Tazoxil Uses

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What is Tazoxil?

Piperacillin (Tazoxil) and Tazobactam (Tazoxil) injection is used to treat bacterial infections in many different parts of the body.

Piperacillin (Tazoxil) and Tazobactam (Tazoxil) combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria and preventing their growth. However, Piperacillin (Tazoxil) and Tazobactam (Tazoxil) will not work for colds, flu, or other virus infections.

Piperacillin (Tazoxil) and Tazobactam (Tazoxil) is to be given only by or under the direct supervision of your doctor.

Tazoxil indications

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Tazoxil is indicated for the treatment of the following systemic and/or local bacterial infections in which susceptible organisms have been detected or are suspected: Lower respiratory tract infections; urinary tract infections (complicated and uncomplicated); intra-abdominal infections; skin and skin structure infections; bacterial septicemia. Polymicrobial infections: Tazoxil is indicated for polymicrobial infections including those where aerobic and anaerobic organisms are suspected (intra-abdominal, skin and skin structure, lower respiratory tract).

Tazoxil, in combination with an aminoglycoside, is indicated for bacterial infections in neutropenic adults or children.

Children Under the Age of 12 Years: In hospitalized children aged 2 to 12 years, Tazoxil is indicated for the treatment of intra-abdominal infections including appendicitis complicated by rupture or abscess, peritonitis, and biliary infections. It has not been evaluated in this indication for pediatric patients below the age of 2 years.

Whilst Tazoxil is indicated only for the conditions listed above, infections caused by Piperacillin (Tazoxil) susceptible organisms are also amendable to Tazoxil treatment due to its Piperacillin (Tazoxil) content. Therefore, the treatment of mixed infections caused by Piperacillin (Tazoxil) susceptible organisms and β-beta lactamase producing organisms susceptible to Tazoxil should not require the addition of another antibiotic.

Tazoxil is particularly useful in the treatment of mixed infections and in presumptive therapy prior to the availability of the results of sensitivity tests because of its broad spectrum of activity.

Tazoxil acts synergistically with aminoglycosides against certain strains of Pseudomonas aeruginosa. Combined therapy has been successful, especially in patients with impaired host defences. Both drugs should be used in full therapeutic doses. As soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted if necessary.

How should I use Tazoxil?

Use Tazoxil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Tazoxil.

Uses of Tazoxil in details

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Use: Labeled Indications

Intra-abdominal infections: Treatment of appendicitis complicated by rupture or abscess and peritonitis caused by beta-lactamase-producing strains of Escherichia coli, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides vulgatus.

Pelvic infections: Treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase-producing strains of E. coli.

Pneumonia, community-acquired: Treatment of moderate severity community-acquired pneumonia (CAP) caused by beta-lactamase-producing strains of Haemophilus influenzae.

Pneumonia, hospital-acquired (nosocomial): Treatment of moderate to severe hospital-acquired (nosocomial) pneumonia caused by beta-lactamase-producing strains of Staphylococcus aureus and by Tazoxil-susceptible Acinetobacter baumannii, H. influenzae, Klebsiella pneumoniae, and P. aeruginosa.

Skin and skin structure infections: Treatment of skin and skin structure infections, including cellulitis, cutaneous abscesses, and ischemic/diabetic foot infections caused by beta-lactamase-producing strains of S. aureus.

Off Label Uses

Bite wound infection, treatment (animal or human bite)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), Piperacillin (Tazoxil) and Tazobactam (Tazoxil) is an effective and recommended treatment of animal bite wound infections.

Clinical experience supports the utility of Piperacillin (Tazoxil) and Tazobactam (Tazoxil) in the treatment of human bite wound infections.

Tazoxil description

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Each 2.25 g single-dose vial contains Piperacillin (Tazoxil) sodium equivalent to Piperacillin (Tazoxil) 2 g and Tazobactam (Tazoxil) sodium equivalent to Tazobactam (Tazoxil) 0.25 g and edetate disodium (dihydrate) (EDTA) 0.5 mg.

Each 4.5 g single-dose vial contains Piperacillin (Tazoxil) sodium equivalent to Piperacillin (Tazoxil) 4 g and Tazobactam (Tazoxil) sodium equivalent to Tazobactam (Tazoxil) 0.5 g and edetate disodium (dihydrate) (EDTA) 1 mg.

