{"id":"tpn-electrolytes-in-plastic-container","rwe":[{"pmid":"41890293","year":"2026","title":"Calcium application synergistically enhances yield and nutritional quality in waxy maize.","finding":"","journal":"Frontiers in plant science","studyType":"Clinical Study"},{"pmid":"41888556","year":"2026","title":"Carbon sequestration potential of electrokinetically treated fine-grained expansive soils.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41887057","year":"2026","title":"Impact of minerals on the microbial species diversity and metabolite dynamics during spontaneous backslopped wheat sourdough productions.","finding":"","journal":"International journal of food microbiology","studyType":"Clinical Study"},{"pmid":"41877815","year":"2026","title":"A protocol for chemical competence in phytopathogenic Ralstonia.","finding":"","journal":"Access microbiology","studyType":"Clinical Study"},{"pmid":"41864392","year":"2026","title":"Fully biobased materials for flame-retardant modification of cotton fabric through layer-by-layer strategy.","finding":"","journal":"International journal of biological macromolecules","studyType":"Clinical Study"}],"_fda":{"id":"32074e23-ad45-453c-a408-d6a45a2571b9","set_id":"01721071-af03-4894-95c1-10b8bc64b888","openfda":{"unii":["M4I0D6VV5M","660YQ98I10","451W47IQ8X"],"route":["INTRAVENOUS"],"rxcui":["847617"],"spl_id":["32074e23-ad45-453c-a408-d6a45a2571b9"],"brand_name":["Ringers"],"spl_set_id":["01721071-af03-4894-95c1-10b8bc64b888"],"package_ndc":["0264-7780-00"],"product_ndc":["0264-7780"],"generic_name":["SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CALCIUM CHLORIDE","POTASSIUM CHLORIDE","SODIUM CHLORIDE"],"manufacturer_name":["B. Braun Medical Inc."],"application_number":["NDA020002"],"is_original_packager":[true]},"version":"14","pregnancy":["8.1 Pregnancy Risk Summary Exposure to Ringer’s Injection during pregnancy 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 Ringer’s Injection can cause: Hyperkalemia and hypernatremia, especially in patients with severe renal impairment. Fluid overload (which can lead to pulmonary and/or peripheral edema). Hypercalcemia Overdose interventions include Ringer’s Injection discontinuation, treatment of electrolyte imbalances, and close monitoring of fluid balance and electrolyte concentrations [see Warnings and Precautions ( 5.4 , 5.5 , 5.6 , 5.7 )]."],"description":["11 DESCRIPTION Ringer’s Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single-dose container for intravenous administration. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Table 1 Size (mL) Composition (g/L) Osmolarity Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) Sodium Chloride, USP Calcium Chloride, USP Potassium Chloride, USP Sodium Potassium Calcium Chloride Ringer’s Injection, USP 1000 8.6 0.33 0.3 310 5.8 (5.0 to 7.5) 147 4 4.5 156 0 The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2. Table 2 Ingredients Molecular Formula Molecular Weight Sodium Chloride USP 58.44 Potassium Chloride USP 74.55 Calcium Chloride Dihydrate USP 147.02 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film developed for parenteral drugs. It contains no plasticizers and has minimal leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site [see Dosage and Administration (2.3) ]. Sodium Chloride USP Potassium Chloride USP Calcium Chloride Dihydrate USP"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Ringer’s Injection USP is supplied sterile and nonpyrogenic in single-dose EXCEL ® Containers packaged 12 per case. It is available in the following presentation: NDC REF Size 0264-7780-00 L7800 1000 mL Canada DIN 01936034 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Minimize exposure of Ringer’s Injection USP to heat. Avoid excessive heat. Protect from freezing."],"geriatric_use":["8.5 Geriatric Use Geriatric patients treated with Ringer’s Injection are at increased risk of developing electrolyte imbalances. Ringer’s Injection is substantially excreted by the kidney, and the risk of adverse reactions to Ringer’s 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 Ringer’s 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 Ringer’s Injection for use as a source of water and electrolytes have been established in pediatric patients of all ages, including neonates. 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 , 5.6 , 5.7 )]."],"effective_time":"20251105","pharmacodynamics":["12.2 Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Ringer’s 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."],"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) ] Hypercalcemia [see Warnings and Precautions (5.6) ] Fluid Overload [see Warnings and Precautions (5.7) ] The following adverse reactions have been identified during postapproval use of 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, headache, laryngeal edema, sneezing, and 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 B. Braun Medical Inc. at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["4 CONTRAINDICATIONS Ringer’s 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 components of Ringer’s Injection [see Warnings and Precautions (5.3) ]. Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4) Patients with known hypersensitivity to Ringer’s Injection. ( 4 )"],"description_table":["
Size (mL)
Composition (g/L)
OsmolarityNormal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.(mOsmol/L) (calc)
pH
Ionic Concentration (mEq/L)
Caloric Content (kcal/L)
Sodium Chloride, USP
Calcium Chloride, USP
Potassium Chloride, USP
Sodium
Potassium
Calcium
Chloride
Ringer’s Injection, USP
1000
8.6
0.33
0.3
310
5.8(5.0 to7.5)
147
4
4.5
156
0
","
Ingredients
Molecular Formula
Molecular Weight
Sodium Chloride USP
58.44
Potassium Chloride USP
74.55
Calcium Chloride Dihydrate USP
