Lidocaine Hci
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1364Lidocaine Hci is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Lidocaine Hci is 51662-1364. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Lidocaine Hci drug includes Lidocaine Hydrochloride - 20 mg/mL . The currest status of Lidocaine Hci drug is Active.
Drug Information:
| Drug NDC: | 51662-1364 |
| 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 |
| 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 |
| 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: | LIDOCAINE HYDROCHLORIDE - 20 mg/mL
|
| 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: | 08 Dec, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | NDA017584 |
| 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, 2024 |
| 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: | 1737761
|
| 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. |
| UPC: | 0363323208011
0363323208059
|
| UPC stands for Universal Product Code. |
| UNII: | V13007Z41A
|
| 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 |
|---|
| 51662-1364-1 | 5 mL in 1 VIAL, SINGLE-DOSE (51662-1364-1) | 08 Dec, 2019 | N/A | No |
| 51662-1364-3 | 25 POUCH in 1 CASE (51662-1364-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1364-2) / 5 mL in 1 VIAL, SINGLE-DOSE | 08 Jan, 2023 | 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 lidocaine hci hydrochloric acid sodium chloride sodium hydroxide lidocaine hydrochloride lidocaine lidocaine
Indications and Usage:
Indications & usage lidocaine hydrochloride injection, usp administered intravenously is specifically indicated in the acute management of 1) ventricular arrhythmias occurring during cardiac manipulation such as cardiac surgery, and 2) life-threatening arrhythmias, particularly those which are ventricular in origin, such as those which occur during acute myocardial infarction.
Warnings:
Warnings constant monitoring of the electrocardiogram and blood pressure is essential in the proper administration of lidocaine hydrochloride injection, usp intravenously. if hypotension or excessive depression of cardiac conductivity (such as prolongation of the pr interval and qrs complex and the appearance of aggravation of arrhythmias) is seen, administration of lidocaine hydrochloride injection, usp should be discontinued. emergency resuscitative equipment and drugs must be immediately available to manage possible adverse reactions involving the cardiovascular, respiratory, or central nervous system. occasional acceleration of ventricular rate may occur when lidocaine hydrochloride injection, usp is administered to patients with atrial fibrillation. toxicity may be manifest as central nervous system depression (sedation) or irritability (twitching), which may progress to frank convulsions accompanied by respiratory depression and/or arrest. early recognition of premonitory signs,
Read more...assurance of adequate oxygenation and (where necessary) establishment of artificial airway with ventilatory support are essential to management of the problem. should convulsions persist despite ventilatory support, small doses of anticonvulsant drugs may be used intravenously. examples of such drugs include benzodiazepines (e.g., diazepam, lorazepam), or an ultrashort acting barbiturate (e.g., thiopental or thiamylal). if the patient is under anesthesia, a short-acting muscle relaxant (succinylcholine) may be used. longer acting drugs should be used only when recurrent convulsions are evidenced.
Dosage and Administration:
Doaage & administration adult for direct injectionâthe usual dose is 50 to 100 mg administered intravenously under ecg monitoring. this dose may be administered at the rate of approximately 25 to 50 mg/min. sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action. if the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be repeated after 5 minutes. no more than 200 to 300 mg of lidocaine hydrochloride injection, usp should be administered during a one hour period. this product is for direct injection only. for continuous infusion protocol, see prescribing information for lidocaine hydrochloride, usp for infusion solution. pediatric although controlled clinical studies to establish pediatric dosing schedules have not been conducted, the american heart associationâs standards and guidelines recommends a bolus dose of 1 mg/kg followed by an infusion rate of 30 mcg/kg/min. this product is for dir
Read more...ect injection only. for continuous infusion protocol, see prescribing information for lidocaine hydrochloride, usp for infusion solution. sterilization, storage and technical procedures it is recommended that chemical disinfection be accomplished by wiping the vial thoroughly with cotton or gauze that has been moistened with either 91% isopropyl alcohol or 70% ethyl alcohol, just prior to use. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications lidocaine hydrochloride injection, usp is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. lidocaine hydrochloride injection, usp should not be used in patients with stokes-adams syndrome, wolff-parkinson-white syndrome, or with severe degrees of sinoatrial, atrioventricular or intraventricular block.
