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Sterile Piperacillin Sodium And Tazobactam Sodium 8:1, Or Piperacillin Sodium Plus Tazobactam Sodium 8:1

Sterile Piperacillin Sodium And Tazobactam Sodium 8:1, Or Piperacillin Sodium Plus Tazobactam Sodium 8:1

Sterile Piperacillin sodium and Tazobactam Sodium 8:1, or Piperacillin sodium Plus Tazobactam Sodium 8:1 Product Name: Piperacillin sodium and Tazobactam Sodium 8:1, or Piperacillin sodium Plus Tazobactam Sodium 8:1 Appearance: White to off-white powder Ratio: Piperacillin sodium : Tazobactam...

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Sterile Piperacillin sodium and Tazobactam Sodium 8:1, or Piperacillin sodium Plus Tazobactam Sodium 8:1

Sterile Piperacillin Sodium And Tazobactam Sodium 8:1, Or Piperacillin Sodium Plus Tazobactam Sodium 8:1.jpg


Product Name:  Piperacillin sodium and Tazobactam Sodium 8:1, or Piperacillin sodium Plus Tazobactam Sodium 8:1

Appearance: White to off-white powder

Ratio:  Piperacillin sodium : Tazobactam Sodium = 8:1 

Package:  6Kgs/Tin; 2Tins/Ctn

Storage: should be stored in a well-closed container at low temperature, keep away from moisture, heat and light.

Shelf-life: 3 years in the original packaging under 'storage conditions

Keywords:  Piperacillin sodium and Tazobactam Sodium 8:1, Piperacillin sodium Plus Tazobactam Sodium 8:1

Description: 

This product is a mixture of Piperacillin sodium and Tazobactam Sodium. The ratio in weight is 8:1.

Indications and usages: 

Antibacterial; β-lactam antibiotic; fixed combination of piperacillin (an extended-spectrum penicillin) and tazobactam (a β-lactamase inhibitor).

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Mechanism of Action:

Piperacillin sodium in this mixture will inhibit bacterial cell-wall synthesis, leading to the cell death. While Tazobactam sodium plays an important role in increasing and promoting piperacillin sodium’s efficacy.

 

Most popular preparations of Piperacillin sodium and / Plus Tazobactam Sodium:

Powder for injection: 2 g piperacillin sodium and 0.25 g tazobactam sodium/vial,; 3 g piperacillin and 0.375 g tazobactam/vial, 4 g piperacillin and 0.5 g tazobactam/vial , that is to say Piperacillin sodium and / plus Tazobactam Sodium 8:1. The only difference is the total amount. The ratio is all the same.

 

Indications and dosages of Piperacillin sodium and / Plus Tazobactam Sodium:

This medication is very effective for the following indications:

Community-acquired pneumonia; ruptured appendix; peritonitis; pelvic inflammatory disease; skin and skin-structure infections, etc.

 

Contraindications of Piperacillin sodium and / Plus Tazobactam Sodium:

1. Hypersensitivity to penicillins, cephalosporins, imipenems, or beta-lactamase inhibitors

2. Neonates

 

Precautions and NOTES especially under the following listed conditions:

1.patients with sodium restrictions

2.Those who are suffering from heart failure, renal insufficiency (in children), seizures, bleeding disorders, uremia, hypokalemia, cystic fibrosis

3. children younger than twelve years old.

4. pregnant or breastfeeding patient.

The above conditions should be paid special attention to when we are trying to use Piperacillin sodium and / Plus Tazobactam Sodium 8:1.

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Classification of Piperacillin Sodium: Extended-spectrum Penicillins

Chemical Name: [2S-[2α,5α,6β(S*)]]-6-[[[[(4-Ethyl-2,3-dioxo-1-piperazinyl)carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid monosodium salt

 

Introduction of Piperacillin Sodium:

Antibacterial; β-lactam antibiotic; fixed combination of piperacillin (an extended-spectrum penicillin) and tazobactam (a β-lactamase inhibitor).

