Universal reference book for medicines
Product name: CEFTRIAXONE KABI (CEFTRIAXONE KABI)

Active substance: ceftriaxone

Type: Third generation cephalosporin

Manufacturer: FRESENIUS KABI DEUTSCHLAND (Germany) manufactured by LABESFAL-LABORATORIOS ALMIRO (Portugal)
Composition, form of production and packaging
Powder for the preparation of a solution for intravenous and /
or injections of almost white or yellowish color, crystalline.

1 f.

ceftriaxone sodium trisecihydrate 1193 mg,

which corresponds to the content of ceftriaxone 1000 mg

1000 mg - bottles of glass with a capacity of 15 ml (1) - packs of cardboard.

1000 mg - bottles of glass with a capacity of 15 ml (10) - packs of cardboard.

Powder for the preparation of a solution for intravenous and / or injections of almost white or yellowish color, crystalline.

1 f.

ceftriaxone sodium trisecihydrate 2386 mg,

which corresponds to the content of ceftriaxone 2000 mg

2000 mg - bottles of glass with a capacity of 15 ml (1) - packs of cardboard.

2000 mg - bottles of glass with a capacity of 15 ml (10) - packs of cardboard.

Powder for the preparation of a solution for intravenous and / or injections of almost white or yellowish color, crystalline.

1 f.

ceftriaxone sodium trisesquihydrate 596.5 mg,

which corresponds to the content of ceftriaxone 500 mg

500 mg - bottles of glass with a capacity of 15 ml (1) - packs of cardboard.

500 mg - bottles of glass with a capacity of 15 ml (10) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Cephalosporin antibiotic III generation of a broad spectrum of action for parenteral administration.
Bactericidal activity is due to the suppression of bacterial cell wall synthesis. It is characterized by resistance to the action of most beta-lactamases of gram-negative and gram-positive microorganisms.
It is active against the following microorganisms: gram-positive aerobes - Staphylococcus aureus (including strains producing penicillinase), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus spp.
groups of viridans; Gram-negative aerobes: Acinetobacter calcoaceticus, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae (including strains forming penicillinase), Haemophilus parainfluenzae, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella catarrhalis, (including penicillinase-producing strains), Morganella morganii, Neisseria gonorrhoeae (including strains forming penicillinase), Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Serratia spp. (including Serratia marcescens), Borrelia burgdorferi; individual strains of Pseudomonas aeruginosa are also sensitive; anaerobes: Bacteroides fragilis, Clostridium spp. (except Clostridium difficile), Peptostreptococcus spp.
It has in vitro activity against most strains of the following microorganisms, although the clinical significance of this is unknown: Citrobacter diversus, Citrobacter freundii, Providencia spp., Providencia rettgeri, Salmonella spp., (Including Salmonella typhi), Shigella spp .;
Streptococcus agalactiae, Bacteroides bivius, Bacteroides melaninogenicus.
Methicillin-resistant staphylococci are resistant to cephalosporins, incl.
to ceftriaxone, many Streptococcus strains of group D and enterococci, incl. Enterococcus faecalis, also resistant to ceftriaxone.
PHARMACOKINETICS

Bioavailability - 100%, time to reach C max after i / m introduction - 2-3 hours, after IV introduction - at the end of injection.
C max after i / m introduction in doses of 0.5 and 1 g - about 38 and 76 m kg / ml, respectively. C max with iv administration in doses of 0.5; 1 and 2 g - an average of 82, 151 and 257 μg / ml, respectively. In adults, 2-24 hours after the administration of a dose of 50 mg / kg, the concentration in the cerebrospinal fluid (CSF) is many times greater than the minimal inhibitory concentration (MIC) for the most common meningitis pathogens. It penetrates well into CSF ​​with inflammation of the meninges. The connection with plasma proteins is 83-96%. V d - 0.12-0.14 l / kg (5.78-13.5 l), in children - 0.3 l / kg. the plasma clearance is 0.58-1.45 l / h. renal 0.32-0.73 l / h.
T 1/2 after the / m administration - 5.8-8.7 hours, after iv introduction at a dose of 50-75 mg / kg in children with meningitis - 4.3-4.6 hours;
in patients on hemodialysis (creatinine clearance 0-5 ml / min), -14.7 h, with creatinine clearance of 5-15 ml / min - 15.7 h, 16-30 ml / min - 11.4 h, 31-60 ml / min - 12.4 hours.
Output unchanged - 33-67% of the kidneys;
40-50% - with bile in the intestine, where the inactivation occurs. About 70% of the drug is excreted through the kidneys in newborn infants. Hemodialysis is ineffective.
INDICATIONS

