Pharmacy No. 84. Delivery of medicines to your home and office.

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Fosfomycin

The following undesirable effects are presented by organ system in accordance with the following gradation of the frequency of their occurrence: very common - more than 10% (≥1/10), frequent - more than 1%, but less than 10% (≥1/100 to <1/10 ), uncommon - more than 0.1%, but less than 1% (≥1/1000 to <1/100), rare - more than 0.01%, but less than 0.1% (≥1/10000 to <1/1000 ), very rare - less than 0.01% (<1/10000, including individual reports), unknown (cannot be estimated based on available data).

Immune system disorders

: rarely - acute hypersensitivity reactions (including anaphylactic shock). If any symptoms of anaphylactic reactions develop, such as dyspnea, hypotension, cyanosis, urticarial rash, severe malaise, it is necessary to discontinue the drug and begin appropriate symptomatic therapy.

Skin and subcutaneous tissue disorders

: uncommon - rash, pruritis, urticaria, exanthema. Skin redness, erythema, frequency unknown - angioedema.

Digestive system disorders

: infrequently - diarrhea, nausea, vomiting, abdominal pain, anorexia, change in taste, loss of appetite, rarely - stomatitis, severe colitis with blood in the stool, pseudomembranous colitis. If patients experience abdominal pain or frequent bowel movements, it is necessary to stop taking the drug and begin appropriate symptomatic therapy.

Disorders of the liver and biliary tract

: often - transient increase in the activity of liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase), infrequently - increased levels of lactate dehydrogenase, bilirubin, rarely - impaired liver function, jaundice, frequency unknown - cholestatic hepatitis. In such cases, patients should be under medical supervision. If any liver dysfunction is detected, it is necessary to stop taking the drug and begin appropriate symptomatic therapy.

Nervous system disorders

: rarely - numbness, headache. Dizziness, decreased sensitivity, frequency unknown - increased fatigue, confusion, convulsions. If seizures develop, it is necessary to stop taking the drug and begin appropriate symptomatic therapy.

Respiratory, thoracic and mediastinal disorders

: infrequently - shortness of breath, rarely - cough, acute attack of bronchial asthma, discomfort in the chest, a feeling of squeezing in the chest.

Blood and lymphatic system disorders

: rarely - leukopenia, anemia, granulocytopenia, eosinophilia, pancytopenia, agranulocytosis or thrombocytopenia. very rarely - aplastic anemia. Therapy must be carried out under the control of the patient's blood count. If any disorders develop, it is necessary to stop taking the drug and begin appropriate symptomatic therapy.

Cardiovascular disorders

: infrequently - thrombophlebitis, rarely - rapid heartbeat, vascular pain, hyperemia.

Renal and urinary tract disorders

: rarely - impaired renal function, edema, increased concentration of urea in the blood, proteinuria.

General and administration site disorders

: infrequently - increased body temperature, pain at the injection site, rarely - phlebitis, thirst, feeling of general malaise.

Laboratory and instrumental data

: rarely - hypernatremia, hypokalemia, electrolyte imbalance.

Buy Fosfomycin Esparma powder for oral solution 3g No. 1 in pharmacies

Dosage form:

powder for solution for oral administration

Compound:

1 package 8 g contains:

Active substance:

fosfomycin trometamol - 5.631 g (equivalent to 3.0 g fosfomycin);

Excipients:

sucrose - 2.244 g; orange flavoring - 0.065 g; tangerine flavoring - 0.050 g; sodium saccharin - 0.010 g.

Description:

homogeneous powder of white or almost white color, with a fruity odor, without agglomerates and foreign particles.

Pharmacotherapeutic group:

antibiotic

Pharmacological properties

Pharmacodynamics:

Broad-spectrum antibiotic. Has a bactericidal effect. It is a structural analogue of phosphoenol pyruvate and penetrates into the microbial cell, j The drug irreversibly inhibits the enzyme N-acetyl-glucosamino-3-o-enolpyruvyl transferase, irreversibly blocks the condensation of uridine diphosphate-N-acetyl-glucosamine with phosphoenolpyruvate, inhibits the synthesis UDP-N-acetyl-muramic acid, thus inhibiting the initial stage of peptidoglycan formation in the bacterial cell wall.

