NDC 0264-7751 Dextrose In Lactated Ringers

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

NDC Product Code 0264-7751

NDC CODE: 0264-7751

Proprietary Name: Dextrose In Lactated Ringers What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dextrose, Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 0264-7751-00

Package Description: 12 CONTAINER in 1 CASE > 1000 mL in 1 CONTAINER

NDC 0264-7751-10

Package Description: 24 CONTAINER in 1 CASE > 500 mL in 1 CONTAINER

NDC Product Information

Dextrose In Lactated Ringers with NDC 0264-7751 is a a human prescription drug product labeled by B. Braun Medical Inc.. The generic name of Dextrose In Lactated Ringers is dextrose, sodium chloride, sodium lactate, potassium chloride, and calcium chloride. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: B. Braun Medical Inc.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Dextrose In Lactated Ringers Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROSE MONOHYDRATE 5 g/100mL
  • SODIUM CHLORIDE .6 g/100mL
  • SODIUM LACTATE .31 g/100mL
  • POTASSIUM CHLORIDE .03 g/100mL
  • CALCIUM CHLORIDE .02 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium - [CS]
  • Cations -
  • Divalent - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: B. Braun Medical Inc.
Labeler Code: 0264
FDA Application Number: NDA019634 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-24-1988 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dextrose In Lactated Ringers Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Each 100 mL of 5% Dextrose in Lactated Ringer's Injection contains:Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.6 gSodium Lactate 0.31 g; Potassium Chloride USP 0.03 gCalcium Chloride Dihydrate USP 0.02 gWater for Injection USP qs pH adjusted with Hydrochloric Acid NFpH: 4.6 (4.0–6.0)Calories per liter: 170Calculated Osmolarity: 530 mOsmol/liter, hypertonicConcentration of Electrolytes (mEq/liter): Sodium 130     Potassium 4Calcium 3      Chloride 112     Lactate (CH3CH(OH)COO−) 285% Dextrose in Lactated Ringer's Injection is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration.The formulas of the active ingredients are:IngredientsMolecular FormulaMolecular Weight  Sodium Chloride USP NaCl   58.44 Sodium Lactate CH3CH(OH)COONa 112.06 Potassium Chloride USP KCl   74.55 Calcium Chloride Dihydrate USP CaCl2•2H2O 147.02 Hydrous Dextrose USP  198.17Not made with natural rubber latex, PVC or DEHP.The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. 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.Addition of medication should be accomplished using complete aseptic technique.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. Refer to the Directions for Use of the container.

Clinical Pharmacology

5% Dextrose in Lactated Ringer's Injection provides electrolytes and calories, and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. This solution also contains lactate which produces a metabolic 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 is a racemic salt containing both the levo form, which is oxidized by the liver to bicarbonate, and the dextro form, which is converted to glycogen. Lactate is slowly metabolized to carbon dioxide and water, accepting one hydrogen ion and resulting in the formation of bicarbonate for the lactate consumed. These reactions depend on oxidative cellular activity. Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

Indications And Usage

This solution is indicated for use in adults and pediatric patients as a source of electrolytes, calories and water for hydration.

Contraindications

This solution is contraindicated where the administration of sodium, potassium, calcium, chloride or lactate could be clinically detrimental.Lactate administration is contraindicated in severe metabolic acidosis or alkalosis, and in severe liver disease or anoxic states which affect lactate metabolism.Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Warnings

Solutions containing lactate are not for use in the treatment of lactic acidosis. Solutions containing lactate should be used with great care in patients with metabolic or respiratory alkalosis, and in those conditions in which there is an increased level or an impaired utilization of lactate, such as severe hepatic insufficiency.The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema.Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium ions retention is present.In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.

General

This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.Extraordinary electrolytes losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.Additional essential electrolytes, minerals and vitamins should be supplied as needed.Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients.Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.The osmolarity of 5% Dextrose in Lactated Ringer’s Injection is 530 mOsmol/liter (calc). Administration of substantially hypertonic solutions may cause venous irritation, including phlebitis.Solutions containing calcium should be used with caution in the presence of cardiac disease, particularly when accompanied by renal disease. Parenteral calcium should be administered with extreme caution to patients receiving digitalis preparations.Solutions containing lactate should be used with caution. Excess administration may result in metabolic alkalosis.The conversion of lactate to bicarbonate is markedly delayed in the presence of tissue anoxia and reduced capacity of the liver to metabolize lactate. This may occur under conditions such as metabolic acidosis associated with circulatory insufficiency, extracorporeal circulation, hypothermia, glycogen storage disease, liver dysfunction, respiratory alkalosis, shock or cardiac decompensation.Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (greater than 300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.Use only if solution is clear and container and seals are intact.

