Lactated Ringers and Dextrose SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATE 5 g/100mL; 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL Injection, Solution, 500 mL
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This medicine belongs to the Organic acids class.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.0088 | $4.40 / 500 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7121 | No ASP payment limit on file for J7121 this quarter. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dextrose in Lactated Ringers 5 g/100mL; .6 g/100mL; .31 g/100mL; .03 g/100mL; .02 g/100mL 00264-7751-00 | B. | 1000 ml | — | — | FDA listed | — |
| Lactated Ringers and Dextrose 5 g/100mL; 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mLthis 00338-0125-03 | Baxter | 500 ml | — | AP | FDA listed | — |
| Lactated Ringers and Dextrose 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL; 5 g/100mL 00990-7929-03 | ICU | 24 pouches | — | AP | FDA listed | — |
| Lactated Ringers And Dextrose 5 g/100mL; 310 mg/100mL; 600 mg/100mL; 30 mg/100mL; 20 mg/100mL 51662-1521-01 | HF | 1000 ml | — | AP | FDA listed | — |
| Lactated Ringers and Dextrose 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL; 5 g/100mL 65219-0241-10 | Fresenius | 1000 ml | — | AP | FDA listed | — |
| Lactated Ringers and Dextrose 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL; 5 g/100mL 65219-0243-50 | Fresenius | 500 ml | — | AP | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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🗺️ Medicaid utilization & spend
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00338-0125-03 You're viewing this | 500 mL in 1 BAG (0338-0125-03) | 1971-03-22 | Active |
| 00338-0125-04 | 1000 mL in 1 BAG (0338-0125-04) | 1979-03-22 | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack accounts for about 3.0% of this product's recent Medicaid fills; most go to the 1 ml pack. See all packs ↓
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What NDC number is used to bill for this package of Lactated Ringers and Dextrose SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATE 5 g/100mL; 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL Injection, Solution?
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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. Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • The recommended dosage and duration are based on the patient’s age, weight, clinical condition, and concomitant therapy. (2.1) • To reduce the risk of air embolism, adhere to the preparation instructions. ( 2.2 , 5.2 ) • 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 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 )
2.1Dosage Considerations The recommended dosage and duration of 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 Lactated Ringer’s and Dextrose (5%) Injection to optimize clinical status.
2.2Important Preparation Instructions Visually inspect the Lactated Ringer’s and Dextrose (5%) Injection solution for particulate matter and discoloration. Do not administer 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 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 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 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.
2.3Important Administration Instructions 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 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 W…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: Lactated Ringer’s and Dextrose (5%) Injection, USP as a clear, sterile, and nonpyrogenic solution packaged in single-dose VIAFLEX plastic containers: 500 mL, 1000 mL Injection: Lactated Ringer’s and Dextrose (5%) Injection, USP packaged in single-dose Viaflex flexible containers: 500 mL and 1,000 mL. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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 Lactated Ringer’s and Dextrose (5%) Injection [see Warnings and Precautions (5.3) ] . • 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 Lactated Ringer’s and Dextrose (5%) Injection. ( 4 ) • Patients with clinically significant hyperglycemia. ( 4 )
⚠️ 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 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 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 )
5.1Serious Risk with Concomitant Use with Ceftriaxone Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as 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.
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 Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid.
5.2Air 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) ] .
5.3Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Lactated Ringer’s solution. Stop the 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.
5.4Potassium Imbalances Hyperkalemia Potassium-containing solutions, including 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 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. Hypokalem…
🤒 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 post approval 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, 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 Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Drugs that Affect Electrolyte and/or Fluid Balance : Avoid concomitant use. If concomitant use cannot be avoided, closely monitor electrolyte concentrations and fluid balance. ( 7.1 ) • Lithium : Avoid concomitant use.
If concomitant use is unavoidable, monitor serum lithium concentrations more frequently. ( 7.2 ) • Digoxin : Consider reducing the volume or rate of 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 )
7.1Drugs that Affect Electrolyte and/or Fluid Balance Hyperkalemia Administration of 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 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 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 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 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 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 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.
7.2Lithium Renal sodium and lithium clearance may be increased during concomitant use of Lactated Ringer’s and Dextrose (5%) Injection and lithium and may result in decreased lithium concentrations. Avoid use of 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.
7.3Digoxin Administration of calcium via use of 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 Lactated Ringer’s and Dextrose (5%) Injection administration.
7.4Drugs with pH-Dependent Renal Elimination Due to the alkalinizing action of lactate (formation of bicarbonate), 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 Lactated Ringer’s a…
👥 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 )
8.1Pregnancy Risk Summary Lactated Ringer’s as a source of water and electrolytes and Dextrose (5%) Injection have been used for decades during labor and delivery. Although there are a few case reports that describe adverse effects of dextrose use and no reports of use of Lactated Ringer’s in other stages of pregnancy, exposure to Lactated Ringer’s and Dextrose (5%) Injection during pregnancy in general 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.
Therefore, it is not known whether Lactated Ringer’s and Dextrose (5%) Injection can cause fetal harm when administered to a pregnant woman. Lactated Ringer’s and Dextrose (5%) Injection should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.
8.2Lactation 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 Imilk, 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 Lactated Ringer’s and Dextrose (5%) Injection and any potential adverse effects on the breastfed infant from Lactated Ringer’s and Dextrose (5%) Injection or from the underlying maternal condition.
8.4Pediatric Use 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.
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 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…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Lactated Ringer’s as a source of water and electrolytes and Dextrose (5%) Injection have been used for decades during labor and delivery. Although there are a few case reports that describe adverse effects of dextrose use and no reports of use of Lactated Ringer’s in other stages of pregnancy, exposure to Lactated Ringer’s and Dextrose (5%) Injection during pregnancy in general 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.
Therefore, it is not known whether Lactated Ringer’s and Dextrose (5%) Injection can cause fetal harm when administered to a pregnant woman. Lactated Ringer’s and Dextrose (5%) Injection should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
8.4Pediatric Use 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.
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 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 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 Lactated Ringer’s and Dextrose (5%) Injection may result in increased serum osmolality and risk of intracranial hemorrhage.
🧓 Geriatric Use ▾
8.5Geriatric Use Geriatric patients treated with Lactated Ringer’s and Dextrose (5%) Injection are at increased risk of developing electrolyte imbalances. Lactated Ringer’s and Dextrose (5%) Injection is substantially excreted by the kidney, and the risk of adverse reactions to 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.
🆘 Overdosage ▾
10 OVERDOSAGE Excessive administration of 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 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 )].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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.
12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Lactated Ringer’s and Dextrose (5%) Injection have not been fully characterized.
12.3Pharmacokinetics 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.
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied 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 2B2073 500 NDC 0338-0125-03 2B2074 1000 NDC 0338-0125-04 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. 07-19-00-9426
📋 Description ▾
11 DESCRIPTION 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. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 . Dextrose is derived from corn.
Table 1 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 Lactated Ringer’s and Dextrose (5%) Injection, USP 500 1000 50 6 3.1 0.3 0.2 525 5.0 (4.0 to 6.5) 130 4 2.7 109 28 180 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
58.44Sodium Lactate 112.06 Potassium Chloride, USP
74.55Calcium 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