Universal reference book for medicines
Product name: CEPOPERABOL ® (CEFOPERABOL)

Active substance: cefoperazone

Type: Third generation cephalosporin

Manufacturer: АБОЛмед (Russia)
Composition, form of production and packaging
Powder for preparation of a solution for iv and in / m introduction
white or white with a yellowish shade of color.

1 f.

cefoperazone (in the form of the sodium salt) 500 mg

Solvent: water d / and (5 ml).

Vials with a capacity of 10 ml (1) - packs cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Vials of glass with a capacity of 10 ml (1) complete with a solvent (1 pc.) - packings of cellular contour (1) - packs of cardboard.

Vials with a capacity of 10 ml (5) - packings, cellular, planimetric (1) - packs cardboard.

Glass bottles with a capacity of 10 ml (5) complete with a solvent (amp 5 pcs.) - packings of cellular contour (2) - packs of cardboard.

Powder for preparation of a solution for iv and in / m introduction white or white with a yellowish shade of color.

1 f.

cefoperazone (in the form of sodium salt) 1 g

Solvent: water d / and (5 ml).

Vials with a capacity of 10 ml (1) - packs cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Vials of glass with a capacity of 10 ml (1) complete with a solvent (1 pc.) - packings of cellular contour (1) - packs of cardboard.

Vials with a capacity of 10 ml (5) - packings, cellular, planimetric (1) - packs cardboard.

Glass bottles with a capacity of 10 ml (5) complete with a solvent (amp 5 pcs.) - packings of cellular contour (2) - packs of cardboard.

Powder for preparation of a solution for iv and in / m introduction white or white with a yellowish shade of color.

1 f.

cefoperazone (in the form of the sodium salt) 2 g

Solvent: water d / and (5 ml).

Vials with a capacity of 10 ml (1) - packs cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Vials of glass with a capacity of 10 ml (1) complete with a solvent (1 pc.) - packings of cellular contour (1) - packs of cardboard.

Vials with a capacity of 10 ml (5) - packings, cellular, planimetric (1) - packs cardboard.

Glass bottles with a capacity of 10 ml (5) complete with a solvent (amp 5 pcs.) - packings of cellular contour (2) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

Cephalosporin antibiotic III generation for parenteral administration.
It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. Has a wide range of action.
It is active against gram-positive microorganisms Staphylococcus aureus and Staphylococcus epidermidis (strains producing and not producing penicillinase), Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic strain of group A), Streptococcus agalactiae (beta-hemolytic strain of group B), Enterococcus faecalis, many others strains of beta-hemolytic Streptococcus spp .;
Gram-negative microorganisms - Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp, Citrobacter spp, Haemophilus influenzae (strains, pneumoniae), Enterobacter spp, Citrobacter spp, Haemophilus influenzae (strains producing and not producing beta-lactamases), Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettqeri (formerly Proteus rettqeri), Providencia spp., Serratia spp. (including Serratia marcescens), Salmonella spp., Shigella spp., many strains of Pseudomonas aeruginosa and Pseudomonas of other species, some strains of Acinetobacter spp., Neisseria gonorrhoeae (strains producing and not producing beta-lactamases), Neisseria meningitides , Bordetella pertussis, Yersinia enterocolitica; anaerobic microorganisms - Gram-positive and Gram-negative cocci (including Peptococcus, Peptostreptococcus and Veilloneilla spp.), gram-positive sporo- and non-spore forming anaerobes (Clostridium spp., Eubacterium spp., Lactobacillus spp.) and Gram-negative (including Fusobacterium spp., many strains of Bacteroides fragilis spp ., Prevotella spp., Etc. representatives of strains of Bacteroides spp.).
PHARMACOKINETICS

The connection with plasma proteins is 82-93%.
T Cmax after intravenous administration - 1 to 2 hours, after IV , at the end of the infusion. With max after the / m administration of 1 g, 2 g - 65-75 μg / ml, 97 ml respectively; after a single intravenous injection of 1, 2, 3 and 4 g C max - 153, 252, 340, 506 μg / ml, respectively.With MAX in the urine after IM and in / in the introduction of 2 g - 1000 and more than 2200 μg / ml, respectively.
Achieves therapeutic concentrations in body tissues and fluids: peritoneal, ascitic fluid and cerebrospinal fluid (with meningitis), urine, bile, gallbladder walls, lungs, sputum, palatine tonsils and sinus mucosa, atria, kidneys, ureters, prostate, testicles , uterus, fallopian tubes, bones, cord blood and amniotic fluid.

V d is 0.14-2 l / kg.
T 1/2 - 1.62.4 h, regardless of the mode of administration, 2.8-4.2 h for hemodialysis, 2.2 h for newborns and children from 2 months to 11 years. It is excreted with bile - 70-80%, kidneys - 20-30% unchanged.
In patients with impaired liver function and bile duct obstruction, T 1/2 - 3-7 hours, urinary excretion - 90% m more.
Even with severe liver damage, therapeutic concentrations are achieved in bile, and T 1/2 is only 2-4 times lengthened.
In patients with renal-hepatic insufficiency can cumulate.

INDICATIONS

Treatment of bacterial infections:

- infections of the upper and lower respiratory tract;

- urinary tract infections;

- abdominal infections (peritonitis, cholecystitis, cholangitis, etc.);

- sepsis;

- meningitis;

- skin and soft tissue infections;

- infections of bones and joints;

- infectious and inflammatory diseases of the pelvic organs (endometritis, gonorrhea and other infections of the genital tract);

Prevention of infectious complications in abdominal, gynecological, cardiovascular and orthopedic operations.

DOSING MODE

In / in and / m.

