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Piperacillin Sodium-Tazobactam Sodium: Dosage, Preparation, and Compatibility Information, Exams of Pharmacy

Information on the dosage, preparation, and compatibility of piperacillin sodium-tazobactam sodium, including details on single-dose and pharmacy bulk packages, reconstitution instructions, and compatibility with various solutions and infusion systems. It also discusses the differences between zosyn and other piperacillin sodium-tazobactam sodium products.

Typology: Exams

2021/2022

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1292 PiPeracillin Sodium–TazobacTam Sodium aSHP inJecTable druG inFormaTion
Piperacillin Sodium–Tazobactam Sodium
AHFS 8:12.16.16
Products
The fixed combination of piperacillin sodium–tazobactam
sodium is available as a lyophilized powd er in preservative-free
single-dose and ADD-Vantage vials containing 2.25 g (pipera-
cillin 2 g plus tazobactam 250 mg), 3.375 g (piperacillin 3 g plus
tazobactam 375 mg), or 4.5 g (piperacillin 4 g plus tazobactam
500 mg) as the sodium salts.2918 2919 2921 The drug is also available
in a pharmacy bulk package containing 40.5 g (piperacillin 36 g
plus tazobactam 4.5 g) as the sodium salts.2918 2920
Generic piperacillin sodium–tazobactam sodium and Zosyn
(Wyeth) products are not identical.2922 2932 In 2006, all Zosyn
products were reformulated to contain edetate disodium dihy-
drate (EDTA) as a metal chelator and sodium citrate as a buffering
agent; these excipients were added to address issues with sporadic
batch failures associated with excessive particulate matter
related to commercially available diluents and solutions with
acidic pH and the presence of trace amounts of zinc ions.2922 2932
Other piperacillin sodium–tazobactam sodium products do n ot
contain EDTA, sodium citrate, or any other excipients.2919 2920 2921
These formulation differences between Zosyn products and other
piperacillin sodium–tazobactam sodium products have been
demonstrated to result in some differing compatibilities with
certain solutions (e.g., Ringer’s injection, lactated).2922 2932 2985
Therefore, results of compatibility tests for one formula-
tion cannot be extrapolated to another.2922 2932 (See Solution
Compatibility.)
Each 2.25, 3.375, or 4.5 g (combined components) single-
dose vial should be reconstituted with 10, 15, or 20 mL, respec-
tively, of s terile water for injection, sodium chloride 0.9%,
bacteriostatic water for injection or bacteriostatic sodium
chloride 0.9% (preserved with benzyl alcohol or parabens), or
dextrose 5% and should be swirled until dissolved.2918 2921 The
contents of each single-dose vial should then be diluted in 50
to 150 mL of a compatible infusion solution; however, if sterile
water for injection is used as the diluent, the maximum recom-
mended volume per dose is 50 mL.2918 2921
ADD-Vantage vials of piperacillin sodium–tazobactam
sodium should be prepared with 50 or 100 mL of dextrose 5% or
sodium chloride 0.9% in ADD-Vantage diluent bags.2919
The 40.5-g pharmacy bulk package should be recons tituted
with 152 mL of sterile water for injection, sodium chloride 0.9%,
bacteriostatic water for injection or bacteriostatic sodium chlo-
ride 0.9% (preserved with benzyl alcohol or parabens), or
dextrose 5% and should be shaken until dissolved; the resulting
solution contains piperacillin 200 mg/mL plus tazobactam 25
mg/mL.2918 2920 The reconstituted pharmacy bulk package solu-
tion mus t be diluted further in a compatible infusion solution;
the recommended volume per dose is 50 to 100 mL;2918 2920 2922
however, if sterile water for injection is used as the diluent, the
maximum recommended volume per dose is 50 mL.2918 2920 2922
Piperacillin sodium–tazobactam sodium (Zosyn, Wyeth) also
is available as a frozen iso-osmotic premixed injection in single-
dose Galaxy containers containing piperacillin 40 mg/mL plus
tazobactam 5 mg/mL or piperacillin 60 mg/mL plus tazobactam
7.5 mg/mL, as well as EDTA and sodium citrate dihydrate, in
water for injection.2918 2922 Dextrose hydrous is added to adjust
the osmolality, and sodium bicarbonate and hydrochloric acid
are used to adjust the pH.2918 2922
pH
Zosyn (Wyeth) products: From 5.5 to 6.8.2918 2922
Sodium Content
Zosyn (Wyeth) products contain 2.79 mEq (64 mg) of sodium
per gram of piperacillin in the combination product.2918
Generic piperacillin sodium–tazobactam sodium products
contain 2.35 mEq (54 mg) of sodium per gram of piperacillin in
the combination product.2919 2920 2921
Trade Name(s)
Zosyn
Administration
Piperacillin–tazobactam solution for infusion prepared from
single-dose vials or the pharmacy bulk package should be
administered by intravenous infusion over at leas t 30 minutes
after dilution in a compatible diluent to provide a recommended
volume per dose of 50 to 150 mL.2918 2920 2921 Such solutions
for infusion prepared using single-dose vials or the pharmacy
bulk package also can be infused using ambulatory infusion
pumps.2918 2920 2921
Piperacillin sodium–tazobactam sodium (Zosyn, Wyeth)
frozen iso-osmotic premixed injection in single-dose Galaxy
containers should be thawed (see Stability: Freezing Solutions),
and the solution should be administered by intravenous infusion
over at least 30 minutes.2918
Use of extended infusion s trategies (e.g., infusion over 4
hours) for piperacillin–tazobactam has been described in the
literature.2934 In such circums tances, however, careful attention
must be paid to the possibility of incomplete dose adminis tra-
tion resulting from drug loss through tubing residuals.2934 Such
loss is a function of both the concentration of the solution being
infused and the residual volume of the specific t ubing used for
administration.2934
Stability
The white to off-white2918 2920 2921 or yellowish2919 piperacillin
sodium–tazobactam sodium lyophilized powder in intact vials
should be stored at controlled room temperature.2918 2919 2920 2921
Single-dose vials of the solution should be used immedi-
ately after reconstitution.2918 2921 Any remaining unused portion
DOI: 10.37573/9781585286850.317
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1292 PiPeracillin Sodium–TazobacTam Sodium aSHP inJecTable druG inFormaTion

