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Drugs › Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride
Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride
FDA Drug Information • Also known as: Potassium Chloride In Lactated Ringers And Dextrose
- Brand Names
- Potassium Chloride In Lactated Ringers And Dextrose
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Potassium Chloride in Lactated Ringer’s and Dextrose (5%) 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 . Dextrose is derived from corn. Table 1 Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, USP Size (mL) Composition (g/L) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) Dextrose, USP Sodium Chloride, USP Sodium Lactate Potassium Chloride, USP Calcium Chloride, USP Sodium Potassium Calcium Chloride Lactate 20 mEq Potassium added 1000 50 6 3.1 1.79 0.2 565 5.0 (3.5 to 6.5) 130 24 3 129 28 170 The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2 . Table 2 Chemical Name Structural Formula Molecular Weight Sodium Chloride, USP 58.44 Sodium Lactate 112.06 Potassium Chloride, USP 74.55 Calcium Chloride, USP 147.02 Dextrose, USP 198.17 The VIAFLEX plastic container is fabricated from polyvinyl chloride (PL 146 Plastic). Small amounts of its chemical components (e.g., di-2-ethylhexyl phthalate [DEHP]) may leach out within the expiration period. Animal tests, USP biological tests for plastic containers, and tissue culture toxicity studies have demonstrated that the container meets safety requirements. The container is overwrapped to provide protection from the physical environment and an additional moisture barrier. Sodium Chloride Structural Formula Sodium Lactate Structural Formula Potassium Chloride Structural Formula Calcium Chloride Structural Formula Dextrose Structural Formula
What Is Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride Used For?
1 INDICATIONS AND USAGE Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients. Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION
The recommended dosage and duration are based on the patient’s age, weight, clinical condition, and concomitant therapy. ( 2.1 ) To reduce the risk of air embolism, adhere to the preparation instructions. ( 2.2 , 5.2 ) Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is for intravenous use. ( 2.3 ) Use a peripheral vein to administer if the final dextrose concentration is 5% or less, and the osmolarity is less than 900 mOsm/L. ( 2.3 ). Consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or more to avoid venous irritation, including phlebitis. ( 2.3 ) Do not administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) due to serious risks. ( 2.4 ) See full prescribing information for information dosage considerations, preparation, administration, and drug incompatibilities. ( 2 ) 2.1 Dosage Considerations The recommended dosage and duration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is based on the patient’s age, weight, clinical condition, and concomitant therapy. Evaluate the patient’s clinical status and monitor changes in blood glucose and electrolyte concentrations especially during prolonged use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to optimize clinical status. 2.2 Important Preparation Instructions Visually inspect the Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection solution for particulate matter and discoloration. Do not administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection unless the solution is clear and the container seals are intact. If additives are determined to be compatible with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection then using aseptic technique, mix thoroughly; do not store solutions containing additives. After mixing, do not use if there is discoloration or formation of precipitates. To reduce the risk of air embolism, adhere to the following preparation instructions for Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection [see Warnings and Precautions (5.2) ] : Use a non-vented infusion set or close the vent on a vented set. Use a dedicated line without any connections (do not connect flexible containers in series). The use of pressure infusion is not recommended as a method to increase flow rates. However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion. If using a pumping device to administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, turn off the pump before the container is empty. Preparation Instructions 1. Tear overwrap downside at slit and remove solution container. 2. Visually inspect the container. o If the outlet port protector is damaged, detached, or not present, discard...Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Serious Risk with Concomitant Use with Ceftriaxone [see Warnings and Precautions (5.1) ] Air Embolism [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Potassium Imbalances [see Warnings and Precautions (5.4) ] Hyponatremia [see Warnings and Precautions (5.5) ] Neonatal Hypoglycemia [see Warnings and Precautions (5.6) ] Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.7) ] Hypercalcemia [see Warnings and Precautions (5.8) ] Fluid Overload [see Warnings and Precautions (5.9) ] Acid/Base Imbalances [see Warnings and Precautions (5.10) ] The following adverse reactions have been identified during postapproval use of Lactated Ringer’s products. Because these reactions are 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: General Disorders and Administration Site Conditions: Phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, and infusion site hypoaesthesia. Hypersensitivity Reactions and Infusion Reactions: Angioedema, chest pain/discomfort, bradycardia or tachycardia, hypotension, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, oral hypoesthesia, dysgeusia, nausea, anxiety, pyrexia, and headache, laryngeal edema, sneezing, injection site infection. Metabolism and Nutrition Disorders: Hyperkalemia, hyponatremia, and hypervolemia. Nervous System Disorders: Hyponatremic encephalopathy. Common adverse reactions include infusion site reactions and symptoms of hypersensitivity reactions (e.g., pruritus, dyspnea, urticaria, rash, cough). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Drug Interactions
