{"id":"sodium-lactate","rwe":[],"_fda":{"id":"127c3c05-ab6d-4c6c-84f9-9552f450f58b","set_id":"05f326e6-10e4-4ceb-8a23-f53c592f00b8","openfda":{"unii":["M4I0D6VV5M","LX22YL083G","660YQ98I10","451W47IQ8X","TU7HW0W0QT"],"route":["INTRAVENOUS"],"rxcui":["847626"],"spl_id":["127c3c05-ab6d-4c6c-84f9-9552f450f58b"],"brand_name":["Potassium Chloride in Lactated Ringers and Dextrose"],"spl_set_id":["05f326e6-10e4-4ceb-8a23-f53c592f00b8"],"package_ndc":["0338-0811-04"],"product_ndc":["0338-0811"],"generic_name":["DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CALCIUM CHLORIDE","DEXTROSE MONOHYDRATE","POTASSIUM CHLORIDE","SODIUM CHLORIDE","SODIUM LACTATE"],"manufacturer_name":["Baxter Healthcare Corporation"],"application_number":["NDA019367"],"is_original_packager":[true]},"version":"16","pregnancy":["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 )]"],"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"],"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"],"geriatric_use":["8.5 Geriatric Use Geriatric patients treated with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection are at increased risk of developing electrolyte imbalances. Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is substantially excreted by the kidney, and the risk of adverse reactions to Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may be greater in patients with renal impairment than in patients with normal renal function. Because geriatric patients are more likely to have decreased renal function, consider monitoring renal function in geriatric patients and consider starting the infusion at the low end of the dosing range."],"pediatric_use":["8.4 Pediatric Use Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in neonates (28 days of age or younger) who are receiving ceftriaxone due to reported deaths that occurred when neonates received ceftriaxone and intravenous calcium-containing solutions concomitantly [see Warnings and Precautions (5.1) ]. The safety and effectiveness of Lactated Ringer’s Injection for use as a source of water, electrolytes, and calories or as an alkalinizing agent have been established in pediatric patients of all ages, including neonates. The safety profile of Potassium Chloride in Dextrose Injection in pediatric patients is similar to adults. Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function who may have decreased ability to maintain fluid and electrolyte balance [see Warnings and Precautions (5.4 , 5.5 , 5.8 , 5.9 )]. Administration of a lactate-containing intravenous solution, including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to pediatric patients should account for liver and kidney maturation (the kidney function affects the biotransformation and renal excretion of lactate) [see Warnings and Precautions (5.9) ]. Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to ensure adequate glycemic control to avoid potential long-term adverse reactions [see Warnings and Precautions (5.6 , 5.7 )]. In very low birth weight neonates, excessive or rapid administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may result in increased serum osmolarity and risk of intracranial hemorrhage."],"effective_time":"20251029","pharmacodynamics":["12.2 Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection have not been fully characterized."],"pharmacokinetics":["12.3 Pharmacokinetics Elimination Metabolism/Excretion Potassium: Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder is excreted in feces and to a smaller extent, in perspiration. Sodium and Chloride: The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output. Lactate: In the liver, lactate is metabolized to carbon dioxide and water by oxidative metabolism and consumption of hydrogen cations. Dextrose: Dextrose injected parenterally undergoes oxidation to carbon dioxide and water."],"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."],"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 )."],"description_table":["
Table 1
Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, USPSize (mL)Composition (g/L)Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.Osmolarity (mOsmol/L) (calc)pHIonic Concentration (mEq/L)Caloric Content (kcal/L)
Dextrose, USPSodium Chloride, USPSodium LactatePotassium Chloride, USPCalcium Chloride, USP SodiumPotassiumCalciumChlorideLactate
20 mEq Potassium added10005063.11.790.25655.0(3.5 to6.5)13024312928170
","
Table 2
Chemical NameStructural FormulaMolecular Weight
Sodium Chloride, USP58.44
Sodium Lactate112.06
Potassium Chloride, USP74.55
Calcium Chloride, USP147.02
Dextrose, USP198.17
"],"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 balance during concomitant use. 7.2 Lithium Renal sodium and lithium clearance may be increased during concomitant use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection and lithium and may result in decreased lithium concentrations. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving lithium. If use cannot be avoided, increase the frequency of monitoring of serum lithium concentrations during concomitant use. 7.3 Digoxin Administration of calcium via use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may increase digoxin’s effects and lead to digoxin toxicity including serious or fatal cardiac arrhythmias. In digoxin-treated patients, consider reducing the volume and/or rate of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection administration. 7.4 Drugs with pH-Dependent Renal Elimination Due to the alkalinizing action of lactate (formation of bicarbonate), Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may interfere with the elimination of drugs with pH-dependent renal elimination. Renal clearance of alkaline drugs may be decreased. In contrast, renal clearance of acidic drugs may be increased. 7.5 Interference of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis Because administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may interfere with the interpretation of serum lactate levels in patients with severe metabolic acidosis, including lactic acidosis, assessment of the patient’s clinical status should not solely rely on the measurement of serum lactate."],"how_supplied_table":["
CodeSize (mL)NDCProduct Name
2B222410000338-0811-0420 mEq/L Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP
"],"mechanism_of_action":["12.1 Mechanism of Action Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is a source of water, electrolytes, and calories, and produces an alkalinizing effect. • Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. • Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. • Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration. • Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability. • Sodium lactate provides sodium and lactate ions. The lactate anion is in equilibrium with pyruvate and has an alkalinizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. The sodium ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). • Dextrose provides a source of calories. Dextrose may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided."],"recent_major_changes":["Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 ) 10/2025 Contraindications ( 4 ) 10/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11 ) 10/2025"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is a source of water, electrolytes, and calories, and produces an alkalinizing effect. • Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. • Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. • Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration. • Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability. • Sodium lactate provides sodium and lactate ions. The lactate anion is in equilibrium with pyruvate and has an alkalinizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. The sodium ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). • Dextrose provides a source of calories. Dextrose may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided. 12.2 Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection have not been fully characterized. 12.3 Pharmacokinetics Elimination Metabolism/Excretion Potassium: Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder is excreted in feces and to a smaller extent, in perspiration. Sodium and Chloride: The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output. Lactate: In the liver, lactate is metabolized to carbon dioxide and water by oxidative metabolism and consumption of hydrogen cations. Dextrose: Dextrose injected parenterally undergoes oxidation to carbon dioxide and water."],"indications_and_usage":["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 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS • Serious Risks with Inappropriate Use with Ceftriaxone : Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone. In patients older than 28 days, ceftriaxone and Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions. ( 4 , 5 . 