Lidocaine Hci And Dextrose
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1565Lidocaine Hci And Dextrose is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Lidocaine Hci And Dextrose is 51662-1565. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Lidocaine Hci And Dextrose drug includes Dextrose Monohydrate - 5 g/100mL Lidocaine Hydrochloride Anhydrous - .8 g/100mL . The currest status of Lidocaine Hci And Dextrose drug is Active.
Drug Information:
| Drug NDC: | 51662-1565 |
| 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: | Lidocaine Hci And Dextrose |
| 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: | Lidocaine Hci And Dextrose |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hf Acquisition Co Llc, Dba Healthfirst |
| 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: | DEXTROSE MONOHYDRATE - 5 g/100mL
LIDOCAINE HYDROCHLORIDE ANHYDROUS - .8 g/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: | 17 Jul, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 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: | NDA019830 |
| 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: | HF Acquisition Co LLC, DBA HealthFirst
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1737723
|
| 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: | LX22YL083G
EC2CNF7XFP
|
| 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: | Amide Local Anesthetic [EPC]
Amides [CS]
Antiarrhythmic [EPC]
Local Anesthesia [PE]
|
| 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 |
|---|
| 51662-1565-1 | 250 mL in 1 CONTAINER (51662-1565-1) | 17 Jul, 2021 | 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:
Lidocaine hci and dextrose lidocaine hci and dextrose dextrose monohydrate anhydrous dextrose lidocaine hydrochloride anhydrous lidocaine water
Indications and Usage:
Indications & usage lidocaine hydrochloride administered intravenously is specifically indicated in the acute management of (1) ventricular arrhythmias occurring during cardiac manipulations, such as cardiac surgery and (2) life-threatening arrhythmias which are ventricular in origin, such as occur during acute myocardial infarction.
Warnings:
Warnings constant monitoring with an electrocardiograph is essential to the proper administration of lidocaine hydrochloride intravenously. signs of excessive depression of cardiac conductivity, such as prolongation of the pr interval, widening of the qrs interval or the appearance or aggravation of arrhythmias, should be followed by prompt cessation of the intravenous infusion of this agent. it is mandatory to have emergency resuscitative equipment and drugs immediately available to manage adverse reactions involving cardiovascular, respiratory, or central nervous systems. occasional acceleration of ventricular rate may occur when lidocaine hydrochloride is administered to patients with atrial fibrillation. evidence for proper usage in pediatric patients is limited. anaphylactic reactions may occur following administration of lidocaine hydrochloride. in the case of severe reaction, discontinue the use of the drug. because dosages of this drug are titrated to response (see dosage and a
Read more...dministration ), no additives should be made to lidocaine hydrochloride and 5% dextrose injection usp.
Dosage and Administration:
Dosage & administration therapy of ventricular arrhythmias is often initiated with a single iv bolus of 1 mg/kg of lidocaine hydrochloride injection usp. following acute treatment by bolus in patients in whom arrhythmias tend to recur and who are incapable of receiving oral antiarrhythmic agents, intravenous infusion of lidocaine hydrochloride and 5% dextrose injection usp is administered continuously. rate of administration adults (20 to 50 mcg/kg/min): pediatric patients (30 mcg/kg/min).1 pharmacokinetic data indicate reduced elimination of lidocaine after prolonged infusion (24 hours) with resultant prolongation of the half-life to approximately three times that seen following a single administration. failure to adjust the rate of infusion in keeping with this altered ability to eliminate lidocaine may result in toxic accumulation of the drug in the patient's serum.2 intravenous infusions of lidocaine hydrochloride must be administered under constant ecg monitoring to avoid potentia
