Potassium Chloride In Sodium Chloride

Sodium Chloride And Potassium Chloride

Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-686

Potassium Chloride In Sodium Chloride also known as Sodium Chloride And Potassium Chloride is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Potassium Chloride In Sodium Chloride is 63323-686. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Potassium Chloride In Sodium Chloride drug includes Potassium Chloride - 150 mg/100mL Sodium Chloride - 900 mg/100mL . The currest status of Potassium Chloride In Sodium Chloride drug is Active.

Drug Information:

Drug NDC:	63323-686
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Potassium Chloride In Sodium Chloride
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Sodium Chloride And Potassium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Fresenius Kabi Usa, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	POTASSIUM CHLORIDE - 150 mg/100mL SODIUM CHLORIDE - 900 mg/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	02 Jun, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	28 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA212347
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Fresenius Kabi USA, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	237367 403890 637551
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	660YQ98I10 451W47IQ8X
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
63323-686-10	10 BAG in 1 CARTON (63323-686-10) / 1000 mL in 1 BAG (63323-686-01)	02 Jun, 2021	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

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Fresenius Kabi USA, LLC
NDC: 63323-688

Product Elements:

Potassium chloride in sodium chloride sodium chloride and potassium chloride sodium chloride sodium cation chloride ion potassium chloride potassium cation chloride ion potassium chloride in sodium chloride sodium chloride and potassium chloride sodium chloride sodium cation chloride ion potassium chloride potassium cation chloride ion potassium chloride in sodium chloride sodium chloride and potassium chloride sodium chloride sodium cation chloride ion potassium chloride potassium cation chloride ion

Drug Interactions:

Drug interactions lithium renal sodium and lithium clearance may be increased during administration of potassium chloride in sodium chloride injection, usp and result in decreased lithium concentrations. monitor serum lithium concentrations during concomitant use. other products that cause hyperkalemia administration of potassium chloride in sodium chloride injection, usp in patients treated concurrently or recently with products that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia. avoid use of potassium chloride in sodium chloride injection, usp in patients receiving such products (e.g., potassium sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or the immunosuppressants cyclosporine and tacrolimus). if use cannot be avoided, monitor serum potassium concentrations. other products that affect fluid and/or electrolyte balance Read more...

administration of potassium chloride in sodium chloride injection, usp in patients treated concomitantly with medications associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. avoid use of potassium chloride in sodium chloride injection, usp in patients receiving such products, such as corticosteroids or corticotropin. if use cannot be avoided, monitor serum electrolytes, fluid balance, and acid-base balance. other drugs that increase the risk of hyponatremia administration of potassium chloride in sodium chloride injection, usp in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. avoid use of potassium chloride in sodium chloride injection, usp in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. if use cannot be avoided, monitor serum sodium concentrations.

Indications and Usage:

Indications and usage potassium chloride in sodium chloride injection, usp is indicated as a source of water and electrolytes.

Warnings:

Warnings hypersensitivity 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. electrolyte imbalances 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 ) Read more...

. 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: with conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with severe renal impairment, acute dehydration, extensive tissue injury or burns, certain cardiac disorders such as congestive heart failure or atrioventricular (av) block (especially if they receive digoxin). who are at risk of experiencing hyperosmolality, acidosis, or undergoing correction of alkalosis (conditions associated with a shift of potassium from intracellular to extracellular space). treated concurrently or recently with agents or products that can cause or increase the risk of hyperkalemia (see drug interactions ). with cardiac arrhythmias. 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 patientâs 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.

Dosage and Administration:

Dosage and administration important administration instructions potassium chloride in sodium chloride injection, usp is intended for intravenous infusion using sterile equipment. 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 (see warnings ). do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. set the vent to the closed position on a vented intravenous administration set to prevent air embolism. use a dedicated line without any connections to avoid air embolism. do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. the choice of a centra Read more...

l or peripheral venous route of infusion should depend on the osmolarity of the final infusate. solutions with osmolarity of greater than or equal to approximately 900 mosm/l must be infused through a central catheter. prior to infusion, visually inspect the solution for particulate matter and discoloration. the solution should be clear and there should be no precipitates. do not administer unless solution is clear and container is undamaged. use of final filter is recommended during administration of all parenteral solutions, where possible. dosing information the choice of the specific potassium chloride and sodium chloride formulation, dosage, volume, rate and duration of administration is dependent upon the age, weight and clinical and metabolic condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. additional electrolyte supplementation may be indicated according to the clinical needs of the patient. additives can be introduced to the container; however, some additives may be incompatible. evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. consult with a pharmacist, if available. if, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. after addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. mix thoroughly when additives have been introduced. do not store solutions containing additives. discard any unused portion. rapid correction of hyponatremia and hypernatremia is potentially dangerous (risk of serious neurologic complications). to avoid complications such as osmotic demyelination syndrome (ods) during administration, follow the important administration instructions, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.

Contraindications:

Contraindications potassium chloride in sodium chloride injection, usp is contraindicated in patients with: known hypersensitivity to potassium chloride and/or sodium chloride (see warnings ). clinically significant hyperkalemia (see warnings ).