Adverse Reactions:
Adverse reactions most adverse reactions accompanying administration of lidocaine hydrochloride injection, usp result from systemic toxicity affecting primarily the central nervous system and the cardiovascular system. systemic reactions of the following types have been reported: 1. central nervous system light-headedness; drowsiness; dizziness; apprehension; euphoria; tinnitus; blurred vision or double vision; vomiting; sensations of heat; cold or numbness; twitching; tremors; convulsions; unconsciousness; respiratory depression and arrest. 2. cardiovascular system hypotension; cardiovascular collapse; and bradycardia which may lead to cardiac arrest. continuous monitoring of blood pressure and the electrocardiogram are essential to prevent these events. 3. allergic reactions may occur but are infrequent. there have been no reports of cross-sensitivity between lidocaine hydrochloride and procainamide or between lidocaine and quinidine.
Overdosage:
Overdosage management of adverse reactionsâ in the case of severe reaction, discontinue the use of lidocaine hydrochloride injection, usp. institute emergency resuscitative procedures and administer the emergency drugs necessary to manage the severe reaction. for severe convulsions, small increments of diazepam or an ultra short-acting barbiturate (thiopental or thiamylal); or if those are not available a short-acting barbiturate (pentobarbital or secobarbital); or if the patient is under anesthesia, a short-acting muscle relaxant (succinylcholine) may be given intravenously. muscle relaxants and intravenous medications should only be used by those familiar with their use. patency of the airway and adequacy of ventilation must be assured. (see warnings ) should circulatory depression occur, vasopressors, such as ephedrine, or meta raminol may be used. should cardiac arrest occur, immediate initiation of standard cpr procedures should commence.
Description:
Description lidocaine hydrochloride, chemical name: acetamide, 2-(diethylamino)-n-(2,6-dimethylphenyl)-, monohydrochloride has the following structural formula: lidocaine hydrochloride injection, usp intravenous for cardiac arrhythmias, is a sterile, nonpyrogenic solution prepared from lidocaine with the aid of hydrochloric acid in water for injection. each ml contains: lidocaine hcl 20 mg; sodium chloride 6 mg; water for injection q.s. hydrochloric acid and/or sodium hydroxide may have been added for ph adjustment (ph 5.0 to 7.0). the container is for single use; solution contains no preservative. structure
Clinical Pharmacology:
Clinicalpharmacology lidocaine hydrochloride exerts its antiarrhythmic effect by raising the electrical stimulation threshold of the ventricle during diastole. in usual therapeutic doses, lidocaine hydrochloride produces no change in myocardial contractility, systemic arterial pressure or in absolute refractory period. onset of action is rapid after an intravenous bolus with a duration of action of approximately 15 to 20 minutes. approximately 90% of an administered dose of lidocaine hydrochloride is metabolized in the liver. the remainder (10%) of the drug is excreted unchanged in the urine. pharmacokinetic data indicate reduced elimination of lidocaine after prolonged (24 hours) infusion with resultant prolongation of the half-life to approximately three times that seen following a single administration.
How Supplied:
How supplied lidocaine hci injection, usp is supplied in the following dosage forms. ndc 51662-1364-1 lidocaine hci injection, usp 2% (100mg/5ml) (20mg/ml) 5ml vial ndc 51662-1364-2 lidocaine hci injection, usp 2% (100mg/5ml) (20mg/ml) 5ml vial,1 vial/pouch ndc 51662-1364-3 lidocaine hci injection, usp 2% (100mg/5ml) (20mg/ml) 5ml vial, 1 vial/pouch, 25 pouches/case hf acquisition co llc, dba healthfirst mukilteo, wa 98275 for direct injection only preservative free discard unused portion. use only if solution is clear and seal intact.
Package Label Principal Display Panel:
Principal display panel - vial label ial label
Principal display panel - serialized labeling serialized labeling
Principal display panel, ndc 51662-1364-2 pouch labeling ndc 51662-1364-2 pouch labeling vial labeling pouch labeling vial label
Principal display panel, ndc 51662-1364-3 case labeling ndc 51662-1364-3 case labeling serialized rfid labeling case labeling serialized label