Composition, form of production and packaging
Powder for solution preparation for intravenous administration 1 fl.
cefuroxime (in the form of a sodium salt) 1.5 g
Vials (1) - 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 of the second generation. It acts bactericidal (it breaks the synthesis of the bacterial cell wall). Has a wide spectrum of antimicrobial action.
It is active against the following microorganisms:
Aerobes, Gram-positive :
Staphylococcus spp. ( sensitive to methicillin ), including Staphylococcus aureus ( sensitive to methicillin ), Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus group B ( Streptococcus agalactiae), Streptococcus mitis ( viridans group ) (and other beta-hemolytic streptococci ), most Clostridium spp.
Aerobics, Gram-negative:
Escherichia coli, Haemophilus influenzae, including strains resistant to ampicillin ; Haemophilus parainfluenzae, including strains resistant to ampicillin ; Klebsiella spp .; Moraxella catarrhalis; Neisseria gonorrhoeae, including strains that produce and do not produce penicillinase ; Proteus mirabilis; Providencia spp. includingProvidencia rettgeri; Neisseria meningitidis; Salmonella spp .; Borrelia burgdorferi; Bordetella pertussis; Shigellae spp.
Anaerobes:
Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp, Fusobacterium spp.
Moderately sensitive microorganisms:
Acinetobacter spp., Citrobacter spp., Enterobacter spp., Morganella morganii.
Resistant
Bacteroides fragilis, Clostridium difficile, Enterococcus spp., Listeria monocytogenes, Proteus vulgaris, Pseudomonas spp., Serratia spp., Legionella spp., Staphylococcus spp . (resistant to methicillin); Mycobacterium spp; Acinetobacter calcoaceticus; Campylobacter spp.
PHARMACOKINETICS
After an intravenous injection, 0.75 g of C max in plasma of 27 Ојg / ml is reached after 45 minutes, 8 hours after the administration, the drug is present in the plasma at the determined concentrations.
With intravenous administration of 0.75 and 1.5 g C max in plasma is achieved after 15 minutes and is 50 and 100 Ојg / ml, respectively. The therapeutic concentration remains 5.3 and 8 hours, respectively.
Cefuroxime is well distributed to organs and tissues of the body; therapeutic concentrations are determined in pleural fluid, sputum, bone tissue, soft tissues, synovial and intraocular fluid.
When meningitis penetrates the blood-brain barrier.
About 50% of cefuroxime binds to plasma proteins. The drug passes through the placenta and penetrates into breast milk. Cefuroxime is not metabolized.
The half-life of the plasma is about 70 minutes; in patients with impaired renal and neonatal function, the half-life of plasma is increased to 2-2.5 hours.
It is excreted by the kidneys through glomerular filtration and canaliculia secretion. Within 24 hours after parenteral administration, cefuroxime is almost completely (85-90%) excreted by the kidneys unchanged, most of the drug in the first 6 hours, a small amount is excreted in the bile.
INDICATIONS
Infectious-inflammatory diseases caused by sensitive microorganisms, including:
- respiratory tract infections and ENT organs: acute and chronic bronchitis, pneumonia, lung abscess, postoperative infectious diseases of the thorax, otitis media, sinusitis, tonsillitis and pharyngitis;
- Urinary tract infections: acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria;
- Gonorrhea;
- skin and soft tissue infections: cellulitis, erysipelas, wound infection, pyoderma, impetigo, furunculosis, erysipeloid;
- infections of bones and joints: osteomyelitis and septic arthritis;
- infection of the pelvic organs;
- septicemia, meningitis, peritonitis;
- Lyme disease (borreliosis);
Prevention of infections after surgery.
DOSING MODE
In / m, in / in (struyno, drip).
Doses for adults:
0.75 g 3 times a day. In cases of a more severe course of infection, the dose can be increased to 1.5 g 3 times a day.
If necessary, the interval between administrations can be reduced to 6 hours (daily dose of 3 to 6 g).
Treatment is continued for 48-72 hours after the disappearance of the symptoms of the disease.
Doses for children older than 3 months
from 30 to 100 mg / kg / day in three to four injections. Most infections use a dose of 60 mg / kg / day.
Doses for newborns and children under 3 months
30 mg / kg / day in 2-3 injections.
Gonorrhea (for adults)
1.5 g once (two doses of 750 mg IM in different areas, for example, in both gluteal muscles).
Meningitis:
Adults: 3 g IV every 8 hours.
Children younger and older: 150-250 mg / kg / day iv in 3-4 injections.
Newborns: The initial dose is 100 mg / kg / day IV in 2-3 injections.
Prevention of postoperative complications
When carrying out abdominal, orthopedic operations and operations on pelvic organs, the usual dose is 1.5 g IV in case of an initial anesthesia. It is possible to additionally administer two doses of 0.75 g IM at 8 and 16 h after the operation. In operations on the heart, lungs, esophagus and vessels, the usual dose is 1.5 g IV with an initial anesthesia, after which for the next 24-48 hours, 0.75 g IM is injected three times per day.
In operations to completely replace the joint, 1.5 g of Xorim powder can be added to each package before mixing the cement polymer methyl methacrylate with the liquid monomer.
Pneumonia
in / m or in / in. for 1.5 g 2-3 times a day, 7-10 days.
Exacerbation of chronic bronchitis
in / m or in / in, for 0.75 g 2-3 times a day, 5-10 days.
