Piptaz

A white to off white colored powder.
2.25 g: Each vial contains: Piperacillin sodium equivalent to Piperacillin 2 g, Tazobactam sodium equivalent to Tazobactam 250 mg.
4.5 g: Each vial contains: Piperacillin sodium equivalent to Piperacillin 4 g, Tazobactam sodium equivalent to Tazobactam 500 mg.

Pharmacotherapeutic group: Antibacterials for systemic use, combinations of penicillins, including beta-lactamase inhibitors.
Pharmacology: Pharmacodynamics Mechanism of action: Piperacillin, a broad-spectrum, semisynthetic penicillin exerts bactericidal activity by inhibition of both septum and cell-wall synthesis. Tazobactam, a beta-lactam structurally related to penicillins, is an inhibitor of many beta-lactamases, which commonly cause resistance to penicillins and cephalosporins but it does not inhibit AmpC enzymes or metallo beta-lactamases. Tazobactam extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria that have acquired resistance to Piperacillin alone.
Mechanism of resistance: The two main mechanisms of resistance to Piperacillin/Tazobactam are: Inactivation of the Piperacillin component by those beta-lactamases that are not inhibited by Tazobactam: beta-lactamases in the Molecular class B, C, and D. In addition, Tazobactam does not provide protection against extended-spectrum beta-lactamases (ESBLS) in the Molecular class A and D enzyme groups.
Alteration of penicillin-binding proteins (PBPs), which results in the reduction of the affinity of Piperacillin for the molecular target in bacteria. Additionally, alterations in bacterial membrane permeability, as well as expression of multidrug efflux pumps, may cause or contribute to bacterial resistance to Piperacillin/Tazobactam, especially in Gram-negative bacteria.
Pharmacokinetics: Both Piperacillin and Tazobactam are not well absorbed in the GIT 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.

For documented multidrug resistant Gram-negative infections due to organisms 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).

Piperacillin/Tazobactam should be administered by intravenous infusion over 30 minutes.
Adults: The usual total daily dose of Piperacillin/Tazobactam is 3.375 g every six hours totaling 13.5 g (12.0 g Piperacillin/1.5 g Tazobactam).
Initial presumptive treatment of patients with nosocomial pneumonia should start with (16.0 g Piperacillin/2.0 g 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 discretion 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: See Table 1.

Click on icon to see table/diagram/image

Duration of Therapy: The usual duration of Piperacillin/Tazobactam treatment is from seven to ten days. However, the recommended duration of treatment of nosocomial pneumonia is 7 to 14 days. In all conditions, the duration of therapy should be guided by the severity of the infection and the patient's clinical and bacteriological progress.
Renal Insufficiency: In patients with renal insufficiency (creatinine clearance <40 mL/min), the intravenous dose of Piperacillin/Tazobactam should be adjusted to the degree of actual renal function impairment. In patients with nosocomial pneumonia receiving concomitant aminoglycoside therapy, the aminoglycoside dosage should be adjusted according to the recommendation of the manufacturer.
Adults: See Table 2.

Click on icon to see table/diagram/image

For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g Piperacillin/Tazobactam should be administered following each dialysis period on hemodialysis days. No additional dosage of Piperacillin + Tazobactam is necessary for CAPD patients.
Pediatrics: There are no dosage recommendation for Piperacillin/Tazobactam in pediatric patients with impaired renal function.

Symptoms: There have been post-marketing reports of overdose with Piperacillin/Tazobactam. The majority of those events experienced including nausea, vomiting, and diarrhea, have also been reported with the usual recommended doses. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure).
Treatment: In the event of an overdose, Piperacillin/Tazobactam treatment should be discontinued. No specific antidote is known. Treatment should be supportive and symptomatic according to the patient's clinical presentation. Excessive serum concentrations of either Piperacillin or Tazobactam may be reduced by hemodialysis.

Piperacillin/Tazobactam is contraindicated in patients with a history of allergic reactions to any of the active ingredients, penicillins, cephalosporins, beta-lactamase antibiotics, tetracycline antibiotics, or beta-lactamase inhibitors.

If the patient is pregnant, planning to become pregnant, or are breastfeeding; if the patient is taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement; if the patient has allergies to medicines, food, or other substances; if the patient has cystic fibrosis, bowel inflammation, bleeding problems, congestive heart failure, or kidney problems, if the patient is on dialysis; or if the patient has a history of severe diarrhea or bowel problems due to antibiotics; and if the patient is on a salt-restricted diet or have low blood potassium levels.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.

Pregnancy: There are no or a limited amount of data from the use of Piperacillin/Tazobactam in pregnant women. Studies in animals have shown developmental toxicity, but no evidence of teratogenicity, at doses that are maternally toxic. Piperacillin and Tazobactam cross the placenta. Piperacillin/Tazobactam should only be used during pregnancy if clearly indicated i.e. only if the expected benefit outweighs the possible risks to the pregnant woman and fetus.
Breastfeeding: Piperacillin is excreted in low concentrations in human milk; Tazobactam concentrations in human milk have not been studied. Women who are breastfeeding should be treated only if the expected benefit outweighs the possible risks to the woman and child.
Fertility: A fertility study in rats showed no effect on fertility and mating after intraperitoneal administration of Tazobactam or the combination Piperacillin/Tazobactam.

Agitation; constipation; diarrhea; dizziness; headache; indigestion; nausea; pain; swelling or redness at the injection site; sleeplessness; vomiting; severe allergic reactions (rash; hives; itching; difficulty of breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; decreased urination; depression; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucination; inflammation at the injection site; prolonged muscle relaxation; red, swollen, or blistered skin; seizure; severe diarrhea, vomiting, or stomach pain; shortness of breath; swelling of the hands, ankles, or feet; tremor; unusual tiredness or weakness: vaginal irritation or discharge; vein inflammation or tenderness; yellowing of the eyes or skin.

Aminoglycosides (e.g., Tobramycin) or oral contraceptives (birth control pills) because their effectiveness may be decreased by Piperacillin/Tazobactam. Anticoagulants (e.g., Warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by Piperacillin/Tazobactam chemotherapy or diuretics (e.g., Furosemide, Hydrochlorothiazide) because the risk of side effects, such as low blood potassium levels, may be increased. Heparin, Methotrexate, or nondepolarizing muscle relaxants (e.g., Vecuronium) because the risk of their side effects may be increased by Piperacillin/Tazobactam. Probenecid because it may increase the risk of Piperacillin/Tazobactam's side effects. Tetracyclines (e.g., Doxycycline) because they may decrease Piperacillin/Tazobactam's effectiveness.

Direction for Reconstitution: 2.5 g: Dissolve the contents of a vial in 10 mL Sterile Water for Injection USP.
4.5 g: Dissolve the contents of a vial in 20 ml Sterile 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.

Store at temperatures not exceeding 30°C.

Penicillins

J01CR05 - piperacillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

Rx