Piperacillin Sodium–Tazobactam Sodium

AHFS 8:12.16.

Products

The fixed combination of piperacillin sodium–tazobactam sodium is available as a lyophilized powder in preservative-free single-dose and ADD-Vantage vials containing 2.25 g (pipera- cillin 2 g plus tazobactam 250 mg), 3.375 g (piperacillin 3 g plus tazobactam 375 mg), or 4.5 g (piperacillin 4 g plus tazobactam 500 mg) as the sodium salts. 2918 2919 2921 The drug is also available in a pharmacy bulk package containing 40.5 g (piperacillin 36 g plus tazobactam 4.5 g) as the sodium salts. 2918 2920

Generic piperacillin sodium–tazobactam sodium and Zosyn (Wyeth) products are not identical. 2922 2932 In 2006, all Zosyn products were reformulated to contain edetate disodium dihy- drate (EDTA) as a metal chelator and sodium citrate as a buffering agent; these excipients were added to address issues with sporadic batch failures associated with excessive particulate matter related to commercially available diluents and solutions with acidic pH and the presence of trace amounts of zinc ions. 2922 2932 Other piperacillin sodium–tazobactam sodium products do not contain EDTA, sodium citrate, or any other excipients. 2919 2920 2921 These formulation differences between Zosyn products and other piperacillin sodium–tazobactam sodium products have been demonstrated to result in some differing compatibilities with certain solutions (e.g., Ringer’s injection, lactated). 2922 2932 2985 Therefore, results of compatibility tests for one formula- tion cannot be extrapolated to another. 2922 2932 (See Solution Compatibility.)

