Fosfomycin Esparma
Fosfomycin Esparma: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Fosfomycin Esparma
ATX code: J01XX01
Active ingredient: Fosfomycin (Fosfomycin)
Producer: Lindopharm, GmbH (Lindopharm, GmbH) (Germany)
Description and photo updated: 2020-19-03
Prices in pharmacies: from 182 rubles.
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Fosfomycin Esparma is a broad-spectrum antibacterial drug belonging to the group of phosphonic acid derivatives.
Release form and composition
The drug is available in the form of a powder for preparing a solution for oral administration: a homogeneous dry mass without foreign particles or agglomerates, white or almost white, with a fruit smell [8 g of powder in three-layer (paper-aluminum-polyethylene) bags, in a cardboard box 1 package and instructions for the use of Fosfomycin Esparma].
1 package contains:
- active substance: Fosfomycin trometamol - 5.631 g, which is equivalent to 3 g of Fosfomycin;
- auxiliary components: sucrose, sodium saccharin, tangerine flavor, orange flavor.
Pharmacological properties
Pharmacodynamics
Fosfomycin Esparma is a broad-spectrum antimicrobial drug with bactericidal action. Its active ingredient, fosfomycin, is a structural analogue of phosphoenol pyruvate. The mechanism of its pharmacological action is due to such properties as the ability to penetrate a microbial cell, irreversibly inhibit the enzyme N-acetyl-glucocosamino-3-o-enolpyruvyl transferase and block the condensation of uridine diphosphate-N-acetylglucosamine with phosphoenol pyruvate. As a result of suppression of the synthesis of uridine-5-diphosphate-N-acetylmuramic acid, the initial stage of peptidoglycan formation in the bacterial cell wall is inhibited.
In vitro fosfomycin trometamol reduces the adhesion of a number of bacteria to the epithelium of the urinary tract. The following microbes show sensitivity to the drug:
- gram-positive microorganisms: Staphylococcus saprophyticus, Enterococcus faecalis;
- gram-negative microorganisms: Escherichia coli, Citrobacter spp. (speciales), Klebsiella pneumoniae, Enterobacter spp., Proteus mirabilis.
Cross-resistance of Fosfomycin Esparma with other antibiotics has not been established. When combined in vitro with cephalexin, amoxicillin, pipemidic acid, a pronounced synergism of antimicrobial action is observed.
Pharmacokinetics
After taking the solution inside, absorption of fosfomycin from the gastrointestinal tract occurs to a moderate extent. The bioavailability of a single dose (3 g) is 32–54%. The maximum concentration (C max) in plasma is reached after 2-3 hours and corresponds to approximately 30 mg / l. With the simultaneous intake of food, the absorption process slows down.
The substance does not bind to plasma proteins, is not metabolized in the body.
The predominant accumulation of fosfomycin is observed in urine, where its therapeutic concentration 2–4 hours after ingestion in a dose of 3 g reaches 2–4 g / l, after 6–12 hours it decreases to 1–2 g / l. The average concentration after 36–48 hours is 0.147 g / l.
The minimum inhibitory concentration is 0.128 g / l, it is bactericidal for most common causative agents of urinary tract infections and persists in the urine for at least 48 hours.
The half-life (T 1/2) from blood plasma is 3-4 hours.
It is excreted unchanged, mainly through the kidneys, and to a small extent through the intestines.
In case of impaired renal function, T 1/2 of fosfomycin lengthens depending on the degree of decrease in renal function.
Indications for use
The use of Fosfomycin Esparma is indicated in the treatment of the following bacterial infections of the urinary tract of various localization caused by microorganisms sensitive to antibiotics:
- acute uncomplicated urinary tract infections;
- asymptomatic bacteriuria.
In addition, the drug is prescribed for the prevention of urinary tract infections caused by transurethral diagnostic studies or surgical interventions.
Contraindications
Absolute:
- severe renal failure with creatinine clearance (CC) less than 20 ml / min;
- deficiency of sucrase or isomaltase, glucose-galactose malabsorption syndrome, fructose intolerance;
- the patient's body weight is less than 50 kg;
- breast-feeding;
- age under 12;
- hypersensitivity to the components of the drug.
Fosfomycin Esparma should be used with caution in diabetes mellitus and during pregnancy.
Fosfomycin Esparma, instructions for use: method and dosage
A solution prepared from Fosfomycin Esparma powder is taken orally, on an empty stomach, 2-3 hours before or after a meal, preferably before bedtime.
