Composition Each single dose vial contains
....
4.5 g of piperacillin sodium - tazobactam sodium
Piperacillin sodium BP equivalent to 4 gms of piperacillin
Tazobactam sodium BP equivalent to 0.5 g of tazobactam
as sterile freeze dried powder for reconstitution
Description Tazact is an injectable antibacterial
combination product consisting of the semi synthetic
antibiotic piperacillin sodium and the ß-lactamase
inhibitor tazobactam sodium for intravenous administration.
Piperacillin sodium exerts bactericidal activity by
inhibiting cell wall synthesis. Tazobactam sodium
is a -lactamase inhibitor of the Richmond-Sykes Class
III penicillinases and cephalosporinases. Tazobactam
does not induce chromosomally mediated ß-lactamses.
Indication Tazact has been shown to be
active against most strains of lactamase producing
micro-organisms both in vitro and in clinical infections.
Indicated for the treatment of moderate to severe
infections.
Appendicitis
(complicated by rupture or abscess) and peritonitis:
the Bacteroides group: B. fragilis etc.
Complicated
skin and skin structure infections: Including cellulitis,
cutaneous abscesses and ischemic/diabetic foot infections.
Postpartum
endometritis or pelvic inflammatory disease.
Nosocomial
pneumonia: Start with 4.5 g every 8 hours plus an
aminoglycoside. The recommended duration of treatment
is 7 to 14 days. Continue the aminoglycoside in
patients from whom P.aeruginosa is isolated.
Renal function
impairment: Patients with renal insufficiency adjust
the IV dose to the degree of actual renal function
impairment.
Haemodialysis: The maximum dose
is 2.25 g every 8 hours. In addition, because haemodialysis
removes 30% to 40% of a dose in 4 hours, one additional
0.75 g dose is recommended following each dialysis
period. No dosage replacement required in peritoneal
dialysis
Duration of therapy: The recommended
duration of Tazact treatment of nosocomial pneumonia
is 7 to 14 days. In all conditions, the duration of
therapy should be guided by severity of infection
and the patient's clinical and bacteriological progress.
Intravenous administration: For
conventional vials, reconstitute Tazact per 1 gram
of piperacillin with 5 ml of a compatible reconstitution
diluent (given below)
Shake well until dissolved.
Compatible reconstituted
diluents: These include 0.9% sodium chloride for injection,
sterile water for injection, dextrose 5%, bacteriostatic
saline/Parabens, bacteriostatic water/Benzyl alcohol.
Lactated Ringer's solution is not compatible. Dilute
to at least 50 ml to 150 ml. Administer over a period
of at least 30 minutes.
Contraindications Tazact is contraindicated in
patients with a history of allergic reactions to any
of the penicillins, cephalosporins, or (beta)-lactamase
inhibitors.
Precautions
GENERAL Tazact is a monosodium salt of
piperacillin and a monosodium salt of tazobactam and
contains a total of 2.35 mEq (54 mg) of Na+ per gram
of piperacillin in the combination product. This should
be considered when treating patients requiring restricted
salt intake.
DRUG
INTERACTIONS Aminoglycosides
The mixing of Tazact with an aminoglycoside in vitro
can result in substantial inactivation of the aminoglycoside.
The aminoglycoside should be reconstituted and administered
separately.
Lactated Ringer's solution
Lactated Ringer's solution is not compatible with Tazact.
Pregnancy/Lactation: Caution
should be exercised when Tazact is administered to a
pregnant and nursing woman.
Paediatric
Use Safety and efficacy in paediatric
patients have not been established.
Geriatric Use: No dosage adjustment required
Side Effects
GI: Diarrhoeas
Skin reactions
Other reactions: rare
Storage/Stability
Use single-dose vials immediately after reconstitution.
Discard any unused portion after 24 hours if stored
at room temperature or after 48 hours if refrigerated
(2o to 8o C) Stable in IV bags up to 24 hours and in
ambulatory IV infusion pumps for 12 hours.