Each 2.25, 3.375, or 4.5 g (combined components) single- dose vial should be reconstituted with 10, 15, or 20 mL, respec- tively, of sterile water for injection, sodium chloride 0.9%, bacteriostatic water for injection or bacteriostatic sodium chloride 0.9% (preserved with benzyl alcohol or parabens), or dextrose 5% and should be swirled until dissolved. 2918 2921 The contents of each single-dose vial should then be diluted in 50 to 150 mL of a compatible infusion solution; however, if sterile water for injection is used as the diluent, the maximum recom- mended volume per dose is 50 mL. 2918 2921

ADD-Vantage vials of piperacillin sodium–tazobactam sodium should be prepared with 50 or 100 mL of dextrose 5% or sodium chloride 0.9% in ADD-Vantage diluent bags. 2919

The 40.5-g pharmacy bulk package should be reconstituted with 152 mL of sterile water for injection, sodium chloride 0.9%, bacteriostatic water for injection or bacteriostatic sodium chlo- ride 0.9% (preserved with benzyl alcohol or parabens), or dextrose 5% and should be shaken until dissolved; the resulting solution contains piperacillin 200 mg/mL plus tazobactam 25 mg/mL. 2918 2920 The reconstituted pharmacy bulk package solu- tion must be diluted further in a compatible infusion solution; the recommended volume per dose is 50 to 100 mL; 2918 2920 2922 however, if sterile water for injection is used as the diluent, the maximum recommended volume per dose is 50 mL. 2918 2920 2922

Piperacillin sodium–tazobactam sodium (Zosyn, Wyeth) also is available as a frozen iso-osmotic premixed injection in single- dose Galaxy containers containing piperacillin 40 mg/mL plus tazobactam 5 mg/mL or piperacillin 60 mg/mL plus tazobactam 7.5 mg/mL, as well as EDTA and sodium citrate dihydrate, in water for injection. 2918 2922 Dextrose hydrous is added to adjust the osmolality, and sodium bicarbonate and hydrochloric acid are used to adjust the pH. 2918 2922

pH

Zosyn (Wyeth) products: From 5.5 to 6.8. 2918 2922

Sodium Content

Zosyn (Wyeth) products contain 2.79 mEq (64 mg) of sodium per gram of piperacillin in the combination product. 2918 Generic piperacillin sodium–tazobactam sodium products contain 2.35 mEq (54 mg) of sodium per gram of piperacillin in the combination product. 2919 2920 2921

Trade Name(s)

Zosyn

Administration

Piperacillin–tazobactam solution for infusion prepared from single-dose vials or the pharmacy bulk package should be administered by intravenous infusion over at least 30 minutes after dilution in a compatible diluent to provide a recommended volume per dose of 50 to 150 mL. 2918 2920 2921 Such solutions for infusion prepared using single-dose vials or the pharmacy bulk package also can be infused using ambulatory infusion pumps. 2918 2920 2921 Piperacillin sodium–tazobactam sodium (Zosyn, Wyeth) frozen iso-osmotic premixed injection in single-dose Galaxy containers should be thawed (see Stability: Freezing Solutions), and the solution should be administered by intravenous infusion over at least 30 minutes. 2918 Use of extended infusion strategies (e.g., infusion over 4 hours) for piperacillin–tazobactam has been described in the literature. 2934 In such circumstances, however, careful attention must be paid to the possibility of incomplete dose administra- tion resulting from drug loss through tubing residuals. 2934 Such loss is a function of both the concentration of the solution being infused and the residual volume of the specific tubing used for administration. 2934

Stability

The white to off-white 2918 2920 2921 or yellowish 2919 piperacillin sodium–tazobactam sodium lyophilized powder in intact vials should be stored at controlled room temperature. 2918 2919 2920 2921 Single-dose vials of the solution should be used immedi- ately after reconstitution. 2918 2921 Any remaining unused portion

DOI: 10.37573/9781585286850.

aSHP inJecTable druG inFormaTion PiPeracillin Sodium–TazobacTam Sodium 1293

should be discarded after 24 hours at room temperature or 48 hours under refrigeration at 2 to 8°C. 2918 2921 Vials should NOT be frozen after reconstitution. 2918 2919 2921

The entire contents of the reconstituted pharmacy bulk package also should be used immediately after reconstitu- tion.^2918 2920 Manufacturers’ recommendations differ on the dura- tion that the bulk pharmacy package may be stored at room temperature following reconstitution; 2918 2920 the specific product labeling should be consulted in such situations. Pharmacy bulk vials should NOT be frozen after reconstitution.^2918