Cross-resistance of the drug with other antibacterial agents is unknown. In vitro, when combined with amoxicillin, cephalexin, pipemidic acid, a pronounced synergism of antimicrobial action is noted.

In vitro, gram-positive (Staphylococcus saprophytticus, Enterococcus faecalis) and gram-negative (Escherichia coli, Klebsiella pneumoniea, Citrobacter spp., Enterobacter spp., Proteus mirabilis) microorganisms are sensitive to fosfomycin. In vitro, fosfomycin trometamol reduces the adhesion of a number of bacteria to the epithelium of the urinary tract.

Pharmacokinetics

Suction:

Fosfomycin is moderately absorbed from the gastrointestinal tract when taken orally. In the body it dissociates into fosfomycin and trometamol.

The bioavailability of a single dose of 3 g when taken orally ranges from 32% to 54%. The maximum concentration in plasma (C max) is observed 2-3 hours (t max) after oral administration and is about 30 mg/l. The half-life from blood plasma varies from 3 to 4 hours.

Distribution:

Fosfomycin does not bind to plasma proteins, is not metabolized, and predominantly accumulates in the urine. Already 2-4 hours after oral administration of a single dose of 3 g, a high therapeutic concentration of 2-4 g/l is achieved in the urine, decreasing to 1-2 g/l after 6-12 hours. Average concentrations after 12-24 hours and after 36-48 hours were 0.762 g/l and 0.147 g/l, respectively.

The minimum inhibitory concentration (0.128 g/l), bactericidal for most common pathogens of urinary tract infections, remains in the urine for at least 48 hours, which determines treatment with a single dose.

Removal:

The main part is excreted unchanged by the kidneys. A small part is excreted through the intestines.

In cases of moderate decline in renal function, the half-life of fosfomycin by the kidneys is slightly prolonged depending on the degree of functional impairment.

Indications for use

Bacterial infections of the urinary tract of various localizations caused by microorganisms sensitive to fosfomycin:

- acute uncomplicated urinary tract infections; - asymptomatic bacteriuria; prevention of infections; — urinary tract after surgery and transurethral diagnostic studies.

Contraindications

- hypersensitivity to fosfomycin or other components of the drug; - severe renal failure (creatinine clearance <20 ml/min); - children under 12 years of age, since there is insufficient data on its use; - sucrase/isomaltase deficiency; - fructose intolerance; - glucose-galactose malabsorption.

Use during pregnancy and breastfeeding

During pregnancy, it is used only if the expected benefit to the mother outweighs the potential risk to the fetus.

When prescribing the drug during lactation, breastfeeding should be stopped for the duration of treatment.

Directions for use and doses

Inside.

Fosfomycin Esparma is used once, on an empty stomach, 2-3 hours before or after a meal, preferably before bedtime, after emptying the bladder: adults and children over 12 years old in a daily dose of 3 g. The contents of one package are dissolved in approximately 150-200 ml of water and taken immediately after preparation.

The course of treatment is 1 day.

To prevent urinary tract infections during surgery and diagnostic procedures, the indicated dose is taken 2 times - 3 hours before the intervention and 24 hours after it.

Fosfomycin Esparma should not be taken by patients weighing less than 50 kg and children under 12 years of age, as the dose cannot be divided or reduced.

Side effect

According to the frequency of development, side effects are in the following groups: Very common: (> 1/10) Frequent: (> 1/100 - < 1/10) Not common: (> 1/1,000 - < 1/100) Rare: (> 1/10,000 - < 1/1,000) Very rare: (< 1/10,000) Unknown: (the incidence of adverse events is not determined based on existing data). From the nervous system: Common: headache, dizziness, asthenia Not common: sensation of numbness of the skin, “crawling”, paresthesia Not known: optic neuritis From the cardiovascular system: Rare: tachycardia Not known: decreased blood pressure From the respiratory system , organs of the chest and mediastinum: Not known: bronchial asthma From the immune system: Not known: skin itching, anaphylactic shock, hypersensitivity reactions (angioedema, skin rash, urticaria) From the gastrointestinal tract: Not common: diarrhea, nausea, dyspepsia Rare: vomiting Unknown: pseudomembranous colitis, abdominal pain From the liver and biliary tract: Not common: increased activity of “liver” transaminases From the genital organs and mammary gland: Not common: vulvovaginitis From the blood and lymphatic system: Not common: thrombocytosis, leukopenia If any of the side effects indicated in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms of overdose: vestibular syndrome, hearing impairment, “metallic” taste and general taste disturbances, diarrhea. A specific antidote has not been identified. If necessary, symptomatic treatment is carried out.