1 , 8.4 ) • Air Embolism : Use a non-vented infusion set or close the vent on a vented set and use a dedicated line without any connections. Pressure infusion is not recommended to increase flow rates, but if necessary, remove all air from the bag prior to initiating infusion. ( 5.2 ) • Hypersensitivity Reactions : Stop the Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection infusion immediately if signs or symptoms of a hypersensitivity reaction develop. ( 5.3 ) • Potassium Imbalances, Hyponatremia, Neonatal Hypoglycemia, Hyperglycemia and Hyperosmolar Hyperglycemic State, Hypercalcemia, Fluid Overload, Acid-Base Imbalances, Interference with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis: See Full Prescribing Information for risk management recommendations. ( 5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11 ) 5.1 Serious Risk with Concomitant Use with Ceftriaxone Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, in the same intravenous administration line. Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used. Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in neonates who receive ceftriaxone [see Contraindications (4) , Use in Specific Populations (8.4) ] . However, in patients older than 28 days, ceftriaxone and Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid. 5.2 Air Embolism Cases of air embolism have been reported with pressurized administration of intravenous fluids. Air embolism may result in stroke, organ ischemia and/or infarction, and death. Use a non-vented infusion set or close the vent on a vented set and use a dedicated line without any connections. If administration is controlled by a pumping device, care must be taken to discontinue the pumping action before the container is empty. If administration is controlled by a pumping device, care must be taken to discontinue the pumping action before the container is empty. Pressure infusion is not recommended to increase flow rates, but if necessary, ensure all air is removed from the bag before infusion. Refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container [see Dosage and Administration (2.2) ] . 5.3 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Lactated Ringer’s solution. Stop the Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated. 5.4 Potassium Imbalances Hyperkalemia Potassium-containing solutions, including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, may increase the risk of hyperkalemia. This risk is increased in patients predisposed to hyperkalemia including those with severe renal impairment, acute dehydration, extensive tissue injury or burns, heart failure, or in those using concomitant drugs that are associated with hyperkalemia. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients with, or at increased risk for, hyperkalemia. If use cannot be avoided in these patients, closely monitor serum potassium concentrations. 5.5 Hyponatremia Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, geriatric patients, patients treated with diuretics, patients with cardiac or pulmonary failure, or patients with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperative patients, patients concomitantly treated with arginine vasopressin analogs, or certain antiepileptic, psychotropic, or cytotoxic drugs) [see Drug Interactions (7.1) , Use in Specific Populations (8.4) ] . Avoid Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients with or at risk for hyponatremia. If use cannot be avoided in these patients, closely monitor serum sodium concentrations. Rapid correction of hyponatremia may result in serious neurologic complications such as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. 5.6 Neonatal Hypoglycemia Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypoglycemia. Closely monitor blood glucose concentration during treatment with intravenous dextrose solutions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. 5.7 Hyperglycemia and Hyperosmolar Hyperglycemic State Administration of solutions containing dextrose and lactate in patients with impaired glucose tolerance including those with diabetes mellitus may worsen hyperglycemia. Hyperglycemia is associated with an increase in serum osmolality, which can result in hypovolemia and electrolyte imbalances due to osmotic diuresis. Patients with underlying central nervous system disease or renal impairment who receive dextrose infusions may be at greater risk of developing hyperosmolar hyperglycemic state. While using Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, closely monitor blood glucose concentrations and treat hyperglycemia to maintain glucose concentrations within normal limits. Anti-diabetic drugs may need to be started or dosages of these drugs may need to be increased to maintain optimal blood glucose concentrations. 5.8 Hypercalcemia Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection contains calcium salts and may cause hypercalcemia. Avoid administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients with hypercalcemia, those with calcium-containing renal calculi or history of such calculi, those with conditions predisposing to hypercalcemia, or those treated with concomitant thiazide diuretics or vitamin D. 5.9 Fluid Overload Depending on the administered volume and the infusion rate, administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection can cause fluid overload, including pulmonary edema. Avoid Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients at risk for fluid and/or solute overload including patients with severe renal impairment. If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations and acid base balance, especially during prolonged use. 5.10 Acid/Base Imbalances Because lactate is metabolized to bicarbonate, administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may result in, or worsen, metabolic alkalosis. Closely monitor the acid-base balance in patients with, or at risk of, alkalosis. In patients with severe hepatic impairment, decreased lactate metabolism may result in worsening anion gap metabolic acidosis. Avoid Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients with severe hepatic impairment. If use cannot be avoided in these patients, closely monitor serum bicarbonate levels. 5.11 Interference of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may result in interference with the interpretation of serum lactate levels in patients with severe metabolic acidosis, including lactic acidosis [see Drug Interactions (7.5)] ."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genetic toxicology, and animal fertility studies have not been conducted with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection."],"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 container as solution path sterility may be impaired. o 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. 3. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. 4. If supplemental medication is desired, follow directions below [see Dosage and Administration (2.3) ] . Preparation for Administration 1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set according to its accompanying directions. 2.3 Important Administration Instructions Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is for intravenous use. Use immediately after removing the overwrap. Discard the unused portion. • Use a peripheral vein to administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection if the final dextrose concentration is 5% or less, and the osmolarity is less than 900 mOsm/L. • Consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or more to avoid venous irritation [see Warnings and Precautions (5.7) ]. Some additives may be incompatible [see Dosage and Administration (2.4) and Contraindications (4) ] . To Add Medication Before Solution Administration 1. Prepare medication site. 2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. 3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. To Add Medication During Solution Administration 1. Close clamp on the set. 2. Prepare medication site. 3. Using syringe with19 to 22 gauge needle, puncture resealable medication port and inject. 4. Remove container from IV pole and/or turn to an upright position. 5. Evacuate both ports by squeezing them while container is in the upright position. 6. Mix solution and medication thoroughly. 7. Return container to in use position and continue administration. 