What is Pybactam?
Piperacillin (Pybactam) and Tazobactam (Pybactam) injection is used to treat bacterial infections in many different parts of the body.
Piperacillin (Pybactam) and Tazobactam (Pybactam) combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria and preventing their growth. However, Piperacillin (Pybactam) and Tazobactam (Pybactam) will not work for colds, flu, or other virus infections.
Piperacillin (Pybactam) and Tazobactam (Pybactam) is to be given only by or under the direct supervision of your doctor.
Pybactam indications
Pybactam is indicated for the treatment of the following systemic and/or local bacterial infections in which susceptible organisms have been detected or are suspected: Lower respiratory tract infections; urinary tract infections (complicated and uncomplicated); intra-abdominal infections; skin and skin structure infections; bacterial septicemia. Polymicrobial infections: Pybactam is indicated for polymicrobial infections including those where aerobic and anaerobic organisms are suspected (intra-abdominal, skin and skin structure, lower respiratory tract).
Pybactam, in combination with an aminoglycoside, is indicated for bacterial infections in neutropenic adults or children.
Children Under the Age of 12 Years: In hospitalized children aged 2 to 12 years, Pybactam is indicated for the treatment of intra-abdominal infections including appendicitis complicated by rupture or abscess, peritonitis, and biliary infections. It has not been evaluated in this indication for pediatric patients below the age of 2 years.
Whilst Pybactam is indicated only for the conditions listed above, infections caused by Piperacillin (Pybactam) susceptible organisms are also amendable to Pybactam treatment due to its Piperacillin (Pybactam) content. Therefore, the treatment of mixed infections caused by Piperacillin (Pybactam) susceptible organisms and β-beta lactamase producing organisms susceptible to Pybactam should not require the addition of another antibiotic.
Pybactam is particularly useful in the treatment of mixed infections and in presumptive therapy prior to the availability of the results of sensitivity tests because of its broad spectrum of activity.
Pybactam acts synergistically with aminoglycosides against certain strains of Pseudomonas aeruginosa. Combined therapy has been successful, especially in patients with impaired host defences. Both drugs should be used in full therapeutic doses. As soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted if necessary.
How should I use Pybactam?
Use Pybactam as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Pybactam is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Pybactam at home, a health care provider will teach you how to use it. Be sure you understand how to use Pybactam. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Pybactam if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Pybactam, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Pybactam.
Uses of Pybactam in details
Use: Labeled Indications
Intra-abdominal infections: Treatment of appendicitis complicated by rupture or abscess and peritonitis caused by beta-lactamase-producing strains of Escherichia coli, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides vulgatus.
Pelvic infections: Treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase-producing strains of E. coli.
Pneumonia, community-acquired: Treatment of moderate severity community-acquired pneumonia (CAP) caused by beta-lactamase-producing strains of Haemophilus influenzae.
Pneumonia, hospital-acquired (nosocomial): Treatment of moderate to severe hospital-acquired (nosocomial) pneumonia caused by beta-lactamase-producing strains of Staphylococcus aureus and by Pybactam-susceptible Acinetobacter baumannii, H. influenzae, Klebsiella pneumoniae, and P. aeruginosa.
Skin and skin structure infections: Treatment of skin and skin structure infections, including cellulitis, cutaneous abscesses, and ischemic/diabetic foot infections caused by beta-lactamase-producing strains of S. aureus.
Off Label Uses
Bite wound infection, treatment (animal or human bite)
Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), Piperacillin (Pybactam) and Tazobactam (Pybactam) is an effective and recommended treatment of animal bite wound infections.
Clinical experience supports the utility of Piperacillin (Pybactam) and Tazobactam (Pybactam) in the treatment of human bite wound infections.
Pybactam description
Each 2.25 g single-dose vial contains Piperacillin (Pybactam) sodium equivalent to Piperacillin (Pybactam) 2 g and Tazobactam (Pybactam) sodium equivalent to Tazobactam (Pybactam) 0.25 g and edetate disodium (dihydrate) (EDTA) 0.5 mg.
