Tazam

Tazam

piperacillin + tazobactam

Manufacturer:

Kalbe Farma
Full Prescribing Info
Contents
Piperacillin sodium, tazobactam sodium.
Description
Each vial contains: Piperacillin sodium equivalent to 4 g piperacillin and tazobactam sodium equivalent to 0.5 g tazobactam.
Action
Pharmacology: Piperacillin and tazobactam are widely distributed into tissues and body fluids including intestinal mucosa, gallbladder, lung, female reproductive tissues (uterus, ovary, and fallopian tube), interstitial fluid, and bile.
Piperacillin is metabolized to a minor microbiologically active desethyl metabolite. Tazobactam is metabolized to a single metabolite that lacks pharmacological and antibacterial activities. Piperacillin is excreted rapidly as unchanged drug with 68% of the administered dose excreted in the urine. Tazobactam and its metabolite are eliminated primarily by renal excretion with 80% of the administered dose excreted as unchanged drug and the remainder as a single metabolite. Piperacillin, tazobactam, and desethyl piperacillin are also secreted into the bile.
The plasma half-life of piperacillin and tazobactam ranged from 0.7-1.2 hours and was unaffected by dose or duration of infusion. tazobactam due to hepatic cirrhosis. Piperacillin and tazobactam are removed from the body during hemodialysis with 31% and 39% of the doses of piperacillin and tazobactam recovered in the dialysis fluid; piperacillin and tazobactam are also removed by peritoneal dialysis with 5% and 12% of the dose appearing in dialysate.
Indications/Uses
Tazam is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam susceptible or β-lactamase producing strains of the designated microorganisms in the specified conditions listed as follows: Appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, β-lactamase producing strains of E. coli or the following members of Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotaomicron, and B. vulgatus.
Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses, and ischemic/diabetic foot infections caused by piperacillin-resistant, β-lactamase producing strains of Staphylococcus aureus.
Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, β-lactamase producing strains of E. coli.
Community-acquired pneumonia (moderate severity only) caused by piperacillin-resistant, β-lactamase producing strains of Haemophillus influenzae.
Infections caused by piperacillin susceptible organisms, for which piperacillin has been shown to be effective are also amenable to Tazam treatment due to its piperacillin content.
Tazam is useful as presumptive therapy in the indicated conditions prior to the identification of causative organisms because of its broad spectrum of bactericidal activity against Gram-positive and Gram-negative aerobic and anaerobic organisms.
Antimicrobial therapy should be adjusted, if appropriate, once the results of culture(s) and antimicrobial susceptibility testing are known.
Dosage/Direction for Use
Tazam should be administered by slow intravenous infusion (e.g., over 20 – 30 minutes) or slow intravenous injection (over at least 3-5 minutes).
Duration of Therapy: The usual duration of Tazam treatment is from seven to ten days. The duration of therapy should be guided by the severity of the infection and the patient's clinical and bacteriological progress.
Adults and Children 12 Years and Older: In general, the recommended total daily dosage is 12 g piperacillin/1.5 g tazobactam given in divided doses every 6 or 8 hours.
Doses as high as 18 g piperacillin/2.25 g tazobactam per day in divided doses can be used in severe infections.
In neutropenia the recommended dose is 4.5 g Tazam (4 g piperacillin/500 mg tazobactam) given every 6 hours in combination with aminoglycoside.
Pediatric Neutropenia: For children aged 2-12 years with normal renal function and weighing less than 50 kg, the dose should be adjusted to 80 mg piperacillin/10 mg tazobactam per kg administered every 6 hours, in combination with the appropriate dose of an aminoglycoside.
For children weighing over 50 kg, follow the adult dosing, in combination with the appropriate dose of an aminoglycoside.
Use in Patients with Renal Impairment: In patients with renal insufficiency or hemodialysis patients, intravenous dosages and administration intervals should be adjusted to the degree of renal function impairment.
Contraindications
History of allergic reactions to penicillins and/or cephalosporins or β-lactamase inhibitors.
Warnings
Before initiating therapy with piperacillin/tazobactam, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens.
Special Precautions
Use in pregnancy & lactation: Pregnant women and women who are breast-feeding should be treated only if the expected benefit outweighs the possible risks to the pregnant woman and fetus or child.
Use In Pregnancy & Lactation
Pregnant women and women who are breast-feeding should be treated only if the expected benefit outweighs the possible risks to the pregnant woman and fetus or child.
Adverse Reactions
Common adverse effects (>1%): Diarrhea, nausea, vomiting, rash.
Uncommon adverse effects (<1%): Hypersensitivity reaction, leukopenia, neutropenia, thrombocytopenia, headache, insomnia, constipation, dyspepsia, jaundice, stomatitis, candidal superinfection, ALT/AST increased, pruritus, urticaria, fever, injection site reaction.
Caution For Usage
Stability and Compatibility: Known compatible solutions for reconstitution with piperacillin/tazobactam are sodium chloride 0.9% for injection, sterile water for injection, and dextrose 5. Reconstitute each vial with 20 mL of compatible solvents on recommended volume. Swirl until dissolved. For administration by IV infusion, reconstituted solution may be further diluted to the desired volume (e.g. 50 mL-150 mL) with one of the compatible solvents for intravenous use.
Maximum recommended volume of sterile water for injection per dose is 50 mL. Piperacillin/tazobactam should not be mixed with other drugs in a syringe or infusion bottle. After reconstitution and dilution on recommended volume, piperacillin/tazobactam solution should be used on 24 hours (on room temperature 20°-25°C) or 48 hours on refrigerator (2°-8°C). Solution that exceed storage time limit should be disposed. Vial should not be frozen after reconstitutions.
Storage
Store below 25°C.
MIMS Class
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
Powd for inj (vial) 4.5 g x 1's.
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