Lactated Ringers
Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride
Asclemed Usa, Inc.
Human Prescription Drug
NDC 76420-129Lactated Ringers also known as Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride is a human prescription drug labeled by 'Asclemed Usa, Inc.'. National Drug Code (NDC) number for Lactated Ringers is 76420-129. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Lactated Ringers drug includes Calcium Chloride - 20 mg/100mL Potassium Chloride - 30 mg/100mL Sodium Chloride - 600 mg/100mL Sodium Lactate - 310 mg/100mL . The currest status of Lactated Ringers drug is Active.
Drug Information:
| Drug NDC: | 76420-129 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Lactated Ringers |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Asclemed Usa, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CALCIUM CHLORIDE - 20 mg/100mL
POTASSIUM CHLORIDE - 30 mg/100mL
SODIUM CHLORIDE - 600 mg/100mL
SODIUM LACTATE - 310 mg/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 24 Jun, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA017641 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Asclemed USA, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 847630
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | M4I0D6VV5M
660YQ98I10
451W47IQ8X
TU7HW0W0QT
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Blood Coagulation Factor [EPC]
Calcium [CS]
Cations
Divalent [CS]
Increased Coagulation Factor Activity [PE]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Potassium Compounds [CS]
Potassium Salt [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 76420-129-01 | 1000 mL in 1 BAG (76420-129-01) | 29 Oct, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Lactated ringers sodium chloride, sodium lactate, potassium chloride, and calcium chloride hydrochloric acid sodium hydroxide sodium chloride sodium cation chloride ion sodium lactate sodium cation lactic acid, unspecified form potassium chloride potassium cation chloride ion calcium chloride calcium cation chloride ion
Drug Interactions:
Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. the presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .
Indications and Usage:
Indications and usage these solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.
Warnings:
Warnings solutions containing calcium ions should not be administered simultaneously through the same administration set as blood because of the likelihood of coagulation. solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. 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 exists edema with sodium retention. in patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. solutions containing lactate ions should be used with great care in patients with metabolic or respiratory alkalosis. the administration of lactate ions should be done with great care where there is an increased level or an impaired utilization of lactate ions, as in
Read more... severe hepatic insufficiency. the intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. the risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Dosage and Administration:
Dosage and administration the dose is dependent upon the age, weight and clinical condition of the patient. drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. the presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .
Contraindications:
Contraindications solutions containing lactate are not for use in the treatment of lactic acidosis.
Adverse Reactions:
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. 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.
Drug Interactions:
Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. the presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .
Use in Pregnancy:
Pregnancy category c. animal reproduction studies have not been conducted with lactated ringer's injection, usp. it is also not known whether these injections can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. these injections should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use: the safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
Overdosage:
Overdosage in the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. see warnings , precautions , and adverse reactions .
Description:
Description these products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (without dextrose) in water for injection. the solutions containing only electrolytes are isotonic. they are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. each 100 ml of lactated ringer's injection, usp contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. a liter provides 9 calories (from lactate), sodium (na + ), 130 meq, potassium (k + ) 4 meq, calcium (ca ++ ) 3 meq, chloride (cl â ) 109 meq and lactate [ch 3 ch(oh) coo â ] 28 meq. the electrolyte content is isotonic (273 mosmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mosmol/liter). the ph of the solution is 6.6 (6.0 â 7.5). the solutions contain no bacteriostat, antimicrobial agent or added buffer (except for ph adjustment) and each is intended only for use as a single-dose injection. when smaller doses are required the unused portion should be discarded. the solutions are parenteral fluid, nutrient and/or electrolyte replenishers. calcium chloride, usp is chemically designated calcium chloride, dihydrate (cacl 2 ⢠2 h 2 o), white fragments or granules freely soluble in water. potassium chloride, usp is chemically designated kcl, a white granular powder freely soluble in water. sodium chloride, usp is chemically designated nacl, a white crystalline powder freely soluble in water. sodium lactate, usp is chemically designated monosodium lactate [ch 3 ch(oh)coona], a 60% aqueous solution miscible in water. it has the following structural formula: water for injection, usp is chemically designated h 2 o. the flexible plastic container is fabricated from a specially formulated polyvinylchloride. water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. however, the safety of the plastic has been confirmed by tests in animals according to usp biological standards for plastic containers. structural formula sodium lactate
Clinical Pharmacology:
Clinical pharmacology when administered intravenously, these solutions provide sources of water and electrolytes with or without minimal carbohydrate calories. their electrolyte content resembles that of the principal ionic constituents of normal plasma and the solutions therefore are suitable for parenteral replacement of extracellular losses of fluid and electrolytes, with or without carbohydrate calories. calcium chloride in water dissociates to provide calcium (ca ++ ) and chloride (cl â ) ions. they are normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%. potassium chloride in water dissociates to provide potassium (k + ) and chloride (cl â ) ions. potassium is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 meq/liter in a healt
Read more...hy adult). it is the chief cation of body cells (160 meq/liter of intracellular water). potassium plays an important role in electrolyte balance. normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. the kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. sodium chloride in water dissociates to provide sodium (na + ) and chloride (cl â ) ions. sodium (na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. chloride (cl â ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. the distribution and excretion of sodium (na+) and chloride (cl â ) are largely under the control of the kidney which maintains a balance between intake and output. sodium lactate provides sodium (na + ) and lactate (c 3 h 5 0 3 â ) ions. the lactate anion is in equilibrium with pyruvate and has an alkalizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. in the liver, lactate is metabolized to glycogen which is ultimately converted to carbon dioxide and water by oxidative metabolism. the sodium (na + ) ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). the normal plasma level of lactate ranges from 0.9 to 1.9 meq/liter. water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). water balance is maintained by various regulatory mechanisms. water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (na + ) plays a major role in maintaining physiologic equilibrium.
How Supplied:
How supplied these solutions are supplied in single-dose flexible plastic containers as follows: ndc no. product name container size (ml) 76420-129-01 (relabeled from 0990-7953-09) lactated ringer's inj., usp 1000 store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] protect from freezing. relabeled by: enovachem pharmaceuticals torrance, ca 90501
Package Label Principal Display Panel:
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