Read more...l overdosage and toxicity. intravenous infusion should be terminated as soon as the patient's basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. it should rarely be necessary to continue intravenous infusions beyond 24 hours. as soon as possible and when indicated, patients should be changed to an oral antiarrhythmic agent for maintenance therapy. caution: concentrated solutions of lidocaine hydrochloride (greater than 0.2%) should be administered by carefully calibrated infusion devices. 1 standards and guidelines for cardiopulmonary resuscitation (cpr) and emergency cardiac care (ecc). american heart association, jama 244 (5):453â509, 1980. 2 lelorier j, grenon d, latour y, et al.: pharmacokinetics of lidocaine after prolonged intravenous infusions in uncomplicated myocardial infarction. ann int med 87:700â702, 1977. pediatric use therapy should be initiated with a single iv bolus of 1 mg/kg of lidocaine hydrochloride injection usp. a maintenance intravenous infusion of lidocaine hydrochloride and 5% dextrose injection usp administered at a recommended infusion rate of 30 mcg/kg/min may be given.1 geriatric use patients with reduced hepatic function or diminished hepatic blood flow (as in heart failure and after cardiac surgery), or those over 70 years of age should receive half the usual loading dose and also should be given lower maintenance levels of intravenous lidocaine. patients over 65 years may benefit from dosing based upon body weight (see clinical pharmacology and precautions, geriatric use ). lidocaine hydrochloride should not be added to blood transfusion assemblies. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. dosage
Contraindications:
Contraindications lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. lidocaine should not be used in patients with stokes-adams syndrome, wolff-parkinson-white syndrome, or with severe degrees of sinoatrial, atrioventricular, or intraventricular block. solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
Adverse Reactions:
Adverse reactions systemic reactions of the following types have been reported: central nervous system: light-headedness; drowsiness; dizziness; apprehension; euphoria; tinnitus; blurred or double vision; nausea and vomiting; sensation of heat, cold or numbness; twitching; tremors; convulsions; unconsciousness; respiratory depression and arrest. cardiovascular system: hypotension; cardiovascular arrest; and bradycardia which may lead to cardiac arrest. hematologic effects: methemoglobinemia allergic reactions, including anaphylactic reactions, may occur but are infrequent. there have been no reports of cross-sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine.
Overdosage:
Overdosage overdosage results in systemic toxicity (see adverse reactions ).
Description:
Description lidocaine hydrochloride and 5% dextrose injection usp is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection. lidocaine hydrochloride is designated chemically as 2-(diethylamino)-2',6'-acetoxylidide monohydrochloride. the solution serves as a cardiac antiarrhythmic agent intended for intravenous use. not 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. the closure system has two ports; the one for the administration set has a tamper evident plastic protector. refer to the directions for use of the container. description
Clinical Pharmacology:
Clinical pharmacology lidocaine hydrochloride exerts an antiarrhythmic effect by increasing the electric stimulation threshold of the ventricle during diastole. in usual therapeutic doses, lidocaine hydrochloride produces no change in myocardial contractility, in systemic arterial pressure, or in absolute refractory period. about 90% of an administered dose of the drug is metabolized in the liver. the remaining 10% is excreted unchanged via the kidneys. lidocaine toxicity is related to systemic blood levels. the decreased clearance and longer half-life of lidocaine should be taken into consideration with prolonged (24 hour) infusions. constant rate of infusion may result in toxic accumulation of lidocaine. infusion should be reduced to approximately one-half to compensate for decreased rate of clearance and concomitant or prior administration of propranolol may further increase blood concentrations by as much as 30% in patients without cardiac or hepatic failure. in clinical studies, p
Read more...atients over 65 years showed decreased lidocaine clearance. this was partly due to the tendency of elderly patients to have lower body weight and the increased risk of cardiac failure in these patients. this solution provides approximately 170 calories per liter.
How Supplied:
How supplied lidocaine hydrochloride and 5% dextrose injection usp is supplied sterile and nonpyrogenic in full fill 500 ml and 250 ml excel® containers packaged 24 per case. exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. protect from freezing. it is recommended that the product be stored at room temperature (25°c); however, brief exposure up to 40°c does not adversely affect the product. storage in automated dispensing machines: brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. rotate stock frequently. hs
Package Label Principal Display Panel:
Principal display panel - 51662-1565-1 250 ml container (bag) - label and serialized labeling 51662-1565-1 lidocaine hci and 5% dextrose injection usp, 2g (8mg/ml) 250ml bag bag serialized