2.4 Drug Incompatibilities 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 [see Contraindications (4) and Warnings and Precautions (5.1) ] . However, in patients older than 28 days, ceftriaxone and Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Warnings and Precautions (5.1) ] . Do not administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation precipitated by the calcium content of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection."],"spl_product_data_elements":["Potassium Chloride in Lactated Ringers and Dextrose DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION WATER"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Injection: Potassium Chloride (20 mEq) in Lactated Ringer’s and Dextrose (5%) Injection, USP as a clear, sterile, and nonpyrogenic solution packaged in a single-dose VIAFLEX plastic container: 1,000 mL. Injection: Potassium Chloride (20 mEq) in Lactated Ringer’s and Dextrose (5%) Injection, USP packaged in a single-dose VIAFLEX plastic container: 1000 mL. ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS • Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function. ( 8.4 ) • Neonates are at increased risk of developing hypo- or hyperglycemia. Closely monitor to ensure adequate glycemic control. ( 8.4 ) • Geriatric patients are more likely to have decreased renal function. Consider monitoring renal function and starting the infusion at the low end of the dosing range. ( 8.5 ) • Avoid in patients with severe renal impairment. ( 8.6 ) • Patients with severe hepatic impairment may have impaired lactate metabolism. Closely monitor serum lactate levels and acid-base status. ( 8.7 ) 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. 8.2 Lactation Risk Summary Lactated Ringer’s as a source of water and electrolytes and Dextrose (5%) Injection have been used for decades and is not expected to cause harm to a breastfed infant. There are no data on the presence of Lactated Ringer’s and Dextrose (5%) Injection in human milk, the effects on the breastfed infant, or the effects on milk production. Potassium is present in human breast milk. There are no data on the effects of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection on a breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection and any potential adverse effects on the breastfed infant from Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection or from the underlying maternal condition. 8.4 Pediatric Use Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in neonates (28 days of age or younger) who are receiving ceftriaxone due to reported deaths that occurred when neonates received ceftriaxone and intravenous calcium-containing solutions concomitantly [see Warnings and Precautions (5.1) ]. The safety and effectiveness of Lactated Ringer’s Injection for use as a source of water, electrolytes, and calories or as an alkalinizing agent have been established in pediatric patients of all ages, including neonates. The safety profile of Potassium Chloride in Dextrose Injection in pediatric patients is similar to adults. Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function who may have decreased ability to maintain fluid and electrolyte balance [see Warnings and Precautions (5.4 , 5.5 , 5.8 , 5.9 )]. Administration of a lactate-containing intravenous solution, including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to pediatric patients should account for liver and kidney maturation (the kidney function affects the biotransformation and renal excretion of lactate) [see Warnings and Precautions (5.9) ]. Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to ensure adequate glycemic control to avoid potential long-term adverse reactions [see Warnings and Precautions (5.6 , 5.7 )]. In very low birth weight neonates, excessive or rapid administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may result in increased serum osmolarity and risk of intracranial hemorrhage. 8.5 Geriatric Use Geriatric patients treated with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection are at increased risk of developing electrolyte imbalances. Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is substantially excreted by the kidney, and the risk of adverse reactions to Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may be greater in patients with renal impairment than in patients with normal renal function. Because geriatric patients are more likely to have decreased renal function, consider monitoring renal function in geriatric patients and consider starting the infusion at the low end of the dosing range. 8.6 Renal Impairment Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients with or at risk of severe renal impairment, may result in hyperkalemia and/or fluid overload [see Warnings and Precautions (5.4 , 5.7 , 5.9 )]. Avoid Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients with severe renal impairment. If use cannot be avoided in such patients, monitor for development of these adverse reactions. 8.7 Hepatic Impairment In patients with severe hepatic impairment, lactate metabolism may be impaired, and Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may not produce alkalinization. Closely monitor serum lactate levels and acid-base status in such patients."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label LOT EXP 2B2224 NDC 0338-0811-04 DIN 00786314 20 mEq Potassium Chloride (20 mEq/L) Potassium Chloride in Lactated Ringer's and 5% Dextrose Injection USP 1000 mL EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP 600 mg SODIUM CHLORIDE USP 310 mg SODIUM LACTATE 179 mg POTASSIUM CHLORIDE USP 20 mg CALCIUM CHLORIDE USP pH 5.0 (3.5 TO 6.5) mEq/L SODIUM 130 POTASSIUM 24 CALCIUM 3 CHLORIDE 129 LACTATE 28 HYPERTONIC OSMOLARITY 565 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS 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 ADMINISTER SIMULTANEOUSLY WITH BLOOD 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 Representative Container Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genetic toxicology, and animal fertility studies have not been conducted with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection."]},"tags":[{"label":"sodium lactate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Intraperitoneal","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Hypokalemia","category":"indication"},{"label":"Hypokalemia Prevention","category":"indication"},{"label":"Hospira","category":"company"},{"label":"Approved 1970s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":1839.624,"date":"","count":1083,"signal":"Death","source":"DrugCentral FAERS","actionTaken":"Reported 1,083 times (LLR=1840)"},{"llr":1496.625,"date":"","count":320,"signal":"Peritonitis bacterial","source":"DrugCentral FAERS","actionTaken":"Reported 320 times (LLR=1497)"},{"llr":1025.619,"date":"","count":294,"signal":"Peritonitis","source":"DrugCentral FAERS","actionTaken":"Reported 294 times (LLR=1026)"},{"llr":910.304,"date":"","count":169,"signal":"Peritoneal dialysis complication","source":"DrugCentral FAERS","actionTaken":"Reported 169 times (LLR=910)"},{"llr":636.8,"date":"","count":112,"signal":"Fungal peritonitis","source":"DrugCentral FAERS","actionTaken":"Reported 112 times (LLR=637)"},{"llr":420.389,"date":"","count":74,"signal":"Device interaction","source":"DrugCentral FAERS","actionTaken":"Reported 74 times (LLR=420)"},{"llr":279.359,"date":"","count":247,"signal":"Sepsis","source":"DrugCentral FAERS","actionTaken":"Reported 247 times (LLR=279)"},{"llr":272.163,"date":"","count":52,"signal":"Encapsulating peritoneal sclerosis","source":"DrugCentral FAERS","actionTaken":"Reported 52 times (LLR=272)"},{"llr":212.583,"date":"","count":37,"signal":"Ultrafiltration failure","source":"DrugCentral FAERS","actionTaken":"Reported 37 times (LLR=213)"},{"llr":208.057,"date":"","count":175,"signal":"Myocardial infarction","source":"DrugCentral FAERS","actionTaken":"Reported 175 times (LLR=208)"},{"llr":189.183,"date":"","count":119,"signal":"Cardiac disorder","source":"DrugCentral FAERS","actionTaken":"Reported 119 times (LLR=189)"},{"llr":181.011,"date":"","count":149,"signal":"Cardiac failure","source":"DrugCentral FAERS","actionTaken":"Reported 149 times (LLR=181)"},{"llr":172.732,"date":"","count":147,"signal":"Cardiac arrest","source":"DrugCentral FAERS","actionTaken":"Reported 147 times (LLR=173)"},{"llr":162.979,"date":"","count":29,"signal":"Peritoneal cloudy effluent","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=163)"},{"llr":160.347,"date":"","count":55,"signal":"Gangrene","source":"DrugCentral FAERS","actionTaken":"Reported 55 times (LLR=160)"}],"drugInteractions":[{"drug":"Drugs that Affect Electrolyte and/or Fluid Balance","severity":"major","mechanism":"Concurrent administration may exacerbate electrolyte imbalances.","management":"Avoid concomitant use. If concomitant use cannot be avoided, closely monitor electrolyte concentrations and fluid balance.","clinicalEffect":"Increased risk of severe and potentially fatal hyperkalemia, hyponatremia, hypercalcemia, hypernatremia, and fluid retention."