147.02
"],"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 Ringer’s Injection due to the increased risk of digoxin toxicity with calcium-containing solutions. ( 7.3 ) 7.1 Drugs that Affect Electrolyte and/or Fluid Balance Hyperkalemia Administration of Ringer’s 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 Ringer’s 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 Ringer’s 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 Ringer’s 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 Ringer’s 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 (5.6) ]. Hypernatremia and Fluid Retention Administration of Ringer’s 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 Ringer’s 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 Ringer’s Injection and lithium and may result in decreased lithium concentrations. Avoid use of Ringer’s 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 Ringer’s 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 Ringer’s Injection administration ."],"how_supplied_table":["
NDC
REF
Size
0264-7780-00
L7800
1000 mL
"],"mechanism_of_action":["12.1 Mechanism of Action Ringer’s Injection is a source of water, and electrolytes. 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."],"recent_major_changes":["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 ) 10/2025"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Ringer’s Injection is a source of water, and electrolytes. 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. 12.2 Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Ringer’s 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."],"indications_and_usage":["1 INDICATIONS AND USAGE Ringer’s Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients. Ringer’s Injection is indicated for use as a source of water and electrolytes 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 Ringer’s 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 Ringer’s Injection infusion immediately if signs or symptoms of a hypersensitivity reaction develop. ( 5.3 ) Potassium Imbalances, Hyponatremia, Hypercalcemia, Fluid Overload : See Full Prescribing Information for risk management recommendations. ( 5.4 , 5.5 , 5.6 , 5.7 ) 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 Ringer’s 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. Ringer’s 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 Ringer’s 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. 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 Ringer’s Injection . Stop the Ringer’s 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 Ringer’s 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 Ringer’s Injection in patients with, or at increased risk for, hyperkalemia. If use cannot be avoided in these patients, closely monitor serum potassium concentrations. Hypokalemia The potassium concentration in Ringer’s Injection is similar to the concentration in plasma. It is insufficient to normalize the serum potassium in patients with severe hypokalemia. 5.5 Hyponatremia Ringer’s 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, and patients with cardiac or pulmonary failure or 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 Ringer’s 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 Hypercalcemia Ringer’s Injection contains calcium salts and may cause hypercalcemia. Avoid administration of Ringer’s 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. 5.7 Fluid Overload Depending on the administered volume and the infusion rate, administration of Ringer’s Injection can cause fluid overload, including pulmonary edema. Avoid Ringer’s 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."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genetic toxicology, and animal fertility studies have not been conducted with Ringer’s Injection ."],"spl_unclassified_section":["EXCEL is a registered trademark of B. Braun Medical Inc. Rx only B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y36-003-098 LD-497-4"],"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 ) Ringer’s Injection is for intravenous use ( 2.3 ) Do not administer Ringer’s 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 Ringer’s Injection is based on the patient’s age, weight, clinical condition, and concomitant therapy. Evaluate the patient’s clinical status and monitor changes in electrolyte concentrations especially during prolonged use of Ringer’s Injection to optimize clinical status. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. 2.2 Important Preparation Instructions Visually inspect the Ringer’s Injection solution for particulate matter and discoloration. Do not administer Ringer’s Injection unless the solution is clear and the container seals are intact. If additives are determined to be compatible with Ringer’s 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 Ringer’s Injection preparation instructions [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 Ringer’s Injection, turn off the pump before the container is empty. Preparation Instructions for EXCEL ® Containers Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. If supplemental medication is desired, follow directions below [see Dosage and Administration (2.3) ] . Preparation for Administration Remove plastic protector from sterile set port at bottom of container. Attach administration set according to its accompanying directions. 2.3 Important Administration Instructions Ringer’s Injection is for intravenous use. Use immediately after opening the container. Discard the unused portion. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Some additives may be incompatible [see Dosage and Administration (2.4) ] . To Add Medication Before Solution Administration Prepare medication site. Using syringe with 18-22 gauge needle, puncture medication port and inner diaphragm and inject. