Tazocine - instructions for use, analogs, reviews and release forms (lyophilizate for the preparation of injections 2 g + 250 mg, 4 g + 500 mg) of the drug for the treatment of bronchitis, pneumonia, cholecystitis in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Tazocin. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Tazocin in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Tazocin in the presence of existing structural analogues.Use for the treatment of bronchitis, pneumonia, cholecystitis, abscess, furuncles and carbuncles in adults, children, as well as during pregnancy and breast-feeding. Composition of the preparation.

Tazocin - piperacillin monohydrate (one of the active substances of the drug Tazocin) is a semi-synthetic bactericidal broad-spectrum antibiotic that is active against many gram-positive and gram-negative aerobic and anaerobic bacteria. Tazobactam (one of the active substances of the drug Tazocin) is a sulfonic derivative of triazolmethylpenicillanic acid, it is a potent inhibitor of many beta-lactamases (including plasmid and chromosomal beta-lactamases), which often cause resistance to penicillins and cephalosporins, including third-generation cephalosporins. The presence of tazobactam in the combination drug Tazocin increases the antimicrobial activity and expands the spectrum of the action of piperacillin by including many bacteria-producers of beta-lactamase, which are usually resistant to piperacillin and other beta-lactam antibiotics.Thus, Tazocin combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.

Composition

Piperacillin sodium + Tazobactam sodium + excipients.

Pharmacokinetics

The maximum concentration of piperacillin and tazobactam in plasma is reached immediately after completion of intravenous administration. The concentration of piperacillin administered in combination with tazobactam is similar to that of administering piperacillin in an equivalent dose as monotherapy.

The binding with proteins of both piperacillin and tazobactam is approximately 30%, while the presence of tazobactam does not affect the binding of piperacillin, and the presence of piperacillin on the binding of tazobactam.

Piperacillin and tazobactam are widely distributed in tissues and body fluids, including in the intestinal mucosa, the mucosa of the gallbladder, lungs, bile, the female reproductive system (uterus, ovaries and fallopian tubes) and bones. The average concentrations in tissues are from 50 to 100% of the concentration in the plasma.

As a result of metabolism, piperacillin is converted into a low-activity desethyl derivative, and tazobactam is converted to an inactive metabolite.

Excretion

Piperacillin and tazobactam are excreted by the kidneys through glomerular filtration and tubular secretion. Piperacillin is rapidly excreted unchanged, 68% of the dose is detected in the urine. Tazobactam and its metabolites are rapidly eliminated by renal excretion, 80% of the dose is found in the unmodified form and the remaining amount as metabolites. Piperacillin, tazobactam and desethylpiperacillin are also excreted with bile.

Pharmacokinetics in special clinical cases

As the creatinine clearance decreases, the half-life of piperacillin and tazobactam increases. By reducing creatinine clearance less than 20 mL per minute half-life of piperacillin and tazobactam increase, respectively, in 2 and 4 times as compared with those in patients with normal renal function.

Although in patients with impaired liver function, the half-life of piperacillin and tazobactam increases, dose adjustments are not required.

Indications

Tazocine is used to treat systemic or local bacterial infections caused by microorganisms sensitive to piperacillin and tazobactam.

Adults and children over 12 years of age:

• infections of the lower respiratory tract;
• urinary tract infections (complicated and uncomplicated);
• intra-abdominal infections;
• infections of the skin and soft tissues;
• septicemia;
• gynecological infections (including endometritis and adnexitis in the postpartum period);
• bacterial infections in patients with neutropenia (in combination with aminoglycosides);
• infection of bones and joints;
• mixed infections (caused by Gram-positive / Gram-negative aerobic and anaerobic microorganisms).

Children between the ages of 2 and 12:

• intra-abdominal infections;
• infection with neutropenia (in combination with aminoglycosides).

Forms of release

Lyophilizate for the preparation of a solution for injections 2 g + 250 mg, 4 g + 500 mg.

Medicinal forms in the form of tablets or ointments at the time of publication of the drug in the Directory did not exist.

