Dextrose, Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride

Prescription

Торговые наименования: Dextrose in Lactated Ringers

Лекарственная Форма

Injection

Путь Введения

INTRAVENOUS

Производитель

B. Braun Medical Inc.

About This Medication

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) Osmolarity Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. (mOsmol/L) (calc) pH pH adjusted with Hydrochloric Acid NF. Ionic Concentration (mEq/L) Lactate Caloric Content (kcal/L) Dextrose, USP Sodium Chloride, USP Sodium Lactate Potassium Chloride, USP Calcium Chloride, USP Sodium Potassium Calcium Chloride Lactated Ringer’s and Dextrose (5%) Injection, USP 500 1000 50 6 3.1 0.3 0.2 530 4.6 (4.0 to 6.0) 130 4 3 112 28 180 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 Na + Cl – 58.44 Sodium Lactate 112.06 Potassium Chloride USP K + Cl – 74.55 Calcium Chloride Dihydrate USP 147.02 Dextrose USP 198.17 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 Lactate Calcium Chloride Dihydrate USP Dextrose USP

Действующие Вещества

Компонент	Дозировка
Calcium Chloride	-
Dextrose Monohydrate	-
Potassium Chloride	-
Sodium Chloride	-
Sodium Lactate	-

Показания и Применение

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.

Как это работает

12.1 Mechanism 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.

Дозировка и Способ Применения

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 ) 2.1 Dosage 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. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. 2.2 Important 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 Lactated Ringer’s and Dextrose (5%) 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 Lactated Ringer’s and Dextrose (5%) Injection , turn off the pump before the container is empty. Preparation Instructions 1. 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. 2. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. 3. 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. 4. If supplemental medication is desired, follow directions below [see Dosage and Administration (2.3) ] . Preparation for Administration 1. Remove plastic protector from sterile set port at bottom of container. 2. Attach administration set according to its accompanying directions. 2.3 Important Administration Instructions Lactated Ringer’s and Dextrose (5%) Injection is for intravenous use. 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 Warnings and Precautions (5.3) ] . It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use immediately after opening the container. Discard the unused portion. Some additives may be incompatible [see Dosage and Administration (2.4) ] . To Add Medication Before Solution Administration 1. Prepare medication site. 2. Using syringe with 18-22 gauge needle, puncture medication port and inner diaphragm and inject. 3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly. To Add Medication During Solution Administration 1. Close clamp on the set. 2. Prepare medication site. 3. Using syringe with 18-22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject. 4. Remove container from IV pole and/or turn to an upright position. 5. Evacuate both ports by tapping and squeezing them while container is in the upright position. 6. Mix solution and medication thoroughly. 7. Return container to in use position and continue administration. 2.4 Drug Incompatibilities Do not administer Lactated Ringer’s and Dextrose (5%) Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) due to serious risks [see Contraindications (4) and Warnings and Precautions (5.1) ] . However, in patients older than 28 days, ceftriaxone and Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Warnings and Precautions (5.1) ]. Do not administer Lactated Ringer’s and Dextrose (5%) Injection simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation precipitated by the calcium content of Lactated Ringer’s and Dextrose (5%) Injection.

Side Effects Overview

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 B. Braun Medical Inc. at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Предупреждения и Меры Предосторожности

