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Composition:


active ingredients: piperacillin sodium, tazobactam sodium;


1 vial contains piperacillin sodium equivalent to piperacillin 2 g or 4 g and tazobactam sodium equivalent to tazobactam 250 mg (0.25 g) or 500 mg (0.5 g).


Dosage form.


Powder for solution for injection and infusion.


Basic physical and chemical properties: freeze-dried powder from white to almost white in color.


Pharmacotherapeutic group.


Antibacterial agents for systemic use. Beta-lactam antibiotics, penicillins. Piperacillin and an enzyme inhibitor.


ATX code J01C R05.


Pharmacological properties.


Pharmacodynamics.


Piperacillin is a broad-spectrum semi-synthetic penicillin that is active against Gram-positive and Gram-negative aerobic and anaerobic bacteria and inhibits bacterial activity by inhibiting cell membrane formation and cell wall synthesis. Tazobactam, a sulfonic derivative of triazolylmethylpenicillanic acid, is an inhibitor of many beta-lactamases, including plasmid and chromosomal enzymes that often cause resistance to penicillins and cephalosporins, including third-generation cephalosporins. Tazobactam has only a small antibacterial activity. The presence of tazobactam in the combination drug Tazpen enhances and expands the antimicrobial spectrum of piperacillin, including bacteria that produce beta-lactamases, which are usually insensitive to it and to other beta-lactam antibiotics. Thus, Tazpen combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor. Tazpen is active against the following microorganisms::


sensitive (aerobic gram – positive bacteria) - Brevibacterium spp., Corynebacterium xerosis, Corynebacterium spp., Enterococcus durans, Enterococcus faecalis, Enterococcus spp., Gemella haemolysans, Gemella morbillorum, Lactococcus lactis cremoris, Listeria monocytogenes, Propionibacterium granulosum, Propionibacterium spp., Staphylococcus aureus, methicillin - sensitive, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus sciuri, Staphylococcus xylosus, Staphylococcus spp. (coagulazonegative), Streptococcus agalactiae, Streptococcus anginosus, Streptococcus β-non-hemolytic groups A. Streptococcus β-hemolytic groups D, Streptococcus constellatus, Streptococcus gordonii, Streptococcus intermedius, Streptococcus milleri, Streptococcus Milleri-group, Streptococcus mitis, Streptococcus Morbillorum, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus sanguis, Streptococcus viridans, Streptococcus viridans group, Streptococcus spp. ;


sensitive (aerobic gram-negative bacteria) – Acinetobacter anitratus, Acinetobacter lwoffii, Aeromonas sobria, Alcaligenens spp., Branhamella catarrhalis, Burkholderia cepacia, Citrobacter diversus, Citrobacter farmeri, Citrobacter freundii, Citrobacter koseri, Citrobacter spp., Eikenella corrodens, Enterobacter agglomerans, Enterobacter cloacae, Enterobacter spp., Escherichia coli, Escherichia hermannii, Escherichia vulneris, Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus spp., Klebsiella ornithinolytica, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp., Morganella morganii, Pasteurella multocida, Proteus, indole positive, Proteus mirabilis, Proteus vulgaris, Proteus spp., Providencia stuartii, Providencia species, Pseudomonas aeruginosa, Pseudomonas fluorescens, Pseudomonas putida, Pseudomonas spp., Salmonella arizonae, Salmonella species, Serratia liquefaciens, Serratia marcescens, Serratia odorifera, Serratia spp., Shigella boydii, Shigella dysenteriae, Shigella flexneri, Shigella sonnei;


sensitive (anaerobic gram – positive bacteria) - Bifidobacterium spp., Clostridium bifermentans, Clostridium butyricum, Clostridium cadaveris, Clostridium clostridiforme, Clostridium difficile, Clostridium hastiforme, Clostridium limosum, Clostridium perfringens, Clostridium ramosum, Clostridium tertium, Clostridium spp., Eubacterium aerofaciens, Eubacterium lentum, Eubacterium spp., Peptococcus asaccharolyticus, Peptococcus spp., Peptostreptococcus anaerobius, Peptostreptococcus magnus, Peptostreptococcus micros, Peptostreptococcus prevotii, Peptostreptococcus species;


