TAZOGET Piperacillin / Tazobactam 2g / 250mg Powder for IM/IV Injection 1's
RXDRUG-DRP-3220-07
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Features
Brand
Tazoget
Full Details
Dosage Strength
2g / 250mg
Drug Ingredients
- Piperacillin
- Tazobactam
Drug Packaging
Powder for IM/IV Injection 1's
Generic Name
Piperacillin Sodium / Tazobactam Sodium
Dosage Form
Powder for IM/IV Injection
Registration Number
DRP-3220-07
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
For documented multidrug-resistant gram-negative infections due to organisms proven or suspected to be susceptible to piperacillin-tazobactam except central nervous system (CNS) infections and for polymicrobial infections (eg, mixed aerobic & anaerobic infections) in which other agents have insufficient activity or are contraindicated due to toxic potential.
Dosage/Direction for Use
Adults and Adolescents: Infections: Usual Dose: 4g/500 mg given every 8 hrs.
Nosocomial Pneumonia and Bacterial Infections in Neutropenic Patients: Recommended Dose: 4 g/500 mg administered every 6 hrs. This regimen may also be applicable to treat patients with other indicated infections when particularly severe.
Severe Pneumonia, Neutropenic Adults with Fever Suspected to be Due to a Bacterial Infection, Complicated Urinary Tract Infection (UTI) (including Pyelonephritis): 2 g/250 mg or 4 g/500 mg every 6 hrs.
Complicated Intra-abdominal Infections, Skin and Soft Tissue Infections (including Diabetic Foot Infections): 2 g/250 mg or 4 g/500 mg every 8 hrs.
Hemodialysis: One (1) additional dose of 2 g/250 mg or 4 g/500 mg (piperacillin/tazobactam) should be administered following each dialysis period, because hemodialysis removes 30-40% of piperacillin in 4 hrs.
Children 2-12 years: Neutropenic Children with Fever Suspected to be Due to Bacterial Infections*: Piperacillin 80 mg/tazobactam 10mg/kg body weight every 8 hrs.
Complicated Intra-abdominal Infections*: Piperacillin 100 mg/tazobactam 10 mg/kg body weight every 8 hrs.
*Not to exceed maximum 4 g/500 mg/dose over 30 min.
Children: Hemodialysis: One (1) additional dose of piperacillin 40 mg/tazobactam 5 mg/kg should be administered following each dialysis period.
Renal Impairment: The IV dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity; medicinal product dose and interval should be adjusted accordingly): Recommended Dose: Adults and Adolescents Creatinine Clearance (CrCl) >40 mL/min: No dose adjustment is necessary, 20-40 mL/min: Maximum Dose: 4 g/500 mg every 8 hrs, >20 mL/min: Maximum Dose: 4 g/500 mg every 12 hrs.
Children CrCl >50 mL/min: 2 g/250 mg, no dose adjustment is necessary, ≤50 mL/min: Piperacillin 70 mg/tazobactam 8.7 mg/kg every 8 hrs.
Hepatic Impairment: No dose adjustment is necessary.
Treatment Duration: The usual duration of treatment for most indications is in the range of 5-14 days. However, the duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress.
Elderly: No dose adjustment is required for the elderly with normal renal function or CrCl values >40 mL/min.
Administration: Piperacillin/tazobactam 2 g/250 mg is administered by IV infusion (over 30 min).
Nosocomial Pneumonia and Bacterial Infections in Neutropenic Patients: Recommended Dose: 4 g/500 mg administered every 6 hrs. This regimen may also be applicable to treat patients with other indicated infections when particularly severe.
Severe Pneumonia, Neutropenic Adults with Fever Suspected to be Due to a Bacterial Infection, Complicated Urinary Tract Infection (UTI) (including Pyelonephritis): 2 g/250 mg or 4 g/500 mg every 6 hrs.
Complicated Intra-abdominal Infections, Skin and Soft Tissue Infections (including Diabetic Foot Infections): 2 g/250 mg or 4 g/500 mg every 8 hrs.
Hemodialysis: One (1) additional dose of 2 g/250 mg or 4 g/500 mg (piperacillin/tazobactam) should be administered following each dialysis period, because hemodialysis removes 30-40% of piperacillin in 4 hrs.
Children 2-12 years: Neutropenic Children with Fever Suspected to be Due to Bacterial Infections*: Piperacillin 80 mg/tazobactam 10mg/kg body weight every 8 hrs.
