POTASSIUM CHLORIDE IN SODIUM CHLORIDE- potassium chloride and sodium chloride injection, solution
Baxter Healthcare Corporation
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Potassium Chloride in Sodium Chloride Injection, USP is a sterile, nonpyrogenic, solution for fluid and electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1.
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Table 1 |
Size (mL) |
Composition (g/L) |
*Osmolarity (mOsmol/L) (Calc.) |
pH |
Ionic Concentration (mEq/L) |
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Sodium Chloride, USP (NaCl) |
Potassium Chloride, USP (KCl) |
Sodium |
Potassium |
Chloride |
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20 mEq/L Potassium Chloride in |
1000 |
4.5 |
1.5 |
194 |
5.5 (3.5 to 6.5) |
77 |
20 |
97 |
20 mEq/L Potassium Chloride in |
1000 |
9 |
1.5 |
348 |
5.5 (3.5 to 6.5) |
154 |
20 |
174 |
40 mEq/L Potassium Chloride in |
1000 |
9 |
3 |
388 |
5.5 (3.5 to 6.5) |
154 |
40 |
194 |
The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Potassium Chloride in Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
Potassium Chloride in Sodium Chloride Injection, USP is contraindicated in patients with:
Hypersensitivity and infusion reactions, including anaphylaxis and chills, have been reported with products containing potassium chloride and sodium chloride. Stop the infusion immediately if signs or symptoms of a hypersensitivity or infusion reaction develops. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Hyperkalemia
Potassium-containing solutions, including Potassium Chloride in Sodium Chloride Injection, USP may increase the risk of hyperkalemia. Hyperkalemia can be asymptomatic and manifest only by increased serum potassium concentrations and/or characteristic electrocardiographic (ECG) changes. Cardiac conduction disorders (including complete heart block) and other cardiac arrhythmias, some fatal, can develop at any time during hyperkalemia. Continuous electrocardiogram (ECG) monitoring may be necessary to aid in the detection of cardiac arrhythmias due to hyperkalemia (see ADVERSE REACTIONS).
To avoid life threatening hyperkalemia, do not administer Potassium Chloride in Sodium Chloride Injection, USP as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access) without a quantitative infusion device.
Patients at increased risk of developing hyperkalemia and cardiac arrhythmias include those:
Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients with, or at risk for, hyperkalemia. If use cannot be avoided, use a product with a low amount of potassium chloride, infuse slowly and monitor serum potassium concentrations and ECGs.
Hypernatremia and Hyperchloremia
Electrolyte imbalances such as hypernatremia, hyperchloremia, and metabolic acidosis may occur with Potassium Chloride in Sodium Chloride Injection, USP.
Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia.
Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS.
Avoid Potassium Chloride in Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia or hyperchloremia. If use cannot be avoided, monitor serum sodium and chloride concentrations and acid-base balance.
Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema.
Hyponatremia
Potassium Chloride in Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.
The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of hypotonic Potassium Chloride in Sodium Chloride Injection, USP.
The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See DRUG INTERACTIONS.
Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular, premenopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Potassium Chloride in Sodium Chloride Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.
Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.
Fluid Overload
Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the intravenous administration of Potassium Chloride in Sodium Chloride Injection, USP can cause electrolyte disturbances such as overhydration/hypervolemia and congested states including central (e.g., pulmonary edema) and peripheral edema.
Avoid Potassium Chloride in Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations and acid base balance as needed and especially during prolonged use.
Administration of sodium and potassium in patients with or at risk of severe renal impairment, may result in hypernatremia, hyperkalemia and/or fluid overload (see WARNINGS). Avoid Potassium Chloride in Sodium Chloride Injection, USP in patients with severe renal impairment. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.
There are no adequate and well controlled studies from the use of Potassium Chloride in Sodium Chloride Injection, USP in pregnant or lactating women and animal reproduction studies have not been conducted with this drug. Therefore, it is also not known whether Potassium Chloride in Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in Sodium Chloride Injection, USP should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Potassium Chloride in Sodium Chloride Injection, USP is administered to a nursing mother.
Pediatric patients are at increased risk of developing hyponatremia as well as for developing encephalopathy as a complication of hyponatremia (see WARNINGS).
Geriatric patients are at increased risk of developing electrolyte imbalances. Potassium Chloride in Sodium Chloride Injection, USP is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Consider monitoring renal function in elderly patients.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
An increased infusion rate of Potassium Chloride in Sodium Chloride Injection, USP can cause:
When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of Potassium Chloride in Sodium Chloride Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).