Each 4.5 g single-dose vial contains Piperacillin (Pybactam) sodium equivalent to Piperacillin (Pybactam) 4 g and Tazobactam (Pybactam) sodium equivalent to Tazobactam (Pybactam) 0.5 g and edetate disodium (dihydrate) (EDTA) 1 mg.
Pybactam is an injectable antibacterial combination consisting of the semisynthetic antibiotic Piperacillin (Pybactam) sodium and the beta-lactamase inhibitor Tazobactam (Pybactam) sodium for intravenous administration. Piperacillin (Pybactam) sodium is derived from D(-)-a-aminobenzylpenicillin. The chemical name of Piperacillin (Pybactam) sodium is sodium (2S, 5R, 6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-phenylacetamido] – 3,3 –dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane – 2 – carboxylate. Piperacillin (Pybactam) sodium is a white, crystalline powder. Piperacillin (Pybactam) sodium is freely soluble in water, in alcohol, and in methyl alcohol; practically insoluble in ethyl acetate. Tazobactam (Pybactam) sodium is a derivative of the penicillin nucleus. Chemically, Tazobactam (Pybactam) is a penicillanic acid sulfone. Its chemical name is sodium (2S-,3S-,5R) – 3 – methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate,4,4-dioxide. Tazobactam (Pybactam) sodium is a white to pale yellow non-hydroscopic crystalline powder.
Pybactam also contains the following excipients: Piperacillin (Pybactam) monohydrate, Tazobactam (Pybactam), sodium hydrogen carbonate, citric acid (monohydrate), EDTA, water for injections and nitrogen.
Pybactam dosage
Pybactam should be administered by intravenous infusion over 30 minutes.
The usual daily dose of Pybactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g Piperacillin (Pybactam)/1.5 g Tazobactam (Pybactam)).
Nosocomial Pneumonia
Initial presumptive treatment of patients with nosocomial pneumonia should start with Pybactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g Piperacillin (Pybactam)/2.0 g Tazobactam (Pybactam)). Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeruginosa is isolated. If Pseudomonas aeruginosa is not isolated, the aminoglycoside may be discontinued at the discretion of the treating physician.
Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, Pybactam and the aminoglycoside are recommended for separate administration. Pybactam and the aminoglycoside should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated.
In circumstances where coadministration via Y-site is necessary, reformulated Pybactam containing EDTA supplied in Galaxy containers is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
The following compatibility information does not apply to the Pybactam (Pybactam) formulation not containing EDTA. This information does not apply to Pybactam in vials or bulk pharmacy containers. Refer to the package insert for Pybactam vials or bulk pharmacy containers for instructions.
| Aminoglycoside | Pybactam Dose (grams) | Aminoglycoside Concentration Range* (mg/mL) | Acceptable Diluents |
|---|---|---|---|
| Amikacin | 2.25, 3.375, 4.5 | 1.75 – 7.5 | 0.9% Sodium Chloride or 5% Dextrose |
| Gentamicin | 2.25, 3.375, 4.5 | 0.7 – 3.32 | 0.9% Sodium Chloride or 5% Dextrose |
| *The concentration ranges in Table 5 are based on administration of the aminoglycoside in divided doses (10-15 mg/kg/day in two daily doses for amikacin and 3-5 mg/kg/day in three daily doses for gentamicin). Administration of amikacin or gentamicin in a single daily dose or in doses exceeding those stated above via Y-site with Pybactam containing EDTA has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions. | |||
Pybactam is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of Pybactam with other aminoglycosides has not been established. Only the concentration and diluents for amikacin or gentamicin with the dosages of Pybactam listed above have been established as compatible for coadministration via Y-site infusion. Simultaneous coadministration via Y-site infusion in any manner other than listed above may result in inactivation of the aminoglycoside by Pybactam.
