Epinephrine
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1381Epinephrine is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Epinephrine is 51662-1381. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Epinephrine drug includes Epinephrine - .1 mg/mL . The currest status of Epinephrine drug is Active.
Drug Information:
| Drug NDC: | 51662-1381 |
| 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: | Epinephrine |
| 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: | Epinephrine |
| 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 |
| 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: | EPINEPHRINE - .1 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRACARDIAC
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: | UNAPPROVED DRUG OTHER |
| 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: | 04 Feb, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Jan, 2026 |
| 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. |
| 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: | 727373
|
| 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. |
| NUI: | N0000000209
N0000000245
N0000175552
N0000175555
N0000175570
M0003647
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | YKH834O4BH
|
| 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 MOA: | Adrenergic alpha-Agonists [MoA]
Adrenergic beta-Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | alpha-Adrenergic Agonist [EPC]
beta-Adrenergic Agonist [EPC]
Catecholamine [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Catecholamines [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Adrenergic alpha-Agonists [MoA]
Adrenergic beta-Agonists [MoA]
Catecholamine [EPC]
Catecholamines [CS]
alpha-Adrenergic Agonist [EPC]
beta-Adrenergic Agonist [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 |
|---|
| 51662-1381-1 | 1 VIAL in 1 CARTON (51662-1381-1) / 10 mL in 1 VIAL | 04 Feb, 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:
Epinephrine epinephrine epinephrine epinephrine sodium bisulfite sodium chloride hydrochloric acid sodium citrate citric acid monohydrate
Indications and Usage:
Indications & usage epinephrine epinephrineâs cardiac effects may be of use in the treatment and prophylaxis of cardiac arrest due to various causes in the absence of ventricular fibrillation and attacks of transitory atrioventricular (av) heart block with syncopal seizures (stokes-adams syndrome), but it is not used in cardiac failure or in hemorrhagic, traumatic or in cardiogenic shock. epinephrine may be used to stimulate the heart in syncope due to complete heart block or carotid sinus hypersensitivity. epinephrine is also used for resuscitation in cardiac arrest following anesthetic accidents. in cardiopulmonary resuscitation, intracardiac puncture and intramyocardial injection of epinephrine may be effective when external cardiac compression and attempts to restore the circulation by electrical defibillation or use of a pacemaker fail. epinephrine is seldom used as a vasopressor except in the treatment of anaphylactic shock and under certain conditions in insulin shock.
Warnings:
Warnings epinephrine contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. the overall prevalence of sulfite sensitivity in the general population is unknown and probably low. sulfite sensitivity is seen more frequently in asthmatic rather than in non-asthmatic people. use with caution in the following: elderly; those with cardiovascular disease, hypertension, diabetes, or hyperthyroidism; in psychoneurotic individuals; bronchial asthma and emphysema with degenerative heart disease. cardiovascular effects: inadvertently induced high arterial blood pressure may result in angina pectoris (especially when coronary insufficiency is present), or aortic rupture. epinephrine may induce potentially serious cardiac arrhythmias in patients not suffering from heart disease and patients with organic heart disease or who are receiving drugs that sensitize the m
Read more...yocardium. with epinephrine, a paradoxical but transient lowering of blood pressure, bradycardia and apnea may occur immediately after injection. cerebrovascular hemorrhage: overdosage or inadvertent i.v. injection of epinephrine may cause cerebrovascular hemorrhage resulting from the sharp rise in the blood pressure. pulmonary edema: fatalities may also result from pulmonary edema because of the peripheral constriction and cardiac stimulation produced.
Dosage and Administration:
Dosage & administration epinephrine as cardiac stimulant: intravenous or intracardiac injection administer by i.v. injection and/or in cardiac arrest, by intracardiac injection into the left ventricular chamber. intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route. adult dosage: 1-10 ml (0.1 - 1 mg of epinephrine), repeated every five minutes, if necessary. pediatric dosage: 0.05 - 0.1 ml/ kg of body weight (0.005 - 0.01 mg/ kg) e.g., 2 kg infant would receive 0.1 - 0.2 ml of epinephrine. note: do not inject if fibrillation is occurring. as vasopressor (anaphylaxis): intravenous injection adult dosage: 1-2.5 ml (0.1 - 0.25 mg of epinephrine), administered slowly. may be repeated every 5 to 15 minutes as needed. pediatric dosage: 3 ml (0.3 mg of epinephrine), repeated every 15 minutes for 3 or 4 doses, if necessary. note: parenteral drug products should be inspected visually
Read more... for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications epinephrine should not be used in the presence of cardiac dilatation or coronary insufficiency. epinephrine is contraindicated in shock during general anesthesia with halogenated hydrocarbons or cyclopropane, and in individuals with organic brain damage. epinephrine is also contraindicated with local anesthesia of certain areas; e.g., fingers, toes, because of the danger of vasoconstriction producing sloughing of tissue; also contraindicated in labor because it may delay the second stage. epinephrine should not be used in those cases where vasopressor drugs may be contraindicated, e.g., in thyrotoxicosis, diabetes, in obstetrics when maternal blood pressure is in excess of 130/80, and in hypertension and other cardiovascular disorders.
