DIAPIPTAZ
4g/ 500mg Powder for Injection (IV)
Piperacillin/ tazobactam is a combination antibiotic containing the extended-spectrum penicillin antibiotic piperacillin and the β-lactamase inhibitor tazobactam (piperacillin sodium/tazobactam sodium) is an injectable antibacterial combination of the semisynthetic antibiotic piperacillin sodium and the ß-lactamase inhibitor tazobactam sodium for intravenous administration. Thus, piperacillin/tazobactam combines the properties of a broad spectrum antibiotic and a β-lactamase inhibitor.
Piperacillin sodium exerts bactericidal activity by inhibiting septum formation and cell wall synthesis. Piperacillin and other β-lactam antibiotics block the terminal transpeptidation step of cell wall peptidoglycan biosynthesis in susceptible organisms by interacting with the penicillin binding proteins (PBPs), the bacterial enzymes that carry out this reaction. In vitro, piperacillin is active against a variety of gram-positive and gram-negative aerobic and anaerobic bacteria.
For the treatment of documented multidrug resistant Gram-negative infections due to organism proven or suspected to be susceptible to piperacillin-tazobactam except CNS infections; and for polymicrobial infections (e.g. mixed aerobic and anaerobic infections) in which other agents have insufficient activity or are contraindicated due to toxic potential.
Absorption: Peak plasma concentrations of tazobactam and piperacillin are attained immediately after completion of an intravenous infusion . Piperacillin plasma concentrations, following a 30 minute infusion are similar to those obtained when equivalent doses of piperacillin are administered alone, with mean peak plasma concentrations of approximately 134, 242, and 298 μg/mL for the 2.0 g/0.25 g, 3.0 g/0.375 g and 4.0 g/0.5 g (piperacillin sodium/tazobactam sodium) doses, respectively. The corresponding mean peak plasma concentrations of tazobactam are 15, 24 and 34 μg/mL.
Distribution: Tazobactam and piperacillin are widely distributed into tissues and body fluids including, but not limited to, intestinal mucosa, gallbladder, lung, female reproductive tissues (uterus, ovary and fallopian tube), interstitial fluid and bile. Mean tissue concentrations were generally 50-100% of those in plasma. Distribution of tazobactam and piperacillin into cerebrospinal fluid is low in subjects with non-inflamed meninges, as with other penicillins.
Metabolism: Piperacillin is metabolized to a minor microbiologically active desethyl metabolite. Tazobactam is metabolized to a single metabolite which lacks pharmacological and antibacterial activities.
Excretion: Both tazobactam and piperacillin are eliminated by the kidney via glomerular filtration and tubular secretion. Tazobactam and its metabolite are eliminated primarily by renal excretion with 80% of the dose as unchanged drug and the remainder as the single metabolite. Piperacillin is excreted rapidly as unchanged drug, with 68% of the dose in the urine. Piperacillin, tazobactam and desethyl piperacillin are also secreted into the bile
Diapiptaz should be administered by intravenous infusion over 30 minutes or as prescribed by the physician.
Adults:
The usual total daily dose of Piperacillin + Tazobactam is 3.375g every six hours totalling 13.5g (12.0g Piperacillin + 1.5g Tazobactam).
Initial presumptive treatment of patients with nosocomial pneumonia should start with 16.0g Piperacillin + 2.0g Tazobactam).
Treatment with 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 direction of the treating physician.
Pediatrics:
Piperacillin + Tazobactam can be administered in pediatric patients from 2 months of age. The dosage and indications in pediatric patients with normal renal function are as follows:
Age of pediatric patients |
||
2 months and 9 months of age |
Community-acquired pneumonia, intra-abdominal infections (appendicitis and/ or peritonitis), uncomplicated and complicated skin problems |
80 mg Piperacillin + 10 mg Tazobactam per kg q8h |
9 months or older weighing up to 40kg |
100 mg Piperacillin + Tazobactam 4.5 q6h (16.0mg Piperacillin + 2.0 mg Tazobactam per day) + aminoglycoside |
|
Weighing over 40 kg |
4.5 mg Piperacillin + Tazobactam 4.5 q6h (16.0 mg Piperacillin + 2.0 mg Tazobactam |
Pregnancy, lactation, taking any prescription or non-prescription medicine, herbal preparation, or dietary supplement, allergies to medicines, food or other substances, cystic fibrosis, bowel inflammation, bleeding problems, congestive heart failure, kidney problems, history of severe diarrhea or bowel problems with antibiotics and on salt-restricted diet or low blood potassium levels.
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