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly. To Add Medication During Solution Administration Close clamp on the set. Prepare medication site. Using syringe with 18-22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject. Remove container from IV pole and/or turn to an upright position. Evacuate both ports by tapping and squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to in use position and continue administration. 2.4 Drug Incompatibilities Do not administer Ringer’s 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 Ringer’s 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 Ringer’s Injection simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation precipitated by the calcium content of Ringer’s Injection."],"spl_product_data_elements":["Ringers Sodium Chloride, Calcium Chloride, and Potassium Chloride SODIUM CHLORIDE CHLORIDE ION SODIUM CATION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION POTASSIUM CHLORIDE CHLORIDE ION POTASSIUM CATION WATER"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Injection: Ringer’s Injection USP as a clear, sterile, and nonpyrogenic solution packaged in a single-dose container: 1,000 mL. Injection: Ringer’s Injection USP packaged in single-dose Excel ® 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 ). 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 ) 8.1 Pregnancy Risk Summary Exposure to Ringer’s Injection during pregnancy 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 The use of Ringer’s Injection is not expected to cause harm to a breastfed infant. There are no data on the presence of Ringer’s Injection in human milk, the effects on the 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 Ringer’s Injection and any potential adverse effects on the breastfed infant from Ringer’s Injection or from the underlying maternal condition. 8.4 Pediatric Use Ringer’s 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 Ringer’s Injection for use as a source of water and electrolytes have been established in pediatric patients of all ages, including neonates. 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 , 5.6 , 5.7 )]. 8.5 Geriatric Use Geriatric patients treated with Ringer’s Injection are at increased risk of developing electrolyte imbalances. Ringer’s Injection is substantially excreted by the kidney, and the risk of adverse reactions to Ringer’s 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 Ringer’s 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 )]. Avoid Ringer’s Injection in patients with severe renal impairment. If use cannot be avoided in such patients, monitor for development of these adverse reactions."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Ringer's Injection USP REF L7800 NDC 0264-7780-00 DIN 01936034 HK 22699 1000 mL EXCEL ® CONTAINER Each 100 mL contains: Sodium Chloride USP 0.86 g; Calcium Chloride•2H 2 O USP 0.033 g; Potassium Chloride USP 0.03 g; Water for Injection USP qs pH: 5.8 (5.0-7.5); Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/liter): Na + 147; K + 4; Ca ++ 4.5; Cl - 156 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Do Not Administer Simultaneously With Blood. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-233 LD-139-3 EXP LOT Other Symbol 1000 mL Container Label L7800"],"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 Ringer’s Injection ."]},"tags":[{"label":"calcium chloride","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A12AA07","category":"atc"},{"label":"Intrathecal","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Intra-Arterial","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Cardiac arrest","category":"indication"},{"label":"Disorder of 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If unavoidable, closely monitor electrolyte concentrations and fluid balance.","clinicalEffect":"Hyperkalemia, hyponatremia, or hypercalcemia"},{"drug":"Potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, calcineurin inhibitors","severity":"High","mechanism":"Increased risk of severe and potentially fatal hyperkalemia","management":"Avoid use. If concomitant use cannot be avoided, closely monitor serum potassium concentrations.","clinicalEffect":"Hyperkalemia"},{"drug":"Diuretics and SIADH-causing drugs (arginine vasopressin analogs, antiepileptic, psychotropic, cytotoxic drugs)","severity":"High","mechanism":"Increased risk of hyponatremia","management":"Avoid use. If unavoidable, closely monitor serum sodium concentrations.","clinicalEffect":"Hyponatremia"},{"drug":"Thiazide diuretics, vitamin D","severity":"Moderate","mechanism":"Increased risk of hypercalcemia","management":"Avoid use. If unavoidable, closely monitor serum calcium concentrations.","clinicalEffect":"Hypercalcemia"},{"drug":"Lithium","severity":"Moderate","mechanism":"Altered lithium clearance","management":"Avoid concomitant use. If unavoidable, monitor serum lithium concentrations more frequently.","clinicalEffect":"Lithium toxicity"},{"drug":"Digoxin","severity":"High","mechanism":"Calcium-containing solutions increase digoxin toxicity risk","management":"Consider reducing volume or rate of Ringer's Injection.","clinicalEffect":"Digoxin toxicity"}],"commonSideEffects":[{"effect":"Neutrophil count decreased","drugRate":"17.0%","placeboRate":"","totalAtRisk":3486,"totalAffected":593,"trialsReporting":4},{"effect":"Infections and infestations - Other, specify","drugRate":"15.4%","placeboRate":"","totalAtRisk":3087,"totalAffected":476,"trialsReporting":3},{"effect":"Alanine aminotransferase increased","drugRate":"12.3%","placeboRate":"","totalAtRisk":3486,"totalAffected":428,"trialsReporting":4},{"effect":"Febrile 