Before taking the drug, you must empty the bladder.
To prepare the solution, the contents of one packet should be dissolved in 150-200 ml of water and immediately drunk.
Recommended dosage of Fosfomycin Esparma:
- treatment of urinary tract infections: once - 1 sachet (3 g), course of treatment - 1 day;
- prevention of urinary tract infections: once 3 g 3 hours before surgery or transurethral diagnostic studies. Then, 24 hours after the end of the operation or study, the patient must re-take the drug at a dose of 3 g.
Side effects
- from the nervous system: often - dizziness, asthenia, headache; sometimes - paresthesia, a feeling of numbness of the skin and / or creeping; frequency not established - optic neuritis;
- on the part of the blood and lymphatic system: sometimes - leukopenia, thrombocytosis;
- on the part of the cardiovascular system: rarely - tachycardia; frequency not established - decrease in blood pressure (BP);
- from the immune system: the frequency has not been established - hypersensitivity reactions (skin rash, urticaria, angioedema), pruritus, anaphylactic shock;
- from the respiratory system, chest and mediastinal organs: frequency not established - bronchial asthma;
- from the liver and biliary tract: sometimes - increased activity of hepatic transaminases;
- from the gastrointestinal tract: sometimes - nausea, diarrhea, dyspepsia; rarely - vomiting; frequency not established - abdominal pain, pseudomembranous colitis;
- from the genitals and mammary gland: sometimes - vulvovaginitis.
Overdose
Symptoms: general taste disturbances (including metallic taste in the mouth), diarrhea, hearing impairment, vestibular syndrome.
Treatment: there is no specific antidote, therefore, careful monitoring of the patient's condition is indicated and the appointment of symptomatic therapy as needed.
special instructions
If you experience any unwanted effects, you should consult your doctor.
Against the background of the use of Fosfomycin Esparma or after the end of treatment, there are cases of acute and persistent diarrhea, which can be a symptom of colitis (including pseudomembranous colitis) caused by taking an antibiotic. Until the cause of diarrhea is established, the use of drugs that slow down peristalsis is contraindicated. If pseudomembranous colitis is confirmed, discontinuation of the drug is required, and immediate appropriate action is taken.
Patients with diabetes should take into account that in one package the content of sucrose is approximately 2.3 g, which corresponds to 0.19 XE (Bread Units).
Influence on the ability to drive vehicles and complex mechanisms
If dizziness occurs while taking Fosfomycin Esparma, patients are advised to refrain from driving or performing other potentially hazardous activities.
Application during pregnancy and lactation
During pregnancy, the use of an antibiotic is indicated only in cases where the intended therapeutic effect for the mother is higher than the potential risk for the fetus.
Fosfomycin Esparma is contraindicated for breastfeeding. If necessary, taking the drug during lactation is recommended to stop breastfeeding for the duration of treatment.
Pediatric use
Due to the fact that the dose cannot be divided or reduced, the appointment of Fosfomycin Esparma is contraindicated for the treatment of children under the age of 12 years.
With impaired renal function
The appointment of Fosfomycin Esparma powder is contraindicated in severe renal failure (CC less than 20 ml / min).
Drug interactions
During the period of treatment with Fosfomycin Esparma, it should be borne in mind that the simultaneous use of metoclopramide, antacids, calcium-containing agents, or drugs that increase the motility of the gastrointestinal tract, can help reduce the level of Fosfomycin in serum and urine. Therefore, if it is necessary to combine with each of the listed funds, it is recommended to observe the interval between doses 2-3 hours.
Analogs
Fosfomycin Esparma analogs are Monural, Monucin, Ovea, Uronormin-F, Urofosfabol, Urofoscin, Fosmicin, Fosforal Rompharm, Ekofomural, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Fosfomycin Esparma
Patients leave mostly positive reviews about Fosfomycin Esparma, which indicate high efficacy, fast action and good tolerance of the drug. They report that when treating cystitis, a single dose of an antibiotic can help relieve the symptoms of the disease.
The price of Fosfomycin Esparma in pharmacies
The price of Fosfomycin Esparma, powder for the preparation of a solution for oral administration, for a package containing 1 sachet of 3 g, is from 248 rubles.
Fosfomycin Esparma: prices in online pharmacies
Drug name Price Pharmacy |
Fosfomycin Esparma 3 g powder for oral solution 1 pc. 182 r Buy |
Fosfomycin Esparma 3 g powder for prig. solution for internal reception package 8 g No. 1 378 r 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!