Complicated Intra-abdominal Infections*: Piperacillin 100 mg/tazobactam 10 mg/kg body weight every 8 hrs.
*Not to exceed maximum 4 g/500 mg/dose over 30 min.
Children: Hemodialysis: One (1) additional dose of piperacillin 40 mg/tazobactam 5 mg/kg should be administered following each dialysis period.
Renal Impairment: The IV dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity; medicinal product dose and interval should be adjusted accordingly): Recommended Dose: Adults and Adolescents Creatinine Clearance (CrCl) >40 mL/min: No dose adjustment is necessary, 20-40 mL/min: Maximum Dose: 4 g/500 mg every 8 hrs, >20 mL/min: Maximum Dose: 4 g/500 mg every 12 hrs.
Children CrCl >50 mL/min: 2 g/250 mg, no dose adjustment is necessary, ≤50 mL/min: Piperacillin 70 mg/tazobactam 8.7 mg/kg every 8 hrs.
Hepatic Impairment: No dose adjustment is necessary.
Treatment Duration: The usual duration of treatment for most indications is in the range of 5-14 days. However, the duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress.
Elderly: No dose adjustment is required for the elderly with normal renal function or CrCl values >40 mL/min.
Administration: Piperacillin/tazobactam 2 g/250 mg is administered by IV infusion (over 30 min).
Contraindications
Hypersensitivity to piperacillin sodium and tazobactam sodium or to any of the components of Tazoget; or to any other penicillin-antibacterial agent. History of acute severe allergic reaction to any other β-lactam active substances (eg, cephalosporin, monobactam or carbapenem).
Special Precautions
Before initiating therapy with piperacillin/tazobactam, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, other β-lactams (eg, cephalosporin, monobactam or carbapenem) and other allergens. Serious and occasionally fatal hypersensitivity [anaphylactic/anaphylactoid (including shock)] reactions have been reported in patients receiving therapy with penicillins, including piperacillin/tazobactam. These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens. Serious hypersensitivity reactions require the discontinuation of the antibiotic and may require administration of epinephrine and other emergency measures.
Antibiotic-induced pseudomembranous colitis may be manifested by severe, persistent diarrhea which may be life-threatening. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. In these cases, piperacillin/tazobactam should be discontinued.
Therapy with piperacillin/tazobactam may result in the emergence of resistant organisms, which might cause superinfections.
Bleeding manifestations have occurred in some patients receiving β-lactam antibiotics. These reactions sometimes have been associated with abnormalities of coagulation tests eg, clotting time, platelet aggregation and prothrombin time, and are more likely to occur in patients with renal failure. If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted.
Leukopenia and neutropenia may occur, especially during prolonged therapy, therefore, periodic assessment of hematopoietic function should be performed.
As with treatment with other penicillins, neurological complications in the form of convulsions may occur when high doses are administered, especially in patients with impaired renal function.
Each vial of piperacillin/tazobactam 2 g/250 mg contains 4.72 mmol (109 mg) of sodium. This should be taken into consideration for patients who are on a controlled sodium diet.
Hypokalemia may occur in patients with low potassium reserves or those receiving concomitant medicinal products that may lower potassium levels; periodic electrolyte determinations may be advisable in such patients.
Use in children: The safety and efficacy of piperacillin/tazobactam 2 g/250 mg in children 0-2 years has not not been established. No data from controlled clinical studies are available.
Antibiotic-induced pseudomembranous colitis may be manifested by severe, persistent diarrhea which may be life-threatening. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. In these cases, piperacillin/tazobactam should be discontinued.
Therapy with piperacillin/tazobactam may result in the emergence of resistant organisms, which might cause superinfections.
Bleeding manifestations have occurred in some patients receiving β-lactam antibiotics. These reactions sometimes have been associated with abnormalities of coagulation tests eg, clotting time, platelet aggregation and prothrombin time, and are more likely to occur in patients with renal failure. If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted.
Leukopenia and neutropenia may occur, especially during prolonged therapy, therefore, periodic assessment of hematopoietic function should be performed.
As with treatment with other penicillins, neurological complications in the form of convulsions may occur when high doses are administered, especially in patients with impaired renal function.
Each vial of piperacillin/tazobactam 2 g/250 mg contains 4.72 mmol (109 mg) of sodium. This should be taken into consideration for patients who are on a controlled sodium diet.
