Universal reference book for medicines
Product name: CEPOPERUS ® (CEFOPERUS)

Active substance: cefoperazone

Type: Third generation cephalosporin

Manufacturer: SYNTHESIS (Russia)
Composition, form of production and packaging
Powder for solution for iv and in / m introduction
white or white with a yellowish hue, crystalline.

1 f.

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

- "- 1 g

- "- 2 g

Vials (1) - packs of cardboard.

Vials (5) - packs of cardboard.

Vials (10) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

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, others strains of beta-hemolytic Streptococcus spp .;
Gram-negative microorganisms: Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Citrobacter spp., Haemophilus influenzae (strains producing and not producing? -lactamases), Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia spp. (including Providencia rettgeri), Serratia spp. (including Serratia marcescens), Salmonella spp., Shigella spp., Pseudomonas spp. (including Pseudomonas aeruginosa), certain strains of Acinetobacter spp., Neisseria gonorrhoeae (strains producing and not producing? -lactamases), Neisseria meningitidis, Bordetella pertussis, Yersinia enterocolitica; anaerobic microorganisms: Gram-positive and Gram-negative cocci (including Peptococcus spp., Peptostreptococcus spp., Veillonella spp.), Gram-positive sporo- and non-spore forming anaerobes (Clostridium spp., Eubacterium spp., Lactobacillus spp.) and Gram-negative (including Fusobacterium spp., Bacteroides spp. / including Bacteroides fragilis /, Prevotella spp.).
PHARMACOKINETICS

Suction

T max after IM for 1-2 h, after IV injection at the end of infusion, C max after I / m administration of the preparation in a dose of 1 g is 65-75 μg / ml, in a dose of 2 g - 97 μg / ml;
after a single IV injection at doses of 1 g, 2 g, 3 g and 4 g C max is 153 μg / ml, 252 μg / ml, 340 μg / ml, 506 μg / ml, respectively. C max in the urine after IM and IV injection at a dose of 2 g - 1000 μg / ml and more than 2200 μg / ml, respectively.
Distribution

Binding to plasma proteins - 82-93%.
Achieves therapeutic concentrations in peritoneal, ascitic fluid and spinal fluid (with meningitis), urine, bile, gallbladder wall, 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.
Excretion

T 1/2 - 1.6-2.4 h, regardless of the mode of administration, 2.8-4.2 h - with hemodialysis, 2.2 h - in newborns and children from 2 months to 11 years.
It is excreted with bile - 70-80%, kidneys - 20-30% in unchanged form.
Pharmacokinetics in special clinical cases

In patients with impaired liver function and bile duct obstruction, T 1/2 is 3-7 hours, excretion in the urine is 90% or 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, cefoperazone can accumulate.

INDICATIONS

- infections of the upper and lower respiratory tract;

- urinary tract infections;

- abdominal infections (peritonitis, cholecystitis, cholangitis);

- 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 after abdominal, gynecological, cardiovascular and orthopedic operations.

DOSING MODE

The drug is injected in / m and / in (jet or drip).

For adults, the drug is prescribed in a 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 - in / m in a dose of 500 mg once.

For the prevention of postoperative complications - IV , 1 g or 2 g for 30-60 min before the start of the operation, with repeated every 12 hours (in most cases within 24 hours).
In case of operations with an increased risk of infection (for example, operations 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.
Patients with renal-hepatic insufficiency appoint no more than 2 g / day.
Patients with a glomerular filtration rate below 18 ml / min, or a serum creatinine content of more than 3.5 mg / ml - 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 to 90% or more.
In children, the daily dose is 50-200 mg / kg body weight in 2 divided doses (every 12 hours) or more, if necessary.
Newborn (less than 8 days) drug is prescribed every 12 hours.
The drug in doses up to 300 mg / kg / day is used without complications in young children and children with severe infections, including bacterial meningitis .

Rules for preparation and administration of the drug

The following solvents can be used for preparation of solutions for intravenous administration: sterile water for injection, 0.9% sodium chloride solution, 0.5% lidocaine hydrochloride solution, which are 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.
With jet intravenous injection, the maximum single dose of cefoperazone for adults is 2 g, for children 50 mg / kg of body weight, while the duration of administration should be at least 3-5 minutes.
A solution for intravenous administration is prepared ex tempore. As solvents, 5% dextrose (glucose) solution, 0.9% sodium chloride solution, Ringer's lactate solution, sterile water for injections can be used.
For intravenous drip injection, 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

On the part of the digestive system: nausea, vomiting, diarrhea, pseudomembranous colitis, increased activity of hepatic transaminases and alkaline phosphatase.

From the coagulation system: bleeding (vitamin K deficiency), hypoprothrombinemia, increased prothrombin time.

From the hemopoietic system: anemia, neutropenia.

Laboratory indicators: hypercreatininaemia.

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

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

- Hypersensitivity to the components of the drug, incl.
to other beta-lactam antibiotics.
With caution should prescribe the drug for kidney and / or liver failure, colitis (including in history), pregnancy, lactation.

PREGNANCY AND LACTATION

Caution should be prescribed during pregnancy.

At appointment in the period of a lactemia it is necessary to stop thoracal feeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should prescribe the drug for kidney failure.

Patients with renal-hepatic insufficiency appoint no more than 2 g / day.
Patients with a glomerular filtration rate below 18 ml / min, or a serum creatinine content of more than 3.5 mg / ml - not more than 4 g / day.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for liver failure.

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 to 90% or more.
APPLICATION FOR CHILDREN

In children, the daily dose is 50-200 mg / kg body weight in 2 divided doses (every 12 hours) or more, if necessary.
Newborn (less than 8 days) drug is prescribed every 12 hours.
The drug in doses up to 300 mg / kg / day is used without complications in young children and children with severe infections, including bacterial meningitis .

SPECIAL INSTRUCTIONS

Cefoperus ® can be used in 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 duct, severe liver disease or concomitant renal dysfunction, it may be necessary to change the 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, t.
possibly the development of disulfiram-like reactions (hyperemia of the facial skin, spasm in the abdomen and in the stomach, nausea, vomiting, headache, lowering blood pressure, tachycardia, dyspnea).
Patients who adhere to a defective diet or who have a malabsorption of food (for example, in cystic fibrosis), as well as patients who are for a long time on parenteral nutrition, may experience a vitamin K deficiency. Such patients should be monitored for prothrombin time, if necessary, exogenous vitamin K.

OVERDOSE

Symptoms: development of an epileptic seizure is possible.

Treatment: sedation with diazepam.

DRUG INTERACTION

With simultaneous use with ethanol, development of disulfiram-like reactions is possible.

Indirect anticoagulants, heparin, thrombolytics with simultaneous application with Cefoperus increase the risk of hypoprothrombinemia, bleeding.

Aminoglycosides and looped diuretics, when used simultaneously with Cefoperus, increase nephrotoxicity, especially in persons with renal insufficiency.

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

Pharmaceutical interaction

Pharmaceutically incompatible with aminoglycosides (if necessary, combined therapy with cefoperazone and aminoglycoside is prescribed as a sequential fractional intravenous drug, using 2 separate intravenous catheters).

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 dry, protected from light, out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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