},{"drug":"Lithium","severity":"major","mechanism":"Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may affect lithium metabolism.","management":"Avoid concomitant use. If concomitant use is unavoidable, monitor serum lithium concentrations more frequently.","clinicalEffect":"Increased risk of lithium toxicity."},{"drug":"Digoxin","severity":"moderate","mechanism":"Calcium in the solution may increase the risk of digoxin toxicity.","management":"Consider reducing the volume or rate of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection.","clinicalEffect":"Increased risk of digoxin toxicity."},{"drug":"Drugs with pH-Dependent Renal Elimination","severity":"moderate","mechanism":"Changes in urine pH can alter the renal clearance of certain drugs.","management":"Monitor for changes in drug efficacy or toxicity.","clinicalEffect":"Renal clearance of acidic drugs may be increased; renal clearance of alkaline drugs may be decreased."}],"commonSideEffects":[{"effect":"Hypervolemia","drugRate":"reported","severity":"unknown"},{"effect":"Hypovolemia","drugRate":"reported","severity":"unknown"},{"effect":"Fluid retention","drugRate":"reported","severity":"unknown"},{"effect":"Hypokalemia","drugRate":"reported","severity":"unknown"},{"effect":"Hyponatremia","drugRate":"reported","severity":"unknown"},{"effect":"Dehydration","drugRate":"reported","severity":"unknown"},{"effect":"Hypochloremia","drugRate":"reported","severity":"unknown"},{"effect":"Hypotension","drugRate":"reported","severity":"unknown"},{"effect":"Hypertension","drugRate":"reported","severity":"unknown"},{"effect":"Dyspnea","drugRate":"reported","severity":"unknown"},{"effect":"Sclerosing encapsulating peritonitis","drugRate":"reported","severity":"unknown"},{"effect":"Peritoneal cloudy effluent","drugRate":"reported","severity":"unknown"},{"effect":"Vomiting","drugRate":"reported","severity":"unknown"},{"effect":"Diarrhea","drugRate":"reported","severity":"unknown"},{"effect":"Nausea","drugRate":"reported","severity":"unknown"},{"effect":"Constipation","drugRate":"reported","severity":"unknown"},{"effect":"Abdominal pain","drugRate":"reported","severity":"unknown"},{"effect":"Abdominal distension","drugRate":"reported","severity":"unknown"},{"effect":"Abdominal discomfort","drugRate":"reported","severity":"unknown"},{"effect":"Stevens-Johnson syndrome","drugRate":"reported","severity":"unknown"},{"effect":"Urticaria","drugRate":"reported","severity":"unknown"},{"effect":"Rash","drugRate":"reported","severity":"unknown"},{"effect":"Pruritus","drugRate":"reported","severity":"unknown"},{"effect":"Myalgia","drugRate":"reported","severity":"unknown"},{"effect":"Muscle spasms","drugRate":"reported","severity":"unknown"},{"effect":"Musculoskeletal pain","drugRate":"reported","severity":"unknown"},{"effect":"Generalized edema","drugRate":"reported","severity":"unknown"},{"effect":"Pyrexia","drugRate":"reported","severity":"unknown"},{"effect":"Malaise","drugRate":"reported","severity":"unknown"}],"contraindications":["Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used.","Patients with known hypersensitivity to any of the components of Potassium Chloride in Lactated Ringer’s solution and Dextrose (5%) Injection.","Patients with clinically significant hyperkalemia.","Patients with clinically significant hyperglycemia."],"specialPopulations":{"Lactation":"The components of DIANEAL solutions are excreted in human milk. Appropriate administration of DIANEAL solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm nursing infant.","Pregnancy":"While there are no adequate and well controlled studies in pregnant women, appropriate administration of DIANEAL solutions, with appropriate monitoring of hematology, electrolytes, blood chemistry and fluid status is not expected to cause fetal harm.","Geriatric use":"Safety and effectiveness have been established based on published clinical data.","Paediatric use":"Safety and effectiveness have been established based on published clinical data. No adequate and well-controlled studies have been conducted with DIANEAL solutions in pediatric patients."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SODIUM LACTATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:02:09.703570+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:02:15.311670+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SODIUM LACTATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:02:15.639261+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:02:08.586630+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:03:13.186136+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:02:08.586652+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"12.1 Mechanism of Action Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is a source of water, electrolytes, and calories, and produces an alkalinizing effect. • Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. • Potassium, the principal cation of ","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:02:29.927705+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:03:02.846922+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1357/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:02:16.836217+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"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 Precau","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:02:32.567870+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:02:38.504477+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA019367","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:02:08.586656+00:00"}},"allNames":"sodium lactate in plastic container","offLabel":[],"synonyms":["sodium lactate","lacolin","lactic acid sodium salt","monosodium lactate"],"timeline":[{"date":"1971-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BAXTER HLTHCARE to Hospira"},{"date":"1971-03-22","type":"positive","source":"DrugCentral","milestone":"FDA approval (Baxter Hlthcare)"},{"date":"1984-09-05","type":"positive","source":"FDA Orange Book","milestone":"Sodium Lactate In Plastic Container approved — 5MEQ/ML"},{"date":"1992-04-21","type":"positive","source":"FDA Orange Book","milestone":"Sodium Lactate 1/6 Molar In Plastic Container approved — 1.87GM/100ML"}],"aiSummary":"Sodium Lactate is a small molecule drug originally developed by Baxter Healthcare and currently owned by Hospira. It was FDA approved in 1971 for the treatment of hypokalemia and prevention of hypokalemia. The commercial status of Sodium Lactate is off-patent, meaning there are no active Orange Book patents. Key safety considerations include the potential for electrolyte imbalances. It is used to treat low potassium levels in the blood.","approvals":[{"date":"1971-03-22","orphan":false,"company":"BAXTER HLTHCARE","regulator":"FDA"}],"brandName":"Sodium Lactate In Plastic Container","ecosystem":[{"indication":"Hypokalemia","otherDrugs":[{"name":"aspartic acid","slug":"aspartic-acid","company":""},{"name":"calcium chloride","slug":"calcium-chloride","company":"Baxter Hlthcare"},{"name":"potassium acetate","slug":"potassium-acetate","company":"B Braun"},{"name":"potassium chloride","slug":"potassium-chloride","company":"Hospira"}],"globalPrevalence":null},{"indication":"Hypokalemia Prevention","otherDrugs":[{"name":"amiloride","slug":"amiloride","company":"Paddock Llc"},{"name":"aspartic acid","slug":"aspartic-acid","company":""},{"name":"calcium chloride","slug":"calcium-chloride","company":"Baxter Hlthcare"},{"name":"potassium acetate","slug":"potassium-acetate","company":"B Braun"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"sodium lactate","explanation":"This solution contains potassium, sodium, chloride, calcium, and dextrose, which work together to maintain fluid balance, electrolyte levels, and acid-base equilibrium. It also provides calories and supports carbohydrate and protein metabolism, helping to prevent metabolic acidosis and ketosis.","oneSentence":"Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection provides water, electrolytes, and calories, and helps regulate fluid balance, acid-base equilibrium, and energy metabolism.","technicalDetail":"Sodium regulates water distribution and osmotic pressure, while potassium is crucial for nerve conduction and muscle contraction. Chloride follows sodium metabolism and reflects acid-base changes. Calcium is essential for blood clotting and cardiac function. Lactate ions have an alkalinizing effect by removing hydrogen ions, and dextrose provides calories and supports glycogen deposition."