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, Hyperglycemic and Hyperosmolar Hyperglycemic State Control, Hypercalcemia, Fluid Overload, Acid-Base Imbalances, Interference with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis : See Full Prescribing Information for risk management recommendations. ( 5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11 ) 5.1 Serious Risk with Concomitant Use with Ceftriaxone Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as 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. 5.2 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 Lactated Ringer’s and Dextrose (5%) Injection . 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. 5.4 Potassium 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. Hypokalemia The potassium concentration in Lactated Ringer’s and Dextrose (5%) Injection is similar to the concentration in plasma. It is insufficient to normalize the serum potassium in patients with severe hypokalemia. 5.5 Hyponatremia Lactated Ringer’s and Dextrose (5%) Injection may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, geriatric patients, patients treated with diuretics, 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 Lactated Ringer’s and Dextrose (5%) Injection in patients with or at risk for hyponatremia. If use cannot be avoided in these patients, closely monitor serum sodium concentrations. Rapid correction of hyponatremia may result in serious neurologic complications such as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. 5.6 Neonatal Hypoglycemia Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypoglycemia. Closely monitor blood glucose concentration during treatment with intravenous dextrose solutions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. 5.7 Hyperglycemia and Hyperosmolar Hyperglycemic State Administration of solutions containing dextrose and lactate in patients with impaired glucose tolerance including those with diabetes mellitus may worsen hyperglycemia. Hyperglycemia is associated with an increase in serum osmolality, which can result in hypovolemia and electrolyte imbalances due to osmotic diuresis. Patients with underlying central nervous system disease or renal impairment who receive dextrose infusions may be at greater risk of developing hyperosmolar hyperglycemic state. While using Lactated Ringer’s and Dextrose (5%) Injection, closely monitor blood glucose concentrations and treat hyperglycemia to maintain glucose concentrations within normal limits. Anti-diabetic drugs may need to be started or dosages of these drugs may need to be increased to maintain optimal blood glucose concentrations. 5.8 Hypercalcemia Lactated Ringer’s and Dextrose (5%) Injection contains calcium salts and may cause hypercalcemia. Avoid administration of Lactated Ringer’s and Dextrose (5%) Injection in patients with hypercalcemia, those with calcium-containing renal calculi or history of such calculi, or those with conditions predisposing to hypercalcemia or treated with concomitant thiazide diuretics or vitamin D. 5.9 Fluid Overload Depending on the administered volume and the infusion rate, administration of Lactated Ringer’s and Dextrose (5%) Injection can cause fluid overload, including pulmonary edema. Avoid Lactated Ringer’s and Dextrose (5%) Injection in patients at risk for fluid and/or solute overload including patients with severe renal impairment. If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations and acid base balance, especially during prolonged use. 5.10 Acid/Base Imbalances Because lactate is metabolized to bicarbonate, administration of Lactated Ringer’s and Dextrose (5%) Injection may result in, or worsen, metabolic alkalosis. Closely monitor the acid-base balance in patients with, or at risk of, alkalosis. In patients with severe hepatic impairment, decreased lactate metabolism may result in worsening anion gap metabolic acidosis. Avoid Lactated Ringer’s and Dextrose (5%) Injection in patients with severe hepatic impairment. If use cannot be avoided in these patients, closely monitor serum bicarbonate levels. 5.11 Interference of Lactated Ringer’s and Dextrose (5%) Injection with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis Administration of Lactated Ringer’s and Dextrose (5%) Injection may result in interference with the interpretation of serum lactate levels in patients with severe metabolic acidosis. [see Drug Interactions (7.5) ] .

Противопоказания

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 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 sodium lactate. ( 4 )

Фармакокинетика

12.3 Pharmacokinetics Elimination Metabolism/Excretion Potassium: Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder is excreted in feces and to a smaller extent, in perspiration. Sodium and Chloride: The distribution and excretion of sodium (Na + ) and chloride (Cl − ) are largely under the control of the kidney which maintains a balance between intake and output. Lactate: In the liver, lactate is metabolized to carbon dioxide and water by oxidative metabolism and consumption of hydrogen cations. Dextrose: Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.

Frequently Asked Questions

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.

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 ) …

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 …

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 components of Lactated Ringer’s and Dextrose (5%) Injection [see Warnings and Precautions (5.3) ]. Patients with clinically significant hyperglycemia …

Dextrose, Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Dextrose, Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride drug label (National Library of Medicine)
• openFDA — Dextrose, Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 847627 (NLM Normalized Drug Names)
• NDC Directory — Dextrose, Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride (FDA National Drug Code)

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Источники данных: DailyMed (NLM), openFDA, MFDS