Ceftriaxone | Lendacin pore. d / pr-r solution for intravenous and intravenous administration 1 g vial 10 pcs

Release form

Powder for solution for intravenous and intramuscular administration.

Pharmacological action

III generation cephalosporin for parenteral administration. It has a bactericidal effect against many gram-negative and gram-positive bacteria. Ceftriaxone is resistant to -Lactamase.

It is active against the following microorganisms: Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus, Staphylococcus epidermidis, Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidochempresseriferiferiformepherippermaeferisferispermisseriferiferiferiformepherifferi Proteus vulgaris.

Ceftriaxone is also susceptible (with the exception of strains producing -lactamases) Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Morganella morganii, Klebsiella spp., Enterobacter spp., Providencia spp.

Ceftriaxone is not active against Acinetobacter spp., Pseudomonas aeruginosa, Campylobacter jejuni, Bacteroides fragilis, Clostridium difficile, Listeria monocytogenes, Enterococcus faecalis and methicillin-resistant staphylococci.

Mycoplasmas, mycobacteria and chlamydia are resistant to cephalosporins.

Ceftriaxone is also active against strains resistant to other cephalosporins.

Due to the long T1 / 2 (about 8 hours), the drug can be administered 1 time / day.

Indications

Lendacin® is used to treat infections caused by ceftriaxone-sensitive bacteria, including the following:

infections of the upper and lower respiratory tract (including pneumonia, lung abscess)

infections in otorhinolaryngology

sperlitis cardiomyopathy abdominal cavity (peritonitis, inflammatory diseases of the gastrointestinal tract, biliary tract)

urinary tract infection

genital tract infection, including gonorrhea and chancroid s rdlkp infections of bones, joints, soft tissues, skin, wound infections

Lyme disease (stage II and III)

febrile neutropenia in patients with malignant neoplasms

prevention of postoperative infections.

Contraindications

Hypersensitivity to ceftriaxone, other cephalosporins, penicillins, or other beta-lactam antibiotics

premature infants who have not reached the “estimated” age of 41 weeks (taking into account the term of intrauterine development and juvenile sperm donor , which shows the intravenous administration of calcium-containing solutions because of the risk of precipitation of the ceftriaxone-calcium salt complex

acidosis, hypoalbuminemia in full-term newborns

period of breastfeeding.

With caution

For concomitant renal and hepatic insufficiency, biliary dyskinesia, gallstone disease and gastrointestinal tract (GIT) history, ulcerative colitis, enteritis, or colitis associated with the use of antibacterial drugs during pregnancy.

Use during pregnancy and lactation

Ceftriaxone crosses the placental barrier. The safety of the drug during pregnancy has not been studied, therefore, LendacinВ® should be used during pregnancy, especially in the first trimester, only if if the expected benefit to the mother outweighs the potential risk to the fetus. Ceftriaxone in small amounts is excreted in breast milk. In infants who are breast-feeding, the development of sensitization, diarrhea, candidiasis of the mucous membranes of the oral cavity is possible. If necessary, use of the drug during breastfeeding should decide on the termination of breastfeeding.

Special instructions

As with other cephalosporins, anaphylactic reactions have been reported, including fatal ones, even in cases where the patient had no history of allergic reactions. In case of allergic reactions, drug therapy should be discontinued and appropriate treatment prescribed.

As with other cephalosporins, autoimmune hemolytic anemia may occur during treatment. Cases of severe hemolytic anemia in adults and children, including fatal cases, have been reported. In the event of anemia, drug therapy should be discontinued.

When using the drug, there have been cases of diarrhea caused by Clostridium diffcile (pseudomembranous colitis), of varying severity: from mild to fatal colitis. A thorough medical history is necessary, since cases of diarrhea caused by Clostridium diffcile have been noted more than 2 months after antibiotic therapy. In accordance with clinical indications, appropriate treatment should be prescribed (compensation for loss of fluid, electrolytes, protein, antibiotic therapy for Clostridium diffcile, surgical treatment is indicated). With the development of pseudomembranous colitis, the use of drugs that inhibit intestinal motility is contraindicated. As with other antibacterial drugs, superinfection may develop.

When using the drug, rare cases of prothrombin time changes are described. Patients with a deficiency of vitamin K (impaired synthesis, malnutrition) may need to control prothrombin time and the appointment of vitamin K (10 mg / week) with an increase in prothrombin time before or during therapy.

In rare cases, ultrasound (ultrasound) of the gallbladder observes blackouts (precipitates of the calcium salt of ceftriaxone), which disappear after discontinuation of treatment. With the development of symptoms or signs indicating a possible gallbladder disease, or in the presence of ultrasound signs of the “sludge phenomenon”, it is recommended to stop the administration of the drug. When using the drug, rare cases of pancreatitis, which developed, possibly due to obstruction of the biliary tract, are described. Most patients had risk factors for stagnation of the biliary tract (for example, previous drug therapy, severe concomitant diseases, completely parenteral nutrition), and the triggering role of precipitate formation in the biliary tract under the influence of ceftriaxone cannot be ruled out. Like other cephalosporins, ceftriaxone can displace bilirubin from its association with serum albumin.