 

Usages and applications for Piperacillin Sodium Plus / and Tazobactam Sodium:

Gynecologic and Obstetric Infections; Treatment of postpartum endometritis or pelvic inflammatory disease (PID) caused by β-lactamase-producing Escherichia coli resistant to piperacillin but susceptible to piperacillin sodium and tazobactam sodium.

 

1.Respiratory Tract Infections:

Treatment of moderately severe community-acquired pneumonia (CAP) caused by β-lactamase-producing Haemophilus influenzae resistant to piperacillin but susceptible to piperacillin sodium and tazobactam sodium.

 

2.Piperacillin sodium and / Plus Tazobactam Sodium 8:1 will also work well when combat treatment of moderate to severe nosocomial pneumonia caused by β-lactamase-producing S. aureus resistant to piperacillin but susceptible to piperacillin sodium and tazobactam sodium or caused by Acinetobacter baumanii, H. influenzae, Klebsiella pneumoniae, or Ps. aeruginosa resistant to piperacillin but susceptible to piperacillin sodium and tazobactam sodium. For nosocomial pneumonia caused by Ps. aeruginosa, used in conjunction with an aminoglycoside or fluoroquinolone with antipseudomonal activity (e.g., ciprofloxacin, levofloxacin).

 

3. For empiric treatment of CAP in adults with risk factors for Pseudomonas aeruginosa, IDSA and ATS recommend a combination regimen that includes an antipneumococcal, antipseudomonal β-lactam (piperacillin and tazobactam, cefepime, imipenem, meropenem) and ciprofloxacin or levofloxacin; one of these β-lactams, an aminoglycoside, and azithromycin; or one of these β-lactams, an aminoglycoside, and an antipneumococcal fluoroquinolone.41 If Ps. aeruginosa has been identified by appropriate microbiologic testing, these experts recommend treatment with a regimen that includes an antipseudomonal β-lactam (cefepime, ceftazidime, aztreonam, imipenem, meropenem, piperacillin, ticarcillin) and ciprofloxacin, levofloxacin, or an aminoglycoside.

 

4.Septicemia:

Piperacillin sodium and / Plus Tazobactam Sodium 8:1 can be used for the treatment of septicemial caused by susceptible gram-negative bacteria. For the initial empiric treatment of life-threatening sepsis, working together with vancomycin with or without an aminoglycoside.

 

5. Urinary Tract Infections (UTIs)

Piperacillin sodium and / Plus Tazobactam Sodium 8:1is also able to treat UTIs in hospitalized patients; used together with or without an aminoglycoside.

 

6.More over, Piperacillin sodium and / Plus Tazobactam Sodium 8:1 also functions well for initial empiric treatment of hospital-acquired pneumonia, ventilator-associated pneumonia, or health-care associated pneumonia in adults who are severely ill or have late-onset disease or risk factors for multidrug-resistant bacteria, ATS, IDSA, and other clinicians recommend an antipseudomonal cephalosporin (cefepime, ceftazidime), antipseudomonal penicillin (piperacillin sodium and tazobactam sodium, ticarcillin and clavulanate), or an antipseudomonal carbapenem (imipenem, meropenem) utilized together with an aminoglycoside (amikacin, gentamicin, tobramycin) or antipseudomonal fluoroquinolone (ciprofloxacin, levofloxacin). Piperacillin sodium and / Plus Tazobactam Sodium 8:1 is also used in hospitals where oxacillin-resistant (methicillin-resistant) Staphylococcus is common or if there are risk factors for these strains, the initial regimen also should include vancomycin or linezolid.

 

7.Skin and Skin Structure Infections:

Piperacillin sodium and / Plus Tazobactam Sodium 8:1 may also be used for fighting against uncomplicated and complicated skin and skin structure infections (such as cellulitis, cutaneous abscess, ischemic/diabetic foot infections, etc) which is related to β-lactamase-producing Staphylococcus aureus resistant to piperacillin but susceptible to piperacillin sodium and tazobactam sodium.