Adverse Reactions:
Adverse reactions transient and minor: anxiety, headache, fear, and palpitations often occur with therapeutic doses, especially in hyperthyroid and hypertensive individuals. cardiac arrhythmias and excessive rise in blood pressure may occur with therapeutic doses or inadvertent overdosage. local: repeated local injections can result in necrosis at sites of injection from vascular constriction. systemic: cerebral hemorrhage; hemiplegia; subarachnoid hemorrhage; anginal pain in patients with angina pectoris; anxiety; restlessness; throbbing headache; tremor; weakness; dizziness; pallor; respiratory difficulty; palpitation; apprehensiveness; sweating; nausea; vomiting. âepinephrine-fastnessâ can occur with prolonged use.
Overdosage:
Overdosage transient and minor: anxiety, headache, fear, and palpitations often occur with therapeutic doses, especially in hyperthyroid and hypertensive individuals. cardiac arrhythmias and excessive rise in blood pressure may occur with therapeutic doses or inadvertent overdosage. local: repeated local injections can result in necrosis at sites of injection from vascular constriction. systemic: cerebral hemorrhage; hemiplegia; subarachnoid hemorrhage; anginal pain in patients with angina pectoris; anxiety; restlessness; throbbing headache; tremor; weakness; dizziness; pallor; respiratory difficulty; palpitation; apprehensiveness; sweating; nausea; vomiting. âepinephrine-fastnessâ can occur with prolonged use.
Description:
Description epinephrine is the active principle of the adrenal medulla. chemically described as (-)-3,4-dihydroxy-α-[(methyl-amino) methyl] benzyl alcohol, it has the following structural formula: epinephrine is a sterile aqueous solution of epinephrine prepared with the aid of hydrochloric acid. each ml of the solution contains 0.1 mg epinephrine and 1 mg sodium bisulfite. sodium bisulfite is an antioxidant. this solution also contains sodium chloride for adjustment of tonicity, and 10% w/v hydrochloric acid to dissolve epinephrine and to adjust ph to meet usp limits of 2.2 to 5.0. additionally, the solution also contains sodium citrate and citric acid as buffers for stabilization. the air above the liquid in the individual containers have been displaced by flushing with nitrogen during the filling operation. no antimicrobial preservatives have been added and each vial is intended as a single dose; once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit. structure
Clinical Pharmacology:
Clinial pharmacology the actions of epinephrine resemble the effects of stimulation of adrenergic nerves. to a variable degree, it acts on both alpha and beta receptor sites of sympathetic effector cells. its most prominent actions are on the beta receptors of the heart, vascular and other smooth muscle. when given by rapid i.v. injection it produces a rapid rise in blood pressure, mainly systolic, direct stimulation of cardiac muscle which increases the strength of ventricular contraction, increases the heart rate, and constricts the arterioles in the skin, mucosa and splanchnic areas of circulation. epinephrine relaxes the smooth muscle of the bronchi and iris and is a physiologic antagonist of histamine. the drug also produces an increase in blood sugar and glycogenolysis in the liver. blood pressure: when given by slow i.v. injection, epinephrine usually produces a moderate rise in systolic and a fall in diastolic pressure. although some increase in pulse pressure occurs, there is
Read more...usually no great elevation in mean blood pressure. accordingly, the compensatory reflex mechanisms that cause a pronounced increase in blood pressure do not antagonize the direct cardiac actions of epinephrine as much as with catecholamines that have a predominant action on alpha receptors. total peripheral resistance: by action of epinephrine on beta receptors of the skeletal muscle vasculature, total peripheral resistance decreases, and blood flow is thereby enhanced. usually, this vasodilator effect predominates so that the modest rise in systolic pressure which follows slow injection or absorption is the result of direct cardiac stimulation and increase in cardiac output. in some instances, peripheral resistance is not altered or may even rise, owing to a greater ratio of alpha to beta activity in different vascular areas. pharmacokinetics: intravenous injection produces an immediate and intensified response. following i.v. injection, epinephrine disappears rapidly from the blood stream. subcutaneously or i.m. administered epinephrine has a rapid onset and short duration of action. subcutaneous administration during asthmatic attacks may produce bronchodilation within 5 to 10 minutes, and maximal effects may occur within 20 minutes. the drug becomes fixed in the tissues and is rapidly inactivated chiefly by enzymic transformation to metanephrine or normetanephrine, either of which is subsequently conjugated and excreted in the urine in the form of sulfates and glucuronides. either sequence results in the formation of 3-methoxy-4-hydroxy-mandelic acid (vanillylmandelic acid, vma) which is also detectable in the urine.
How Supplied:
How supplied epinephrine is supplied in the following dosage forms. ndc 51662-1381-1 epinephrine inj. usp, 0.1 mg/ml 1mg per 10ml luer-jet⢠syr hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms how supplied
Package Label Principal Display Panel:
Principal display panel - syringe syringe
Principal display panel-51662-1381 carton labeling se3rialized rfid label serialized carton labeling carton labeling