},"commercial":{"launchDate":"1971","_launchSource":"DrugCentral (FDA 1971-03-22, BAXTER HLTHCARE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4202","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=SODIUM%20LACTATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SODIUM LACTATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:39:09.536687","_validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T03:03:13.686192+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"genericName":"sodium lactate","indications":{"approved":[{"id":"sodium-lactate-electrolyte-and-caloric-suppor","name":"Electrolyte and Caloric Support","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adults and pediatric patients","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adults and pediatric patients","diagnosticRequired":null,"brandNameForIndication":"Sodium Lactate In Plastic Container"},{"id":"sodium-lactate-alkalinizing-agent","name":"Alkalinizing Agent","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adults and pediatric patients","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adults and pediatric patients","diagnosticRequired":null,"brandNameForIndication":"Sodium Lactate In Plastic Container"}],"offLabel":[],"pipeline":[]},"currentOwner":"Hospira","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT07487675","phase":"PHASE2","title":"Evaluation of Intravenous Sodium Valproate on Interleukin-6 Levels in Patients With TMJ Disc Displacement","status":"ACTIVE_NOT_RECRUITING","sponsor":"Tanta University","startDate":"2024-09-29","conditions":["Temporomandibular Joint Internal Derangement (ADWR)"],"enrollment":10,"completionDate":"2026-05-06"},{"nctId":"NCT07483151","phase":"","title":"Venous Congestion And Cognitive Dysfunction After Cardiac Surgery","status":"RECRUITING","sponsor":"Zhuan Zhang","startDate":"2024-11-01","conditions":["Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac Surgery"],"enrollment":110,"completionDate":"2026-10-31"},{"nctId":"NCT06839326","phase":"NA","title":"Efficacy of Autologous Conditioned Serum in Temporomandibular Joint Disorder","status":"COMPLETED","sponsor":"Batman University","startDate":"2024-11-01","conditions":["Temporomandibular Joint Osteoarthritis"],"enrollment":75,"completionDate":"2025-08-01"},{"nctId":"NCT04102371","phase":"PHASE3","title":"Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis","status":"COMPLETED","sponsor":"Children's Hospital of Philadelphia","startDate":"2020-08-25","conditions":["Shock","Septic"],"enrollment":9041,"completionDate":"2026-01-31"},{"nctId":"NCT07438262","phase":"PHASE2","title":"The AminoECMO Pilot Trial","status":"NOT_YET_RECRUITING","sponsor":"Australian and New Zealand Intensive Care Research Centre","startDate":"2026-02-01","conditions":["Acute Kidney Injury"],"enrollment":40,"completionDate":"2027-11-30"},{"nctId":"NCT07329660","phase":"NA","title":"Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients","status":"NOT_YET_RECRUITING","sponsor":"Air Force Military Medical University, China","startDate":"2026-02-16","conditions":["Transcatheter Aortic Valve Replacement","Hemodynamic Stability","Anesthesia Induction"],"enrollment":116,"completionDate":"2026-12-31"},{"nctId":"NCT07426172","phase":"NA","title":"Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism.","status":"RECRUITING","sponsor":"Ricardo Mora","startDate":"2026-01-20","conditions":["Hyperlactatemia","Metabolic Syndrome (MetS)","Lipolysis","Exercise"],"enrollment":24,"completionDate":"2028-09-30"},{"nctId":"NCT04966507","phase":"PHASE2","title":"Antibacterial Mouthwash for Pharyngeal Gonorrhea Prevention","status":"COMPLETED","sponsor":"University of California, Los Angeles","startDate":"2022-02-17","conditions":["Gonorrhea"],"enrollment":89,"completionDate":"2025-12-12"},{"nctId":"NCT05208242","phase":"PHASE2,PHASE3","title":"Strong Albumin Solutions in Patients With Septic Shock","status":"COMPLETED","sponsor":"Manchester University NHS Foundation Trust","startDate":"2023-11-10","conditions":["Sepsis","Septic Shock","Shock, Toxic"],"enrollment":47,"completionDate":"2026-01-31"},{"nctId":"NCT06558422","phase":"PHASE1","title":"Human Models of Selective Insulin Resistance: Pancreatic Clamp","status":"NOT_YET_RECRUITING","sponsor":"Columbia University","startDate":"2027-01-01","conditions":["Insulin Resistance","Hyperinsulinemia","Metabolic Dysfunction Associated Steatotic Liver Disease","Non-Alcoholic Fatty Liver Disease","Prediabetic State","Obesity"],"enrollment":36,"completionDate":"2029-02-28"},{"nctId":"NCT07389837","phase":"NA","title":"Maple Syrup Carbohydrate Dose-Response on 20-km Cycling Time-Trial Performance","status":"NOT_YET_RECRUITING","sponsor":"Université de Montréal","startDate":"2026-02-01","conditions":["Exercise","Endurance Cycling Performance","Carbohydrate Intolerance","Sport Nutrition"],"enrollment":32,"completionDate":"2027-06-01"},{"nctId":"NCT04680728","phase":"","title":"Venous Congestion and Organ Dysfunction.","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire Dijon","startDate":"2020-10-06","conditions":["Venous Congestion","Organ Dysfunction Syndrome"],"enrollment":185,"completionDate":"2022-11-14"},{"nctId":"NCT06327581","phase":"NA","title":"Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata","status":"RECRUITING","sponsor":"Zagazig University","startDate":"2023-12-15","conditions":["Alopecia Areata"],"enrollment":88,"completionDate":"2026-12-30"},{"nctId":"NCT06114498","phase":"","title":"Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Medical Research Center for Therapy and Preventive Medicine","startDate":"2023-09-01","conditions":["Heart Failure With Preserved Ejection Fraction","Obesity, Mild","Decompensated Heart Failure"],"enrollment":240,"completionDate":"2026-07-31"},{"nctId":"NCT06701760","phase":"PHASE2","title":"Sodium Lactate in Severe TBI","status":"NOT_YET_RECRUITING","sponsor":"University of California, Los Angeles","startDate":"2028-01-10","conditions":["Traumatic Brain Injury"],"enrollment":264,"completionDate":"2038-07-01"},{"nctId":"NCT07263698","phase":"PHASE3","title":"Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash","status":"ACTIVE_NOT_RECRUITING","sponsor":"Colgate Palmolive","startDate":"2025-12-01","conditions":["Gingivitis","Plaque, Dental"],"enrollment":80,"completionDate":"2026-03"},{"nctId":"NCT07285187","phase":"","title":"Venous Congestion And Delirium After Cardiac Surgery","status":"RECRUITING","sponsor":"Zhuan Zhang","startDate":"2024-11-01","conditions":["Intraoperative","Venous Congestion","Postoperative Delirium (POD)","Cardiac Surgery"],"enrollment":120,"completionDate":"2026-10-31"},{"nctId":"NCT04043598","phase":"NA","title":"Crystalloid Fluid Choice and Neurological Outcome in Patients After Subarachnoid Haemorrhage","status":"RECRUITING","sponsor":"Insel Gruppe AG, University Hospital Bern","startDate":"2022-05-24","conditions":["Subarachnoid Hemorrhage","Critical Illness","Infusion Fluid","Sodium Disorder"],"enrollment":320,"completionDate":"2026-07"},{"nctId":"NCT06121323","phase":"NA","title":"Physiological Effects of Lactate in Individuals With Chronic Heart Failure","status":"COMPLETED","sponsor":"Henrik Wiggers","startDate":"2023-11-22","conditions":["Heart Failure, Systolic"],"enrollment":12,"completionDate":"2025-01-16"},{"nctId":"NCT07239713","phase":"NA","title":"Clinical Effects of Ringers Lactate Versus Sterofundin/ Plasmalyte Solution in Patients With Sepsis","status":"RECRUITING","sponsor":"CMH Lahore Medical College and Institute of Dentistry","startDate":"2025-11-15","conditions":["Post Abdominal Surgery","Sepsis Abdominal"],"enrollment":82,"completionDate":"2026-06-15"},{"nctId":"NCT03528213","phase":"PHASE2,PHASE3","title":"Utility of Sodium Lactate Infusion During Septic Shock","status":"COMPLETED","sponsor":"University Hospital, Lille","startDate":"2019-10-04","conditions":["Septic Shock"],"enrollment":59,"completionDate":"2023-02-21"},{"nctId":"NCT06770114","phase":"PHASE3","title":"Clinical Study to Investigate a New Mouthwash in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use","status":"COMPLETED","sponsor":"Colgate Palmolive","startDate":"2021-10-18","conditions":["Gingivitis"],"enrollment":80,"completionDate":"2022-05-09"},{"nctId":"NCT07240701","phase":"PHASE4","title":"Normal Saline Versus Ringer's Lactate for Initial Fluid Resuscitation in Sepsis","status":"NOT_YET_RECRUITING","sponsor":"Egemen Yildiz","startDate":"2025-11","conditions":["Sepsis"],"enrollment":88,"completionDate":"2026-11"},{"nctId":"NCT06992843","phase":"NA","title":"Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest","status":"RECRUITING","sponsor":"Xiangya Hospital of Central South University","startDate":"2025-10-22","conditions":["Cardiac Arrest","Post-cardiac Arrest Care"],"enrollment":1008,"completionDate":"2027-08"},{"nctId":"NCT07232277","phase":"","title":"Venous Congestion and Cardiac Surgery-Associated Acute Kidney Injury","status":"RECRUITING","sponsor":"Zhuan Zhang","startDate":"2024-10-15","conditions":["Intraoperative","Venous Congestion","Cardiac Surgery-associated Acute Kidney Injury"],"enrollment":114,"completionDate":"2026-09-30"},{"nctId":"NCT06189963","phase":"PHASE1,PHASE2","title":"Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease","status":"RECRUITING","sponsor":"NKGen