sensitive (anaerobic gram-negative bacteria) – Bacteroides caccae, Bacteroides capillosus, Bacteroides distasonis, Bacteroides fragilis, Bacteroides fragilis group, Bacteroides ovatus, Bacteroides putredinis, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides ureolyticus, Bacteroides vulgatus, Bacteroides spp., Fusobacterium necrophorum, Fusobacterium nucleatum, Fusobacterium varium, Fusobacterium spp., Porphyromonas asaccharolytica, Porphyromonas gingivalis, Porphyromonas species, Prevotella bivia, Prevotella disiens, Prevotella intermedia, Prevotella melaninogenica, Prevotella oralis, Prevotella spp.;


with intermediate sensitivity – aerobic gram-positive bacteria) - Enterococcus avium, Enterococcus faecium, Propionibacterium acnes;


with intermediate sensitivity (aerobic gram – negative bacteria) - Acinetobacter baumannii, Acinetobacter calcoaceticus, Acinetobacter spp., Enterobacter aerogenes, Pseudomonas stutzeri, Stenotrophomonas maltophilia, Pseudomonas stutzeri;


resistant (aerobic gram-positive bacteria) - Corynebacterium jeikeium, Staphylococcus coagulase-negative (methicillin-resistant);


resistant (aerobic gram-negative bacteria) - Legionella spp., Stenotrophomonas maltophilia.

Output. Piperacillin and tazobactam are excreted by the kidneys by glomerular filtration and tubular secretion. Piperacillin is rapidly excreted unchanged, 68% of the dose taken is found in the urine. Tazobactam and its metabolites are rapidly eliminated by renal excretion, 80% of the dose taken is unchanged, and the remaining amount is in the form of metabolites. After that, further excretion of piperacillin, tazobactam and desethylpiperacillin with bile is insignificant.


After single and repeated doses of Tazpen in healthy volunteers, the plasma half-lives of Piperacillin and tazobactam ranged from 0.7 hours to 1.2 hours and did not depend on the dose or duration of the infusion. With a decrease in creatinine clearance, the Half-Life of Piperacillin and tazobactam is prolonged.


Impaired renal function. With a decrease in creatinine clearance, the half-lives of Piperacillin and tazobactam increase. If creatinine clearance decreases below 20 mL/min, The Half-Lives of Piperacillin and tazobactam increase 2 and 4 times, respectively, compared to those in patients with normal renal function. During hemodialysis, 30 to 50% of the received dose of Piperacillin and 5% of tazobactam are eliminated in the form of a metabolite. During peritoneal dialysis, about 6% and 21% of Piperacillin and tazobactam are excreted, respectively, and 18% of tazobactam is excreted in the form of its metabolite.


Impaired liver function. Although the half-lives of Piperacillin and tazobactam are increased in patients with impaired liver function, no dose adjustment is required.


Clinical characteristics.


Indications.


Treatment of infections caused by Gram-positive and Gram-negative aerobic and anaerobic bacteria sensitive to piperacillin or piperacillin/tazobactam.


In adults and elderly patients:


- lower respiratory tract infections (including hospital-acquired pneumonia);


- complicated urinary tract infections (including pyelonephritis);


- complicated skin and soft tissue infections (abscess, infected trophic ulcers);


- complicated intraabdominal infections;


- bacterial septicemia;


– in combination with aminoglycosides, it is used in the treatment of patients with fever that has occurred against the background of neutropenia.


For children aged 2 to 12 years:


– in combination with aminoglycosides, it is used in the treatment of patients with fever that has occurred against the background of neutropenia;


- intraabdominal infections, including complicated forms of acute appendicitis with widespread diffuse peritonitis; with appendicular infiltrate associated with abscessing.


Contraindications.


Increased individual sensitivity to active substances and to any other penicillin antibiotics. A history of severe allergic reaction to another beta-lactam antibiotic (such as cephalosporin, monobactam, or carbapenem).


Interactions with other drugs and other types of interactions.


Aminoglycosides.


Piperacillin, including when co-administered with tazobactam, did not significantly affect the pharmacokinetics of tobramycin in both patients with preserved renal function and patients with mild to moderate renal impairment. The pharmacokinetics of piperacillin, tazobactam, and metabolites were also significantly unchanged when tobramycin was administered.


Inactivation of tobramycin and gentamicin was observed in patients with acute renal failure due to the use of piperacillin.

Application features.


Before starting treatment with Tazpen, it is necessary to read in detail the patient's medical history regarding hypersensitivity reactions to penicillins and cephalosporins, as well as to other allergens.


Severe and rarely fatal hypersensitivity reactions (anaphylaxis) have been reported in patients treated with penicillins when using penicillin group drugs. Severe allergic reactions may require discontinuation of antibiotics, administration of epinephrine, and other urgent measures.