Instructions for use and dosing regimen

Tazocin is administered intravenously slowly by jet for no less than 3-5 minutes or drip for 20-30 minutes. Doses of the drug and the duration of treatment are determined by the severity of the infectious process and the dynamics of clinical and bacteriological indicators.

Adults and children over 12 years with normal renal function

The recommended daily dose is 12 g of piperacillin and 1.5 g of tazobactam, which is divided for several administrations every 6-8 hours.

The total daily dose depends on the severity and localization of the infection. The daily dose can reach 18 g of piperacillin and 2.25 g of tazobactam, which is divided for several administrations.

Children from 2 to 12 years old

When neutropenia in patients with normal kidney function and body weight less than 50 kg, the dose of Tazocin is 90 mg (80 mg piperacillin and 10 mg tazobactam) per kg body weight, which is administered every 6 hours in combination with the appropriate dose of aminoglycoside.

In children with a body weight of more than 50 kg, the dose corresponds to an adult and is administered in combination with aminoglycosides.

With intra-abdominal infection in children weighing up to 40 kg and normal kidney function, the recommended dose is 100 mg of piperacillin and 12.5 mg of tazobactam per kg of body weight every 8 hours. Children with a body weight of more than 40 kg and normal kidney function are given the same dose as adults.

Treatment should be conducted for at least 5 days and not more than 14 days, given that the administration of the drug is continued for at least 48 hours after the disappearance of clinical signs of infection.

Impaired renal function

Patients with renal insufficiency or a patient on hemodialysis, dose and frequency of administration should be adjusted for the degree of impaired renal function.

Recommended doses of the drug for adults and children (body weight over 50 kg) with renal failure:

• QC more than 40 - dose adjustment is not required;
• KK 20-40 - 12 g of piperacillin and 1.5 tazobactam every 8 hours;
• KK less than 20 - 8 g of piperazillin and 1 g of tazobactam every 12 hours.

For patients on hemodialysis, the maximum daily dose is 8 g and 1 g of piperacillin and tazobactam, respectively. In addition, since 30 to 50% piperacillin is withdrawn from the hemodialysis during 4 hours, one additional dose of 2 g and 250 mg piperacillin and tazobactam should be given after each dialysis session, respectively.

Recommended doses of the drug for children (body weight less than 50 kg) with renal failure:

• KK more than 50 ml per minute - 112.5 mg per kilogram (100 mg piperacillin and 12.5 mg tazobactam) every 8 hours;
• KK less than 50 ml per minute - 78.75 mg per kilogram (70 mg piperacillin and 8,75 mg tazobactam) every 8 hours.

Recommendations for the preparation of solution

Tazocine is used only for intravenous administration! The preparation is dissolved in one of the following solvents in accordance with the indicated volumes. The vial is rotated in a circular motion until the content is completely dissolved (with constant rotation, usually for 5-10 minutes). The prepared solution is a colorless or pale yellow liquid. The dosage is as follows:

• vial 2 g + 250 mg - 10 ml of the solvent;
• vial 4 g + 500 mg - 20 ml of the solvent.

Solvents compatible with Tazocin - 0.9% sodium chloride solution, sterile water for injection, 5% Dextrose solution, Ringer's lactate solution. The prepared solution can be diluted to the desired volume for intravenous administration (eg from 50 ml to 150 ml) by one of the following compatible solvents: 0.9% sodium chloride solution, sterile water for injection (maximum recommended volume is 50 ml), 5 % dextrose solution, Ringer's lactate solution. The prepared solution should be used within 24 hours after preparation when stored at a temperature of no higher than 25 degrees or for 48 hours when stored at a temperature of 2 to 8 degrees.