Biotech, Inc.","startDate":"2023-11-21","conditions":["Moderate Alzheimer Disease"],"enrollment":36,"completionDate":"2026-06"},{"nctId":"NCT07202117","phase":"PHASE4","title":"PLLA and CaHA-R for Aesthetic Rejuvenation","status":"RECRUITING","sponsor":"Erevna Innovations Inc.","startDate":"2025-11-01","conditions":["Aesthetic"],"enrollment":45,"completionDate":"2026-12-01"},{"nctId":"NCT06737380","phase":"PHASE1","title":"UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients","status":"RECRUITING","sponsor":"LiveKidney.Bio","startDate":"2025-01-07","conditions":["SLE","Lupus","Systemic Lupus Erthematosus","Systemic Lupus Erythematosus","Systemic Lupus Erythematosus (SLE)"],"enrollment":10,"completionDate":"2026-07"},{"nctId":"NCT07107399","phase":"PHASE2,PHASE3","title":"Therapeutic Effect of Microfragmented Adipose Tissue (Lipogems) Injection on Maximum Interincisal Opening Versus Injectable Platelet-rich Plasma (PRP) for the Treatment of Anterior Disc Displacement With Reduction : A Randomized Clinical Trial","status":"NOT_YET_RECRUITING","sponsor":"Cairo University","startDate":"2025-08-05","conditions":["TMJ Disc Disorder"],"enrollment":16,"completionDate":"2025-12-01"},{"nctId":"NCT07023159","phase":"","title":"Predicting 28-Day Survival in OHCA Patients","status":"COMPLETED","sponsor":"Haseki Training and Research Hospital","startDate":"2023-05-01","conditions":["Out of Hospital Cardiac Arrest","Cardiac Arrest (CA)"],"enrollment":327,"completionDate":"2024-06-01"},{"nctId":"NCT05219110","phase":"NA","title":"Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection","status":"RECRUITING","sponsor":"University of Calgary","startDate":"2022-09-29","conditions":["Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection","Hemolytic-Uremic Syndrome"],"enrollment":1040,"completionDate":"2027-08-31"},{"nctId":"NCT06997666","phase":"NA","title":"Effect of Prone Position on Oxygen, Blood Gas, and Respiratory Parameters in Intensive Care Patients With COVID-19-induced ARDS","status":"COMPLETED","sponsor":"Medet Korkmaz","startDate":"2021-03-01","conditions":["COVID - 19","ARDS (Acute Respiratory Distress Syndrome)"],"enrollment":90,"completionDate":"2021-11-30"},{"nctId":"NCT06048627","phase":"PHASE3","title":"Anti-gingivitis Mouthrinse","status":"COMPLETED","sponsor":"Colgate Palmolive","startDate":"2024-03-06","conditions":["Gingivitis"],"enrollment":90,"completionDate":"2024-10-01"},{"nctId":"NCT04512950","phase":"PHASE4","title":"Crystalloid FLUID Choices for Resuscitation of Hospitalized Patients","status":"COMPLETED","sponsor":"Ottawa Hospital Research Institute","startDate":"2016-08-15","conditions":["Fluid Therapy"],"enrollment":43626,"completionDate":"2020-06-13"},{"nctId":"NCT06634069","phase":"PHASE2","title":"Study SOLACE SEPSIS","status":"RECRUITING","sponsor":"University Hospital Pilsen","startDate":"2024-11-24","conditions":["Septic Shock","Intracranial Hypertension"],"enrollment":40,"completionDate":"2027-10"},{"nctId":"NCT04141371","phase":"PHASE3","title":"Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Nice","startDate":"2022-02-14","conditions":["Subarachnoid Hemorrhage, Aneurysmal"],"enrollment":3,"completionDate":"2024-06-07"},{"nctId":"NCT06865911","phase":"PHASE4","title":"Cold Versus Warm Tumescent Solution in Arm Liposculpture","status":"COMPLETED","sponsor":"Eternal Beauty SAS","startDate":"2023-01-12","conditions":["Arm Pain","Arm Aesthetics","Liposuction","Safety of Intervention"],"enrollment":52,"completionDate":"2024-06-30"},{"nctId":"NCT05004610","phase":"PHASE2","title":"Hypertonic Lactate After Cardiac Arrest","status":"RECRUITING","sponsor":"Erasme University Hospital","startDate":"2025-02-19","conditions":["Cardiac Arrest","Ischemia Reperfusion Injury","Anoxic Brain Injury"],"enrollment":125,"completionDate":"2028-05-15"},{"nctId":"NCT04046861","phase":"NA","title":"Influence of High Vitamin C Dose on Lactate During and After Extracorporeal Circulation","status":"COMPLETED","sponsor":"University Medical Centre Maribor","startDate":"2023-03-01","conditions":["Hyperlactatemia","Cardiac Disease","Bypass Complication","Valve Disease, Heart","Vitamin C"],"enrollment":70,"completionDate":"2024-09-01"},{"nctId":"NCT06817681","phase":"NA","title":"Exercise-Induced Lactate and Cognitive Function (ExLBC)","status":"NOT_YET_RECRUITING","sponsor":"McMaster University","startDate":"2025-02-10","conditions":["Cognition","Sodium Bicarbonate","Lactate","Exercise"],"enrollment":32,"completionDate":"2025-09-20"},{"nctId":"NCT05130814","phase":"NA","title":"EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers","status":"COMPLETED","sponsor":"Emoled","startDate":"2021-12-01","conditions":["Pressure Sore","Pressure Ulcer","Pressure Ulcers Stage III","Pressure Ulcers Stage II"],"enrollment":48,"completionDate":"2024-03-07"},{"nctId":"NCT05576038","phase":"NA","title":"Tryptophan for Impaired AhR Signaling in Celiac Disease","status":"RECRUITING","sponsor":"McMaster University","startDate":"2022-12-01","conditions":["Tryptophan Metabolism Alterations","Celiac Disease"],"enrollment":50,"completionDate":"2025-06-01"},{"nctId":"NCT05435638","phase":"PHASE1","title":"Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases","status":"COMPLETED","sponsor":"Kamari Pharma Ltd","startDate":"2022-07-17","conditions":["Punctate Palmoplantar Keratoderma Type 1","Pachyonychia Congenita"],"enrollment":14,"completionDate":"2024-09-05"},{"nctId":"NCT05830136","phase":"NA","title":"Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy","status":"RECRUITING","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2022-02-01","conditions":["Hepatic Ischemia"],"enrollment":100,"completionDate":"2026-05-01"},{"nctId":"NCT06665763","phase":"NA","title":"The Lactate Project: Investigating the Impact of Lactate to Preserve Vital Organ Blood Supply and Function in Heart and Brain","status":"NOT_YET_RECRUITING","sponsor":"University of Aarhus","startDate":"2025-02-01","conditions":["Healthy","Lactate Blood Increase"],"enrollment":8,"completionDate":"2026-06-01"},{"nctId":"NCT03717896","phase":"PHASE2","title":"Thiamine As Adjunctive Therapy for Diabetic Ketoacidosis","status":"COMPLETED","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2018-11-21","conditions":["Diabetic Ketoacidosis"],"enrollment":100,"completionDate":"2024-10-01"},{"nctId":"NCT05963204","phase":"NA","title":"A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator with a Skincare Regimen","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2023-07-07","conditions":["Photodamaged Skin","Volume Deficiency of the Midface"],"enrollment":21,"completionDate":"2024-03-19"},{"nctId":"NCT06626984","phase":"PHASE1,PHASE2","title":"Investigation of Novel and Established Therapies in a Human Intravenous Lipopolysaccharide Model of Sepsis","status":"NOT_YET_RECRUITING","sponsor":"Belfast Health and Social Care Trust","startDate":"2024-12-01","conditions":["Sepsis","Fluid Overload","Endothelial Dysfunction","Microcirculation"],"enrollment":65,"completionDate":"2026-07-01"},{"nctId":"NCT06586060","phase":"NA","title":"Lung Ultrasound Guided Fluid Balance Strategy in Patients with Lung Contusion","status":"NOT_YET_RECRUITING","sponsor":"Assiut University","startDate":"2024-10","conditions":["Lung Contusion"],"enrollment":100,"completionDate":"2025-10"},{"nctId":"NCT03066440","phase":"PHASE4","title":"Double Blinded Randomized Control Trial of Types of IVF in Children With DKA","status":"TERMINATED","sponsor":"State University of New York at Buffalo","startDate":"2018-09-01","conditions":["Diabetic Ketoacidosis"],"enrollment":53,"completionDate":"2024-03-18"},{"nctId":"NCT06487299","phase":"PHASE2","title":"Iron Administration Via Colonic TET Combined With WMT for ID","status":"NOT_YET_RECRUITING","sponsor":"The Second Hospital of Nanjing Medical University","startDate":"2024-07-25","conditions":["Iron Deficiency Anemia in Childbirth"],"enrollment":60,"completionDate":"2026-06-01"},{"nctId":"NCT05355974","phase":"PHASE3","title":"Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure","status":"COMPLETED","sponsor":"Wright State University","startDate":"2022-08-09","conditions":["Respiratory Failure","Hypotension and Shock","Hypotension on Induction","Intubation Complication","Anesthesia Intubation Complication"],"enrollment":42,"completionDate":"2024-07-10"},{"nctId":"NCT06457698","phase":"NA","title":"Temporomandibular Bioviscosuplementation (Platelet-Rich Plasma Combined With Hyaluronic Acid) After Double-Puncture Arthrocentesis: a Randomized Controlled Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"Instituto Portugues da Face","startDate":"2022-06-01","conditions":["Temporomandibular Joint Disorders"],"enrollment":50,"completionDate":"2024-12-01"},{"nctId":"NCT03679780","phase":"PHASE1","title":"The Effect of Endothelin and L-Arginine on Racial Differences