Description
Release form
Powder for solution for injection
Packaging
In a bottle of 1 g of powder.
Pharmacological action
Semisynthetic cephalosporin III generation broad-spectrum antibiotic.
The bactericidal activity of ceftriaxone is due to inhibition of cell membrane synthesis. The drug is highly resistant to beta-lactamases (penicillinases and cephalosporinases) of gram-positive and gram-negative microorganisms.
Ceftriaxone is active against gram-negative aerobic microorganisms: Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Klebssiella spp. (including Klebssiella pneumoniae), Neisseria gonorrhoeae (including strains forming and non-forming penicillinase), Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Serratia marcescens, Citrobacter freundii, Citrobacterppers. , Salmonella spp., Shigella spp., Acinetobacter calcoaceticus.
A number of strains of the above microorganisms that show resistance to other antibiotics, such as penicillins, cephalosporins, aminoglycosides, are sensitive to ceftriaxone.
Certain strains of Pseudomonas aeruginosa are also sensitive to the drug.
The drug is active against gram-positive aerobic microorganisms: Staphylococcus aureus (including penicillinase-forming strains), Staphylococcus epidermidis (methicillin-resistant staphylococci, are resistant to all cephalosporins, ceftriococcus pyrexeton, pyrophytococcus resistance) A), Streptococcus agalactiae (group B streptococci), Streptococcus pneumoniae of anaerobic microorganisms: Bacteroides spp., Clostridium spp. (excluding Clostridium difficile).
Indications
Treatment of functional symptoms of benign prostatic hyperplasia. biliary and gastrointestinal infections)
bone and joint infections
skin and soft tissue infections
wound infections
infections in immunocompromised patients
pelvic infections
kidney and urinary tract infections
respiratory tract infections (especially pneumonia) ENT infections
genital infections, including gonorrhea.
Prevention of infections in the postoperative period.
Contraindications
– Hypersensitivity (including to ceftriaxone, carbapenems, penicillins).
– I trimester of pregnancy.
Precautions:
– Hyperbilirubinemia in newborns.
– Premature babies.
– Renal / Hepatic Insufficiency.
– Nonspecific ulcerative colitis.
– Enteritis or colitis associated with the use of antibacterial drugs.
– Pregnancy – trimester.
– During lactation.
Use during pregnancy and lactation
During pregnancy, use only if the intended benefit to the mother outweighs the risk to the fetus (Ceftriaxone crosses the placental barrier). If necessary, the use of the drug during lactation should (Ceftriaxone excreted in breast milk).
Special instructions
Despite a detailed history, which is the rule for other cephalosporin antibiotics, the possibility of the development of anaphylactic shock, which requires immediate treatment, cannot be ruled out – first adrenaline is administered intravenously, then glucocorticoids. Ultrasound examination of the gallbladder sometimes indicates a shadow indicating precipitation. This symptom disappears after the end or temporary cessation of therapy with ceftriaxone. Even in the presence of pain, such cases do not require surgical intervention, conservative treatment is sufficient.
In vitro studies have shown that, like other cephalosporin antibiotics, ceftriaxone is able to displace bilirubin bound to serum albumin. Therefore, in newborns with hyperbilirubinemia, and especially in premature infants, the use of Ceftriaxone requires even greater caution.
In case of arterial hypertension and disturbance of the water-electrolyte balance, it is necessary to check the sodium level in plasma. With simultaneous severe renal and hepatic insufficiency, in patients undergoing hemodialysis, the plasma concentration of the drug should be regularly determined, because they may decrease the rate of its excretion, with prolonged treatment, it is necessary to regularly monitor the picture of peripheral blood, indicators of the functional state of the liver of the kidneys.
Ethanol is contraindicated during treatment – disulfiram-like effects are possible (facial flushing, cramping in the abdomen and stomach, nausea, vomiting, headache, lowering blood pressure, tachycardia, shortness of breath).
Elderly and debilitated patients may need vitamin K. Ceftriaxone is used only in a hospital!
Composition
1 vial of powder for solution for injection contains: ceftriaxone sodium 1.0 g (in terms of ceftriaxone).
Dosage and administration
The drug is administered intramuscularly and intravenously.
For adults and for children over 12 years: the average daily dose is 1-2 g of Ceftriaxone once a day or 0.5-1 g every 12 hours. In severe cases or in cases of infections caused by moderately sensitive pathogens, the daily dose of hometta should be increased to 4 g.