Side effect

• leukopenia (decrease in the number of leukocytes);
• neutropenia (reduced level of neutrophils, leading to a decrease in immunity);
• thrombocytopenia (decrease in the number of platelets);
• anemia (decreased hemoglobin level);
• bleeding (including purpura, nasal bleeding, increased bleeding time);
• eosinophilia (increase in the number of eosinophils);
• hemolytic anemia (increased destruction of erythrocytes);
• anaphylactic reactions (a rapidly developing manifestation of an allergy that can threaten the life of the patient);
• hypoalbuminemia (decrease in serum albumin level below 35 grams per liter);
• hypoglycemia (low blood sugar);
• hypoproteinemia (abnormally low level of protein in plasma);
• hypokalemia (low concentration of potassium ions in the blood);
• headache;
• insomnia;
• convulsions;
• hypotension (low blood pressure);
• phlebitis (inflammation of the venous wall);
• thrombophlebitis (inflammation of the venous walls with the formation of inflamed veins of thrombi in the lumen);
• flushes of blood to the skin of the face;
• diarrhea;
• nausea, vomiting;
• constipation;
• dyspepsia (indigestion);
• jaundice;
• stomatitis (inflammation of the oral mucosa);
• abdominal pain;
• pseudomembranous colitis (acute inflammation of the large intestine);
• hepatitis (inflammation of the liver);
• rash;
• itching;
• bullous dermatitis (the occurrence of water bubbles on the skin);
• erythema multiforme (reddish spots on the skin of the hands and extensor surfaces of the forearms);
• arthralgia (pain in the joints);
• increased serum creatinine concentration;
• interstitial nephritis (inflammatory process in interstitial tissue and kidney tubules);
• kidney failure;
• fungal superinfections;
• temperature increase;
• redness, compaction at the site of injection.

Contraindications

• children under 2 years;
• increased sensitivity to beta-lactam drugs (including penicillins, cephalosporins), other components of the drug, or to inhibitors of beta-lactamases.

Carefully:

• severe bleeding (including in history);
• cystic fibrosis (increased risk of hyperthermia and skin rash);
• pseudomembranous enterocolitis;
• childhood;
• pregnancy, lactation;
• renal failure (creatinine clearance below 20 ml per minute);
• patients on hemodialysis;
• co-administration of high doses of anticoagulants;
• hypokalemia.

Application in pregnancy and lactation

There is insufficient data on the use of Tazocine in pregnant women. Piperacillin and tazobactam penetrate the placental barrier. Pregnant women drug can be prescribed only in those cases when the expected benefit for the mother exceeds the possible risk to the fetus.

Piperacillin is secreted in low concentrations with breast milk, the secretion of tazobactam into milk has not been studied. The drug can be prescribed to women who breastfeed only if the expected benefit to the mother exceeds the possible risk for the breastfed baby, or breastfeeding should be stopped at the time of treatment.

Use in children

Tazocin is approved for use in children from the age of 2 with strict adherence to the dosing regimen. No experience in children under 2 years of age.

Application in elderly patients

In elderly patients, dose adjustment is necessary only if there is a violation of kidney function.

special instructions

Before starting treatment with Tazocin, the patient should be interviewed in detail in order to identify possible reactions of heightened sensitivity in the history, including those associated with penicillins or cephalosporins.Severe allergic reactions are more likely to develop in patients with increased sensitivity to several allergens. Such reactions require the cessation of the administration of the drug and the appointment of epinephrine (adrenaline) and other emergency measures.

The pseudomembranous colitis caused by antibiotics can be manifested by severe, prolonged diarrhea, which poses a threat to life. Pseudomembranous colitis can develop both during antibiotic therapy and after its completion. In such cases, immediate administration of Tazocine should be discontinued and appropriate therapy should be prescribed (eg, vancomycin, Metronidazole orally). Preparations that inhibit peristalsis are contraindicated.

In the treatment of Tazocine, especially prolonged, it is possible to develop leukopenia and neutropenia, therefore it is necessary to periodically monitor the peripheral blood.

Patients with renal insufficiency or a patient on hemodialysis, dose and frequency of administration should be adjusted for the degree of impaired renal function.

