Dextrose And Potassium Chloride
FDA Drug Information • Also known as: Potassium Chloride In Dextrose
- Brand Names
- Potassium Chloride In Dextrose
- Route
- INTRAVENOUS
- Dosage Form
- SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION (See chart below for quantitative information.) Potassium Chloride in 5% Dextrose Injection USP is sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply. It contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Potassium Chloride USP KCl 74.55 Hydrous Dextrose USP 198.17 Composition – Each 100 mL contains: Concentration of Electrolytes (mEq/liter) Calories per liter Calculated Osmolarity mOsmol/liter pH Solution Hydrous Dextrose USP Potassium Chloride USP Potassium Chloride 0.15% Potassium Chloride in 5% Dextrose Injection USP 5 g 0.15 g 20 20 170 295 4.3 (3.5-6.5) Water for Injection USP qs Dextrose is derived from corn. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Chem structure
What Is Dextrose And Potassium Chloride Used For?
1 INDICATIONS AND USAGE Potassium Chloride in Dextrose Injection is indicated as a source of electrolytes, calories, and water for hydration. Potassium Chloride in Dextrose Injection is indicated as a source of electrolytes, calories, and water for hydration.
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 Dextrose Injection is only for intravenous infusion [see Warnings and Precautions (5.2)] . For patients receiving Potassium Chloride in Dextrose Injection at greater than maintenance rates, frequent monitoring of serum potassium concentrations and serial electrocardiograms (ECGs) are recommended. The osmolarity of Potassium Chloride in Dextrose Injection is 295 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 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 To Open Tear overwrap down at notch and remove solution container. Visually inspect the container. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Evaluate the following: Read the label. Ensure solution is the one ordered and is within the expiration date. If the outlet port protector is damaged, detached or not present, discard container. Invert the container and check to ensure the solution is clear and there is no haze or particulate matter. Discard if there is a color change and/or the appearance of precipitates,...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in 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. To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-866-854-6851 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 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 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 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 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 and/or dextrose ( 5.1) clinically significant hyperkalemia (5.2) clinically significant hyperglycemia (5.3)
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Appropriate administration of Potassium Chloride in 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 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 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 supplied sterile and nonpyrogenic in 1000 mL EXCEL® Containers packaged 12 per case. REF Size NDC mEq Potassium Product Name L6250 1000 mL 0264-7625-00 (Canada DIN 01931539) 20 mEq Potassium Chloride in 5% Dextrose Injection, USP Not made with natural rubber latex, PVC or DEHP. Storage Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product. Storage in automated dispensing machines : Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.
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.