Potassium Chloride in Sodium Chloride Injection, USP in VIAFLEX Plus Plastic Container is available as follows:
Code |
Size (mL) |
NDC |
Product Name |
2B1357 |
1000 |
0338-0704-34 |
20 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP |
2B1764 |
1000 |
0338-0691-04 |
20 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP |
2B1984 |
1000 |
0338-0695-04 |
40 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP |
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored between 20ºC to 25°C (68º F to 77°F). [See USP controlled room temperature.]; brief exposure up to 40° C (104° F) does not adversely affect the product.
For information on risk of air embolism – see PRECAUTIONS.
Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA
07-19-78-210
Rev. January 2019
Baxter, and Viaflex are trademarks of Baxter International Inc.
For Product Information
1-800-933-0303
Container Label
LOT EXP
2B1357
NDC 0338-0704-34
20 mEq
Potassium Chloride
(20 mEq/L)
Potassium Chloride in
0.45% Sodium Chloride Injection USP
1000 mL
EACH 100 mL CONTAINS 450 mg SODIUM CHLORIDE USP
150 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)
mEq/L SODIUM 77 POTASSIUM 20 CHLORIDE 97
OSMOLARITY 194 mOsmol/L (CALC) HYPOTONIC STERILE
NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE
INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN
INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX
THOROUGHLY DO NOT STORE USUAL DOSAGE INTRAVENOUSLY
AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS
SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT
STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED
IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS
CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP
AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT
VIAFLEX PLUS CONTAINER PL 146 PLASTIC
BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC
Baxter
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN USA
FOR PRODUCT INFORMATION
1-800-933-0303
LOT EXP
2B1764
NDC 0338-0691-04
DIN 00786209
1000 mL
EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP
150 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)
mEq/L SODIUM 154 POTASSIUM 20 CHLORIDE 174
OSMOLARITY 348 mOsmol/L (CALC) STERILE
NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE
INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE
WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX
THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS
DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS
SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT
STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED
IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS
CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER
OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY
TO USE AVOID EXCESSIVE HEAT SEE INSERT
VIAFLEX PLUS CONTAINER PL 146 PLASTIC
BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC
FOR PRODUCT INFORMATION 1-800-933-0303
Baxter
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN USA
DISTRIBUTED IN CANADA BY
BAXTER CORPORATION
TORONTO ONTARIO CANADA
LOT EXP
2B1984
NDC 0338-0695-04
DIN 00786217
1000 mL
EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP
300 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)
mEq/L SODIUM 154 POTASSIUM 40 CHLORIDE 194
OSMOLARITY 388 mOsmol/L (CALC) STERILE
NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE
INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE
WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX
THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS
DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS
SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT
STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED
IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS
CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER
OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY
TO USE AVOID EXCESSIVE HEAT SEE INSERT
VIAFLEX PLUS CONTAINER PL 146 PLASTIC
BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC
FOR PRODUCT INFORMATION 1-800-933-0303
Baxter
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN USA
DISTRIBUTED IN CANADA BY
BAXTER CORPORATION
TORONTO ONTARIO CANADA
POTASSIUM CHLORIDE IN SODIUM CHLORIDE
potassium chloride and sodium chloride injection, solution |
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POTASSIUM CHLORIDE IN SODIUM CHLORIDE
potassium chloride and sodium chloride injection, solution |
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POTASSIUM CHLORIDE IN SODIUM CHLORIDE
potassium chloride and sodium chloride injection, solution |
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Labeler - Baxter Healthcare Corporation (005083209) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Baxter Healthcare Corporation | 059140764 | MANUFACTURE(0338-0695, 0338-0691, 0338-0704) , ANALYSIS(0338-0695, 0338-0691, 0338-0704) , LABEL(0338-0695, 0338-0691, 0338-0704) , PACK(0338-0695, 0338-0691, 0338-0704) , STERILIZE(0338-0695, 0338-0691, 0338-0704) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Baxter Healthcare Corporation | 194684502 | ANALYSIS(0338-0695, 0338-0691, 0338-0704) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Baxter Healthcare Corporation | 189326168 | ANALYSIS(0338-0695, 0338-0691, 0338-0704) , LABEL(0338-0695, 0338-0691, 0338-0704) , MANUFACTURE(0338-0695, 0338-0691, 0338-0704) , PACK(0338-0695, 0338-0691, 0338-0704) , STERILIZE(0338-0695, 0338-0691, 0338-0704) |