Hypokalemia may occur in patients with low potassium reserves or those receiving concomitant medicinal products that may lower potassium levels; periodic electrolyte determinations may be advisable in such patients.
Use in children: The safety and efficacy of piperacillin/tazobactam 2 g/250 mg in children 0-2 years has not not been established. No data from controlled clinical studies are available.
Adverse Reactions
See table.
Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.
Drug Interactions
Nondepolarizing Muscle Relaxants: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vecuronium. Due to their similar mechanisms of action, it is expected that the neuromuscular blockade produced by any of the nondepolarizing muscle relaxants could be prolonged in the presence of piperacillin.
Oral Anticoagulants: During simultaneous administration of heparin, oral anticoagulants and other substances that may affect the blood coagulation system including thrombocyte function, appropriate coagulation tests should be performed more frequently and monitored regularly.
Methotrexate: Piperacillin may reduce the excretion of methotrexate; therefore, serum levels of methotrexate should be monitored in patients to avoid substance toxicity.
Probenecid: As with other penicillins, concurrent administration of probenecid and piperacillin/tazobactam produces a longer t½ and lower renal clearance for both piperacillin and tazobactam, however, peak plasma concentrations of either substances are unaffected.
Aminoglycosides: Piperacillin, either alone or with tazobactam, did not significantly alter the pharmacokinetics of tobramycin in subjects with normal renal function and with mild or moderate renal impairment. The pharmacokinetics of piperacillin, tazobactam and the M1 metabolite were also not significantly altered by tobramycin administration.
The inactivation of tobramycin and gentamicin by piperacillin has been demonstrated in patients with severe renal impairment.
Effects on Laboratory Tests: Non-enzymatic methods of measuring urinary glucose may lead to false-positive results, as with other penicillins. Therefore, enzymatic urinary glucose measurement is required under piperacillin/tazobactam therapy.
A number of chemical urine protein measurement methods may lead to false-positive results. Protein measurement with dip sticks is not affected.
The direct Coombs' test may be positive.
Positive test results for the assays stated previously in patients receiving piperacillin/tazobactam should be confirmed by other diagnostic methods.
Oral Anticoagulants: During simultaneous administration of heparin, oral anticoagulants and other substances that may affect the blood coagulation system including thrombocyte function, appropriate coagulation tests should be performed more frequently and monitored regularly.
Methotrexate: Piperacillin may reduce the excretion of methotrexate; therefore, serum levels of methotrexate should be monitored in patients to avoid substance toxicity.
Probenecid: As with other penicillins, concurrent administration of probenecid and piperacillin/tazobactam produces a longer t½ and lower renal clearance for both piperacillin and tazobactam, however, peak plasma concentrations of either substances are unaffected.
Aminoglycosides: Piperacillin, either alone or with tazobactam, did not significantly alter the pharmacokinetics of tobramycin in subjects with normal renal function and with mild or moderate renal impairment. The pharmacokinetics of piperacillin, tazobactam and the M1 metabolite were also not significantly altered by tobramycin administration.
The inactivation of tobramycin and gentamicin by piperacillin has been demonstrated in patients with severe renal impairment.
Effects on Laboratory Tests: Non-enzymatic methods of measuring urinary glucose may lead to false-positive results, as with other penicillins. Therefore, enzymatic urinary glucose measurement is required under piperacillin/tazobactam therapy.
A number of chemical urine protein measurement methods may lead to false-positive results. Protein measurement with dip sticks is not affected.
The direct Coombs' test may be positive.
Positive test results for the assays stated previously in patients receiving piperacillin/tazobactam should be confirmed by other diagnostic methods.
Caution For Usage
Directions for Reconstitution: Dissolve the contents of a vial in 10 mL water for injection USP. The reconstituted solution should be used immediately after preparation and discard the unused remaining portion. It should not be allowed to freeze.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Action
Pharmacology: Pharmacokinetics: Both piperacillin and tazobactam are not well absorbed in the gastrointestinal tract but have good bioavailability after an IM injection. They are both widely distributed into different body compartments but penetration into the meninges of tazobactam is poor when meninges are not inflamed. Tazobactam is metabolized to a single inactive metabolite while piperacillin is metabolized to the desethyl metabolite, which has minor activity. Approximately 68% and 80% of an administered dose of piperacillin and tazobactam, respectively are excreted unchanged in the urine.
MedsGo Class
Penicillins
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