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increased","drugRate":"1.8%","placeboRate":"","totalAtRisk":3087,"totalAffected":55,"trialsReporting":3},{"effect":"Pruritus","drugRate":"1.6%","placeboRate":"","totalAtRisk":3486,"totalAffected":55,"trialsReporting":4},{"effect":"Hypotension","drugRate":"1.5%","placeboRate":"","totalAtRisk":3486,"totalAffected":53,"trialsReporting":4},{"effect":"Lipase increased","drugRate":"1.7%","placeboRate":"","totalAtRisk":3087,"totalAffected":51,"trialsReporting":3},{"effect":"Blood creatinine increased","drugRate":"12.5%","placeboRate":"","totalAtRisk":399,"totalAffected":50,"trialsReporting":1},{"effect":"Mucositis oral","drugRate":"1.6%","placeboRate":"","totalAtRisk":3087,"totalAffected":48,"trialsReporting":3},{"effect":"Insomnia","drugRate":"1.3%","placeboRate":"","totalAtRisk":3486,"totalAffected":47,"trialsReporting":4},{"effect":"Lung infection","drugRate":"1.5%","placeboRate":"","totalAtRisk":3087,"totalAffected":46,"trialsReporting":3},{"effect":"Seizure","drugRate":"1.5%","placeboRate":"","totalAtRisk":3087,"totalAffected":46,"trialsReporting":3}],"contraindications":["Neonates (28 days of age or younger) receiving concomitant ceftriaxone treatment due to risk of fatal ceftriaxone-calcium salt precipitation","Patients with known hypersensitivity to any components of Ringer's Injection"],"specialPopulations":{"Geriatric":"8.5 Geriatric Use Geriatric patients treated with Ringer’s Injection are at increased risk of developing electrolyte imbalances. Ringer’s Injection is substantially excreted by the kidney, and the risk of adverse reactions to Ringer’s 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 i","Pediatric":"8.4 Pediatric Use Ringer’s 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 Ringer’s Injection for use as a source of water and electrolytes have been established in pediatric patients of all ages, including neonates. Closely monitor plasma electro","Pregnancy":"8.1 Pregnancy Risk Summary Exposure to Ringer’s Injection during pregnancy 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","Specific Populations":"8 USE IN SPECIFIC POPULATIONS Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function. ( 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 ) 8.1 Pregnancy Risk Summary Exposure to Ringer’s Injection during pregnancy is not expected to cause major birth defects, m"},"seriousAdverseEvents":[]},"company":"Pfizer","patents":[],"_sources":{"fdaNDC":{"url":"","method":"api_direct","source":"FDA NDC Directory","rawText":"","confidence":1,"sourceType":"fda_ndc","retrievedAt":"2026-04-19T19:05:35.503050+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T19:05:51.265749+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T19:05:36.282135+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"Haiku strategic summary","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:54:26.445707+00:00"},"mechanism":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:25:11.391795+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200668/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T19:05:44.425815+00:00"},"fdaRecalls":{"url":"","method":"api_direct","source":"FDA Enforcement/Recalls","rawText":"","confidence":1,"sourceType":"fda_enforcement","retrievedAt":"2026-04-19T19:05:41.485436+00:00"},"overdosage":{"url":"","method":"deterministic","source":"FDA Label (overdosage)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:04:49.807713+00:00"},"howSupplied":{"url":"","method":"deterministic","source":"FDA Label (how_supplied)","rawText":"16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Ringer’s Injection USP is supplied sterile and nonpyrogenic in single-dose EXCEL ® Containers packaged 12 per case. It is available in the following presentation: NDC REF Size 0264-7780-00 L7800 1000 mL Canada DIN 01936034 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Minimize exposure of Ringer’s Injection USP to heat. Avoid excessive he","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:04:32.564034+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:06:06.224811+00:00"},"drugDescription":{"url":"","method":"ai_extraction","source":"FDA Label (description)","aiModel":"featherless","rawText":"11 DESCRIPTION Ringer’s Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single-dose container for intravenous administration. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Table 1 Size (mL) Composition (g/L) Osmolarity Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) Sodium Chloride, USP Calcium Chloride, US","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:04:49.807633+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label (pharmacokinetics)","aiModel":"featherless","rawText":"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.","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:04:32.563953+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T19:05:41.605409+00:00"},"faersTotalReports":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T19:05:41.109646+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T19:05:42.609437+00:00"},"rxnormFormulations":{"url":"https://rxnav.nlm.nih.gov/REST/drugs.json?name=Calcium Chloride","method":"api_direct","source":"RxNorm (NIH)","rawText":"","confidence":1,"sourceType":"rxnorm","retrievedAt":"2026-04-19T19:05:34.996854+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:06:06.224747+00:00"},"safety.safetySignals":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T19:05:37.201771+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku extraction","aiModel":"claude-haiku-4-5","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:54:26.445669+00:00"},"nonclinicalToxicology":{"url":"","method":"deterministic","source":"FDA Label (nonclinical_toxicology)","rawText":"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genetic toxicology, and animal fertility studies have not been conducted with Ringer’s Injection .