Lactated Ringers
Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride
Icu Medical Inc.
Human Prescription Drug
NDC 0990-7828Lactated Ringers also known as Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride is a human prescription drug labeled by 'Icu Medical Inc.'. National Drug Code (NDC) number for Lactated Ringers is 0990-7828. This drug is available in dosage form of Irrigant. 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: | 0990-7828 |
| 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: | Icu Medical Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Irrigant |
| 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: | IRRIGATION
|
| 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: | 01 Jul, 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: | NDA019416 |
| 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: | ICU Medical Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 847628
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 0990-7828-08 | 4 POUCH in 1 CASE (0990-7828-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG | 01 Jul, 2019 | 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 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 water sodium hydroxide hydrochloric acid
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. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (see precautions .)
Indications and Usage:
Indications and usage lactated ringerâs irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Warnings:
Warnings for irrigation only. not for injection. irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus this irrigation must be regarded as a systemic drug. absorption of large amounts 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. do not heat container over 66°c (150°f).
Dosage and Administration:
Dosage and administration the dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. when used as a vehicle for other drugs, the manufacturerâs recommendations should be followed. tear at notch and along dotted line and remove container. 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. drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (see precautions .)
Contraindications:
Contraindications not for injection by usual parenteral routes. an electrolyte solution should not be used for irrigation during electrosurgical procedures.
Adverse Reactions:
Adverse reactions possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. accidental contamination from careless technique may transmit infection. should any adverse reaction occur, discontinue the irrigant, 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. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (see precautions .)
Use in Pregnancy:
Pregnancy category c. animal reproduction studies have not been conducted with lactated ringerâs irrigation. it is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. it should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use: the safety and effectiveness of lactated ringerâs irrigation have not been established. its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
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 lactated ringerâs irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. the composition is based on a modification of the injectable formula originally known as hartmannâs solution. each 100 ml of lactated ringerâs irrigation contains: sodium chloride 600 mg; sodium lactate, anhydrous 310 mg; potassium chloride 30 mg; calcium chloride, dihydrate 20 mg. the ph is 6.6 (6.0 â 7.5). the solution is isotonic (274 mosmol/liter, calc.) and has the following electrolyte content (meq/liter): sodium (na + ) 130; potassium (k + ) 4; calcium (ca ++ ) 3; chloride (cl â ) 109 and lactate (ch 3 ch(oh)coo â ) 28. contains sodium hydroxide and may contain hydrochloric acid for ph adjustment. the solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose or short procedure irrigation. when smaller volumes are required, the unused portion should be discarded. lactated ringerâs irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. calcium chloride, usp is chemically designated calcium chloride, dihydrate (cacl 2 ⢠2h 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 c 3 h 5 nao 3 , 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 its 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 lactated ringerâs irrigation exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. it also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations. lactated ringerâs irrigation provides an isotonic irrigation with the same ionic constituents as lactated ringerâs injection, usp, a modification of hartmannâs solution. lactated ringerâs irrigation is considered generally compatible with living tissues and organs. 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 a
Read more...s 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 the chief cation of body cells (160 meq/liter of intracellular water). it is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 meq/liter in a healthy adult). 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 in water dissociates to provide sodium (na + ) and lactate (c 3 h 5 o 3 â ) ions. the lactate anion provides an alkalizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. in the liver, the lactate is metabolized to glycogen which is ultimately converted to carbon dioxide and water by oxidative metabolism. the lactate anion acts as a source (alternate) of bicarbonate when normal production and utilization of lactic acid is not impaired as a result of disordered lactate metabolism. since metabolic conversion is dependent on the integrity of cellular oxidative processes, lactate may be inadequate or ineffective as a source of bicarbonate in patients suffering from acidosis associated with shock or other disorders involving reduced perfusion of body tissues. when oxidative activity is intact, one to two hours time is required for metabolism of lactate. 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 lactated ringerâs irrigation is supplied in single-dose 3000 ml flexible irrigation containers (ndc no. 0409â7828â08 / 0990-7828-08). icu medical is transitioning ndc codes from the "0409" to a "0990" labeler code. both ndc codes are expected to be in the market for a period of time. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] protect from freezing. revised: june 2018 en-4659 icu medical, inc., lake forest, illinois 60045 usa
Package Label Principal Display Panel:
Principal display panel - 3000 ml bag label 3000 ml ndc 0990-7828-08 lactated ringer's irrigation each 100 ml contains sodium chloride 600 mg; sodium lactate, anhyd. 310 mg; potassium chloride 30 mg; calcium chloride, dihydrate 20 mg in water for injection. contains naoh and may contain hcl for ph adjustment. electrolytes per 1000 ml (not including ph adjustment): sodium 130 meq; potassium 4 meq; calcium 3 meq; chloride 109 meq; lactate 28 meq. 274 mosmol/liter (calc). ph 6.6 (6.0 to 7.5) sterile nonpyrogenic. isotonic solution for irrigation. contraindications: not for injection. use only if solution is clear and container is undamaged. warnings: do not heat container over 66°c (150°f). single- dose container. contains no bacteriostat. discard unused portion. use aseptic technique. usual dosage: see insert. rx only 3 v contains dehp im-4373 icu medical, inc., lake forest, illinois, 60045, usa icumedical principal display panel - 3000 ml bag label
Principal display panel - pouch label to open tear at notch 2 hdpe do not remove from overwrap until ready for use. after removing the overwrap, check for minute leaks by squeezing container firmly. if leaks are found, discard solution as sterility may be impaired. recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see insert. 98-4321-r14-3/98 principal display panel - pouch label