Dosing regimen for renal dysfunction:
Creatinine clearance (mL / min) Recommended dose of Xorima (g)
> 20 0.75 g-1.5 g 3 times a day
10-20 0.75 g 2 times a day
<10 0.75 g 1 time per day
In patients with creatinine clearance above 20 ml / min, there is no need to reduce the standard dose of the drug (750 mg-1.5 g 3 times per day).
The dosage regimen for renal dysfunction in children is adjusted in accordance with the recommendations for adults.
Patients who are on continuous hemodialysis using an arteriovenous shunt or on high-speed haemofiltration in intensive care units are prescribed 750 mg 2 times a day; for patients on low-velocity haemofiltration, doses recommended for renal impairment are prescribed.
Patients on hemodialysis need an additional dose of 0.75 g of Xorim at the end of each dialysis procedure.
Rules for the preparation of solutions
Ksorim 0.75 g: for the preparation of a solution for the / m introduction
add 3 ml of water for injections into the vial; gently shake until a suspension is obtained.
Xorim 1.5 g is not intended for intramuscular administration.
Ksorim 0.75 g and 1.5 g: for the preparation of solution for intravenous administration
add at least 6 ml of solvent (water for injection, 0.9% solution of sodium chloride or 5% solution of glucose) into bottles of 0.75 g and at least 15 ml in 1.5 g bottles;gently shake until a clear solution is obtained.
Ksorim 1.5 g: for the preparation of a solution for infusions
add 50 ml of solvent (water for injection, 0.9% sodium chloride solution or 5% glucose solution) into the vial; gently shake until a clear solution is obtained.
The content and concentration of Xorim, used in the form of a solution, are given in the table below.
Xorim [mg] per vial Volume [ml] of added solvent Volume [ml] of the solution obtained Ksorim concentration [mg / ml]
750 6 6.8 110
1500 15 16.5 91
1500 50 51.5 29
SIDE EFFECT
The frequency of occurrence of side effects is characterized as very often (> 10%), often (> 1% <10%), sometimes (> 0.1% <1%), rare (> 0.01% <0.1%) and very rare (<0.01% ).
On the part of the hemopoiesis : a decrease in the level of hemoglobin, eosinophilia, leukopenia, neutropenia and thrombocytopenia; very rare - hemolytic anemia.
Allergic reactions : chills, skin itching, rash, urticaria; rarely - serum sickness, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis, drug fever; very rarely - bronchospasm, anaphylactic shock, vasculitis.
From the side of the central nervous system : sometimes - headache, dizziness; very rare - an excited state, nervousness, confusion, convulsions.
On the part of the digestive system : nausea, vomiting, cramps and abdominal pain, diarrhea, ulceration of the oral mucosa; sometimes - a transient increase in the activity of "liver" enzymes (alanine aminotransferase, aspartate aminotransferase), alkaline phosphatase and lactate dehydrogenase, hyperbilirubinemia; rarely -pseudomembranous colitis; very rarely - jaundice.
From the urinary system : dysuria, increased serum creatinine and urea levels, especially in patients with impaired renal function; sometimes - renal dysfunction, acute interstitial nephritis.
Other : candidiasis, superinfection, hearing loss, itching in the perineum, vaginitis.
Local reactions : with the / m introduction - irritation, infiltration and soreness at the injection site, with iv injection - phlebitis.
Laboratory indicators : false-positive Coombs reaction (may affect the results of cross-compatibility tests of blood).
CONTRAINDICATIONS
- hypersensitivity to cefuroxime or other cephalosporins, penicillins, carbapenems.
With caution: chronic renal failure, neonatal period, prematurity, bleeding and gastrointestinal tract diseases (including in history, ulcerative colitis), weakened and depleted patients, pregnancy.
PREGNANCY AND LACTATION
The use of the drug during pregnancy is possible only if the intended benefit for the mother exceeds the potential risk to the fetus.
If you need to use the drug during lactation, you should decide whether to stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution in chronic renal failure.
APPLICATION FOR CHILDREN
With caution: the period of newborns, prematurity.
SPECIAL INSTRUCTIONS
In patients with allergic reactions in the anamnesis to penicillins, hypersensitivity to cephalosporin antibiotics is possible. In the process of treatment, control of kidney function is necessary, especially in patients receiving the drug in high doses. Treatment continues for 48-72 hours after the disappearance of symptoms, in the case of infections caused by Streptococcus pyogenes, treatment course - at least 7-10 days. When treating patients, it is necessary to take into account the risk of developing pseudomembranous colitis. With the development of colitis, drug use should be discontinued and appropriate treatment initiated.
During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible. In patients receiving cefuroxime, glucose oxidase or hexokinase tests are recommended when determining blood glucose concentrations.
OVERDOSE
Symptoms: increased excitability of the cerebral cortex with the development of seizures.
Treatment: symptomatic therapy, hemodialysis or peritoneal dialysis.
DRUG INTERACTION
Simultaneous administration of "loop" diuretics slows down the tubular secretion, reduces renal clearance, increases plasma concentration and increases the half-life of cefuroxime.
When used simultaneously with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.
It is 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, Ringer's solution , Hartman's solution, sodium lactate solution, heparin (10 U / ml and 50 U / ml) in a 0.9% solution of sodium chloride. Pharmaceutically incompatible with aminoglycosides, sodium bicarbonate solution.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B.
The drug should be stored in a dark place at a temperature of no higher than 25 В° C. Keep out of the reach of children.
The prepared solution is stored in a dark place at a temperature of 2 В° - 8 В° C.
Shelf life - 2 years.
Shelf life of the prepared solution is 24 hours. Do not use the drug after the expiry date.