Infectious and inflammatory diseases caused by microorganisms sensitive to ceftrnaxone: infections of the abdominal cavity organs (peritonitis, inflammatory diseases of the gastrointestinal tract (GIT), bile ducts including cholangitis, empyema of the gallbladder), pelvic infection, lower respiratory infections pathways (including pneumonia, lung abscess, pleural empyema), acute otitis media, infections of bones and joints, skin and soft tissues (including infected wounds and burns), urinary tract infections (complicated and not
slozhnennye), uncomplicated gonorrhea, bacterial meningitis, bacterial septicemia, Lyme disease (borreliosis). Prevention of postoperative infections. Infectious diseases in persons with weakened immunity.
DOSING MODE

In / in (drip and jet) and / m.
Do not use calcium-containing solutions for breeding!
Adults and children over 12 years - 1-2 grams per day or 0.5-1 g every 12 hours, the total daily dose should not exceed 4 g. The dose for newborns is 20-50 mg / kg / day.

For infants and children under 12, the maximum daily dose is 50-75 mg / kg.
In children with a body weight of 50 kg and above, doses for adults are used. A dose of more than 50 mg / kg of body weight should be given as an IV infusion for 30 minutes. The length of the course depends on the nature and severity of the disease.Lyme disease: adults and children - 50 mg / kg (but not more than 2 g) 1 time per day for 14 days.
With uncomplicated gonorrhea - in / m once 250 mg.

For the prevention of postoperative complications - once 1 g for 30-60 minutes before the operation.
In operations on the colon and rectum, additional administration of a drug from the group of 5-nitroimindazoles is recommended.
For bacterial meningitis in children, the initial dose is 100 mg / kg (but not more than 4 g) 1 time per day, then 100 mg / kg / day (but not more than 4 g) once a day or divided into 2 divided doses 12 h) or can be reduced.

The duration of treatment is 7-14 days.

For children with skin and soft tissue infections, the recommended daily dose is 50-75 mg / kg 1 time per day or 25-37.5 mg / kg every 12 hours. For severe infections of another site, 25-37.5 mg / kg every 12 hours. Maximum daily intake in children should not exceed 2 g.

In the treatment of acute otitis media in children - in / m, once.
50 mg / kg, not more than 1 g.
Patients with chronic renal insufficiency (CRF) dose adjustment is required only with creatinine clearance (CC) below 10 ml / min.
In this case, the daily dose should not exceed 2 g. Patients on hemodialysis do not require an additional dose after a hemodialysis session, however, it is necessary to control the concentration of ceftriaxone in the plasma, since its excretion in such patients may be slowed down (dose adjustment may be required).
In patients with renal-hepatic insufficiency, the daily dose should not exceed 2 g without determining the concentration of the drug in the blood plasma.
Treatment with ceftriaxone should continue for at least 2 more days after the disappearance of symptoms and signs of infection. The course of treatment is usually 4-14 days, with complicated infections may require a longer introduction. The course of treatment for infections caused by Streptococcus pyogenes should be at least 10 days.
Rules for the preparation and administration of solutions: use only freshly prepared solutions.
For the / m introduction 0.5 g of the drug is dissolved in 2 ml, and 1 g - in 3.5 ml of a 1% solution of lidocaine. Recommend to enter no more than 1 g in one muscle.
For intravenous injection, 0.5 g is dissolved in 5 ml, and 1 g - in 10 ml of water for injection.
Enter into / in slowly (2-4 minutes).
For intravenous infusions, dissolve 2 g in 40 ml of a solution that does not contain calcium (0.9% sodium chloride solution, 5-10% dextrose solution, 5% levulose solution).
Doses of 50 mg / kg or more should be administered intravenously in drip, for 30 minutes.
SIDE EFFECT

Allergic reactions: rash, itching, fever, or chills.

Local reactions: with intravenous injection - phlebitis, tenderness along the vein;
Intramuscular injection - soreness, sensation of warmth, tightness or condensation at the injection site.
From the side of the central nervous system: headache, dizziness.

On the part of the reproductive system: candidiasis of the vagina, vaginitis.

On the part of the digestive system: diarrhea, nausea, vomiting, taste disorders, pseudomembranous colitis.

On the part of the organs of hematopoiesis: anemia (including hemolytic), leukopenia, lymphopenia, neutropenia, thrombocytopenia, thrombocytosis, eosinophilia.