Tazoxil is an injectable antibacterial combination consisting of the semisynthetic antibiotic Piperacillin (Tazoxil) sodium and the beta-lactamase inhibitor Tazobactam (Tazoxil) sodium for intravenous administration. Piperacillin (Tazoxil) sodium is derived from D(-)-a-aminobenzylpenicillin. The chemical name of Piperacillin (Tazoxil) sodium is sodium (2S, 5R, 6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-phenylacetamido] – 3,3 –dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane – 2 – carboxylate. Piperacillin (Tazoxil) sodium is a white, crystalline powder. Piperacillin (Tazoxil) sodium is freely soluble in water, in alcohol, and in methyl alcohol; practically insoluble in ethyl acetate. Tazobactam (Tazoxil) sodium is a derivative of the penicillin nucleus. Chemically, Tazobactam (Tazoxil) is a penicillanic acid sulfone. Its chemical name is sodium (2S-,3S-,5R) – 3 – methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate,4,4-dioxide. Tazobactam (Tazoxil) sodium is a white to pale yellow non-hydroscopic crystalline powder.

Tazoxil also contains the following excipients: Piperacillin (Tazoxil) monohydrate, Tazobactam (Tazoxil), sodium hydrogen carbonate, citric acid (monohydrate), EDTA, water for injections and nitrogen.

Tazoxil dosage

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Tazoxil should be administered by intravenous infusion over 30 minutes.

The usual daily dose of Tazoxil for adults is 3.375 g every six hours totaling 13.5 g (12.0 g Piperacillin (Tazoxil)/1.5 g Tazobactam (Tazoxil)).

Nosocomial Pneumonia

Initial presumptive treatment of patients with nosocomial pneumonia should start with Tazoxil at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g Piperacillin (Tazoxil)/2.0 g Tazobactam (Tazoxil)). Treatment with the 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.

Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, Tazoxil and the aminoglycoside are recommended for separate administration. Tazoxil and the aminoglycoside should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated.

In circumstances where coadministration via Y-site is necessary, reformulated Tazoxil containing EDTA supplied in Galaxy containers is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:

The following compatibility information does not apply to the Tazoxil (Tazoxil) formulation not containing EDTA. This information does not apply to Tazoxil in vials or bulk pharmacy containers. Refer to the package insert for Tazoxil vials or bulk pharmacy containers for instructions.

TABLE 5
Aminoglycoside Tazoxil Dose

(grams)

Aminoglycoside Concentration Range*

(mg/mL)

Acceptable

Diluents

Amikacin 2.25, 3.375,

4.5

1.75 – 7.5 0.9% Sodium Chloride or 5% Dextrose
Gentamicin 2.25, 3.375, 4.5 0.7 – 3.32 0.9% Sodium Chloride or 5% Dextrose
*The concentration ranges in Table 5 are based on administration of the aminoglycoside in divided doses (10-15 mg/kg/day in two daily doses for amikacin and 3-5 mg/kg/day in three daily doses for gentamicin). Administration of amikacin or gentamicin in a single daily dose or in doses exceeding those stated above via Y-site with Tazoxil containing EDTA has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.

Tazoxil is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of Tazoxil with other aminoglycosides has not been established. Only the concentration and diluents for amikacin or gentamicin with the dosages of Tazoxil listed above have been established as compatible for coadministration via Y-site infusion. Simultaneous coadministration via Y-site infusion in any manner other than listed above may result in inactivation of the aminoglycoside by Tazoxil.

Renal Insufficiency

In patients with renal insufficiency (Creatinine Clearance ≤ 40 mL/min), the intravenous dose of Tazoxil 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. The recommended daily doses of Tazoxil for patients with renal insufficiency are as follows:

Recommended Dosing of Tazoxil in Patients with Normal Renal Function and Renal Insufficiency (As total grams Tazoxil)
Renal Function

(Creatinine Clearance,

mL/min)

All Indications (except nosocomial pneumonia) Nosocomial Pneumonia
>40 mL/min 3.375 q 6 h 4.5 q 6 h
20-40 mL/min* 2.25 q 6 h 3.375 q 6 h
<20 mL/min* 2.25 q 8 h 2.25 q 6 h
Hemodialysis** 2.25 q 12 h 2.25 q 8 h
CAPD 2.25 q 12 h 2.25 q 8 h
* Creatinine clearance for patients not receiving hemodialysis

** 0.75 g should be administered following each hemodialysis session on hemodialysis days

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 Tazoxil should be administered following each dialysis period on hemodialysis days. No additional dosage of Tazoxil is necessary for CAPD patients.

Duration of Therapy

The usual duration of Tazoxil treatment is from seven to ten days. However, the recommended duration of Tazoxil 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.

Pediatric Patients

For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended Tazoxil dosage is 100 mg Piperacillin (Tazoxil)/12.5 mg Tazobactam (Tazoxil) per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended Tazoxil dosage based on pharmacokinetic modeling, is 80 mg Piperacillin (Tazoxil)/10 mg Tazobactam (Tazoxil) per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. There are no dosage recommendations for Tazoxil in pediatric patients with impaired renal function.

