Operaz - instructions for use, doses, side effects, contraindications

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 other 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 beta-lactamases), Proteus mirabilis, Proteus vulgaris, Morqanella morqanii, 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 qonorrhoeae (strains producing and not producing beta-lactamases), Neisseria meningitidis , 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., And other representatives of strains of Bacteroides spp.).

Pharmacokinetics:

The connection with plasma proteins is 82-93%. The time to reach the maximum concentration (T_C_max) after the / m introduction - 1 -2 hours, after / in - at the end of the infusion, the maximum concentration (C_max) after the / m introduction of 1r, 2g-65-75 mcg / ml, 97 mcg / ml, respectively; after a single intravenous injection of 1, 2, 3 and 4 g of C_max - 153, 252, 340, 506 μg / ml, respectively. C_max in the urine after the / m and / in the introduction of 2 g - 1000 and more than 2200 mcg / ml, respectively.

Achieves therapeutic concentrations in body tissues and fluids: peritoneal, ascitic fluid and spinal 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.

The volume of distribution is 0.14-2 l / kg. Half-life (T_1/2) - 1.6-2.4 hours, regardless of the mode of administration, 2.8-4.2 hours for hemodialysis, 2.2 hours 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, excretion in the urine - 90% or more. Even with severe liver damage, therapeutic concentrations are achieved in bile, and T1 / 2 is only 2-4 times longer. In patients with renal-hepatic insufficiency can cumulate.

Indications:

Bacterial infections of the upper and lower respiratory tract, urinary tract, 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 after abdominal, gynecological, cardiovascular and orthopedic operations.

Contraindications:Hypersensitivity (including to beta-lactam antibiotics).

Carefully:

Renal and hepatic insufficiency, pregnancy, lactation, colitis in the anamnesis.

Pregnancy and lactation:When appointing during lactation it is necessary to stop breastfeeding.

Dosing and Administration:

In / in, / m. Adults - in an average daily dose of 2-4 g, 2 times a 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. With uncomplicated gonococcal urethritis - once, in / 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, 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.

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 - no 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.

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.

Side effects:

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

From the digestive system: nausea, vomiting, diarrhea, pseudomembranous colitis.

On the part of the organs of hematopoiesis and the system of hemostasis 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 - soreness in the injection site.

Overdose:

An epileptic fit. Treatment: sedation with diazepam.

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.

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 duct, severe liver disease or concomitant renal dysfunction, it may be necessary to change the dosage regimen (see section "Method of administration and dose").

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 be refrained from taking ethanol - there may be effects similar to the action of disulfiram (facial skin hyperemia, stomach and stomach spasms, nausea, vomiting, headache, lowering blood pressure, tachycardia, dyspnea).

When appointing during lactation it is necessary to stop breastfeeding.

Patients who adhere to inadequate diet or with malabsorption of food (eg, cystic fibrosis), as well as patients who are in for a long time on parenteral nutrition, monitoring of prothrombin time may be deficient in vitamin K. Such patients should be carried out, and if necessary, they the purpose of exogenous vitamin K.

Shelf life of the prepared solutions should not exceed 24 hours at room temperature, 5 days - when stored in the refrigerator at a temperature of 2 to 8 degrees C and 3 weeks at a temperature of 10-20 degrees. Solutions should be stored in glass or plastic syringes, glass or plastic bottles, designed to store solutions for parenteral administration.

Thawing of the frozen preparation should occur at room temperature. The solution can not be re-frozen. After thawing, the unused solution of the drug must be disposed of.

Form release / dosage:

Powder for solution for injection in bottles of 1.0 g.

Packaging:

Each vial with the instruction for use is placed in a cardboard box.

Storage conditions:

List B.In a place protected from light, inaccessible to children, at a temperature not exceeding 25 ° С.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015385 / 01

Date of registration:11.01.2009

Expiration Date:Unlimited

The owner of the registration certificate:Protek Biosystems Pvt. Ltd.Protek Biosystems Pvt. Ltd. India

Manufacturer: & nbsp

PROTECH BIOSYSTEMS, PVT. Ltd. India

Representation: & nbspProtekh Biosystems Pvt.LtdProtekh Biosystems Pvt.LtdRussia

Information update date: & nbsp09.06.2017

Illustrated instructions

Instructions

Opera (Operaz)