STERICEF

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 injection1 fl.
ceftriaxone (sodium salt)1 g

Bottles (1) – packs cardboard.

Powder for solution for injection1 fl.
ceftriaxone (sodium salt)250 mg

Bottles (1) – packs cardboard.

Powder for solution for injection1 fl.
ceftriaxone (sodium salt)500 mg

Bottles (1) – packs cardboard.

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: Gram-positive aerobes – 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: at / in the introduction – phlebitis, pain along the vein; / m introduction – tenderness at the injection site. 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”-syndrome), 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, activity increase “Hepatic” transaminases and alkaline phosphatase, 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 s daily dose – 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. Gonorrhoea – / m once, 250 mg. For the prevention of postoperative complications – single, 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. In bacterial meningitis in infants and young children – 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. Children with infections of the skin and soft tissues – daily dose 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.. Localization – 25-37.5 mg / kg every 12 no, no more 2 g / day. When otitis media – / m, 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 g – in 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 g – in 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. During treatment contraindicated the use of ethanol – possible effects disulfiramopodobnye (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. Together with the application “loop” diuretics, etc.. nephrotoxic drugs increases the risk of nephrotoxicity. Pharmaceutically compatible with solutions, containing other. antibiotics.

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