Tazoxil in Galaxy containers should not be used in pediatric patients who require less than the full adult dose of Tazoxil in order to prevent unintentional overdose. The other available formulations of Tazoxil can be used in this population.

DIRECTIONS FOR USE OF Tazoxil (Piperacillin (Tazoxil) AND Tazobactam (Tazoxil) INJECTION) IN GALAXY CONTAINERS (PL 2040 PLASTIC)

Tazoxil Injection (PL 2040 Plastic) is to be administered using sterile equipment after thawing to room temperature.

Tazoxil containg EDTA is compatible for co-administration via a Y-site intravenous tube with Lactated Ringer's injection, USP.

Administer by infusion over a period of at least 30 minutes. During the infusion it is desirable to discontinue the primary infusion solution.

Tazoxil should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

Tazoxil is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.

Tazoxil should not be added to blood products or albumin hydrolysates.

Tazoxil interactions

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What other drugs will affect Tazoxil?

The following drug interactions are chosen on the basis of their potential clinical significance:

Aminoglycosides: The mixing of Tazoxil in vitro can result in substantial inactivation of the aminoglycosides.

When Tazoxil is administered together with tobramycin, the AUC, renal clearance and urinary recovery of tobramycin were decreased by 11%, 32% and 38%, respectively. The alterations in the pharmacokinetics of tobramycin when administered in conjunction with Tazoxil may be due to inactivation of tobramycin in the presence of Tazoxil. It has been postulated that penicillin-aminoglycoside complexes form and these complexes are micobiologically inactive and unknown toxicity.

Probenecid: Probenecid administered concomitantly with Tazoxil prolongs the t½ of Piperacillin (Tazoxil) by 21% and that of Tazobactam (Tazoxil) by 71%.

Heparin, Anticoagulants and Drugs Affecting the Blood: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, anticoagulants and Tazoxil that may affect the blood coagulation system or the thrombocyte function.

Vecuronium: Tazoxil when used concomitantly with vecuronium has been implicated in the prolongation of vecuronium's neuromuscular blockade. It is also expected that neuromuscular blockade produced by any of the nondepolarizing muscle muscle relaxants could be prolonged in the presence of Piperacillin (Tazoxil).

Methotrexate: Limited data suggest that the clearance of methotrexate is reduced when co-administered with Piperacillin (Tazoxil), due to competition for renal secretion. The impact of Tazobactam (Tazoxil) on the elimination of methotrexate has not been evaluated. If Tazoxil and methotrexate are administered concomitantly, serum concentrations of methotrexate as well as signs and symptoms of methotrexate toxicity should be closely monitored.

Drug/Laboratory Test Interactions: As with other penicillins, the administration of Tazoxil may result in a false positive reaction of glucose in the urine using copper-reduction method (Clinitest). It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

In patients with renal failure, Tazoxil is reported to cause abnormalities in clotting time, platelet aggregation and prothrombin time that close monitoring of the patient's coagulation tests is recommended.

Tazoxil side effects

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What are the possible side effects of Tazoxil?

Adverse drug reactions reported with Tazoxil are similar to those reported with Piperacillin (Tazoxil) alone and generally are transient and mild to moderate in severity. Adverse events have been reported in about ≤10% of patients receiving parenteral Tazoxil and have been severe enough to require discontinuance in ≤3% of patients.

The most common frequent adverse effects reported with Tazoxil are gastrointestinal (GI) effects, headache and hypersensitivity reactions.

Hypersensitivity Reactions: Rash, pruritus and fever have been reported in up to 4% of patients receiving Tazoxil. Rare reports of bronchospasm have also been reported.

Gastrointestinal Effects: Diarrhea, nausea, constipation have been reported in up to 11% of patients receiving Tazoxil. Vomiting, dyspepsia, stool changes and abdominal pain can occur in up to 3%, while melena, flatulence, hemorrhage, gastritis, hiccups and ulcerative stomatitis are reported in ≤1% of patients.

Clostridium difficile-associated diarrhea and colitis or antibiotic-associated pseudomembranous colitis have been reported in at least 1 patient receiving Tazoxil. Colitis may occur during or following discontinuance of anti-infective therapy and may range in severity from mild to life-threatening.

Hematologic Effects: Transient leukopenia, neutropenia and thrombocytopenia have been reported in patients receiving Tazoxil for a prolonged period of time (eg, after ≥21 days) and generally were reversible, systemic symptoms (eg, fever, rigors and chills) may also occur in some patients. Epistaxis and purpura have been reported in ≤1% patients.

Hepatic Effects: Transient increases in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and bilirubin can occur.

Renal Effects: Increases in serum concentrations of creatinine and blood urea nitrogen (BUN) may be observed. Urinary retention, dysuria, oliguria, hematuria and incontinence have been reported in ≤1% and proteinuria, pyuria, leukorrhea and vaginitis can also occur.