In cases of concomitant severe renal and hepatic insufficiency, as well as in patients undergoing hemodialysis, plasma concentrations of ceftriaxone should be regularly determined. With prolonged treatment, it is necessary to regularly monitor the picture of peripheral blood, indicators of the functional state of the liver and kidneys.

Fatal reactions resulting from the deposition of ceftriaxone-calcium precipitates in the lungs and kidneys of newborns are described. Theoretically, there is a likelihood of ceftriaxone interacting with calcium-containing solutions for intravenous administration and in other age groups of patients, therefore ceftriaxone should not be mixed with calcium-containing solutions (including for parenteral nutrition), and also administered simultaneously, including through separate access for infusion in various areas. Theoretically, based on the calculation of 5 T1 / 2 of ceftriaxone, the interval between the administration of ceftriaxone and calcium-containing preparations should be at least 48 hours. Data on the possible interaction of ceftriaxone with calcium-containing preparations for oral administration, as well as ceftriaxone for i / m administration with calcium-containing preparations (iv or for oral administration) are absent.

Contraindications to lidocaine should be taken into account when it is co-administered with Lendacin® (when using lidocaine as a solvent, the solution can be administered only intramuscularly).

Intramuscular administration of the drug Lendacin without lidocaine is painful!

Influence on laboratory test results: during treatment with ceftriaxone, false positives of the Coombs test, false positive tests for galactosemia, and urine glucose can be detected (glucosuria is recommended to be determined only by the enzyme method). Patient information following a diet with a low sodium content: 1 bottle of Lendacin® 2.0 g contains 166.0 mg (7.2 mEq) of sodium.

Effect on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions

In rare cases, Lendacin® causes dizziness, therefore, during treatment with Lendacin®, caution should be exercised when driving and practicing other potentially dangerous types activities requiring increased concentration of attention and speed of psychomotor reactions.

Composition

Active ingredient: ceftriaxone sodium 298.3 mg (corresponding to 250 mg of ceftriaxone) 1.193 g (corresponding to 1 g of ceftriaxone).

Dosage and Administration

Ceftriaxone is administered intramuscularly or intravenously. Dosage and method of application are determined on the basis of data on the severity of infection, the sensitivity of microorganisms, the age and condition of the patient.

The duration of therapy depends on the course of the disease. The introduction of the drug LendacinΠshould be continued for at least 48 to 72 hours after normalization of body temperature and confirmation of the eradication of the pathogen.

The course of treatment is usually 4? 14 days for complicated infections, a longer administration may be required. The course of treatment for infections caused by Streptococcus pyogenes should be at least 10 days.

Adults and children over 12 years old weighing? 50 kg:

The usual dose is 1 to 2 g of ceftriaxone once a day (every 24 hours). The maximum daily dose is 4 g. In order to avoid a local reaction with intramuscular injection, injections into the left and right muscles should be alternated.

Uncomplicated gonorrhea: LendacinΠis administered once intramuscularly at a dosage of 250 mg.

Meningitis: with bacterial meningitis in infants and young children, treatment begins with a dose of 100 mg / kg (but not more than 4 g) 1 time per day. After identifying the pathogen and determining its sensitivity, the dose can be accordingly reduced. The best results with meningococcal meningitis were achieved with a treatment duration of 4 days, with meningitis caused by Haemophilus influenzae - 6 days, Streptococcus pneumonia - 7 days.

Lyme disease (stage II and III): LendacinΠis prescribed at a dose of 50 mg / kg once a day, the daily dose should not exceed 2 g. The duration of treatment is 14 days.

Prevention of postoperative infections: LendacinΠis administered once at a dose of 1 - 2 g, depending on the risk of infection, it is recommended to be administered 30 - 90 minutes before surgery.

Children from 15 days to 12 years of age with

body weight, the recommended dose is 20 - 80 mg / kg once a day. The total daily dose should not exceed 2 g. A dose of more than 50 mg / kg of body weight should be prescribed as an intravenous infusion over a period of 30 minutes.

Newborns (age 0 - 14 days): the recommended dose is 20 to 50 mg / kg intravenously as a slow infusion once a day.

Elderly patients: dose adjustment not required.

In patients with impaired renal function, there is no need to reduce the dose if liver function remains normal. In case of acute renal failure (CC) In patients with impaired liver function, there is no need to reduce the dose if renal function remains normal. With a combination of severe renal and hepatic insufficiency, the plasma concentration of ceftriaxone should be regularly determined and the dose adjusted if necessary.

In patients with renal -hepatic insufficiency, the daily dose should not exceed 2 g without determining the concentration of the drug in blood plasma.

With hemodialysis or peritoneal dialysis, patients do not need additional administration of the drug after dialysis. It is necessary to control the concentration of ceftriaxone in the blood serum for possible dose adjustment, since the excretion rate in such patients may decrease.

In the treatment of acute otitis media in children, a single i / m administration at a dose of 50 mg / kg (but not more than 1 g) is recommended.

Rules for the preparation and administration of solutions: only freshly prepared solutions must be used!