Adults - in an average daily dose of 2-4 g 2 times / day.
In severe infections , the dose can be increased to 12 g / day: 2-4 g every 8 hours, or 3-6 g every 12 hours.
Treatment can be initiated before the results of a study of the sensitivity of microorganisms.

In uncomplicated gonococcal urethritis - once in the / m 500 mg.

For antibacterial prophylaxis of postoperative complications - iv, 1 g or 2 g for 30-60 min before the beginning of the operation, with repetition every 12 hours (in most cases for no more than 24 hours).
In case of operations with an increased risk of infection (for example, surgery in the colorectal area), or if the infection can be particularly harmful (for example, in open-heart surgery or joint prosthetics), the prophylactic use of the drug may continue for 72 hours after the operation is completed.
In patients with renal-hepatic insufficiency - no more than 2 g / day.

Patients with a glomerular filtration rate below 18 ml / min or creatinine above 3.5 mg / dL - not more than 4 g / day.

With isolated liver failure, no dose reduction is required if the patient does not receive the maximum dose,
compensatory increases in renal excretion of the drug up to 90% or more.
Children - daily doses from 50 to 200 mg per 1 kg / body weight;
in 2 admission (every 12 hours) or more, if necessary. Newborns (less than 8 days), every 12 hours. Daily doses, up to 300 mg / kg, are used without complications in young children and children with severe infections , including bacterial meningitis.
Intramuscular injection

For the preparation of solutions for the / m introduction, the following solvents can be used: sterile water for injection;
0.9% solution of sodium chloride, 0.5% solution of lidocaine hydrochloride, which is added to 1 g of cefoperazone in a volume of 3 ml. With the / m introduction, the drug is injected deep into the gluteus muscle. Freshly prepared solutions of cefoperazone are stored for no more than 24 hours at a temperature of 5 to 25 ° C.
IV introduction

With direct (jet) IV injection, the maximum single dose of cefoperazone for adults is 2 g, for children - 50 mg / kg of mass, with the duration of administration should be at least 3-5 minutes.
A solution for intravenous administration is prepared ex tempore. As solvents can be used: glucose 5%; 0.9% solution of sodium chloride;Ringer's lactate solution; sterile water for injection.
For intravenous drip every 1 g of cefoperazone is dissolved in 5 ml of sterile water for injection, the resulting solution is added to the infusion solution to a concentration of 20-100 mg / ml.
The duration of administration, depending on the volume of the solution, can be from 10 to 30 minutes or more.
SIDE EFFECT

Allergic reactions: urticaria, maculopapular rash, fever, eosinophilia, erythema multiforme, malignant erythema exudative (Stevens-Johnson syndrome), Coombs positive reaction.

On the part of the digestive system: nausea, vomiting, diarrhea, pseudomembranous colitis.

On the part of the hemopoiesis and hemostasis system of bleeding: (vitamin K deficiency).

Laboratory indicators: hypoprothrombinemia, increased prothrombin time, increased activity of hepatic transaminases and alkaline phosphatase, hypercreatininaemia, anemia, neutropenia.

Local reactions: with iv injection, phlebitis;
with the / m introduction, pain in the injection site.
CONTRAINDICATIONS

- hypersensitivity (including to beta-lactam antibiotics).

With caution: renal-hepatic insufficiency, pregnancy, lactation, colitis in history.

PREGNANCY AND LACTATION

Use with caution during pregnancy.

When appointing during lactation it is necessary to stop breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

With dedication to apply for kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Use with caution in liver failure.

APPLICATION FOR CHILDREN

Children - daily doses from 50 to 200 mg per 1 kg / body weight;
in 2 admission (every 12 hours) or more, if necessary. Newborns (less than 8 days), every 12 hours. Daily doses, up to 300 mg / kg, are used without complications in young children and children with severe infections, including bacterial meningitis.
SPECIAL INSTRUCTIONS

Can be used with combination therapy in combination with other antibiotics.

Patients with hypersensitivity to penicillin should be prescribed with great care.

In cases of obstruction of the bile ducts, severe liver disease or concomitant renal dysfunction, it may be necessary to change the dosage regimen (see section "Dosage regimen").

Long-term use can lead to the development of resistance of the pathogen.

During the use of the drug, a false positive reaction to glucose in the urine with a solution of Benedict or Feling can take place.

During treatment should refrain from taking ethanol - possible effects similar to the action of disulfiram (hyperemia of the face, stomach and stomach spasms, nausea, vomiting, headache, lowering blood pressure, tachycardia, dyspnea).

Patients who adhere to a defective diet or who have a food intake disorder (for example, suffering from cystic fibrosis), as well as patients who have been on parenteral nutrition for a long time, may have vitamin K deficiency. Such patients should be monitored for prothrombin time and, if necessary, the purpose of exogenous vitamin K.

OVERDOSE

An epileptic fit.

Treatment: sedation with diazepam.

DRUG INTERACTION

Pharmaceutically incompatible with aminoglycosides (if necessary combined therapy with cefoperazonom and aminoglycoside is prescribed in the form of consecutive fractional intravenous drugs, using 2 separate iv catheters).

With ethanol - disulfiram-like reactions.

Indirect anticoagulants, heparin, thrombolytics increase the risk of hypoprothrombinemia, bleeding.

Aminoglycosides and looped diuretics increase nephrotoxicity, especially in individuals with renal insufficiency.

Drugs that reduce tubular secretion, increase the concentration of the drug in the blood and slow its elimination.

TERMS OF RELEASE FROM PHARMACY

According to doctor's prescription.

TERMS AND CONDITIONS OF STORAGE

List B. In a dry, the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life - 2 years.
Do not use after the expiration date.
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