Laboratory Tests

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or an alternative solution.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies with 5% Dextrose in Lactated Ringer's Injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with 5% Dextrose in Lactated Ringer's Injection. It is also not known whether 5% Dextrose in Lactated Ringer's Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Dextrose in Lactated Ringer's Injection should be given to a pregnant woman only if clearly needed.

Labor And Delivery

The effects of 5% Dextrose in Lactated Ringer's Injection on the duration of labor or delivery, on the possibility that forceps delivery or other intervention or resuscitation of the newborn will be necessary, and on the later growth, development, and functional maturation of the child are unknown.As reported in the literature, 5% Dextrose in Lactated Ringer's Injection has been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 5% Dextrose in Lactated Ringer's Injection is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of 5% Dextrose in Lactated Ringer's Injection in pediatric patients has not been established by adequate and well-controlled studies. However, as referenced in the medical literature, potassium chloride injection has been used to treat pediatric patients with potassium deficiency when oral replacement therapy is not feasible .For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended.Dextrose is safe and effective for the stated indications in pediatric patients (see INDICATIONS AND USAGE). As reported in the literature, the dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.In neonates or in very small infants even small volumes of fluid may affect fluid and electrolyte balance. Care must be exercised in treatment of neonates, especially pre-term neonates, whose renal function may be immature and whose ability to excrete fluid and solute loads may be limited. Fluid intake, urine output, and serum glucose and electrolytes should be monitored closely.See WARNINGS and DOSAGE AND ADMINISTRATION.

There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. See WARNINGS and PRECAUTIONS.

Geriatric Use

Clinical studies of 5% Dextrose in Lactated Ringer's Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.See WARNINGS.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended. (See DOSAGE AND ADMINISTRATION.)Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation.If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.Abnormally high plasma levels of calcium can result in depression, amnesia, headaches, drowsiness, disorientation, syncope, hallucinations, hypotonia of both skeletal and smooth muscles, dysphagia, arrhythmias and coma. Calcium deficits can result in neuromuscular hyperexcitability, including cramps and convulsions.Although the metabolism of lactate to bicarbonate is a relatively slow process, aggressive administration of sodium lactate may result in metabolic alkalosis. Careful monitoring of blood acid-base balance is essential during the administration of sodium lactate. The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.Other manifestations of hypersensitivity/infusion reactions: decreased heart rate, tachycardia, blood pressure decreased, respiratory distress, laryngeal edema, flushing, throat irritation, paresthesias, hypoesthesia oral, dysgeusia, anxiety, headache, and sneezing.HyperkalemiaHypervolemiaOther infusion site reactions: infection at the site of injection, phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pain, infusion site burning.

Overdosage

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.

Dosage And Administration

This solution is for intravenous use only.Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.The presence of calcium ions in this solution should be considered when phosphate is present in additive solutions, in order to avoid precipitation.Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How Supplied

5% Dextrose in Lactated Ringer's Injection is supplied sterile and nonpyrogenic in EXCEL® Containers. The 1000 mL containers are packaged 12 per case and the 500 mL containers are packaged 24 per case.NDCREFSize 5% Dextrose in Lactated Ringer's Injection  0264-7751-00 L7510 1000 mL 0264-7751-10 L7511   500 mL

Directions For Use Of Excel® Container

  • Caution: Do not use plastic containers in series connection.To OpenTear 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. NOTE: Before use, perform the following checks: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. Use only if solution is clear and container and seals are intact.Preparation for AdministrationRemove plastic protector from sterile set port at bottom of container.
  • Attach administration set. Refer to complete directions accompanying set. To Add MedicationWarning: Some additives may be incompatible.To Add Medication Before Solution AdministrationPrepare 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 AdministrationClose 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.

* Please review the disclaimer below.