Zinacef powder for injection vial 750mg №1

II generation cephalosporin antibiotic for oral and parenteral use. Bactericidal effect (violates the synthesis of the bacterial cell wall). It has a wide spectrum of antimicrobial action. Highly active against Gram-positive microorganisms, including strains resistant to penicillins (except for strains resistant to methicillin), Staphylococcus aureus, Streptococcus pyogenes (et al. Beta-hemolytic streptococci), Streptococcus pneumoniae, Streptococcus Group B (Streptococcus agalactiae), Streptococcus mitis (viridans group), Bordetella pertussis, most Clostridium spp.), gram-negative microorganisms (Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgeri, Haemophilus influenzae, including ampicillin-resistant strains, which are non-ampicillin-like, and have a number of people who are resistant to ampicillinus, and they can be used as a source, which can be used by a non-human, non-human, for example, for non-ampicillus sop. ampicillin-resistant, Moraxella catarrhalis, Neisseria difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus, Staphylococcus epidermidis, Legionella spp., Streptococcus (Enterococcus) faecalis, Morganella morganii, Proteus vulgaris, Enterobacter spp., Citrobacter spp., Serratia spp., Bacteroides fragilis.

Parenteral administration: after i / m administration, 750 mg of Cmax is achieved in 15-60 minutes and is 27 μg / ml. With the on / in the introduction of 750 mg and 1.5 g Cmax after 15 min is 50 and 100 μg / ml, respectively. The therapeutic concentration is maintained at 5.3 and 8 h, respectively. T1 / 2 with in / in and in / m injection - 1.3-1.5 h, in newborns - in 2-2.5 h.Communication with plasma proteins - 33-50%. Not metabolized in the liver. Excreted by the kidneys by glomerular filtration and tubular secretion of 85-90% unchanged for 8 hours (most of the drug is excreted during the first 6 hours, creating high concentrations in the urine); after 24 hours it is cleared completely (50% - by canalicular secretion, 50% - by glomerular filtration). Therapeutic concentrations are recorded in the pleural fluid, bile, sputum, myocardium, skin and soft tissues. Cefuroxime concentrations exceeding the IPC for most microorganisms can be achieved in bone tissue, synovial and intraocular fluids. When meningitis penetrates the BBB. It passes through the placenta and penetrates into breast milk. Inside: it is well absorbed and quickly hydrolyzed in the intestinal mucosa, distributed in extracellular fluid. Bioavailability after a meal increases (up to 37-52%). Cmax in plasma is created after applying the pills after 2.5-3 hours, suspensions - 2.5-3.5 hours, T1 / 2 - 1.2-1.3 hours and 1.4-1.9 hours, respectively. It is excreted unchanged by the kidneys: in adults, 50% of the dose after 12 hours. In case of impaired renal function, T1 / 2 is extended.

Indications and usage

Bacterial infections caused by susceptible microorganisms: respiratory diseases (bronchitis, pneumonia, lung abscess, empyema, etc.), ENT organs (sinusitis, tonsillitis, pharyngitis, otitis, etc.), urinary tract (pyelonephritis, cystitis, asymptomatic bacteriuria, gonorrhea, etc.), skin and soft tissues (erysipelas, pyoderma, impetigo,furunculosis, phlegmon, wound infection, erisipeloid, etc.), bones and joints (osteomyelitis, septic arthritis, etc.), pelvic organs (endometritis, adnexitis, cervicitis), sepsis, meningitis, borreliosis, prevention of infectious complications during organ surgery chest, abdominal cavity, pelvis, joints (including during operations on the lungs, heart, esophagus, in vascular surgery with a high degree of risk of infectious complications, orthopedic operations).

Contraindications

Hypersensitivity (including to other cephalosporins, penicillins and carbapenems). With care - the neonatal period, prematurity, chronic kidney disease, bleeding and gastrointestinal diseases (including history, ulcerative colitis), debilitated and exhausted patients, pregnancy, lactation