In a number of cases (most often in patients with renal insufficiency), the appearance of increased bleeding andconcomitant changes in laboratory parameters of the blood coagulation system (blood coagulation time, platelet aggregation and prothrombin time). When bleeding occurs, it is necessary to cancel the treatment with the drug and prescribe the appropriate therapy.

It should be borne in mind the possibility of the emergence of resistant microorganisms, which can cause superinfection, especially with prolonged course of treatment with Tazotine.

This drug contains 64 mg of sodium per gram of piperacillin, which can lead to a general increase in sodium intake in patients. In patients with hypokalemia or receiving drugs that promote the excretion of potassium, during the treatment with Tazocin hypokalemia may develop (it is necessary to check the electrolyte content in the blood serum regularly).

Drug Interactions

The joint administration of tazocine with probenecid increases the half-life and reduces the renal clearance of both piperacillin and tazobactam, but the maximum plasma concentrations of both drugs remain unchanged.

There was no pharmacokinetic interaction between Tazocine and vancomycin.

Piperacillin, including when combined with tazobactam, did not have a significant effect on the pharmacokinetics of tobramycin both in patients with preserved renal function and in patients with mild to moderate renal impairment. The pharmacokinetics of piperacillin, tazobactam and metabolites also did not significantly change with the appointment of tobramycin.

Simultaneous administration of Tazocin and vecuronium bromide may result in a longer neuromuscular blockade caused by the latter (a similar effect can be observed with a combination of piperacillin with other non-depolarizing muscle relaxants).

With simultaneous appointment with Tazocin heparin, indirect anticoagulants or other drugs that affect the blood coagulation system, including the function of platelets, it is necessary to more often monitor the state of the blood coagulation system.

Piperacillin may delay the excretion of Methotrexate (in order to avoid a toxic effect, it is necessary to control the concentration of methotrexate in the blood serum).

During the appointment of Tazocin, a false positive result can be obtained for glucose in the urine using a method based on the reduction of copper ions.Therefore, it is recommended to carry out a test based on the enzymatic oxidation of glucose.

When mixing solutions of Tazocin and aminoglycosides, their inactivation is possible. Therefore, these drugs are recommended to be administered separately. In situations where joint use is preferred, solutions of Tazocin and aminoglycosides must be prepared separately. For the introduction, use only the V-shaped catheter.

Tazocine should not be mixed in a single syringe or dropper with other medications other than gentamicin, Amikacin and the above solvents, since there is no compatibility data.

When using Tazocin together with other antibiotics, the drugs should be administered separately.

Given the chemical instability of Tazocin, the drug should not be used in conjunction with solutions containing sodium bicarbonate.

Tazocine should not be added to blood products or albumin hydrolysates.

Analogues of the drug Tazocin

Structural analogs for the active substance:

• Piperacillin + Tazobactam;
• Santa's;
• Tacillin.

Analogues for the pharmacological group (penicillins in combinations):

• Amovicomb;
• Amoxivan;
• Amoxiclav;
• Amoxicillin + Clavulanic acid;
• Ampioks;
• Ammisid;
• Ampicillin + Sulbactam;
• Arlette;
• Augmentin;
• Bactocklave;
• Betaclav;
• Bicillin;
• Verklav;
• Clamosar;
• Lancid;
• Libacil;
• Médoclase;
• Novaklav;
• Oxamp;
• Oksamsar;
• Panklav;
• Ranklav;
• Rapiklav;
• Sultasin;
• Taromentine;
• Timentin;
• Trifamox;
• Unazine;
• Fibell;
• Flemoclav;
• Helicocin;
• Helithrix;
• Ecoclave.

Response of infectious diseases physician

Tazocin is an effective drug for the treatment of many bacterial infections. I assign it to patients with infectious bronchitis and pneumonia, with complicated and uncomplicated urinary tract infections. Effectively, this drug for gynecological pathologies of bacterial genesis, with infections of bones and joints, infections of the skin and soft tissues. The drug is allowed to use to treat children older than two years. There are many side effects in Tazocin, so therapy, in order to avoid the development of serious complications, requires strict adherence to the dosing regimen.

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