Pseudomembranous colitis caused by antibiotics can manifest as severe, persistent diarrhea that can endanger the patient's life. Pseudomembranous colitis can begin during or after antibacterial treatment. In these cases, the drug should be discontinued.


With Tazpen therapy, microbial resistance may develop, which can cause superinfection.


Some patients who received beta-lactam antibiotics experienced bleeding.


Sometimes these reactions were accompanied by changes in laboratory blood clotting parameters, such as blood clotting time, platelet aggregation, and prothrombin time; more often they occurred in patients with renal insufficiency. If signs of bleeding occur, antibiotic therapy should be discontinued and appropriate treatment should be prescribed.


During therapy with Tazpen, a false positive result of a urine glucose test is possible when using a method based on the reduction of copper ions. Therefore, it is recommended to conduct a test based on the enzymatic oxidation of glucose.


The sodium content in a bottle of Tazpen, 4 g/0.5 g, is 217 mg (9.44 mmol), which can increase the total sodium content in the patient's body. Patients with low potassium levels or those who simultaneously take medications that can reduce potassium levels may develop hypokalemia; in such patients, blood electrolyte levels should be monitored periodically.


During long-term treatment, leukopenia and neutropenia may develop, so the hematological status of the patient should be periodically determined.


For severe infections, empirical therapy with Tazpen can be initiated before the results of seeding for antibiotic sensitivity are known.


Renal failure due to potential nephrotoxicity, tazobactam should be used with caution in patients with impaired renal function, as well as in patients undergoing hemodialysis. Intravenous doses and the interval between injections should be adjusted for the degree of impaired renal function. In a secondary analysis using data from a large multicenter randomized trial on glomerular filtration rate after administration of commonly used antibiotics for the treatment of critically ill patients, the use of the piperacillin/tazobactam combination was associated with a lower glomerular filtration rate compared to that of other antibiotics. According to the results of this secondary analysis, it was found that the use of the piperacillin/tazobactam combination is the cause of delayed recovery of renal function in these patients.

Use during pregnancy or lactation.


Pregnancy. Currently, there are no appropriate and well-controlled studies of the combination of piperacillin/tazobactam, piperacillin, or tazobactam separately conducted in pregnant women. Tazpen passes through the placenta. The drug can only be used in cases where the expected benefit to the pregnant woman exceeds the potential risk to the fetus


Breast-feeding period. Piperacillin is excreted in small concentrations in breast milk, the concentration of tazobactam in breast milk has not been studied. Therefore, the drug can be used during breast-feeding only in cases where the expected benefit exceeds the potential risk to the woman and fetus.


Fertility. In studies of reproductive function in rats after intraperitoneal administration of tazobactam or the combination of piperacillin/tazobactam, no signs of undesirable effects on fertility and mating were found.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


No data available.


During treatment, the possibility of dizziness, convulsions, which affects the speed of psychomotor reactions should be taken into account.


Dosage and administration.


Tazpen should be administered intravenously drip for approximately 20-30 minutes or intravenously jet slowly for at least 3-5 minutes.


In patients with neutropenia, fever is most often a sign of infection. In this case, you can start empirical therapy with Tazpen before the results of seeding for antibiotic sensitivity are known.


Adults and children over 12 years of age with normal renal function.


The recommended daily dose is 12 g of piperacillin/1.5 g of tazobactam, i.e. 4 G/500 mg of Tazpen every 8 hours (3 times a day). The total daily dose of Tazpen depends on the severity and spread of the infection and can vary from 2 g/250 mg (2 g of piperacillin/250 mg of tazobactam) to 4 G/500 mg (4 g of piperacillin/500 mg of tazobactam) every 6-8 hours (3-4 times a day).


For patients with fever that occurs on the background of neutropenia, the recommended dose is 4 G/500 mg of Tazpen (4 g of piperacillin/500 mg of tazobactam) every 6 hours (4 times a day) in combination with aminoglycosides.


In elderly patients with normal renal function, the recommended daily dose of Tazpen can be used the same as in adults (except in cases of impaired liver function).


Patients (adults, elderly patients, and children over 12 years of age) with renal insufficiency.


When prescribing the drug to patients with renal insufficiency or patients who are on hemodialysis, it is necessary to adjust the doses and the interval between them depending on the degree of renal failure.

Tags: Tazpen® [Piperacillin, tazobactam]