Renal Insufficiency
In patients with renal insufficiency (Creatinine Clearance ≤ 40 mL/min), the intravenous dose of Pybactam should be adjusted to the degree of actual renal function impairment. In patients with nosocomial pneumonia receiving concomitant aminoglycoside therapy, the aminoglycoside dosage should be adjusted according to the recommendations of the manufacturer. The recommended daily doses of Pybactam for patients with renal insufficiency are as follows:
| Renal Function (Creatinine Clearance, mL/min) | All Indications (except nosocomial pneumonia) | Nosocomial Pneumonia |
|---|---|---|
| >40 mL/min | 3.375 q 6 h | 4.5 q 6 h |
| 20-40 mL/min* | 2.25 q 6 h | 3.375 q 6 h |
| <20 mL/min* | 2.25 q 8 h | 2.25 q 6 h |
| Hemodialysis** | 2.25 q 12 h | 2.25 q 8 h |
| CAPD | 2.25 q 12 h | 2.25 q 8 h |
| * Creatinine clearance for patients not receiving hemodialysis ** 0.75 g should be administered following each hemodialysis session on hemodialysis days | ||
For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g Pybactam should be administered following each dialysis period on hemodialysis days. No additional dosage of Pybactam is necessary for CAPD patients.
Duration of Therapy
The usual duration of Pybactam treatment is from seven to ten days. However, the recommended duration of Pybactam treatment of nosocomial pneumonia is 7 to 14 days. In all conditions, the duration of therapy should be guided by the severity of the infection and the patient's clinical and bacteriological progress.
Pediatric Patients
For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended Pybactam dosage is 100 mg Piperacillin (Pybactam)/12.5 mg Tazobactam (Pybactam) per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended Pybactam dosage based on pharmacokinetic modeling, is 80 mg Piperacillin (Pybactam)/10 mg Tazobactam (Pybactam) per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. There are no dosage recommendations for Pybactam in pediatric patients with impaired renal function.
Pybactam in Galaxy containers should not be used in pediatric patients who require less than the full adult dose of Pybactam in order to prevent unintentional overdose. The other available formulations of Pybactam can be used in this population.
DIRECTIONS FOR USE OF Pybactam (Piperacillin (Pybactam) AND Tazobactam (Pybactam) INJECTION) IN GALAXY CONTAINERS (PL 2040 PLASTIC)
Pybactam Injection (PL 2040 Plastic) is to be administered using sterile equipment after thawing to room temperature.
Pybactam containg EDTA is compatible for co-administration via a Y-site intravenous tube with Lactated Ringer's injection, USP.
Administer by infusion over a period of at least 30 minutes. During the infusion it is desirable to discontinue the primary infusion solution.
Pybactam should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Pybactam is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Pybactam should not be added to blood products or albumin hydrolysates.
Pybactam interactions
See also:
What other drugs will affect Pybactam?
The following drug interactions are chosen on the basis of their potential clinical significance:
Aminoglycosides: The mixing of Pybactam in vitro can result in substantial inactivation of the aminoglycosides.
When Pybactam is administered together with tobramycin, the AUC, renal clearance and urinary recovery of tobramycin were decreased by 11%, 32% and 38%, respectively. The alterations in the pharmacokinetics of tobramycin when administered in conjunction with Pybactam may be due to inactivation of tobramycin in the presence of Pybactam. It has been postulated that penicillin-aminoglycoside complexes form and these complexes are micobiologically inactive and unknown toxicity.
Probenecid: Probenecid administered concomitantly with Pybactam prolongs the t½ of Piperacillin (Pybactam) by 21% and that of Tazobactam (Pybactam) by 71%.
Heparin, Anticoagulants and Drugs Affecting the Blood: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, anticoagulants and Pybactam that may affect the blood coagulation system or the thrombocyte function.
Vecuronium: Pybactam when used concomitantly with vecuronium has been implicated in the prolongation of vecuronium's neuromuscular blockade. It is also expected that neuromuscular blockade produced by any of the nondepolarizing muscle muscle relaxants could be prolonged in the presence of Piperacillin (Pybactam).
Methotrexate: Limited data suggest that the clearance of methotrexate is reduced when co-administered with Piperacillin (Pybactam), due to competition for renal secretion. The impact of Tazobactam (Pybactam) on the elimination of methotrexate has not been evaluated. If Pybactam and methotrexate are administered concomitantly, serum concentrations of methotrexate as well as signs and symptoms of methotrexate toxicity should be closely monitored.
Drug/Laboratory Test Interactions: As with other penicillins, the administration of Pybactam may result in a false positive reaction of glucose in the urine using copper-reduction method (Clinitest). It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.