For newborns and infants and children up to 12 years of age: with a single daily dosage, the following scheme is recommended – for newborns (up to two weeks of age): 20-50 mg / kg per day (a dose of 50 mg / kg is not allowed to be exceeded due to immature enzyme system of newborns) for infants and children and children under 12 years old – the daily dose is 20-80 mg / kg. In children weighing 50 kg or more, adult dosage should be followed. Intravenous doses of 50 mg / kg or higher should be administered dropwise for at least 30 minutes. Duration of therapy: depends on the course of the disease. As always with antibiotic therapy, administration of the drug should be continued for patients for at least 48-72 hours after normalization of temperature and confirmation of the eradication of the pathogen.
Lyme borreliosis: 50 mg / kg (highest daily dose – 2 g) for adults and children over 12 years of age once a day for 14 days.
Meningitis: In bacterial meningitis in infants and young children, the initial dose is 100 mg / kg once a day (maximum 4 g). Once it was possible to isolate the pathogenic microorganism and determine its sensitivity, it is necessary to adjust the dose.
Gonorrhea: for the treatment of gonorrhea caused by both forming and non-forming penicillinase strains, the recommended dose is 250 mg once intramuscularly.
Prevention in the preoperative period: 30-90 minutes before surgery, a single administration of Ceftriaxone in a dose of 1-2 g is recommended.
Use in patients with impaired liver and / or kidney function: in patients with impaired renal function, subject to normal liver function, there is no need to reduce the dose of Ceftriaxone. Only with severe renal failure (creatinine clearance below 10 ml / min), it is necessary that the daily dose of Ceftriaxone does not exceed 2 g. In patients with impaired liver function, while maintaining renal function, the dose of Ceftriaxone is also not necessary. In cases of simultaneous presence of severe pathology of the liver and kidneys, the concentration of ceftriaxone in the blood serum must be regularly monitored. In patients undergoing hemodialysis, there is no need to change the dose of the drug.
Intramuscular injection: for intramuscular administration, Ceftriaxone 0.5 g must be diluted in 2 ml, and Ceftriaxone 1 g in 3.5 ml of a 1% lidocaine solution and injected deep into the gluteus muscle (not more than 1 g of the drug in one buttock). The lidocaine solution should never be administered intravenously!
Intravenous administration: for intravenous injection, Ceftriaxone 0.5 g must be diluted in 5 ml, and Ceftriaxone 1 g in 10 ml of sterile distilled water and administered slowly intravenously for 2-4 minutes.
Intravenous Infusion: The duration of the intravenous infusion is at least 30 minutes. For intravenous infusion, 2 g of the powder must be diluted in approximately 40 ml of a calcium-free solution, for example: in a 05% sodium chloride solution, in a 0.45% sodium chloride solution containing 2.5% glucose, in 5% glucose solution, in 10 % glucose solution, 5% fructose solution, in a 6% solution of dextran.
Drug interaction
Ceftriaxone and aminoglycosides have synergies with many gram-negative bacteria. Incompatible with ethanol. Nonsteroidal anti-inflammatory drugs and other platelet aggregation inhibitors increase the chance of bleeding. With simultaneous use with “loop” diuretics and other nephrotoxic drugs, the risk of developing nephrotoxicity increases. Pharmaceutically incompatible with solutions containing other antibiotics or other solvents, except as listed above. Ceftriaxone, by inhibiting the intestinal flora, inhibits the synthesis of vitamin K.
Overdose
Symptoms: excitation of the central nervous system, convulsions. With an overdose, hemodialysis and peritoneal dialysis will not reduce the concentration of the drug. There is no special antidote.
Treatment: symptomatic.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 20 ° C.
Active ingredient
Ceftriaxone
Form of Treatment
simply entails dlya inaektsiy and infusing
Destination
Pregnant Purpose, Adult Purpose Doctor, prescription
Indications of respiratory infections From respiratory infections , From otitis media, From cholecystitis, From bile duct infections, From sinusitis, From bronchitis, From intestinal infections, From osteomyelitis, From urinary tract infections, From lung infections, From skin infections
Possible product names
CEFTRIAXON – LEXVM POR. D / PRIG. R-RA FOR I / O AND I / O INTRODUCTION. FL 1G No. 1 (IND.UP.)
CEFTRIAXON POR. D / IN. FL 1G
CEFTRIAXON POR. D / PREPARATION. R-RA V / V AND V / M INTRODUCTION. FL 1G. No. 50
Ceftriaxone 1 g No. 1 v / v, oil
Ceftriaxone 1 g No. 50 v / v, oil