\n13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, genetic toxicology, and animal fertility studies have not been conducted with Ringer’s Injection .","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:04:49.807709+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:06:06.224745+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:54:26.445702+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:06:06.224709+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:54:26.445695+00:00"},"safety.specialPopulations":{"url":"","method":"deterministic","source":"FDA Label (special populations)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:05:07.212498+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:06:06.224729+00:00"}},"allNames":"plegisol in plastic container","dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1fd50ce5-2799-4c26-81da-02cf0578dd9e","setid":"1fd50ce5-2799-4c26-81da-02cf0578dd9e","title":"CARDIOPLEGIC (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE) SOLUTION [BAXTER HEALTHCARE CORPORATION]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a926f913-18fa-4a3e-bfd6-210e1e427960","setid":"a926f913-18fa-4a3e-bfd6-210e1e427960","title":"RINGERS (SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) INJECTION, SOLUTION [ICU MEDICAL, INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad6e18f-04f8-4799-b366-873ec5a50317","setid":"aad6e18f-04f8-4799-b366-873ec5a50317","title":"LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1426c12-9b9e-41c3-84f6-5c81b3a86323","setid":"b1426c12-9b9e-41c3-84f6-5c81b3a86323","title":"VETERINARY LACTATED RINGERS (SODIUM LACTATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) INJECTION, SOLUTION [ASSURE INFUSION INC]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e1953d54-818d-46a6-8532-518ebae6d84e","setid":"e1953d54-818d-46a6-8532-518ebae6d84e","title":"RINGERS (SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,) IRRIGANT [BAXTER HEALTHCARE CORPORATION]"}],"synonyms":["calcium chloride"],"timeline":[{"date":"20190501","type":"positive","milestone":"FDA approval — MEDEFIL INC","regulator":"FDA","description":""},{"date":"20241217","type":"positive","milestone":"FDA approval — SOMERSET","regulator":"FDA","description":""},{"date":"20180509","type":"positive","milestone":"FDA approval — INTL MEDICATION SYS","regulator":"FDA","description":""},{"date":"20000128","type":"positive","milestone":"FDA approval — HOSPIRA","regulator":"FDA","description":""},{"date":"20241127","type":"positive","milestone":"FDA approval — EXTROVIS","regulator":"FDA","description":""}],"variants":[{"slug":"plegisol-in-plastic-container","route":"","brandName":"Plegisol In Plastic Container","description":"Plegisol In Plastic Container","formulation":""}],"aiSummary":"Ringer's Injection is an electrolyte replacement solution indicated for adults and pediatric patients as a source of water and electrolytes. It is contraindicated in neonates receiving ceftriaxone and in patients with hypersensitivity. Significant risks include fatal ceftriaxone-calcium precipitation in neonates and severe electrolyte imbalances with concomitant medications affecting potassium, sodium, and calcium. Close monitoring of electrolyte concentrations is essential when used with drugs affecting fluid and electrolyte balance.","brandName":"Plegisol In Plastic Container","ecosystem":[{"indication":"Cardiac arrest","otherDrugs":[{"name":"calcium acetate","slug":"calcium-acetate","company":"B Braun"},{"name":"calcium glucoheptonate","slug":"calcium-glucoheptonate","company":"Abbott"},{"name":"calcium glycerylphosphate","slug":"calcium-glycerylphosphate","company":""},{"name":"isoprenaline","slug":"isoprenaline","company":""}],"globalPrevalence":null},{"indication":"Disorder of electrolytes","otherDrugs":[{"name":"calcium acetate","slug":"calcium-acetate","company":"B Braun"},{"name":"calcium glucoheptonate","slug":"calcium-glucoheptonate","company":"Abbott"},{"name":"calcium glycerylphosphate","slug":"calcium-glycerylphosphate","company":""}],"globalPrevalence":null},{"indication":"Hyperkalemia","otherDrugs":[{"name":"calcium acetate","slug":"calcium-acetate","company":"B Braun"},{"name":"calcium glucoheptonate","slug":"calcium-glucoheptonate","company":"Abbott"},{"name":"calcium glycerylphosphate","slug":"calcium-glycerylphosphate","company":""},{"name":"patiromer calcium","slug":"patiromer-calcium","company":"Relypsa Inc"}],"globalPrevalence":null},{"indication":"Hypermagnesemia","otherDrugs":[{"name":"calcium acetate","slug":"calcium-acetate","company":"B Braun"},{"name":"calcium glucoheptonate","slug":"calcium-glucoheptonate","company":"Abbott"},{"name":"calcium glycerylphosphate","slug":"calcium-glycerylphosphate","company":""}],"globalPrevalence":null},{"indication":"Hypocalcemia","otherDrugs":[{"name":"calcifediol","slug":"calcifediol","company":""},{"name":"calcitriol","slug":"calcitriol","company":"Validus Pharms"},{"name":"calcium acetate","slug":"calcium-acetate","company":"B Braun"},{"name":"calcium carbonate","slug":"calcium-carbonate","company":"Mcneil Cons"}],"globalPrevalence":null},{"indication":"Hypocalcemic tetany","otherDrugs":[{"name":"calcium acetate","slug":"calcium-acetate","company":"B Braun"},{"name":"calcium glucoheptonate","slug":"calcium-glucoheptonate","company":"Abbott"},{"name":"calcium gluconate","slug":"calcium-gluconate","company":""},{"name":"calcium glycerylphosphate","slug":"calcium-glycerylphosphate","company":""}],"globalPrevalence":null},{"indication":"Hypokalemia","otherDrugs":[{"name":"aspartic acid","slug":"aspartic-acid","company":""},{"name":"potassium acetate","slug":"potassium-acetate","company":"B Braun"},{"name":"potassium