Tazolitt

Tazolitt

piperacillin + tazobactam

Manufacturer:

Inject Care Parenterals

Distributor:

Littman
Concise Prescribing Info
Contents
Per 4 g/500 mg Piperacillin 4 g, tazobactam 500 mg
Indications/Uses
Documented multidrug resistant gm -ve infections due to organisms proven or suspected to be susceptible to piperacillin + tazobactam except CNS infections; 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
Administer by IV infusion over 30 min. Adult Usual total dose: 3.375 g every 6 hr totaling 13.5 g (12 g piperacillin/1.5 g tazobactam). Usual treatment duration: 7-10 days. Nosocomial pneumonia Initially 4.5 g every 6 hr + aminoglycoside, totaling 18 g (16 g piperacillin/2 g tazobactam). Duration of treatment: 7-14 days. Treatment w/ aminoglycoside should be continued in patient from whom Pseudomonas aeruginosa is isolated. Serious complicated infection 200-300 mg/kg daily in divided doses IV: Usual dose: 3-4 g every 4-6 hr. Mild or uncomplicated infection 100-125 mg/kg daily. Usual doses: 2 g every 6-8 hr, or 4 g every 12 hr IV, or 2 g every 8 or 12 hr IM. Uncomplicated gonorrhoea 2 g single IM dose. Prophylaxis infection during surgery 2 g before the procedure. All indications (except nosocomial pneumonia) Renal function CrCl >40 mL/min 3.375 g every 6 hr, 20-40 mL/min (patient not receiving hemodialysis) 2.25 g every 6 hr, <20 mL/min (patient not receiving hemodialysis) 2.25 g every 8 hr. Patient on hemodialysis Max dose: 2.25 g every 12 hr. Additional dose: 0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days. CAPD 2.25 g every 12 hr. Nosocomial pneumonia Renal function CrCl >40 mL/min 4.5 g every 6 hr, 20-40 mL/min (patient not receiving hemodialysis) 3.375 g every 6 hr, <20 mL/min (patient not receiving hemodialysis) 2.25 g every 6 hr. Patient on hemodialysis Max dose: 2.25 g every 8 hr. Additional dose: 0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days. CAPD 2.25 g every 8 hr. Childn w/ appendicitis &/or peritonitis ≥9 mth, wt up to 40 kg, & normal renal function 100 mg piperacillin/12.5 mg tazobactam per kg every 8 hr, ped patient 2-9 mth 80 mg piperacillin/10 mg tazobactam per kg, every 8 hr.
Contraindications
Hypersensitivity to piperacillin, tazobactam or any other penicillin-antibacterial agent. History of acute severe allergic reaction to any other β-lactam active substance (eg, cephalosporin, monobactam or carbapenem).
Special Precautions
Reports of serious & occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions (including shock). Discontinue if allergic reaction occurs. May cause severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, & acute generalized exanthematous pustulosis). Monitor closely if patient develops skin rash & discontinue use if lesions progress. Discontinue if bleeding manifestations occur. May experience neuromuscular excitability or convulsions if higher than recommended doses are given IV (particularly in the presence of renal failure). Report of Clostridium difficile-associated diarrhea (CDAD). Consider treating patients w/ restricted salt intake. Perform periodic assessment of hematopoietic function, especially w/ prolonged therapy (ie, ≥21 days). Perform periodic electrolyte determinations in patients w/ low K reserves; possibility of hypokalemia in patients w/ potentially low K reserves & who are receiving cytologic therapy or diuretics. May lead to false +ve results to a number of chemical urine protein measurement methods; non-enzymatic methods of measuring urinary glucose; Bio-Rad Laboratories Platelia Aspergillus EIA tests. Direct Coombs test may be +ve. Reports of cross-reactions w/ non-Aspergillus polysaccharides & polyfuranoses w/ Bio-Rad Laboratories Platelia Aspergillus EIA test. Nephrotoxicity in critically ill patients; monitor renal function during treatment w/ piperacillin/tazobactam if alternative treatment options are inadequate or unavailable. Combined use w/ vancomycin may be associated w/ increased incidence of acute kidney injury. Pregnancy & breastfeeding. Adjustment of dosage in ped patient w/ renal impairment has not been determined.
Adverse Reactions
Diarrhea, constipation, nausea, vomiting, dyspepsia, abdominal pain; fever, inj site reaction; hypoglycemia; headache; insomnia; rash, pruritus; thrombophlebitis, hypotension. Rigors; anaphylaxis; candidiasis, pseudomembranous colitis; myalgia, arthralgia; purpura; phlebitis, flushing; epistaxis. Decrease in Hb & hematocrit, thrombocytopenia, increases in platelet count, eosinophilia, leukopenia, neutropenia; +ve direct Coombs test, prolonged partial thromboplastin time; transient elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin; increases in serum creatinine, BUN; electrolyte abnormalities (ie, increases & decreases in Na, K, & Ca), hyperglycemia, decreases in total protein or albumin, decreased blood glucose, increased γ-glutamyl transferase, hypokalemia, & prolonged bleeding time. Nosocomial pneumonia trials: Thrombocythemia, anemia; stomatitis; oral candidiasis, candidiasis; increased blood creatinine, abnormal LFT; renal failure. Other trials: Nephrotoxicity.
Drug Interactions
Simultaneous administration of heparin, oral anticoagulants & other drugs that may affect blood coagulation system including thrombocyte function (appropriate coagulation tests should be performed more frequently & monitored regularly). Produces longer t½ & lower renal clearance for both piperacillin & tazobactam in concurrent administration of probenecid. Increased incidence of acute kidney injury in patients concomitantly administered w/ vancomycin. Piperacillin: Concomitant use w/ vecuronium has been implicated in the prolongation of neuromuscular blockade. May reduce excretion of MTX. Inactivation of tobramycin & gentamicin in patients w/ severe renal impairment.
MIMS Class
Penicillins
ATC Classification
J01CR05 - piperacillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
Form
Tazolitt 4 g/500 mg powd for inj
Packing/Price
(30 mL) 1's