After dilution in compatible infusion solutions, the drug is stable for up to 24 hours at room temperature or 1 week under refrigeration. 2918 2920 2921 Glass and plastic (including syringes, intravenous solution bags, and tubing) do not affect stability. 2918 2919 2920 2921

Solutions prepared using the ADD-Vantage vials are stable for up to 24 hours at room temperature. 2919 These solutions should not be refrigerated nor frozen following reconstitution. 2919

Concentration Effects

In one study, piperacillin plus tazobactam dissolved in sterile water for injection to concentrations greater than 128 plus 16 g/L, respectively, resulted in unacceptably viscous solutions that impeded flow from elastomeric pumps to less than 75% of the nominal flow rate. 3105

Freezing Solutions

The commercially available, premixed frozen injection in single- dose Galaxy containers should be stored at or below −20°C. 2918 Thaw at room temperature or under refrigeration but not in a warm water bath or by microwave radiation. 2918 Thawed solu- tions should not be refrozen. 2918 After thawing, the solutions are stable for 24 hours at room temperature or 14 days refriger- ated. 2918

Piperacillin 80 mg/mL plus tazobactam 10 mg/mL in poly- vinyl chloride (PVC) bags of dextrose 5% and sodium chloride 0.9% was frozen at −15°C for 30 days and thawed by microwave radiation for 45 seconds with no loss of either component. 1768

Piperacillin 150 mg/mL plus tazobactam 18.75 mg/mL and piperacillin 200 mg/mL plus tazobactam 25 mg/mL in dextrose 5% and sodium chloride 0.9% were drawn as 20-mL aliquots into polypropylene syringes (Becton Dickinson). The syringes were frozen at −15°C for 30 days and then stored at 4°C for 7 days with no loss of either component. 1768 Piperacillin 40 mg/mL plus tazobactam 5 mg/mL in dextrose 5% lost less than 3% after 3 months stored at −20°C. After microwave thawing, refrigerated storage resulted in 10% loss in 35 days. 2614

Syringes

Piperacillin 150 mg/mL plus tazobactam 18.75 mg/mL and piperacillin 200 mg/mL plus tazobactam 25 mg/mL in dextrose 5% and sodium chloride 0.9% were drawn as 20-mL aliquots into polypropylene syringes (Becton Dickinson). The syringes were stored at 25°C for 1 day and at 4°C for 7 days with no loss of either drug in the dextrose 5% samples. Similarly, no tazo- bactam loss occurred in the sodium chloride 0.9% solutions. However, piperacillin losses of 7% in 1 day at 25°C and 4% in 7 days at 4°C were found in the sodium chloride 0.9% solu- tions. 1768

Ambulatory Pumps

Infusion solutions prepared from single-dose vials and the bulk product have been shown to be stable for up to 12 hours at room temperature in an ambulatory infusion pump. 2918 2920 2921 (^2922) Each dose was diluted to 25 or 37.5 mL, and stability was not affected. 2918 2920 2921

Central Venous Catheter

Piperacillin 10 mg/mL plus tazobactam 1.25 mg/mL (Lederle) in dextrose 5% was found to be compatible with the ARROW- g+ard Blue Plus (Arrow International) chlorhexidine-bearing triple-lumen central catheter. Essentially complete delivery of the drug was found with little or no drug loss occurring. Further- more, chlorhexidine delivered from the catheter remained at trace amounts with no substantial increase due to the delivery of the drug through the catheter. 2335

Compatibility Information

Solution Compatibility

Piperacillin sodium–tazobactam sodium

Test Soln Name Mfr Mfr Conc/L or % Remarks Ref C/I Dextrose 5% WY d^ 13.3 to 80e^ g Compatible 2918 C Dextrose 5% c^ 13.3 to 80 e^ g Compatible 2920, 2921 C Dextrose 5% HOS HOS c^ 20 to 80 e^ g Stable up to 24 hours at room temperature 2919 C Dextrose 5% BA a^ WY d^20 e, 80e^ g Visually compatible. Little loss of either drug in 28 days at 5°C then 72 hr at 23°C in light

2806 C

Ringer’s injection, lactated c^ Incompatible 2920, 2921 I