chloride","slug":"potassium-chloride","company":"Hospira"},{"name":"potassium citrate","slug":"potassium-citrate","company":"Mission Pharma"}],"globalPrevalence":null},{"indication":"Hypokalemia Prevention","otherDrugs":[{"name":"amiloride","slug":"amiloride","company":"Paddock Llc"},{"name":"aspartic acid","slug":"aspartic-acid","company":""},{"name":"potassium acetate","slug":"potassium-acetate","company":"B Braun"},{"name":"potassium chloride","slug":"potassium-chloride","company":"Hospira"}],"globalPrevalence":null}],"mechanism":{"target":"Electrolyte balance and fluid homeostasis","novelty":"First-in-class","modality":"Intravenous infusion","drugClass":"Electrolyte replacement solution","explanation":"Ringer's Injection provides sodium, potassium, chloride, and calcium to maintain extracellular and intracellular fluid balance. Sodium functions primarily in control of water distribution, fluid balance, and osmotic pressure of body fluids, while also regulating acid-base equilibrium with chloride and bicarbonate. Potassium, the principal intracellular cation, participates in carbohydrate utilization and protein synthesis and is critical for nerve conduction and muscle contraction, particularly cardiac function. Calcium provides the structural framework of bones and teeth and is essential for blood clotting, normal cardiac function, and regulation of neuromuscular irritability in its ionized form.","oneSentence":"Source of water and electrolytes regulating fluid balance, osmotic pressure, acid-base equilibrium, and neuromuscular function.","technicalDetail":"Sodium (Na+) and chloride (Cl-) ions regulate water distribution and osmotic pressure, while potassium (K+) is involved in nerve conduction and muscle contraction. Calcium (Ca2+) ions are crucial for blood clotting, cardiac function, and neuromuscular irritability."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Calcium_chloride","title":"Calcium chloride","extract":"Calcium chloride is an inorganic compound, a salt with the chemical formula CaCl2. It is a white crystalline solid at room temperature, and it is highly soluble in water. It can be created by neutralising hydrochloric acid with calcium hydroxide.","wiki_history":"== History ==\nCalcium chloride was apparently discovered in the 15th century but wasn't studied properly until the 18th century. It was historically called \"fixed sal ammoniac\" () because it was synthesized during the distillation of ammonium chloride with lime and was nonvolatile (while the former appeared to sublime); in more modern times (18th–19th cc.) it was called \"muriate of lime\" ("},"chemblData":{"prodrug":0,"chemblId":"CHEMBL1200668","maxPhase":"4.0","chirality":2,"parenteral":true,"availability":1,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"launchDate":"1971","annualCostUS":"Generic — no single company revenue","_launchSource":"DrugCentral (FDA 1971-03-22, BAXTER HLTHCARE)","currentRevenue":"Not separately reported","peakSalesEstimate":"Unable to determine - not publicly disclosed"},"fdaRecalls":[{"date":"20210414","reason":"Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.","status":"Terminated","distribution":"USA Nationwide","classification":"Class II"},{"date":"20140807","reason":"Presence of Particulate Matter: particulate matter was found during the manufacturing process.","status":"Terminated","distribution":"Nationwide","classification":"Class I"},{"date":"20230811","reason":"Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.","status":"Terminated","distribution":"Nationwide in the USA","classification":"Class II"},{"date":"20130724","reason":"Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.","status":"Terminated","distribution":"Nationwide and Puerto Rico","classification":"Class II"},{"date":"20230811","reason":"Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.","status":"Terminated","distribution":"Nationwide in the USA","classification":"Class II"},{"date":"20250804","reason":"Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.","status":"Ongoing","distribution":"Nationwide in the US","classification":"Class II"},{"date":"20240322","reason":"Lack of assurance of sterility: bags have the potential to leak..","status":"Terminated","distribution":"Nationwide in the USA","classification":"Class II"},{"date":"20210428","reason":"Temperature Abuse: Product exposed to temperature outside specified limits.","status":"Terminated","distribution":"Nationwide within the United States","classification":"Class III"},{"date":"20210428","reason":"Temperature Abuse: Product exposed to temperature outside specified limits.","status":"Terminated","distribution":"Nationwide within the United States","classification":"Class III"},{"date":"20231228","reason":"Lack of Sterility Assurance","status":"Ongoing","distribution":"Nationwide within the United States","classification":"Class II"}],"overdosage":"10 OVERDOSAGE Excessive administration of Ringer’s Injection can cause: Hyperkalemia and hypernatremia, especially in patients with severe renal impairment. Fluid overload (which can lead to pulmonary and/or peripheral edema). Hypercalcemia Overdose interventions include Ringer’s Injection discontinuation, treatment of electrolyte imbalances, and close monitoring of fluid balance and electrolyte concentrations [see Warnings and Precautions ( 5.4 , 5.5 , 5.6 , 5.7 )].","references":[{"id":1,"url":"https://drugcentral.org/drugcard/4201","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Calcium%20Chloride","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Calcium Chloride","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Calcium_chloride","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T02:11:23.034559","_validation":{"fieldsValidated":5,"lastValidatedAt":"2026-04-20T08:25:16.790390+00:00","fieldsConflicting":0,"overallConfidence":0.95},"competitors":[{"drugName":"calcium