in Vasoconstriction","status":"COMPLETED","sponsor":"The University of Texas at Arlington","startDate":"2018-10-01","conditions":["Cardiovascular Diseases","Cardiovascular Risk Factor","Vasoconstriction"],"enrollment":19,"completionDate":"2023-07-26"},{"nctId":"NCT06379815","phase":"NA","title":"Effect of Oral Lactate Ingestion on Appetite Regulation","status":"NOT_YET_RECRUITING","sponsor":"Wilfrid Laurier University","startDate":"2024-05-01","conditions":["Appetitive Behavior"],"enrollment":12,"completionDate":"2024-08"},{"nctId":"NCT05808972","phase":"PHASE4","title":"0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis","status":"COMPLETED","sponsor":"Tunis University","startDate":"2022-11-01","conditions":["Metabolic Ketoacidosis","Ketoacidemia","Acetonemia","Acetonuria"],"enrollment":92,"completionDate":"2023-12-30"},{"nctId":"NCT04945213","phase":"PHASE3","title":"Biperiden Trial for Epilepsy Prevention","status":"RECRUITING","sponsor":"Hospital Sirio-Libanes","startDate":"2023-01-10","conditions":["Brain Injury Traumatic Moderate","Brain Injury Traumatic Severe","Post Traumatic Epilepsy"],"enrollment":312,"completionDate":"2026-12-20"},{"nctId":"NCT05620043","phase":"NA","title":"Gene Expression Study Between Two Dermal Injectables Hydroxylapatite Semi-permanent Filler","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2022-09-28","conditions":["Gene Expression"],"enrollment":21,"completionDate":"2023-11-06"},{"nctId":"NCT06148662","phase":"PHASE4","title":"The Effect of Oral Sprays on Salivary pH","status":"COMPLETED","sponsor":"I.M. Sechenov First Moscow State Medical University","startDate":"2023-12-01","conditions":["Oral Health"],"enrollment":33,"completionDate":"2024-01-25"},{"nctId":"NCT06125730","phase":"NA","title":"A Single-Group Study to Evaluate the Effects of an Eyelash Serum on Improving Eyelash Growth","status":"COMPLETED","sponsor":"Dime Beauty Co.","startDate":"2023-08-23","conditions":["Eyelash Growth"],"enrollment":35,"completionDate":"2024-02-10"},{"nctId":"NCT06209229","phase":"PHASE1","title":"Role of Neutrophils and Electro-bioluminescence in the Rehabilitation","status":"COMPLETED","sponsor":"MIPO Clinic","startDate":"2022-05-01","conditions":["Nonsmall-cell Lung Cancer"],"enrollment":34,"completionDate":"2023-10-01"},{"nctId":"NCT06158555","phase":"NA","title":"Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion","status":"UNKNOWN","sponsor":"King's College Hospital NHS Trust","startDate":"2023-04-01","conditions":["Critically Ill"],"enrollment":30,"completionDate":"2024-12-01"},{"nctId":"NCT06168175","phase":"PHASE2","title":"Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder","status":"NOT_YET_RECRUITING","sponsor":"Centre Hospitalier Universitaire Vaudois","startDate":"2024-01","conditions":["Major Depressive Disorder"],"enrollment":46,"completionDate":"2028-01"},{"nctId":"NCT06146712","phase":"NA","title":"A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity","status":"COMPLETED","sponsor":"Asutra","startDate":"2023-08-07","conditions":["Sleep"],"enrollment":35,"completionDate":"2023-10-02"},{"nctId":"NCT06110429","phase":"PHASE3","title":"Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients","status":"UNKNOWN","sponsor":"University Hospital, Geneva","startDate":"2024-01","conditions":["Intra Cerebral Hypertension","Lactate Sodium Solution"],"enrollment":52,"completionDate":"2026-01"},{"nctId":"NCT04488874","phase":"PHASE3","title":"Sodium Lactate and Brain Relaxation (LSD)","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Besancon","startDate":"2020-09-29","conditions":["Sodium Lactate","Intracranial Hypertension","Brain Relaxation"],"enrollment":50,"completionDate":"2023-06-30"},{"nctId":"NCT06022588","phase":"NA","title":"Chronic Mesenteric Ischemia Breath Testing","status":"COMPLETED","sponsor":"Erasmus Medical Center","startDate":"2021-03-01","conditions":["Chronic Mesenteric Ischemia"],"enrollment":20,"completionDate":"2021-08-01"},{"nctId":"NCT05627791","phase":"PHASE2,PHASE3","title":"Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman","status":"TERMINATED","sponsor":"Department of Medical Services Ministry of Public Health of Thailand","startDate":"2022-11-30","conditions":["Vaginal Atrophy","Oxytocin Gel","Postmenopausal Women","Vaginal Maturation Index"],"enrollment":6,"completionDate":"2023-08-28"},{"nctId":"NCT05962619","phase":"NA","title":"Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2023-08-01","conditions":["Temporomandibular Joint Dysfunction Syndrome","Arthrocenteses","Hyaluronic Acid"],"enrollment":42,"completionDate":"2024-08-02"},{"nctId":"NCT04910906","phase":"","title":"Non-Interventional Multicentre Post-market Study of Ectoin® Vaginal Gel for Symptomatic Treatment of Vaginal Atrophy","status":"COMPLETED","sponsor":"Bitop AG","startDate":"2021-05-03","conditions":["Vaginal Atrophy"],"enrollment":155,"completionDate":"2022-02-09"},{"nctId":"NCT05821712","phase":"PHASE3","title":"A New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems","status":"COMPLETED","sponsor":"Colgate Palmolive","startDate":"2021-03-08","conditions":["Plaque","Gum Disease"],"enrollment":80,"completionDate":"2021-09-24"},{"nctId":"NCT05810662","phase":"NA","title":"RL Versus Glucose Saline in Cancer Patient Undergoing Major Surgeries and Its Impact on Electrolytes, GLC & pH","status":"UNKNOWN","sponsor":"National Cancer Institute, Egypt","startDate":"2022-09-04","conditions":["Fluid and Electrolyte Imbalance"],"enrollment":60,"completionDate":"2023-12"},{"nctId":"NCT05743751","phase":"NA","title":"Normothermic Machine Perfusion (NMP) Versus Hypothermic Machine Perfusion (HMP) in Human Kidney Transplantation","status":"UNKNOWN","sponsor":"Zhang Tianyu","startDate":"2023-03-03","conditions":["Kidney Transplantation"],"enrollment":60,"completionDate":"2025-09-03"},{"nctId":"NCT04239872","phase":"PHASE1","title":"Fluoride Retention in the Mouth of Older Adults","status":"COMPLETED","sponsor":"University of Michigan","startDate":"2020-03-11","conditions":["Hyposalivation"],"enrollment":20,"completionDate":"2021-04-05"},{"nctId":"NCT05628571","phase":"PHASE3","title":"Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate","status":"UNKNOWN","sponsor":"Hospital Israelita Albert Einstein","startDate":"2023-02-01","conditions":["Oral Bacterial Infection"],"enrollment":130,"completionDate":"2023-06-30"},{"nctId":"NCT04432675","phase":"PHASE4","title":"Effects of Crystal Solution and Colloid Solution on Mother and Fetus","status":"COMPLETED","sponsor":"China International Neuroscience Institution","startDate":"2022-01-30","conditions":["Cesarean Section","Spinal Anesthesia","Parturition"],"enrollment":100,"completionDate":"2022-11-15"},{"nctId":"NCT04112862","phase":"EARLY_PHASE1","title":"Sodium Lactate Infusion in GLUT1DS Patients","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2022-05-20","conditions":["GLUT1 Deficiency Syndrome","GLUT1DS1","GLUT1DS2","Epilepsy","Lactic Acid Blood Increased","Ketogenic Dieting"],"enrollment":2,"completionDate":"2022-11-18"},{"nctId":"NCT05572060","phase":"NA","title":"Effect of Metformin Use on Mortality in Diabetic and Non Diabetic Patients With Sepsis and Septic Shock.","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2022-12-01","conditions":["Septic Shock"],"enrollment":75,"completionDate":"2025-01-31"},{"nctId":"NCT04744389","phase":"NA","title":"Comparison of Hypothermic Versus Normothermic Ex-vivo Preservation.","status":"UNKNOWN","sponsor":"Azienda Ospedaliero, Universitaria Pisana","startDate":"2020-12-15","conditions":["End Stage Liver DIsease"],"enrollment":60,"completionDate":"2023-03-31"},{"nctId":"NCT05400343","phase":"NA","title":"Efficacy of Lung and Inferior Vena Cava Sonography for Fluid Optimization","status":"UNKNOWN","sponsor":"Mansoura University","startDate":"2022-06-15","conditions":["Traumatic Brain Injury"],"enrollment":72,"completionDate":"2023-09"},{"nctId":"NCT03576534","phase":"NA","title":"Pre Bypass Ultrafiltration (PBUF) in Children Requiring Cardiopulmonary Bypass","status":"TERMINATED","sponsor":"Boston Children's Hospital","startDate":"2019-10-03","conditions":["Congenital Heart Disease"],"enrollment":13,"completionDate":"2021-09-13"},{"nctId":"NCT05259007","phase":"PHASE4","title":"Effect of Propolis on Patients Infected With H. Pylori","status":"UNKNOWN","sponsor":"Fatma Zehra Arvas","startDate":"2022-02-22","conditions":["Helicobacter Pylori Infection"],"enrollment":96,"completionDate":"2022-04-05"},{"nctId":"NCT04537962","phase":"NA","title":"Salivary SARS-CoV-2 Load of Covid-19 Patients After Oral Antimicrobial Solutions and Dentifrices","status":"COMPLETED","sponsor":"Hospital Israelita Albert Einstein","startDate":"2020-07-14","conditions":["Corona Virus Infection"],"enrollment":202,"completionDate":"2021-09-30"},{"nctId":"NCT05221788","phase":"NA","title":"Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns","status":"COMPLETED","sponsor":"Guangzhou