Instructions Fosfomycin granules sachet 3 g No. 1
Composition
active ingredient: fosfomycin;
1 sachet contains 5.631 g of fosfomycin trometamol, which is equivalent to 3.0 g of fosfomycin;
excipients: saccharin, sucrose, tangerine flavoring, orange flavoring.
Dosage form
Granules for oral solution.
Main physicochemical properties: white granular powder with a characteristic smell of tangerine flavoring.
Pharmacotherapeutic group
Antimicrobials for systemic use. Other antimicrobials. ATX code J01X X01.
Pharmacological properties
Pharmacodynamics
The drug has a broad spectrum of antibacterial activity. It is effective against the most commonly isolated strains of urinary tract infections: E. coli, Citrobacter spp., Klebsiella spp., Proteus spp., Serratia spp., P. aeruginosa and Enterococcus faecalis, even if they are resistant to other antibacterial agents. The drug also acts on penicillinase-producing strains. Fosfomycin has an anti-adhesive effect on bacteria that have the property of adhesion to the epithelium lining the urinary tract.
Pharmacokinetics
Fosfomycin is easily absorbed from the digestive tract. The maximum concentration in the blood plasma is observed after 2 hours and is 30-35 μg/ml. The half-life from the blood plasma is 2 hours. Fosfomycin is not metabolized in the body, it is excreted by glomerular filtration in a biologically active form. The drug accumulates mainly in the kidneys at a concentration of 2500-3500 μg/ml, and its minimum inhibitory concentration for E. coli is 128 μg/ml. Enterohepatic circulation of fosfomycin allows you to maintain the therapeutic level of the drug for 48 hours, this time is sufficient for urine sterilization and recovery.
Indication
Treatment of acute uncomplicated lower urinary tract infections caused by organisms susceptible to fosfomycin in men, girls aged 12 years and older and adult women. Prophylaxis during diagnostic procedures and surgical interventions in adult patients.
Contraindication
Hypersensitivity to fosfomycin or to other components of the drug, severe renal failure (creatinine clearance < 10 ml/min), children under 12 years of age, undergoing hemodialysis.
Interaction with other medicinal products and other types of interactions
Concomitant use with metoclopramide and other drugs that increase gastrointestinal motility reduces the absorption of fosfomycin, which leads to a decrease in the concentration of the drug in serum and urine.
Application features
The use of broad-spectrum antibiotics, including fosfomycin trometamol, may lead to the development of antibiotic-associated colitis (including pseudomembranous colitis). Therefore, the possibility of this diagnosis should be considered in patients who develop severe diarrhea during or after taking fosfomycin trometamol. If the diagnosis is confirmed, appropriate treatment should be initiated immediately. In this case, drugs that inhibit peristalsis are contraindicated.
Simultaneous food intake slows down the absorption of fosfomycin. Therefore, it is advisable to use the drug on an empty stomach or 2-3 hours after a meal.
The drug contains sucrose. Patients with diabetes mellitus and those who need to follow a diet should take into account that 1 sachet of the drug contains 2.213 g of sucrose. Fosfomycin is not used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrose-isomaltase deficiency.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data confirming the effect of the drug on the reaction rate.
Use during pregnancy or breastfeeding
During pregnancy, the use of the drug is possible only when the expected effect of therapy for the mother outweighs the potential risk to the fetus.
According to available data, fosfomycin trometamol has neither teratogenic nor fetotoxic effects.
During breastfeeding, the use of the drug should be discontinued. Studies on the use of Fosfomycin during breastfeeding have not been conducted.
Method of administration and doses
The drug is taken orally on an empty stomach, preferably before bedtime after emptying the bladder. The contents of the sachet are dissolved in ½ glass of water. The dosage regimen is set individually by the doctor.
Usually, a single dose for adults, including elderly patients (up to 75 years of age), in the acute phase of the disease is 3 g (1 sachet) once.
In order to prevent urinary tract infections during surgical interventions and transurethral diagnostic studies, the contents of one sachet are taken 3 hours before the intervention and the second sachet 24 hours after the intervention.
Children
Possible use for the treatment of acute uncomplicated lower urinary tract infections in girls aged 12 years and older.
There is insufficient data on the use of the drug for therapeutic purposes in boys aged 12 years and older, as well as sufficient data on the use of the drug for preventive purposes in both boys and girls.
Overdose
Symptoms: vestibular disorders, hearing loss, metallic taste in the mouth, and a general decrease in taste perception.
Treatment: symptomatic and supportive therapy. It is recommended to drink plenty of fluids to increase diuresis.
Adverse reactions
The most common adverse reactions with a single dose of fosfomycin trometamol are possible from the digestive tract, mainly diarrhea. These phenomena are usually short-lived and resolve on their own.
Infections and infestations: vulvovaginitis.
On the part of the immune system: anaphylactic shock, allergic reactions.
From the nervous system: headache, dizziness, paresthesia.
Cardiovascular system: tachycardia, arterial hypotension.
Respiratory system: asthma.
On the part of the digestive tract: diarrhea, nausea, indigestion, abdominal pain, vomiting, pseudomembranous colitis.
Skin: rash, urticaria, itching, angioedema.
General disorders: increased fatigue.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
Sachets made of laminated foil. 1 sachet in a cardboard box.
Vacation category
According to the recipe.
Producer
ASTRAPHARM LLC, Ukraine.
Location of the manufacturer and its business address
08132, Kyiv region, Kyiv-Svyatoshynskyi district, Vyshneve town, Kyivska st., 6.