Adverse Reactions:

Adverse reactions the following adverse reactions associated with the use of potassium chloride in sodium chloride injection, usp were identified in clinical trials or postmarketing reports. because postmarketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. general disorders and administration site condition s: chills, and infusion site pain. hypersensitivity reactions : generalized papules and erythema, rash, fever, vomiting, hypertension, tachycardia. metabolism and nutrition disorders : hyperkalemia, hyponatremia, hypernatremia, hyperchloremia acidosis, fluid overload. cardiac disorders : cardiac arrest as a manifestation of rapid intravenous administration and/or of hyperkalemia. nervous system disorders : hyponatremic encephalopathy. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropria Read more...

te therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Drug Interactions:

Use in Pregnancy:

Pregnancy 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.

Pediatric Use:

Pediatric use the use of potassium chloride in sodium chloride injection, usp in pediatric patients is based on clinical practice. (see dosage and administration ). safety and effectiveness of potassium chloride in sodium chloride injection, usp in pediatric patients have not been established by adequate and well-controlled studies. pediatric patients are at increased risk of developing hyponatremia as well as for developing encephalopathy as a complication of hyponatremia (see warnings ).

Geriatric Use:

Geriatric use 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.

Overdosage:

Overdosage an increased infusion rate of potassium chloride in sodium chloride injection, usp can cause: hyperkalemia, manifestations may include disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation. the presence of any ecg findings that are suspected to be caused by hyperkalemia should be considered a medical emergency. if hyperkalemia is present or suspected, discontinue the infusion immediately and institute close ecg, laboratory and other monitoring and, as necessary, corrective therapy to reduce serum potassium concentrations. muscle weakness (up to and including muscular and respiratory paralysis, paresthesia of extremities) may occur as a complication of hyperkalemia. hyponatremia, manifestations may include seizures, coma, cerebral edema and death. hypernatremia, especially in patients with severe renal impairment. hypotension. gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain). fluid overload (which can lead to central and/or peripheral edema). see warnings and adverse reactions . 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).

Description:

Description 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 . table 1 *normal physiologic osmolarity range is approximately 280 to 310 mosmol/l. administration of substantially hypertonic solutions (â¥ 600 mosmol/l) may cause vein damage. size (ml) composition (g/l) *osmolarity (mosmol/l) (calc.) ph ionic concentration (meq/l) sodium chloride, usp nacl potassium chloride, usp kcl sodium potassium chloride 20 meq/l potassium chloride in 0.45% sodium chloride injection, usp 1000 4.5 1.5 194 5.5 (3.5 to 6.5) 77 20 97 20 meq/l potassium chloride in 0.9% sodium chloride injection, usp 1000 9 1.5 348 5.5 (3.5 to 6.5) 154 20 174 40 meq/l potassium chloride in 0.9% sodium chloride injection, usp 1000 9 3 388 5.5 (3.5 to 6.5) 154 40 194 the flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex Â® bag). the amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. the suitability of the container material has been confirmed by tests in animals according to usp biological tests for plastic containers.

Clinical Pharmacology:

Clinical pharmacology 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.

How Supplied:

How supplied potassium chloride in sodium chloride injection, usp is supplied in single-dose flexible plastic containers as follows: product code unit of use strength unit of sale 683110 ndc 63323-683-01 one 1000 ml free flex Â® bag 20 meq potassium chloride in 0.45% sodium chloride ndc 63323-683-10 package of 10 free flex Â® bags 686110 ndc 63323-686-01 one 1000 ml free flex Â® bag 20 meq potassium chloride in 0.9% sodium chloride ndc 63323-686-10 package of 10 free flex Â® bags 688110 ndc 63323-688-01 one 1000 ml free flex Â® bag 40 meq potassium chloride in 0.9% sodium chloride ndc 63323-688-10 package of 10 free flex Â® bags exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. it is recommended the product be stored between 20Âºc to 25Â°c (68Âº f to 77Â°f). [see usp controlled room temperature.]; brief exposure up to 40Â°c (104Â°f) does not adversely affect the product. the container closure is not made with natural rubber l Read more...

atex. non-pvc, non-dehp, sterile.

Package Label Principal Display Panel:

Package label - principal display â potassium chloride in 0.45% sodium chloride injection, usp bag label free flex Â® ndc 63323- 683 -01 1000 ml 20 meq potassium chloride (20 meq/l) potassium chloride in 0.45% sodium chloride injection, usp for intravenous use. rx only package label - principal display â potassium chloride in 0.45% sodium chloride injection, usp bag label

Package label - principal display â potassium chloride in 0.9% sodium chloride injection, usp bag label free flex Â® ndc 63323- 686 -01 1000 ml 20 meq potassium chloride (20 meq/l) potassium chloride in 0.9% sodium chloride injection, usp for intravenous use. rx only package label - principal display â potassium chloride in 0.9% sodium chloride injection, usp bag label

Package label - principal display â potassium chloride in 0.9% sodium chloride injection, usp bag label free flex Â® ndc 63323- 688 -01 1000 ml 40 meq potassium chloride (40 meq/l) potassium chloride in 0.9% sodium chloride injection, usp for intravenous use. rx only package label - principal display â potassium chloride in 0.9% sodium chloride injection, usp bag label

Comments/ Reviews:

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