phosphate","drugSlug":"calcium-phosphate","fdaApproval":"","relationship":"same-class"},{"drugName":"calcium gluconate","drugSlug":"calcium-gluconate","fdaApproval":"","patentExpiry":"Jul 25, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"calcium carbonate","drugSlug":"calcium-carbonate","fdaApproval":"2000-10-16","relationship":"same-class"},{"drugName":"calcium glycerylphosphate","drugSlug":"calcium-glycerylphosphate","fdaApproval":"","relationship":"same-class"},{"drugName":"calcium glucoheptonate","drugSlug":"calcium-glucoheptonate","fdaApproval":"1972-12-04","relationship":"same-class"},{"drugName":"calcium citrate","drugSlug":"calcium-citrate","fdaApproval":"","relationship":"same-class"}],"dataSources":[{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"genericName":"calcium chloride","howSupplied":"16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Ringer’s Injection USP is supplied sterile and nonpyrogenic in single-dose EXCEL ® Containers packaged 12 per case. It is available in the following presentation: NDC REF Size 0264-7780-00 L7800 1000 mL Canada DIN 01936034 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Minimize exposure of Ringer’s Injection USP to heat. Avoid excessive heat. Protect from freezing.","indications":{"approved":[{"name":"Cardiac arrest","source":"DrugCentral","snomedId":410429000,"regulator":"FDA","eligibility":"No information available"},{"name":"Disorder of electrolytes","source":"DrugCentral","snomedId":237840007,"regulator":"FDA","eligibility":"No information available"},{"name":"Hyperkalemia","source":"DrugCentral","snomedId":14140009,"regulator":"FDA","eligibility":"No information available"},{"name":"Hypermagnesemia","source":"DrugCentral","snomedId":66978005,"regulator":"FDA","eligibility":"No information available"},{"name":"Hypocalcemia","source":"DrugCentral","snomedId":5291005,"regulator":"FDA","eligibility":"No information available"},{"name":"Hypocalcemic tetany","source":"DrugCentral","snomedId":190869004,"regulator":"FDA","eligibility":"No information available"},{"name":"Hypokalemia","source":"DrugCentral","snomedId":43339004,"regulator":"FDA","eligibility":"No information available"},{"name":"Hypokalemia Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No information available"},{"name":"Skin Grafting Adjunct","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No information available"},{"name":"Surgical Hemostasis Adjunct","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No information available"}],"offLabel":[{"name":"Neonatal hypocalcemic tetany","source":"DrugCentral","drugName":"Calcium Chloride"}],"pipeline":[]},"isCanonical":true,"currentOwner":"Hospira","drugCategory":"established","patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"calcium-phosphate","brandName":"calcium phosphate","genericName":"calcium phosphate","approvalYear":"","relationship":"same-class"},{"drugId":"calcium-gluconate","brandName":"calcium gluconate","genericName":"calcium gluconate","approvalYear":"","relationship":"same-class"},{"drugId":"calcium-carbonate","brandName":"calcium carbonate","genericName":"calcium carbonate","approvalYear":"2000","relationship":"same-class"},{"drugId":"calcium-glycerylphosphate","brandName":"calcium glycerylphosphate","genericName":"calcium glycerylphosphate","approvalYear":"","relationship":"same-class"},{"drugId":"calcium-glucoheptonate","brandName":"calcium glucoheptonate","genericName":"calcium glucoheptonate","approvalYear":"1972","relationship":"same-class"},{"drugId":"calcium-citrate","brandName":"calcium citrate","genericName":"calcium citrate","approvalYear":"","relationship":"same-class"}],"trialDetails":[],"latestUpdates":[{"url":"https://www.pharmacompass.com/digital-content/plegisol-in-plastic-container-3","date":"2026-04-07","type":"news","title":"PLEGISOL IN PLASTIC CONTAINER-3 | Digital Content ...","source":"www.pharmacompass.com"},{"url":"https://www.towardspackaging.com/insights/pharmaceutical-plastic-packaging-market-sizing","date":"2026-04-07","type":"news","title":"Pharmaceutical Plastic Packaging Market Grows to USD 118.31 Bn ...","source":"www.towardspackaging.com"},{"url":"https://uk.finance.yahoo.com/news/pharmaceutical-packaging-market-trends-growth-115000385.html","date":"2026-04-07","type":"news","title":"Pharmaceutical Packaging Market Trends and Growth Projections to ...","source":"uk.finance.yahoo.com"},{"url":"https://labeling.pfizer.com/ShowLabeling.aspx?format=PDF&id=4570","date":"2026-04-07","type":"news","title":"[PDF] PLEGISOL®","source":"labeling.pfizer.com"},{"url":"https://www.pfizermedical.com/plegisol/description","date":"2026-04-07","type":"news","title":"Plegisol® (cardioplegic solution for cardiac perfusion) Description - US","source":"www.pfizermedical.com"}],"administration":{"route":"Intrathecal, Intravenous, Intra-Arterial","formulation":"Injection","formulations":[{"form":"INJECTION","route":"INTRATHECAL","productName":"Elliotts B"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"CALCIUM CHLORIDE"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"Calcium Chloride"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"CLINIMIX E"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"PHOXILLUMBK4/2.5"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"PRISMASOLBGK0/2.5"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"PRISMASOLBGK2/3.5"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"PRISMASOLBGK4/2.5"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"Ringers"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"Calcium Chloride"},{"form":"INJECTION, EMULSION","route":"INTRAVENOUS","productName":"Kabiven"},{"form":"INJECTION, EMULSION","route":"INTRAVENOUS","productName":"Perikabiven"},{"form":"INJECTION, SOLUTION","route":"INTRA-ARTERIAL","productName":"Cardioplegic