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Piperacillin sodium and / plus Tazobactam sodium for Injection is an injectable antibacterial mixture product consisting of the semisynthetic antibiotic piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration.

 

Piperacillin sodium is a semisynthetic broad-spectrum penicillin for parenteral use derived from D(-)-a-aminobenzylpenicillin. The chemical name of piperacillin 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. The chemical formula is C23H26N5NaO7S, and the molecular weight is 539.54.

Tazobactam sodium, a derivative of the penicillin nucleus, 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. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3.

Piperacillin sodium and / plus Tazobactam sodium Injection parenteral combination is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. Piperacillin sodium and / plus Tazobactam sodium does not contain any excipients or preservatives.

 

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1 INDICATIONS AND USAGE

Piperacillin sodium and / plus tazobactam sodium for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.

 

1 Intra-abdominal Infections

Appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis , B. ovatus , B. thetaiotaomicron , or B. vulgatus. The individual members of this group were studied in fewer than 10 cases.

 

2 Skin and Skin Structure Infections

Piperacillin sodium and / plus tazobactam sodium will help to cure uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by β-lactamase producing isolates of Staphylococcus aureus.

 

3 Female Pelvic Infections

Piperacillin sodium and / plus tazobactam sodium will fight against postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of Escherichia coli.

 

4 Community-acquired Pneumonia

Community-acquired pneumonia (moderate severity only) can also be effectively caused by β-lactamase producing isolates of Haemophilus influenzae controlled by Piperacillin sodium and / plus tazobactam sodium.

 

5 Nosocomial Pneumonia

Piperacillin sodium and / plus tazobactam sodium 8:1 is also good to combat Nosocomial pneumonia (moderate to severe) caused by β-lactamase producing isolates of Staphylococcus aureus and by piperacillin sodium / tazobactam sodium-susceptible Acinetobacter baumannii , Haemophilus influenzae , Klebsiella pneumoniae , and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside)

1.6 Usage

Piperacillin sodium and / plus tazobactam sodium will reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin sodium and tazobactam sodium for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

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Certificate of Analysis of Piperacillin sodium and Tazobactam Sodium 8:1

Testing Item

Standard

Result

Appearance

White or almost white    powder

Complies

Identification A

The    retention time of major peaks in the Chromatogram of the assay preparation    should correspond to that in the Chromatogram of the standard preparation as    obtained in the assay.

Complies

Related Substances

Tazobactam Related    Compound A ≤ 1.0%

0.16%

Piperacillin impurity 4    ≤ 1.0%

0.07%

Piperacillin impurity 1    ≤ 1.0%

0.09%

Piperacillin related    compound A ≤ 5.0%

0.05%

Piperacillin related    compound C ≤ 1.0%

0.37%

Piperacillin impurity 5    ≤ 1.0%

Absent

Piperacillin impurity 6    ≤ 1.0%

0.07%

Any single unspecified    impurity ≤ 1.0%

0.05%

Total impurity ≤ 5.0%

0.76%

Sterility

Must be sterile

sterile

Water

≤ 2.5%

0.82%

pH

5.0 ~ 7.0

5.89

Particulate Matter

≥10um: Not Exceed 6000

289.2 Particles/g

≥25um: Not Exceed 600

37.9 Particles/g

Bacterial Endotoxins

≤ 0.04 EU/mg of    Piperacillin Sodium and Tazobactam Sodium mixture

< 0.04 EU/mg

Assay

Piperacillin: ≥76.5%

82.6%

Tazobactam: ≥9.6%

10.4%

Residual Solvents

Acetone ≤    0.5%

0.002%

Ethyl Acetate ≤    0.5%

0.03%

Dichloromethane ≤    0.06%

0.007%

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Skype: frankrenful2002
E-Mail: frank_feng@fengchengroup.com
Tel: +86-186-7846 1007
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WHATSAPP: +86-18678461007
Add: Room 1101, 5th Building, No.168 Shenzhen Road, Qingdao, China
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