piperacillin + tazobactam


Zhuhai United


Global Pharmatrade
Full Prescribing Info
Piperacillin sodium, tazobactam sodium.
Each vial contains: Piperacillin (as Sodium) 2 g, Tazobactam (as Sodium) 250 mg and Piperacillin (as Sodium) 4 g, Tazobactam (as Sodium)500 mg, respectively.
Piperacillin and Tazobactam Sodium is an injectable antibacterial combination product consisting of the semisynthetic antibiotic Piperacillin sodium and the (beta)-lactamase inhibitor Tazobactam sodium for intravenous administration.
Piperacillin and Tazobactam Sodium is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible, (beta)-lactamase producing strains of the designated microorganisms in the specified conditions listed below: Appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, (beta)-lactamase producing strains of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotamicron, or B. vulgatus.
Uncomplicated and complicated skin and skin structure infections, including cellulites, cutaneous abscesses and ischemic/diabetic foot infections caused by piperacillin-resistant, (beta)-lactamase producing strains of Staphylococcus aureus.
Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, (beta)-lactamase producing strains of Escherichia coli.
Community-acquired pneumonia (moderate severity only) caused by piperacillin-resistant, (beta)-lactamase producing strains Haemophilius influenzae.
Nosocomial pneumonia (moderate to severe) caused by piperacillin-resistant, (beta) lactamase producing strains of Staphylococcus aureus.
Dosage/Direction for Use
Piperacillin and Tazobactam sodium should be administered by intravenous over 30 minutes.
Renal Insufficiency: In patients with renal insufficiency (Creatinine Clearance < 90 mL/min), the intravenous dose of Piperacillin and Tazobactam Sodium 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 recommendations of the manufacturer.
Dosage Recommendation: For All Indication Including Nosocomial Pneumonia: Creatinine clearance >40-90 mL/min 12 g/1.5 g/day in divided doses of 3.375 g q 6 h; 20-40 mL/min 8 g/1.0 g/day in divided doses of 2.25 g q 6 h; <20 mL/min 6 g/0.75 g/day in divided dose of 2.25 g q 8 h.
Hemodialysis: The maximum dose is 2.25 g Piperacillin and Tazobactam Sodium every eight hours. In addition, because hemodialysis removes 30% to 40% of a Piperacillin and Tazobactam Sodium dose in four hours, one additional dose of 0.75 g Piperacillin and Tazobactam Sodium should be administered following each dialysis period.
Duration of Therapy: The usual duration of Piperacillin and Tazobactam Sodium treatment is from seven to ten days. However, the recommended duration of Piperacillin and Tazobactam Sodium treatment of nosocomial pneumonia is seven to fourteen days. In all conditions, the duration of therapy should be guided by the severity of the infection and the patient's clinical and bacteriologist progress.
Intravenous Administration: For conventional vials, reconstitute Piperacillin and Tazobactam Sodium per gram of piperacillin with 5 mL of a compatible reconstitution diluent from the list provided below. Shake well until dissolved. Single dose vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature [20° to 25°C (68° to 77°F)], or after 48 hours if stored at refrigerated temperature [2° to 8°C (36° to 46°F)].
Information on overdosage of Piperacillin and Tazobactam Sodium in humans is not available.
Excessive serum levels of either Piperacillin or Tazobactam may be reduced by hemodialysis. No specific antidote is known.
Piperacillin and Tazobactam Sodium is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporin's, or (beta)-lactamase inhibitors.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy, these reactions are more likely to occur in individuals with a history of penicillin hypersensitivity.
Piperacillin and Tazobactam sodium should be discontinued and appropriate therapy instituted.
Serious anaphylactic reactions require immediate emergency treatment with epinephrine.
Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Special Precautions
General: Bleeding manifestations have occurred in some patients receiving (beta-lactam antibiotics, including piperacillin.
These reactions have sometimes been associated with abnormalities of coagulation tests such as clotting time, platelet aggregation, and prothrombin time, and are more likely to occur in patients with renal failure. If bleeding manifestation occurs Piperacillin and Tazobactam Sodium should be discontinued and appropriate therapy instituted.
