patients with diabetes should consider that in 1 package of the drug with a dosage of 2 g or 3 g of fosfomycin contains 2,100 g or 2.213 g of sucrose, respectively.
In patients with rare hereditary diseases, such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency, this drug is contraindicated.

Impact on the ability to drive trans. Wed and fur .:

Patients should be warned about the possibility of developing vertigo, and if dizziness appears, they should refrain from performing these types of activities.

Form release / dosage:

Powder for solution for oral administration, 2 g and 3 g.
Packaging:
At 6.0 g (for dosing 2 g) or at 8.0 g (for dosing 3 g) in heat-sealable bags (buflen) from four-layer laminated foil (paper-polyethylene-aluminum-polyethylene).
On 1, 2 or 3 packages together with the instruction for application are placed in a pack from a cardboard.

Storage conditions:

Store at a temperature not higher than 25 ° С.
Keep out of the reach of children.

Shelf life:

2 years.
Do not use beyond the expiration date printed on the package.