In patients with renal failure, Pybactam is reported to cause abnormalities in clotting time, platelet aggregation and prothrombin time that close monitoring of the patient's coagulation tests is recommended.
Pybactam side effects
See also:
What are the possible side effects of Pybactam?
Adverse drug reactions reported with Pybactam are similar to those reported with Piperacillin (Pybactam) alone and generally are transient and mild to moderate in severity. Adverse events have been reported in about ≤10% of patients receiving parenteral Pybactam and have been severe enough to require discontinuance in ≤3% of patients.
The most common frequent adverse effects reported with Pybactam are gastrointestinal (GI) effects, headache and hypersensitivity reactions.
Hypersensitivity Reactions: Rash, pruritus and fever have been reported in up to 4% of patients receiving Pybactam. Rare reports of bronchospasm have also been reported.
Gastrointestinal Effects: Diarrhea, nausea, constipation have been reported in up to 11% of patients receiving Pybactam. Vomiting, dyspepsia, stool changes and abdominal pain can occur in up to 3%, while melena, flatulence, hemorrhage, gastritis, hiccups and ulcerative stomatitis are reported in ≤1% of patients.
Clostridium difficile-associated diarrhea and colitis or antibiotic-associated pseudomembranous colitis have been reported in at least 1 patient receiving Pybactam. Colitis may occur during or following discontinuance of anti-infective therapy and may range in severity from mild to life-threatening.
Hematologic Effects: Transient leukopenia, neutropenia and thrombocytopenia have been reported in patients receiving Pybactam for a prolonged period of time (eg, after ≥21 days) and generally were reversible, systemic symptoms (eg, fever, rigors and chills) may also occur in some patients. Epistaxis and purpura have been reported in ≤1% patients.
Hepatic Effects: Transient increases in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and bilirubin can occur.
Renal Effects: Increases in serum concentrations of creatinine and blood urea nitrogen (BUN) may be observed. Urinary retention, dysuria, oliguria, hematuria and incontinence have been reported in ≤1% and proteinuria, pyuria, leukorrhea and vaginitis can also occur.
Effect on the Central Nervous System: Headache and insomnia have been reported in up to 7-8%, while agitation, dizziness and anxiety have been reported in ≤2% patients. Tremors, seizures, vertigo, confusion, hallucination, malaise and depression have been reported in ≤1% of patients receiving Pybactam. Neuromuscular excitability or seizures could occur in higher than recommended doses are given IV, especially in patients with kidney failure.
Local Reactions: Adverse reactions at the injection site have been reported in ≤1% of patients. Adverse local reactions include phlebitis, pain, inflammation, thrombophlebitis and edema.
Other Adverse Effects: Hypertension, chest pain, edema, moniliasis, rhinitis, dyspnea, hypotension, ileus, syncope and rigors have been reported in ≤2% of patients. Tachycardia, bradycardia, heart failure and myocardial infarction have been reported in at most 1%.
Pybactam contraindications
See also:
What is the most important information I should know about Pybactam?
Piperacillin (Pybactam) and Tazobactam (Pybactam) for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors.
Active ingredient matches for Pybactam:
Piperacillin/Tazobactam in Indonesia.