As with other penicillins, patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously.
This should be considered when treating patients requiring restricted salt intake. Periodic electrolyte determinations should be performed in patients with low potassium reserves, and the possibility of hypokalemia should be kept in mind with patients who have potentially low potassium reserves, and the possibility of hypokalemia should be kept in mind with patients who have potentially low potassium reserves and who are receiving cytotoxic therapy or diuretics.
Pediatric Use: Safely and efficacy in pediatric have not been established.
Geriatric Use: Patients over 65 years are not an increased risk of developing adverse effects solely because of age. However, dosage should be adjustable in the presence of renal insufficiency.
Use In Pregnancy & Lactation
Pregnancy: Reproduction studies have been performed in rats and have revealed no evidence of impaired fertility due to piperacillin/tazobactam administered up to a dose which is similar to the maximum recommendation human daily dose based on body-surface area (mg/m2).
Nursing Mothers: Piperacillin is excreted in low concentrations in human milk; Tazobactam concentrations in human milk have not been studied. Caution should be exercised when Piperacillin and Tazobactam Sodium is administered to a nursing woman.
Side Effects
Autonomic nervous system: Hypotension, ileus, syncope.
Body as a whole: Rigors, back pain, malaise [asthenia, chest pain].
Cardiovascular: Tachycardia, including supraventricular and ventricular; bradycardia; arrhythmia, including atrial fibrillation, ventricular fibrillation, cardiac failure, circulatory failure, myocardial infarction [angina].
Central nervous system: Tremor, convulsions, vertigo.
Gastrointestinal: Melena, flatulence, hemorrhage, gastritis, hiccough, ulcerative stomatitis [fecal incontinence, gastric ulcer, pancreatitis].
Piperacillin Sodium + Tazobactam Sodium: Pseudomembranous colitis was reported in one patient during the clinical trials. The onset pseudomembranous colitis symptoms may occur during or after antibacterial treatment.
Hearing and Vestibular System: Tinnitus [deafness, earache].
Hypersensitivity: Anaphylaxis.
Metabolic and Nutritional: Symptomatic hypoglycemia, thirst [gout, vitamin B12 deficiency anemia].
Musculoskeletal: Myalgia, arthralgia.
Platelet, Bleeding, Clotting: Mesenteric embolism, purpura, epistaxis, pulmonary embolism [ecchymosis, hemoptysis].
Psychiatric: Confusion, hallucination, depression.
Reproductive, Female: Leucorrhea, vaginitis [perineal irritation/pain].
Reproductive, Male: Balanoposthitis.
Respiratory: Pharyngitis, pulmonary edema, bronchospasm, coughing [atelectasis, dyspnea, hypoxia].
Skin and Appendages: Genital pruritis, diaphoresis, conjunctivitis, xerosis.
Special senses: Taste perversion.
Urinary: Urinary retention, dysuria, oliguria, hematuria, incontinence, urinary tract infection with trichomonas, yeast in urine.
Vision: Photophobia.
Vascular (extracardiac): Flushing, cerebrovascular accident.
Gastrointestinal: Hepatitis, cholestatic jaundice.
Hematologic: Hemolytic anemia.
Renal: Rarely, interstitial nephritis.
Drug Interactions
Aminoglycosides: The mixing of Piperacillin and Tazobactam Sodium with an aminoglycosides in vitro can result in substantial inactivation of the aminoglycoside should be reconstituted separately.
Probenecid: Probenecid administered concomitantly with Piperacillin and Tazobactam Sodium prolongs the half-life of Piperacillin by 21% and that of Tazobactam by 71%Vancomycin.
No pharmacokinetic interactions have been noted between Piperacillin and Tazobactam Sodium and vancomycin.
Heparin: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function.
Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vecuronium.
Store at temperatures not exceeding 30°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.
2 g/250 mg inj (lyo) for soln (vial) 1's. 4 g/500 mg inj (lyo) for soln (vial) 1's.
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