Dosing regimen

V / m, in / in or inside. In / in and / m adults appoint 750 mg 3 times a day; for severe infections, the dose is increased to 1,500 mg 3–4 times a day (if necessary, the interval between injections can be reduced to 6 hours). The average daily dose is 3000-6000 mg. Children are prescribed 30-100 mg / kg / day in 3-4 doses. For most infections, the optimal dose is 60 mg / kg / day. Newborns and children up to 3 months prescribed 30 mg / kg / day in 2-3 doses. For gonorrhea - in / m, 1500 mg once (or as 2 injections of 750 mg with the introduction in different areas, for example, in both gluteus muscles). With bacterial meningitis - in / in, 3000 mg every 8 hours; young children and older - 150-250 mg / kg / day in 3-4 doses, newborn - 100 mg / kg / day.During operations on the abdominal cavity, pelvic organs and during orthopedic operations - in / in, 1500 mg with the induction of anesthesia, then additionally in / m 750 mg, 8 and 16 hours after the operation. During operations on the heart, lungs, esophagus and vessels - in / in, 1500 mg with induction of anesthesia, then - in / m, 750 mg 3 times a day for the next 24-48 hours. For pneumonia - in / m or / in, 1500 mg 2-3 times a day for 48-72 hours, then move to the ingestion of 500 mg 2 times a day for 7-10 days. When exacerbation of chronic bronchitis is prescribed in the / m or / in, 750 mg 2-3 times a day for 48-72 h, then go to the oral administration of 500 mg 2 times a day for 5-10 days. With chronic kidney disease, correction of the dosage regimen is necessary: ​​with QC of 10-20 ml / min, 750 mg twice a day is prescribed intravenously or intramuscularly, and if QC is less than 10 ml / min, 750 mg is administered once a day. Patients on continuous hemodialysis using an arterio-venous shunt or on high-speed hemofiltration in intensive care units are prescribed 750 mg 2 times a day; for patients undergoing low-rate hemofiltration, doses recommended for impaired renal function are prescribed.

Adverse reactions

Allergic reactions: chills, rash, pruritus, urticaria, rarely - erythema multiforme, bronchospasm, malignant exudative erythema (Stevens-Johnson syndrome), anaphylactic shock. Local reactions: irritation, infiltration and pain at the injection site, phlebitis. From the genitourinary system: itching in the perineum, vaginitis. On the part of the urinary system: renal dysfunction, dysuria.On the part of the digestive system: diarrhea, nausea, vomiting, flatulence, cramps and abdominal pain, ulceration of the oral mucosa, oral candidiasis, glossitis, rarely - pseudomembranous enterocolitis, abnormal liver function, cholestasis. From the side of blood formation organs: anemia, eosinophilia, neutropenia, leukopenia, agranulocytosis, thrombocytopenia. Laboratory indicators: hypoprothrombinemia, prolongation of prothrombin time, decrease in Hb and hematocrit, increased activity of “liver” enzymes, alkaline phosphatase, LDH, hyperbilirubinemia. Overdose. Symptoms: CNS arousal, convulsions. Treatment: prescription of antiepileptic drugs, control and maintenance of vital body functions, hemodialysis, and peritoneal dialysis.

Special notes

Patients with a history of allergic reactions to penicillins may have hypersensitivity to cephalosporin antibiotics. In the course of treatment, control of renal function is necessary, especially in patients receiving the drug in high doses. Treatment is continued for 48-72 hours after the disappearance of symptoms, in the case of infections caused by Streptococcus pyogenes, the course of treatment is not less than 7-10 days. During treatment, a false-positive direct Coombs reaction and a false-positive reaction of urine to glucose are possible. The ready-to-use solution can be stored at room temperature for 7 hours, in a refrigerator for 48 hours. It is allowed to use the solution which has turned yellow during storage.Ethanol should not be consumed during treatment. In patients receiving cefuroxime, when determining the level of glucose in the blood, it is recommended to use tests with glucose oxidase or hexokinase. When switching from parenteral administration to ingestion, the severity of the infection, the sensitivity of the microorganisms and the general condition of the patient should be taken into account. If there is no clinical improvement within 72 hours after taking cefuroxime orally, then parenteral administration should be continued.

Simultaneous oral administration of "loop" diuretics slows down channel secretion, reduces renal clearance, increases plasma concentration and increases T1 / 2 cefuroxime. With simultaneous use with aminoglycosides and diuretics increases the risk of nephrotoxic effects. Drugs that reduce the acidity of gastric juice, reduce the absorption of cefuroxime and its bioavailability. Pharmaceutically compatible with aqueous solutions containing up to 1% Lidocaine hydrochloride, 0.9% sodium chloride solution, 5% and 10% dextrose solution, 0.18% sodium chloride solution and 4% dextrose solution, 5% dextrose solution and 0.9% sodium chloride solution, solution Ringer, Hartman solution, sodium lactate solution, Heparin (10 units / ml and 50 units / ml) in a 0.9% solution of sodium chloride. Pharmaceutically incompatible with aminoglycosides, sodium bicarbonate solution 2.74%.