Potassium Chloride, Dextrose Monohydrate
FDA Drug Information • Also known as: Potassium Chloride
- Brand Names
- Potassium Chloride
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Potassium Chloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single-dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 . Table 1 * Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. ** Size (mL) Composition (g/L) Ionic Concentration (mEq/L) Caloric Content (kcal/L) Potassium Chloride in 5% Dextrose Injection, USP **Dextrose Hydrous, USP Potassium Chloride, USP (KCl) *Osmolarity (mOsmol/L) (calc.) pH Potassium Chloride mEq Potassium 10 mEq 1000 50 0.75 272 4.5 (3.5 to 6.5) 10 10 170 20 mEq 1000 50 1.5 293 4.5 (3.5 to 6.5) 20 20 170 D-Glucose monohydrate Dextrose is derived from corn. The flexible plastic container is fabricated from a specially formulated nonplasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® 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. Structural Formula
What Is Potassium Chloride, Dextrose Monohydrate Used For?
1 INDICATIONS AND USAGE Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories. Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Only for intravenous infusion. ( 2.1 , 5.2 ) See full prescribing information for information on preparation, administration, dosing considerations and instructions for use. ( 2.1 , 2.2 , 2.3 ) 2.1 Important Administration Instructions Potassium Chloride in 5% Dextrose Injection is only for intravenous infusion [see Warnings and Precautions ( 5.2 )] . For patients receiving Potassium Chloride in 5% Dextrose Injection at greater than maintenance rates, frequent monitoring of serum potassium concentrations and serial electrocardiograms (ECGs) are recommended. The osmolarity of 10 mEq Potassium Chloride in 5% Dextrose Injection is 272 mOsmol/L (calc). The osmolarity of 20 mEq Potassium Chloride in 5% Dextrose is 293 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain. Do not administer Potassium Chloride in 5% Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudo agglutination or hemolysis. To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry. Prior to infusion, visually inspect the solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged. Use of a final filter is recommended during administration of parenteral solutions, where possible. 2.2 Recommended Dosage The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient. The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient's tolerance to dextrose. Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] . 2.3 Instructions for Use Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. Flexible Plastic Container ( free flex ® bag) To Open Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact,...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in 5% Dextrose Injection were identified in post marketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions : including anaphylaxis and chills [see Warnings and Precautions ( 5.1 )] . Hyperkalemia, including cardiac arrest, as a manifestation [see Warnings and Precautions ( 5.2 )] Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] Hypokalemia [see Warnings and Precautions ( 5.5 )] Hypervolemia [see Warnings and Precautions ( 5.6 )] Injection site reactions : infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, infusion site rash, infusion site pain, infusion site vesicles, infusion site pruritus, pyrexia and chills Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
7 DRUG INTERACTIONS Other Products that Cause Hyperkalemia : Avoid use in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. ( 7.1 ) Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance : Monitor blood glucose concentrations, fluid balance serum electrolyte concentrations and acid-base balance. ( 7.2 ) 7.1 Other Products that Cause Hyperkalemia Administration of Potassium Chloride in 5% Dextrose Injection in patients treated concurrently or recently with other products that can cause hyperkalemia or increase the risk of hyperkalemia (e.g., potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions ( 5.2 )] . Avoid use of Potassium Chloride in 5% Dextrose Injection in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. 7.2 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Potassium Chloride in 5% Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions ( 5.3 , 5.4 , 5.5 , 5.6 )] . Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Potassium Chloride in 5% Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.
Contraindications
4 CONTRAINDICATIONS Potassium Chloride in 5% Dextrose Injection is contraindicated in patients with: known hypersensitivity to potassium chloride and/or dextrose [see Warnings and Precautions 5.1 )] clinically significant hyperkalemia [see Warnings and Precautions ( 5.2 )] clinically significant hyperglycemia [see Warnings and Precautions ( 5.3 )] Known hypersensitivity to potassium chloride or dextrose ( 4 , 5.1 ) Clinically significant hyperkalemia ( 4 , 5.2 ) Clinically significant hyperglycemia ( 4 , 5.3 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Appropriate administration of Potassium Chloride in 5% Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Potassium Chloride in 5% Dextrose Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Overdosage
10 OVERDOSAGE Excess administration of Potassium Chloride in 5% Dextrose Injection can cause: Hyperkalemia Manifestations of hyperkalemia may include: disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation, and ECG changes (peaking of T waves, loss of P waves, and QRS widening) hypotension, muscle weakness up to and including muscular and respiratory paralysis, paresthesia of extremities, gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain) 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 [see Warnings and Precautions ( 5.2 )] . Other Electrolyte and Fluid Disorders Hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance, and corresponding complications, which can be fatal [see Warnings and Precautions ( 5.3 , 5.6 )] . Hyponatremia, manifestations may include seizures, coma, cerebral edema and death) [see Warnings and Precautions ( 5.4 )] . Fluid overload (which can lead to central and/or peripheral edema) [see Warnings and Precautions ( 5.6 )] . Hypernatremia, especially in patients with severe renal impairment. Interventions include discontinuation of the infusion, dose reduction, monitoring of fluid balance, electrolyte concentrations and acid-base balance and institution of appropriate corrective measures such as administration of exogenous insulin.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride in 5% Dextrose Injection, USP is a clear solution in 1000 mL single-dose, flexible containers available as follows: Product code Unit of Use Strength Unit of Sale 667110 NDC 63323-667-01 One 1000 mL free flex ® Bag 10 mEq Potassium NDC 63323-667-10 Package of 10 free flex ® Bags 669110 NDC 63323-669-01 One 1000 mL free flex ® Bag 20 mEq Potassium NDC 63323-669-10 Package of 10 free flex ® Bags Avoid excessive heat. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; brief exposure up to 40°C does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.