Intramuscular injection of

250 mg of ceftriaxone dissolved in 2 ml and 1 g in 3.5 ml of a 1% lidocaine solution.

The solution is injected deep into the gluteus muscle. It is recommended to inject no more than 1 g into each muscle.

Solution with lidocaine is forbidden to enter intravenously!

Intravenous administration of

250 mg of ceftriaxone is dissolved in 5 ml and 1 g in 10 ml of water for injection.

The solution is slowly injected into a vein for 2 to 4 minutes.

The prepared ceftriaxone solution is stable for 24 hours if stored at a temperature not exceeding 25 РC or 48 hours at a temperature of 2-8 РC.

Side effects

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (? 1/10), often (? 1/100, Infectious and parasitic diseases:

fungal genital infection

Immune system disorders:

fever or chills, anaphylactic or anaphylactoid reactions (e.g. bronchospasm)

Disorders of the skin and subcutaneous tissue:

rash, itching, allergic dermatitis, urticaria, edema, exudation vnaya erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)

disorders of the nervous system:.

headache, dizziness, vertigo, convulsions

Violations of the gastrointestinal tract.:

abdominal pain, diarrhea, nausea, vomiting, taste disturbance, dyspepsia, bloating, stomatitis, pancreatitis, glossitis, pseudomembranous colitis.

Disorders of the liver and biliary tract:

cholelithiasis, jaundice, the “sludge phenomenon” of the gallbladder.

Disorders of the blood and lymphatic system:

anemia (including hemolytic), leukopenia, lymphopenia, leukocytosis, lymphocytosis, monocytosis, neutropenia, thrombocytosis, granulocytopenia, eosinophilia, basophilia, thrombocytopenia, increase in time (decrease) agranulocytosis.

Laboratory and instrumental data:

increased activity of hepatic transaminases and alkaline phosphatase, hyperbilirubinemia, hypercreatininemia, increased urea concentration, sediment in the urine, hematuria, glucosuria.

Disorders of the kidneys and urinary tract:

oliguria, vaginitis, nephrolithiasis.

General disorders and disorders at the injection site:

for iv administration - phlebitis, soreness, tightening along the vein with i / m administration - soreness, sensation of warmth, tightness or tightness at the injection site.

Other:

increased sweating, flushing, allergic pneumonitis, nosebleeds, palpitations, serum sickness, precipitation in the lungs.

Drug Interactions

Ceftriaxone solutions should not be mixed with solutions containing other antimicrobial agents. Solvents containing calcium salts (Ringer's or Hartmann's solution) cannot be used to prepare ceftriaxone solutions for intravenous administration and subsequent dilution, due to the formation of a precipitate of calcium ceftriaxone salt.

No interaction has been reported between ceftriaxone and calcium-containing oral preparations or ceftriaxone for intramuscular use and intravenous or oral calcium-containing preparations.

Pharmaceutically incompatible with amsacrine, vancomycin, fluconazole and aminoglycosides. Probenecid does not affect drug excretion.

With the simultaneous use of ceftriaxone in large doses and "loop" diuretics (eg furosemide), renal dysfunction was not observed.

Concomitant use with indirect anticoagulants may increase the effect of antivitamin K and increase the risk of bleeding.

Recommended monitoring of the international normalized ratio (INR) and dose selection of indirect anticoagulants during and after treatment with ceftriaxone.

With the simultaneous use of ceftriaxone with aminoglycosides, it is recommended to monitor the concentration of aminoglycosides and renal function.

There is no indication that ceftriaxone increases the nephrotoxicity of aminoglycosides. The synergism between ceftriaxone and aminoglycosides in relation to many gram-negative bacteria is shown. Although the increased effectiveness of such combinations is not always predictable, it should be borne in mind for severe, life-threatening infections, such as those caused by Pseudomonas aeruginosa.

Alcohol consumption after ceftriaxone administration was not accompanied by a disulfiram-like reaction. Ceftriaxone does not contain an N-methylthiotetrazole group, which can cause ethanol intolerance and bleeding.

Bacteriostatic antibiotics reduce the bactericidal effect of ceftriaxone.

In vitro antagonism with chloramphenicol. Ceftriaxone reduces the effectiveness of oral contraceptives, therefore, the use of additional non-hormonal contraceptives is recommended during the period of taking the drug and within 1 month after the end of the drug.

Overdose

Symptoms: nausea, vomiting, diarrhea.

Symptomatic treatment. There is no specific antidote. Hemodialysis or peritoneal dialysis is not effective.

Storage conditions

At a temperature not exceeding 25 РC, in a dark place.

Keep out of the reach and sight of children!

Expiration

3 years.

active substance

Ceftriaxone

Terms of sale from

pharmacies Prescription

lekarstvennaja form

Solution for and infusions

Indications

Bronchitis, Pneumonia, Urinary tract infections, Gastrointestinal infections, Skin infections, Otitis, Sinusitis, Vaginal infections

Possible Product Names

Lendacin por. d / pr-r for intravenous and intravenous administration 1 g vial 10 pcs.