Interaction with other drugs

Concomitant use with other drugs that increase gastrointestinal motility can also lead to a decrease in the concentration of fosfomycin in the blood serum and urine.

special instructions

The occurrence of acute and persistent diarrhea during or after antibiotic treatment may be a symptom of antibiotic-induced colitis. The most serious form is pseudomembranous colitis.

In the case of pseudomembranous colitis, appropriate measures must be taken immediately. In this case, the use of drugs that slow down peristalsis is contraindicated.

The drug contains sucrose. Patients with rare hereditary diseases, fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this drug.

One packet of Fosfomycin Esparma contains approximately 2.3 g of sucrose, which is equivalent to approximately 0.19 bread units (XU).

Simultaneous food intake slows down the absorption of granules, so it is recommended to take the drug on an empty stomach, 2-3 hours before or after a meal.

Impact on the ability to drive vehicles and machines Patients should be warned about the possibility of developing dizziness and if dizziness occurs, they should refrain from performing these types of activities.

Release form:

Powder for solution for oral administration 3 g.

8 g of powder in bags made of three-layer material (paper-aluminum-polyethylene).

1 package with instructions for use in a cardboard box.

Storage conditions:

At a temperature not higher than 25 °C.

Keep out of the reach of children.

Best before date:

2 years.

Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies:

On prescription.

Fosfomycin (por.d.prig.solution d.pr.inward 3 g No. 1)

A country

Germany
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Compound:

1 package of 8 g contains: Active substance: fosfomycin trometamol - 5.631 g (equivalent to 3.0 g fosfomycin); Excipients: sucrose - 2.244 g; orange flavoring - 0.065 g; tangerine flavoring - 0.050 g; sodium saccharin - 0.010 g. Description: homogeneous powder of white or almost white color, with a fruity odor, without agglomerates and foreign particles. Release form: Powder for the preparation of a solution for oral administration, 3 g. 8 g of powder in bags made of three-layer material (paper-aluminum-polyethylene). 1 package with instructions for use in a cardboard box.

Pharmacological properties

Pharmacodynamics: Broad-spectrum antibiotic. Has a bactericidal effect. It is a structural analogue of phosphoenol pyruvate and penetrates the microbial cell. The drug irreversibly inhibits the enzyme N-acetyl-glucosamino-3-o-enolpyruvyl transferase, irreversibly blocks the condensation of uridine diphosphate-N-acetyl-glucosamine with phosphoenolpyruvate, suppresses the synthesis of UDP-N-acetylmuramic acid, thus inhibiting the initial stage of peptidoglycan formation bacterial cell wall. Cross-resistance of the drug with other antibacterial agents is unknown. In vitro, when combined with amoxicillin, cephalexin, pipemidic acid, a pronounced synergism of antimicrobial action is noted. In vitro, gram-positive (Staphylococcus saprophytticus, Enterococcus faecalis) and gram-negative (Escherichia coli, Klebsiella pneumoniea, Citrobacter spp., Enterobacter spp., Proteus mirabilis) microorganisms are sensitive to fosfomycin. In vitro, fosfomycin trometamol reduces the adhesion of a number of bacteria to the epithelium of the urinary tract. Pharmacokinetics Absorption: Fosfomycin is moderately absorbed from the gastrointestinal tract when administered orally. In the body it dissociates into fosfomycin and trometamol. The bioavailability of a single dose of 3 g when taken orally ranges from 32% to 54%. The maximum concentration in plasma (Cmax) is observed 2-3 hours (tmax) after oral administration and is about 30 mg/l. The half-life from blood plasma varies from 3 to 4 hours. Distribution: Fosfomycin does not bind to plasma proteins, is not metabolized, and predominantly accumulates in the urine. Already 2-4 hours after oral administration of a single dose of 3 g, a high therapeutic concentration of 2-4 g/l is achieved in the urine, decreasing to 1-2 g/l after 6-12 hours. The average concentrations after 12-24 hours and after 36-48 hours were 0.762 g/L and 0.147 g/L, respectively. The minimum inhibitory concentration (0.128 g/l), bactericidal for most common pathogens of urinary tract infections, remains in the urine for at least 48 hours, which determines treatment with a single dose. Excretion: The main part is excreted unchanged by the kidneys. A small part is excreted through the intestines. In cases of moderate decline in renal function, the half-life of fosfomycin by the kidneys is slightly prolonged depending on the degree of functional impairment.