Red Cross Hospital","startDate":"2020-01-01","conditions":["Hemodynamics"],"enrollment":100,"completionDate":"2021-12-01"},{"nctId":"NCT04710875","phase":"NA","title":"The Role of Lactate in Lipolysis and Catabolism in Humans","status":"COMPLETED","sponsor":"University of Aarhus","startDate":"2021-03-10","conditions":["Hyperlactatemia","Healthy","Lactate"],"enrollment":8,"completionDate":"2021-06-29"},{"nctId":"NCT02776488","phase":"PHASE2","title":"Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI)","status":"WITHDRAWN","sponsor":"University of California, Los Angeles","startDate":"2020-09","conditions":["Brain Injuries, Traumatic"],"enrollment":0,"completionDate":"2026-06"},{"nctId":"NCT01573507","phase":"NA","title":"Lactate Therapy After Traumatic Brain Injury","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire Vaudois","startDate":"2012-03","conditions":["Traumatic Brain Injury","Subarachnoid Hemorrhage"],"enrollment":42,"completionDate":"2017-12-18"},{"nctId":"NCT02596828","phase":"PHASE2","title":"Prospective Pilot Trial to Assess a Multimodal Molecular Targeted Therapy in Children, Adolescent and Young Adults With Relapsed or Refractory High-grade Pineoblastoma","status":"COMPLETED","sponsor":"University of Regensburg","startDate":"2016-04","conditions":["Pineoblastoma"],"enrollment":4,"completionDate":"2021-04"},{"nctId":"NCT04872946","phase":"NA","title":"Topical and Oral Regimen for Skin Health","status":"COMPLETED","sponsor":"Integrative Skin Science and Research","startDate":"2019-11-26","conditions":["Skin Abnormalities"],"enrollment":74,"completionDate":"2020-05-07"},{"nctId":"NCT04846361","phase":"NA","title":"Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis","status":"UNKNOWN","sponsor":"Universiti Kebangsaan Malaysia Medical Centre","startDate":"2021-05","conditions":["Bacterial Vaginoses"],"enrollment":56,"completionDate":"2022-01"},{"nctId":"NCT03455296","phase":"NA","title":"Fluid Management Surgical Patients in Intensive Care Unit.","status":"COMPLETED","sponsor":"National Hepatology & Tropical Medicine Research Institute","startDate":"2018-08-01","conditions":["Post Operative Fluid Management"],"enrollment":60,"completionDate":"2020-05-15"},{"nctId":"NCT02638623","phase":"NA","title":"Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery","status":"COMPLETED","sponsor":"West Virginia University","startDate":"2015-10","conditions":["Osteoarthritis"],"enrollment":52,"completionDate":"2016-12"},{"nctId":"NCT04615702","phase":"","title":"Evidence Based Management of Acute Biliary Pancreatitis","status":"COMPLETED","sponsor":"Zagazig University","startDate":"2017-05-15","conditions":["Acute Pancreatitis"],"enrollment":30,"completionDate":"2019-05-15"},{"nctId":"NCT04596956","phase":"PHASE4","title":"Safety and Efficacy of Sodium Bicarbonate Ringer Injection","status":"UNKNOWN","sponsor":"Chinese PLA General Hospital","startDate":"2020-10","conditions":["Ringer Bicarbonate","Elderly Abdominal Surgery","Safety","Effectiveness"],"enrollment":5000,"completionDate":"2025-12"},{"nctId":"NCT01467986","phase":"PHASE2","title":"Multimodal Molecular Targeted Therapy to Treat Relapsed or Refractory High-risk Neuroblastoma","status":"COMPLETED","sponsor":"University of Regensburg","startDate":"2013-08","conditions":["Neuroblastoma Recurrent"],"enrollment":130,"completionDate":"2020-09-30"},{"nctId":"NCT04299815","phase":"NA","title":"Lactate in the Gut","status":"COMPLETED","sponsor":"University of Aarhus","startDate":"2020-04-01","conditions":["Lactate","Healthy","Hyperlactatemia"],"enrollment":10,"completionDate":"2020-07-29"},{"nctId":"NCT03296072","phase":"PHASE3","title":"In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-11-13","conditions":["Tooth Erosion"],"enrollment":62,"completionDate":"2018-01-16"},{"nctId":"NCT02028208","phase":"PHASE2","title":"Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study","status":"COMPLETED","sponsor":"Allerderm","startDate":"2013-11-04","conditions":["Contact Dermatitis"],"enrollment":56,"completionDate":"2016-05-24"},{"nctId":"NCT03107377","phase":"PHASE2,PHASE3","title":"Phase 2B/3 Double-blinded Placebo-controlled","status":"COMPLETED","sponsor":"Evofem Inc.","startDate":"2017-11-03","conditions":["Chlamydia Trachomatis Infection"],"enrollment":860,"completionDate":"2019-08-22"},{"nctId":"NCT02875769","phase":"PHASE3","title":"Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols","status":"COMPLETED","sponsor":"University of Guarulhos","startDate":"2015-02","conditions":["Chronic Periodontitis"],"enrollment":60,"completionDate":"2015-04"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Intravenous","formulation":"Injection","formulations":[{"form":"INJECTION","route":"INTRAVENOUS","productName":"Dextrose and Electrolyte No. 48"},{"form":"INJECTION, SOLUTION","route":"INTRAPERITONEAL","productName":"DIANEAL Low Calcium with Dextrose"},{"form":"INJECTION, SOLUTION","route":"INTRAPERITONEAL","productName":"DIANEAL PD-2 with Dextrose"},{"form":"INJECTION, SOLUTION","route":"INTRAPERITONEAL","productName":"EXTRANEAL"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"LACTATED RINGERS"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Lactated Ringers and Dextrose"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Potassium Chloride in Lactated Ringers and Dextrose"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Dextrose in Lactated Ringers"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Ionosol MB and Dextrose"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"LACTATED RINGERS"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"LACTATED RINGERS AND DEXTROSE"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Lacellate Solution - 1000"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Lacellate Solution - 250"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Lacellate Solution - 500"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Lactated Ringers"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000147000","MMSL":"1084","NDDF":"000750","UNII":"TU7HW0W0QT","VUID":"4018691","CHEBI":"CHEBI:75228","VANDF":"4018691","INN_ID":"4157","RXNORM":"56489","UMLSCUI":"C0142874","chemblId":"CHEMBL1357","ChEMBL_ID":"CHEMBL1357","KEGG_DRUG":"D02183","PUBCHEM_CID":"23666456","SNOMEDCT_US":"387306001","MESH_DESCRIPTOR_UI":"D019354"},"formularyStatus":[],"originalProduct":{"form":"INJECTION, SOLUTION","route":"INTRAPERITONEAL","company":"Baxter Healthcare Corporation","brandName":"DIANEAL Low Calcium with Dextrose","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1971-","companyName":"Baxter Hlthcare","relationship":"Original Developer"},{"period":"present","companyName":"Pfizer","relationship":"Current Owner"}],"publicationCount":1223,"therapeuticAreas":["Hematology"],"biosimilarFilings":[],"originalDeveloper":"Baxter Hlthcare","recentPublications":[],"combinationProducts":[{"brandName":"DELFLEX","ingredients":"calcium chloride + glucose + magnesium chloride + sodium chloride + sodium lactate"},{"brandName":"DIANEAL Low Calcium with Dextrose","ingredients":"calcium chloride + glucose + magnesium chloride + sodium chloride + sodium lactate"},{"brandName":"DIANEAL PD-2 with Dextrose","ingredients":"calcium chloride + glucose + magnesium chloride + sodium chloride + sodium lactate"},{"brandName":"Dextrose and Electrolyte No. 48","ingredients":"glucose + magnesium chloride + potassium chloride + potassium phosphate, monobasic + sodium chloride + sodium lactate"},{"brandName":"Dextrose in Lactated Ringers","ingredients":"calcium chloride + glucose + potassium chloride + sodium chloride + sodium lactate"},{"brandName":"EXTRANEAL","ingredients":"calcium chloride + icodextrin + magnesium chloride + sodium chloride + sodium lactate"},{"brandName":"Ionosol MB and Dextrose","ingredients":"glucose + magnesium chloride + potassium chloride + potassium phosphate, monobasic + sodium lactate + sodium phosphate, monobasic, monohydrate"},{"brandName":"LACTATED RINGERS","ingredients":"calcium chloride + potassium chloride + sodium chloride + sodium lactate"},{"brandName":"LACTATED RINGERS AND DEXTROSE","ingredients":"calcium chloride + glucose + potassium chloride + sodium chloride + sodium lactate"},{"brandName":"Lacellate Solution - 1000","ingredients":"calcium chloride + potassium chloride + sodium chloride + sodium lactate"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Hospira","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"1971","enrichmentLevel":4,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1971-03-22T00:00:00.000Z","mah":"BAXTER HLTHCARE","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":2,"withResults":0},"validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T03:03:13.686192+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}