Effect on the Central Nervous System: Headache and insomnia have been reported in up to 7-8%, while agitation, dizziness and anxiety have been reported in ≤2% patients. Tremors, seizures, vertigo, confusion, hallucination, malaise and depression have been reported in ≤1% of patients receiving Tazoxil. Neuromuscular excitability or seizures could occur in higher than recommended doses are given IV, especially in patients with kidney failure.

Local Reactions: Adverse reactions at the injection site have been reported in ≤1% of patients. Adverse local reactions include phlebitis, pain, inflammation, thrombophlebitis and edema.

Other Adverse Effects: Hypertension, chest pain, edema, moniliasis, rhinitis, dyspnea, hypotension, ileus, syncope and rigors have been reported in ≤2% of patients. Tachycardia, bradycardia, heart failure and myocardial infarction have been reported in at most 1%.

Tazoxil contraindications

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What is the most important information I should know about Tazoxil?

Piperacillin (Tazoxil) and Tazobactam (Tazoxil) for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors.

Active ingredient matches for Tazoxil:

Piperacillin/Tazobactam

Piperacillin sodium/tazobactam sodium in Brazil.


List of Tazoxil substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tazpen 4.5 g x 1's (Biofarma)
Tazpen / vial 4.5 g x 1's (Biofarma)
Tazpen 1 Bottle (Biofarma)
Tazpip Piperacillin 4 g, Tazobactam0.5 g. VIAL / 1 (Tulip)
1's (Zenacts Pharma (Kaizen Drugs (P) Ltd))$ 5.20
Tazprik 4000+500 Injection (Zenacts Pharma (Kaizen Drugs (P) Ltd))$ 5.20
Tazprik Piperacillin 4 g, tazobactam0.5 g. INJ / 1 (Zenacts Pharma (Kaizen Drugs (P) Ltd))$ 5.20
Tazprik Piperacillin 4 g, tazobactam0.5 g. INJ / 1 (Zenacts Pharma (Kaizen Drugs (P) Ltd))$ 5.20
Tazum-P Piperacillin 4 g, Tazobactam0.5 g. VIAL / 1 (Veliko)$ 5.42
Tebranic 12 Box small, moãi Box small chöùa 1 Bottle boät
Tebranic 2 g/250 mg x 1's$ 13.87
Tebranic 4 g/500 mg x 1's$ 24.13
1's (Maxo Chem Ltd)$ 7.22
Tipten 4000+500 Injection (Maxo Chem Ltd)$ 7.22
Tipten Piperacillin 4 g, tazobactam0.5 g. INJ / 1 (Maxo Chem Ltd)$ 7.22
Tipten Piperacillin 4 g, tazobactam0.5 g. INJ / 1 (Maxo Chem Ltd)$ 7.22
1's (Hauz Pharma Pvt Ltd)$ 5.20
Tipzo 4000+500 Injection (Hauz Pharma Pvt Ltd)$ 5.20
Tipzo Piperacillin 4 g, tazobactam0.5 g. INJ / 1 (Hauz Pharma Pvt Ltd)$ 5.20
Tipzo Piperacillin 4 g, tazobactam0.5 g. INJ / 1 (Hauz Pharma Pvt Ltd)$ 5.20
Tiszo Piperacillin 4g, Tazobactam0.5g INJ / 1 (Iscon Lifesciences)$ 4.22
Tiszo 4000+500 Injection (Iscon Lifesciences)$ 4.22
Tobz Piperacillin Na 4g, TazobactamNa 0.5g VIAL / 1 (Shreya Life Sciences Pvt. Ltd)$ 8.70
1's (Shreya Life Sciences Pvt. Ltd)$ 8.70
Tobz 4000+500 Injection (Shreya Life Sciences Pvt. Ltd)$ 8.24
TOBZ 4000MG/500MG INJECTION 1 vial / 1 injection each (Shreya Life Sciences Pvt. Ltd)$ 8.46
Tobz 4000 mg/500 mg Injection (Shreya Life Sciences Pvt. Ltd)$ 8.46
Torbac Piperacillin 2gm, Tazobactam0.25gm VIAL / 1 (Torrent Pharmaceuticals Ltd.)$ 2.04
Torbac Piperacillin 4gm, Tazobactam0.5gm VIAL / 1 (Torrent Pharmaceuticals Ltd.)$ 3.60
1's (Torrent Pharmaceuticals Ltd.)$ 3.60
Torbac 4000+500 Injection (Torrent Pharmaceuticals Ltd.)$ 3.60

References

  1. PubChem. "piperacillin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. PubChem. "Tazobactam". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "Tazobactam". http://www.drugbank.ca/drugs/DB01606 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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