Indications for use

Bacterial urinary tract infections of various localizations caused by microorganisms sensitive to fosfomycin: acute uncomplicated urinary tract infections; asymptomatic bacteriuria; prevention of urinary tract infections after surgery and transurethral diagnostic studies.

Contraindications

- hypersensitivity to fosfomycin or other components of the drug; - severe renal failure (creatinine clearance - children under 12 years of age, since there is insufficient data on its use; - sucrase/isomaltase deficiency; - fructose intolerance; - glucose-galactose malabsorption.

Use during pregnancy and breastfeeding

During pregnancy, it is used only if the expected benefit to the mother outweighs the potential risk to the fetus. When prescribing the drug during lactation, breastfeeding should be stopped for the duration of treatment.

Directions for use and doses

Inside. Fosfomycin Esparma is used once, on an empty stomach, 2-3 hours before or after a meal, preferably before bedtime, after emptying the bladder: adults and children over 12 years old in a daily dose of 3 g. The contents of one package are dissolved in approximately 150-200 ml of water and taken immediately after preparation. The course of treatment is 1 day. For the prevention of urinary tract infections during surgery and diagnostic procedures, the indicated dose is taken 2 times - 3 hours before the intervention and 24 hours after it. Fosfomycin Esparma should not be taken by patients weighing less than 50 kg and children under 12 years of age, as the dose cannot be divided or reduced.

Side effect

According to the frequency of development, side effects are in the following groups: Very common: (≥ 1/10) Frequent: (≥ 1/100 - Not common: (≥ 1/1,000 - Rare: (≥ 1/10,000 - Very rare: (Unknown: (the incidence of side effects is not determined based on existing data.) From the nervous system: Common: headache, dizziness, asthenia Not common: numbness of the skin, crawling, paresthesia Not known: optic neuritis From the cardiovascular system : Rare: tachycardia Not known: decreased blood pressure From the respiratory system, chest and mediastinal organs: Not known: bronchial asthma From the immune system: Not known: skin itching, anaphylactic shock, hypersensitivity reactions (angioedema, skin rash, urticaria) With Parts of the gastrointestinal tract: Not common: diarrhea, nausea, dyspepsia Rare: vomiting Not known: pseudomembranous colitis, abdominal pain From the liver and biliary tract: Not frequent: increased activity of “liver” transaminases From the genital organs and mammary gland: Not common: vulvovaginitis From the blood and lymphatic system: Not common: thrombocytosis, leukopenia If any of the side effects indicated in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Interaction with other drugs

Concomitant use with metoclopramide, antacids or drugs containing calcium salts may lead to a decrease in the concentration of fosfomycin in the blood serum and urine. For this reason, it is recommended to take medications at intervals of 2-3 hours. Concomitant use with other drugs that increase gastrointestinal motility can also lead to a decrease in the concentration of fosfomycin in the blood serum and urine.

special instructions

The occurrence of acute and persistent diarrhea during or after antibiotic treatment may be a symptom of antibiotic-induced colitis. The most serious form is pseudomembranous colitis. In the case of pseudomembranous colitis, appropriate measures must be taken immediately. In this case, the use of drugs that slow down peristalsis is contraindicated. The drug contains sucrose. Patients with rare hereditary diseases, fructose intolerance, glucose-lactose malabsorption or sucrase-isomaltase deficiency should not take this drug. One packet of Fosfomycin Esparma contains approximately 2.3 g of sucrose, which is equivalent to approximately 0.19 bread units (XU). Simultaneous food intake slows down the absorption of granules, so it is recommended to take the drug on an empty stomach, 2-3 hours before or after a meal.

Impact on the ability to drive vehicles and machinery

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

Dispensing conditions in pharmacies

On prescription