Active material: Ceftriaxone
When ATH: J01DD04
CCF: III generation cephalosporins
When CSF: 06.02.03
Manufacturer: IPCA LABORATORIES Ltd. (India)
Pharmaceutical form, composition and packaging
| Powder for solution for injection |
1 fl. |
| ceftriaxone (sodium salt) |
1 g |
Bottles (1) – пачки картонные.
| Powder for solution for injection |
1 fl. |
| ceftriaxone (sodium salt) |
250 mg |
Bottles (1) – пачки картонные.
| Powder for solution for injection |
1 fl. |
| ceftriaxone (sodium salt) |
500 mg |
Bottles (1) – пачки картонные.
Pharmacological action
Cephalosporin antibiotic III generation broad-spectrum parenteral. Bactericidal activity due to suppression of the synthesis of the bacterial cell wall. Different resistant to most beta-lactamases of gram-negative and gram-positive microorganisms. It is active against the following microorganisms: грамположительные аэробы – Staphylococcus aureus (including strains, penicillinase), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans; Gram-negative aerobic: Acinetobacter calcoaceticus, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae (incl. strains, forming penicillinase), Haemophilus parainfluenzae, Klebsiella spp. (incl. Klebsiella pneumoniae), Moraxella catarrhalis, (including strains penitsillinprodutsiruyuschie), Morganella morganii, Neisseria gonorrhoeae (incl. strains, forming penicillinase), Neisseria meningitidis, Proteus is wonderful, Proteus vulgaris, Serratia spp. (incl. Serratia wilting); selected Pseudomonas aeruginosa strains are also sensitive; anaerobes: Bacteroides fragilis), Clostridium spp. (other than Clostridium difficile), Peptostreptococcus spp. It has in vitro activity against most strains of the following organisms, although the clinical significance of this is unknown: Citrobacter different, Citrobacter freundii, Providencia spp., Rettgeri Providence, Salmonella spp., (including Salmonella typhi), Shigella spp.; Streptococcus agalactiae, Bacteroides bivius, Bacteroides melaninogenicus. Metitsillinoustoychivye staphylococci resistant to cephalosporins, incl. ceftriaxone, many strains of group D streptococci and enterococci, incl. Enterococcus faecalis, also resistant to ceftriaxone.
Testimony
Bacterial infections, caused by susceptible microorganisms: abdominal infections (peritonitis, inflammatory diseases of the gastrointestinal tract, Biliary, incl. kholangit, gallbladder empyema), diseases of the upper and lower respiratory tract (incl. pneumonia, lung abscess, empyema), bone infections, joints, skin and soft tissue, urogenital area (incl. gonorrhea, pyelonephritis), bacterial meningitis and endocarditis, sepsis, infected wounds and burns, chancroid and syphilis, Lyme disease (ʙorrelioz), typhoid fever, salmonellosis, Salmonella carrier. Prevention of postoperative infections. Infectious diseases in people with weakened immune systems.
Contraindications
Hypersensitivity (incl. to others. cephalosporins, penicillins, carbapenems).C care. Hyperbilirubinemia in neonates, premature babies, kidney and / or liver failure, nespetsificheskiy yazvennыy colitis, эnterit or colitis, associated with the use of antibacterial drugs, pregnancy, lactation.
Side effects
Allergic reactions: fever, eozinofilija, skin rash, hives, itching, erythema multiforme exudative, swelling, anaphylactic shock, serum sickness, chills. Local reactions: при в/в введении – флебиты, pain along the vein; в/м введение – болезненность в месте введения. From the nervous system: headache, dizziness. From the urinary system: oligurija. From the digestive system: nausea, vomiting, taste disturbance, flatulence, stomatitis, glossitis, diarrhea, pseudomembranous enterocolitis; psevdoholelitiaz gallbladder (“sludge”-синдром), candidiasis, etc.. superinfekcii. From the side of hematopoiesis: anemia, leukopenia, leukocytosis, lymphopenia, neutropenia, granulocytopenia, thrombocytopenia, thrombocytosis, ʙazofilija, hematuria; nosebleeds, gemoliticheskaya anemia. Laboratory findings: increase (reduction) prothrombin time, повышение активности “печеночных” трансаминаз и ЩФ, giperʙiliruʙinemija, giperkreatininemiя, increasing concentrations of urea, glycosuria.