7 DRUG INTERACTIONS
Drugs that Affect Electrolyte and/or Fluid Balance : Avoid concomitant use. If concomitant use cannot be avoided, closely monitor electrolyte concentrations and fluid balance. ( 7.1 ) Lithium : Avoid concomitant use. If concomitant use is unavoidable, monitor serum lithium concentrations more frequently. ( 7.2 ) Digoxin : Consider reducing the volume or rate of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection due to the increased risk of digoxin toxicity with calcium-containing solutions. ( 7.3 ) Drugs with pH-Dependent Renal Elimination : Renal clearance of acidic drugs may be increased. In contrast, renal clearance of alkaline drugs may be decreased. ( 7.4 ) 7.1 Drugs that Affect Electrolyte and/or Fluid Balance Hyperkalemia Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients concomitantly treated or recently treated with drugs that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, especially in the presence of other hyperkalemia risk factors. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving drugs that are associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or calcineurin inhibitors). If concomitant use cannot be avoided, closely monitor serum potassium concentrations during concomitant use [see Warnings and Precautions (5.4) ]. Hyponatremia Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia. These drugs include diuretics and those that cause SIADH (e.g., arginine vasopressin analogs, certain antiepileptic, psychotropic, or cytotoxic drugs). Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5) ]. Hypercalcemia Avoid the use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients treated with thiazide diuretics or vitamin D because these drugs can increase the risk of hypercalcemia. If use cannot be avoided, closely monitor serum calcium concentrations during concomitant use [see Warnings and Precautions (5.8) ]. Hypernatremia and Fluid Retention Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients treated concomitantly with drugs associated with sodium and fluid retention (e.g., corticosteroids or corticotropin) may increase the risk of hypernatremia and volume overload. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum electrolytes, fluid balance, and acid-base...Contraindications
4 CONTRAINDICATIONS Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in:
Neonates (28 days of age or younger) who are receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.1) and Specific Populations (8.4) ] . Patients with known hypersensitivity to any of the components of Potassium Chloride in Lactated Ringer’s solution and Dextrose (5%) Injection [see Warnings and Precautions (5.3) ] . Patients with clinically significant hyperkalemia [see Warnings and Precautions (5.4) ] . Patients with clinically significant hyperglycemia [see Warnings and Precautions (5.7) ] . Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 ) Patients with known hypersensitivity to any of the components of Potassium Chloride in Lactated Ringer’s solution and Dextrose (5%) Injection ( 4 ) Patients with clinically significant hyperkalemia ( 4 ). Patients with clinically significant hyperglycemia ( 4 ).Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection as a source of water and electrolytes has been used for decades during labor and delivery. Appropriate administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with this drug. The 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 Excessive administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection can cause:
Hyperkalemia and hypernatremia, especially in patients with severe renal impairment. Fluid overload (which can lead to pulmonary and/or peripheral edema). Hyperglycemia, hyperosmolarity, and osmotic diuresis, dehydration, and electrolyte loss. Metabolic alkalosis with or without hypokalemia. Loss of bicarbonate with an acidifying effect. Hypercalcemia. Overdose interventions include Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection discontinuation, treatment of electrolyte imbalances, treatment of hyperglycemia, and close monitoring of fluid balance, electrolyte concentrations, and acid-base balance [see Warnings and Precautions (5.4 , 5.5 , 5.6 , 5.7 , 5.9 , 5.10 )]How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, USP is supplied as a clear solution in single-dose VIAFLEX plastic containers as follows: Code Size (mL) NDC Product Name 2B2224 1000 0338-0811-04 20 mEq/L Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP Storage and Handling Store at room temperature (recommended 25°C/77°F). Brief exposure up to 40°C (104°F) does not adversely affect the product. Exposure to heat should be minimized. Avoid excessive heat. Baxter Healthcare Corporation Deerfield, IL 60015 USA Baxter, PL 146 and Viaflex are trademarks of Baxter International Inc. or its subsidiaries. 07-19-00-9427
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.