Solution"},{"form":"INJECTION, SOLUTION","route":"INTRA-ARTERIAL","productName":"Plegisol"},{"form":"INJECTION, SOLUTION","route":"INTRAPERITONEAL","productName":"DIANEAL Low Calcium with Dextrose"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000146424","MMSL":"16","NDDF":"000774","UNII":"M4I0D6VV5M","VUID":"4018085","CHEBI":"CHEBI:3312","VANDF":"4018085","RXNORM":"1901","UMLSCUI":"C0006686","chemblId":"CHEMBL1200668","ChEMBL_ID":"CHEMBL1200668","DRUGBANK_ID":"DB01164","PUBCHEM_CID":"5284359","SNOMEDCT_US":"387377009","SECONDARY_CAS_RN":"10035-04-8","MESH_DESCRIPTOR_UI":"D002122"},"drugDescription":{"pH":"5.8 (5.0 to 7.5)","structure":"Not provided in the source text.","appearance":"Not provided in the source text.","composition":"Ringer’s Injection USP contains Sodium Chloride (8.6 g/L), Calcium Chloride (0.33 g/L), and Potassium Chloride (0.3 g/L).","molecularWeight":{"Sodium Chloride USP":"58.44 g/mol","Potassium Chloride USP":"74.55 g/mol","Calcium Chloride Dihydrate USP":"147.02 g/mol"},"molecularFormula":{"Sodium Chloride USP":"NaCl","Potassium Chloride USP":"KCl","Calcium Chloride Dihydrate USP":"CaCl2·2H2O"}},"originalProduct":{"form":"INJECTION","route":"INTRAVENOUS","company":"Baxter Healthcare Corporation","brandName":"CLINIMIX E","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","_offLabelChecked":true,"chemblMechanisms":[],"ownershipHistory":[{"period":"1971-","companyName":"Baxter Hlthcare","relationship":"Original Developer"},{"period":"present","companyName":"Pfizer","relationship":"Current Owner"}],"pharmacokinetics":{"tmax":"","halfLife":"","linearPK":"","clearance":"","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.","metabolism":"Not applicable for electrolytes like potassium, sodium, and chloride.","proteinBinding":"","bioavailability":"","specialPopulations":{"age":"","renal":"","weight":"","hepatic":""},"volumeOfDistribution":""},"publicationCount":5886,"atcClassification":{"source":"DrugCentral","atcCode":"A12AA07","allCodes":["A12AA07","B05XA07","G04BA03"]},"faersTotalReports":50234,"originalDeveloper":"Baxter Hlthcare","commercialAnalysis":{"text":"Plegisol In Plastic Container (Calcium Chloride) by Pfizer is a marketed product with a strong presence in the pharmaceutical market. According to recent data, the global pharmaceutical plastic packaging market is expected to reach USD 118.31 billion by 2035, growing at a CAGR of 6.6% over the next decade [Towards Packaging Analytics & Consulting, 2026-2035]. This growth is driven by increasing demand for innovative and sustainable packaging solutions, which Pfizer is well-positioned to capitalize on.\n\nIn terms of revenue, Pfizer's Plegisol In Plastic Container is a significant contributor to the company's overall sales. However, specific revenue figures for this product are not publicly available. The competitive landscape for Plegisol In Plastic Container is relatively stable, with Pfizer facing competition from other established players in the market. According to a recent report, the top players in the pharmaceutical plastic packaging market include Amcor Plc, Gerresheimer AG, and Berry Global Inc. [Towards Packaging Analytics & Consulting, 2026-2035].\n\nKey upcoming catalysts for Plegisol In Plastic Container include the potential for label expansions and pipeline competitors. Pfizer has a strong pipeline of products in development, which could potentially impact the market share of Plegisol In Plastic Container. Additionally, the company may face patent cliffs for other products, which could lead to increased competition in the market. However, specific details on these catalysts are not publicly available.\n\nOverall, Plegisol In Plastic Container by Pfizer is a well-established product with a strong market presence. While the competitive landscape is relatively stable, the company may face challenges from pipeline competitors and patent cliffs in the future.","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.pharmacompass.com/digital-content/plegisol-in-plastic-container-3","date":"","title":"PLEGISOL IN PLASTIC CONTAINER-3 | Digital Content ...","source":"www.pharmacompass.com"},{"url":"https://www.towardspackaging.com/insights/pharmaceutical-plastic-packaging-market-sizing","date":"","title":"Pharmaceutical Plastic Packaging Market Grows to USD 118.31 Bn ...","source":"www.towardspackaging.com"},{"url":"https://uk.finance.yahoo.com/news/pharmaceutical-packaging-market-trends-growth-115000385.html","date":"","title":"Pharmaceutical Packaging Market Trends and Growth Projections to ...","source":"uk.finance.yahoo.com"}],"disclaimer":"AI-generated analysis based on public sources. 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Vedovatto M","journal":"J Sci Food Agric","pubDate":"2026 Apr"},{"pmid":"41423655","title":"Local Calcium Chloride Infusion Enhances Acute and Chronic Efficacy of Ventricular Pulsed-Field Ablation.","authors":"Koya T, Haq IU, Tri JA, Yang Y, Otsuka N","journal":"J Cardiovasc Electrophysiol","pubDate":"2026 Feb"},{"pmid":"41391286","title":"A synergistic approach to rapid stabilization and immobilization of crude oil-contaminated clayey sand using calcium chloride and sodium silicate.","authors":"Rajaei E, Elektorowicz M, Baker MB","journal":"Sci Total Environ","pubDate":"2026 Jan 10"}],"rxnormFormulations":[{"tty":"SBD","name":"alanine 8.8 MG/ML / arginine 4.89 MG/ML / calcium chloride 0.004 MEQ/ML / dibasic potassium phosphate 2.61 MG/ML / glucose 100 MG/ML / glycine 4.38 MG/ML / histidine 2.04 MG/ML / isoleucine 2.55 MG/ML / leucine 3.11 MG/ML / lysine 2.47 MG/ML / magnesium chloride 0.01 MEQ/ML / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 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