List of Pybactam substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| PT-NAC (India) | |
| Pt-Nac Piperacillin 4 mg, tazobactam0.5 mg. INJ / 4.5mg (Servocare) | |
| Rabactam (Philippines) | |
| Racelax (Philippines) | |
| Racibact (India) | |
| Racibact Piperacillin 4 g, Tazobactam0.5 g. VIAL / 1 (Andic) | |
| RAPROZO (India) | |
| 1's (Kamakshi) | $ 6.93 |
| Raprozo Piperacillin 4 g, tazobactam0.5 g. VIAL / 1 (Kamakshi) | $ 6.93 |
| Raprozo Piperacillin 4 g, tazobactam0.5 g. VIAL / 1 (Kamakshi) | $ 6.93 |
| RECOPEP-T (India) | |
| 1's (Solitaire (Radix)) | $ 6.01 |
| Recopep-T Piperacillin 4 g, tazobactam0.5 g. INJ / 1 (Solitaire (Radix)) | $ 6.01 |
| Recopep-T Piperacillin 1 g, tazobactam0.125 g. INJ / 1 (Solitaire (Radix)) | |
| Recopep-T Piperacillin 4 g, tazobactam0.5 g. INJ / 1 (Solitaire (Radix)) | $ 6.01 |
| Recopep-T Piperacillin 1 g, tazobactam0.125 g. INJ / 1 (Solitaire (Radix)) | |
| REEZO (India) | |
| 1's (Schon (Reco)) | $ 1.93 |
| Reezo Piperacillin 4g, Tazobactam0.5g VIAL / 1 (Schon (Reco)) | $ 1.93 |
| Reezo Piperacillin 4g, Tazobactam0.5g VIAL / 1 (Schon (Reco)) | $ 1.93 |
| Repita (Italy) | |
| REVOTAZ (India) | |
| 1's (Alkem (Ulticare)) | $ 3.82 |
| Revotaz Piperacillin 4 g, tazobactam0.5 g. VIAL / 1 (Alkem (Ulticare)) | $ 3.82 |
| Revotaz Piperacillin 1 g, tazobactam125 mg. VIAL / 1 (Alkem (Ulticare)) | |
| REVOTAZ 4000 MG/500 MG INJECTION 1 vial / 1 GM injection each (Alkem (Ulticare)) | $ 4.70 |
| Revotaz Piperacillin 4 g, tazobactam0.5 g. VIAL / 1 (Alkem (Ulticare)) | $ 3.82 |
| Revotaz Piperacillin 1 g, tazobactam125 mg. VIAL / 1 (Alkem (Ulticare)) | |
| Revotaz 4000 mg/500 mg Injection (Alkem (Ulticare)) | $ 4.70 |
| Rifco (India) | |
| Rifco Piperacillin 4g, Tazobactam0.5g VIAL / 1 (Adley) | $ 6.07 |
| 1's (Adley) | $ 6.07 |
| RIFCO 4000MG/500MG INJECTION (Adley) | $ 6.07 |
| ROXTAZ (India) | |
| SANOTAZ (India) | |
| 1's (Arvincare) | |
| Sanotaz Piperacillin 4 g, tazobactam500 mg. INJ / 1 (Arvincare) | |
| Sanotaz Piperacillin 4 g, tazobactam500 mg. INJ / 1 (Arvincare) | |
| Santaz (India) | |
| Santaz Piperacillin Na 4g, Tazobactam0.5g VIAL / 1 (Sanjivani Parenteral Ltd) | $ 3.71 |
| 1's (Sanjivani Parenteral Ltd) | $ 3.71 |
| Santaz 4000+500 Injection (Sanjivani Parenteral Ltd) | $ 3.71 |
| Sinibec (India) | |
| Sinibec Piperacillin 4gm, Tazobactam0.5gm INJ / 4.5g (St. Morrison (Aamorb Pharmaceuticals Pvt Ltd)) | $ 3.84 |
| 1's (St. Morrison (Aamorb Pharmaceuticals Pvt Ltd)) | $ 3.84 |
| Sinibec 4000+500 Injection (St. Morrison (Aamorb Pharmaceuticals Pvt Ltd)) | $ 3.84 |
| SINIBEC 4000MG/500MG INJECTION 1 vial / 1 ML injection each (St. Morrison (Aamorb Pharmaceuticals Pvt Ltd)) | $ 2.94 |
| Sinibec 4000 mg/500 mg Injection (St. Morrison (Aamorb Pharmaceuticals Pvt Ltd)) | $ 2.94 |
| SIPRACILLIN-TZ (India) | |
| 1's (Sipra) | $ 5.31 |
| Sipracillin-TZ Piperacillin 4 g, tazobactam0.5 g. INJ / 1 (Sipra) | $ 5.31 |
| Sipracillin-TZ Piperacillin 4 g, tazobactam0.5 g. INJ / 1 (Sipra) | $ 5.31 |
| Sixacin 4.5 (Paraguay) | |
See 1079 substitutes for Pybactam | |
References
- PubChem. "piperacillin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- PubChem. "Tazobactam". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Tazobactam". http://www.drugbank.ca/drugs/DB01606 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