Dosing and Administration
B /, / m. Adults and children over 12 years - by 1-2 g 1 once a day, or 0.5-1 g every 12 no, the daily dose should not exceed 4 g. For newborns (to 2 Sun) – 20-50 mg / kg / day. For infants and children up to 12 лет суточная доза – 20-80 mg / kg. In children weighing 50 kg and higher doses employed for adult. The dose more 50 mg / kg of body weight should be administered in the form of in / infusion over 30 m. Course duration depends on the nature and severity of the disease. При гонорее – в/м однократно, 250 mg. Для профилактики послеоперационных осложнений – однократно, 1-2 g (depending on the severity of infection) for 30-90 minutes prior to surgery. With operations in the colon and rectum recommend additional injection of the drug from the group of 5-nitroimidazoles. При бактериальном менингите у грудных детей и детей младшего возраста – 100 mg / kg (but not more 4 g) 1 once a day. The duration of treatment depends on the pathogen and can range from 4 days to Neisseria meningitidis 10-14 days for susceptible strains Enterobacteriaceae. Детям с инфекциями кожи и мягких тканей – в суточной дозе 50-75 mg / kg 1 once a day, or 25-37.5 mg / kg every 12 no, no more 2 g / day. In severe infections, etc.. локализации – 25-37.5 mg / kg every 12 no, no more 2 g / day. При среднем отите – в/м, single, 50 mg / kg, no more 1 g. Patients with chronic renal failure dose adjustment is required only when the spacecraft below 10 ml / min. In this case, the daily dose should not exceed 2 g. Terms of preparation and administration solutions: Use only freshly prepared solutions. For the / m 0.25 or 0.5 g of drug dissolved in 2 ml, and 1 г – в 3.5 ml 1% lidocaine. Recommend enter no more 1 g in one buttock. For I / injection 0.25 or 0.5 g is dissolved in 5 ml, and 1 г – в 10 ml water for injection. Enter in / in slowly (2-4 m). For in / infusion dissolved 2 g 40 ml, containing no Ca2 + (0.9% NaCl solution, 5-10% Dextrose, 5% levulose solution). Doses 50 mg / kg or more should be administered in / in the drip, during 30 m.
Cautions
Ceftriaxone is used only in hospital. At simultaneous severe renal and hepatic failure, patients, hemodialysis, regularly to determine the concentration of drug in plasma. Long-term treatment should be regularly monitored picture peripheral blood, the functional state of the liver and kidneys. In rare cases, the gallbladder ultrasound marked blackout, which disappear after cessation of treatment. Even if this phenomenon is accompanied by pain in the right upper quadrant, recommends continuation of the appointment of an antibiotic and conduct symptomatic treatment. Во время лечения противопоказано употребление этанола – возможны дисульфирамоподобные эффекты (flushing of the face, abdominal cramps and stomach area, nausea, vomiting, headache, decrease in blood pressure, tachycardia, breathlessness). Freshly prepared solutions ceftriaxone physically and chemically stable for 6 hours at room temperature. If necessary, the appointment during lactation should stop breastfeeding. Elderly or debilitated patients may require vitamin K.
Cooperation
Ceftriaxone and aminoglycosides have synergistic against many Gram-negative bacteria. Incompatible with ethanol. NSAIDs, etc.. platelet aggregation inhibitors increases the likelihood of bleeding. При одновременном применении с “петлевыми” диуретиками и др. nephrotoxic drugs increases the risk of nephrotoxicity. Pharmaceutically compatible with solutions, containing other. antibiotics.