Laboratory indicators: increase (decrease) in prothrombin time, hematuria, increased activity of "liver" transaminases and alkaline phosphatase (APF), hyperbilirubinemia, hypercreatininemia, increased urea concentration, the presence of sediment in the urine.

Other: increased sweating, "hot flashes" of blood.

Undesirable reactions with a frequency of less than 0.1%: abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, cholelithiasis, bronchospasm, colitis, dyspepsia, epistaxis, bloating, "sluggish phenomenon" of the gallbladder, glucosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, convulsions, serum sickness, stomatitis, glossitis, oliguria, allergic dermatitis, urticaria, edema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome.

CONTRAINDICATIONS

Hypersensitivity (including to other cephalosporins, penicillins, carbapenems);
Hyperbilirubinemia in newborns; Newborns, who are shown IV administration of solutions containing calcium; lactation period.
Carefully.
Premature infants, renal and / or hepatic insufficiency, ulcerative colitis, enteritis or colitis associated with the use of antibacterial drugs.
Application of the drug during pregnancy and during lactation.
In pregnancy, the drug is used only if the intended benefit to the mother exceeds the potential risk to the fetus. When applying the drug, breast-feeding should be discontinued.
PREGNANCY AND LACTATION

In pregnancy, the drug is used only if the intended benefit to the mother exceeds the potential risk to the fetus.
When applying the drug, breast-feeding should be stopped

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution: kidney failure.
Patients with chronic renal insufficiency (CRF) dose adjustment is required only with creatinine clearance (CC) below 10 ml / min.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution: liver failure.

APPLICATION FOR CHILDREN

Contraindicated in hyperbilirubinemia in newborns.
Do not use in newborns who are shown iv administration of solutions containing calcium. With caution: premature babies

SPECIAL INSTRUCTIONS

With simultaneous severe renal and hepatic insufficiency, as well as in patients on hemodialysis, the concentration of the drug in plasma should be regularly determined.

With long-term treatment, it is necessary to regularly monitor the picture of peripheral blood, indicators of the functional state of the liver and kidneys.
In rare cases, ultrasound examination (ultrasound) of the gallbladder shows blackouts (precipitates of the calcium salt of ceftriaxone), which disappear after the cessation of treatment. With the development of symptoms or signs indicating a possible gallbladder disease, or if there are ultrasound signs of a "slang phenomenon," it is recommended that the drug be discontinued. The use of the drug describes rare cases of pancreatitis, which may have developed due to obstruction of the biliary tract (previous drug therapy, severe co-morbidities, completely parenteral nutrition), and the starting role of precipitate formation in the biliary tract under the influence of ceftriaxone can not be ruled out. Does not contain an N-methylthiotetrazol group, which causes disulfiram-like effects with simultaneous use of ethanol and bleeding, which are inherent in some cephalosporins. When using the drug, rare cases of prothrombin time change are described.
Patients with vitamin K deficiency (impaired synthesis, eating disorders) may need to monitor prothrombin time and prescribe vitamin K (10 mg / week) with an increase in prothrombin time before or during therapy.

Cases of fatal reactions as a result of deposition of ceftriaxone-calcium precipitates in the lungs and kidneys of newborns are described.
Theoretically, there is a probability of interaction of ceftriaxone 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, incl. through separate accesses for infusions at different sites. Theoretically, based on the calculation of 5 half-lives of ceftriaxone, the interval between the administration of ceftriaxone and calcium-containing solutions should be at least 48 hours.
In the treatment of ceftriaxone, false-positive results of Coombs test, a test for galactosemia, glucose in urine (glucosuria is recommended to be determined only by enzyme method).

Impact on the ability to drive vehicles and manage mechanisms.
Patients using ceftriaxone should be careful when driving a car and engaging in other potentially dangerous activities that require increased attention and speed of psychomotor reactions.
OVERDOSE

Excessively high concentrations of ceftriaxone in plasma can not be reduced by hemodialysis or peritoneal dialysis.
Symptomatic measures are recommended for the treatment of overdose cases. There is no specific antidote.
DRUG INTERACTION

Bacteriostatic antibiotics reduce the bactericidal effect of ceftriaxone.
Pharmaceutically incompatible with solutions containing calcium (including Hartman and Ringer's solution), as well as with amsacrine, vancomycin, fluconazole and aminoglycosides.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

At a temperature of no higher than 25 ° C in a dark place.
Keep out of the reach of children.
Shelf life.
3 years. Do not use after the expiration date printed on the package.
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