Epinephrine
Medical Purchasing Solutions, Llc
Human Prescription Drug
NDC 71872-7120Epinephrine is a human prescription drug labeled by 'Medical Purchasing Solutions, Llc'. National Drug Code (NDC) number for Epinephrine is 71872-7120. This drug is available in dosage form of Injection, Solution. 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: | 71872-7120 |
| 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: | Medical Purchasing Solutions, Llc |
| 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: | EPINEPHRINE - .1 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ENDOTRACHEAL
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: | 22 Dec, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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. |
| 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: | Medical Purchasing Solutions, LLC
|
| 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 |
|---|
| 71872-7120-1 | 1 CARTON in 1 BAG (71872-7120-1) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE | 05 Mar, 2018 | 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 sodium chloride sodium metabisulfite anhydrous citric acid trisodium citrate dihydrate epinephrine epinephrine
Indications and Usage:
Indications and usage epinephrine injection, usp is indicated for intravenous injection in (1) treatment of acute hypersensitivity (anaphylactoid reactions to drugs, animal serums and other allergens), (2) treatment of acute asthmatic attacks to relieve bronchospasm not controlled by inhalation or subcutaneous administration of other solutions of the drug and (3) treatment and prophylaxis of cardiac arrest and attacks of transitory atrioventricular (a-v) heart block with syncopal seizures (stokes-adams syndrome). in acute attacks of ventricular standstill, physical measures should be applied first. when external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a pacemaker fail, intracardiac puncture and intramyocardial injection of epinephrine may be effective.
Warnings:
Warnings inadvertently induced high arterial blood pressure may result in angina pectoris, aortic rupture or cerebral hemorrhage. 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 myocardium. parenterally administered epinephrine initially may produce constriction of renal blood vessels and decrease urine formation. epinephrine is the preferred treatment for serious allergic or other emergency situations even though this product contains sodium metabisulfite, a sulfite that may in other products cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons. the alternatives to using epinephrine in a life-threatening situation may not be satisfactory. the presence of a sulfite(s) in this product should not deter administration of the drug for treatment of seriou
Read more...s allergic or other emergency situations.
Dosage and Administration:
Dosage and administration epinephrine injection, usp is administered by intravenous injection and/or in cardiac arrest, by intracardiac injection into the left ventricular chamber or via endotracheal tube directly into the bronchial tree. the adult intravenous dose for hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg (1 to 2.5 ml of 0.1 mg/ml solution), injected slowly. neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks. in cardiac arrest, 0.5 to 1.0 mg (5 to 10 ml of 0.1 mg/ml solution) may be given. during a resuscitation effort, 0.5 mg (5 ml) should be administered intravenously every five minutes. 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. the intracardiac dose usually
Read more...ranges from 0.3 to 0.5 mg (3 to 5 ml of 0.1 mg/ml solution). alternatively, if the patient has been intubated, epinephrine can be injected via the endotracheal tube directly into the bronchial tree at the same dosage as for intravenous injection. it is rapidly absorbed through the lung capillary bed. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (see precautions .) to prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.
Contraindications:
Contraindications epinephrine is contraindicated in patients with known hypersensitivity to sympathomimetic amines, in patients with angle closure glaucoma, and patients in shock (nonanaphylactic). it should not be used in patients anesthetized with agents such as cyclopropane or halothane as these may sensitize the heart to arrhythmic action of sympathomimetic drugs. epinephrine should not ordinarily 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 side effects of anxiety, headache, fear and palpitations occur with systemic therapeutic doses, especially in hyperthyroid individuals. adverse effects such as cardiac arrhythmias and excessive rise in blood pressure may also occur with therapeutic doses or inadvertent overdosage. other adverse reactions include cerebral hemorrhage, hemiplegia, subarachnoid hemorrhage, anginal pain in patients with angina pectoris, anxiety, restlessness, throbbing headache, tremor, weakness, dizziness, pallor and respiratory difficulty.
Overdosage:
Overdosage erroneous administration of large doses of epinephrine may lead to precordial distress, vomiting, headache, dyspnea, as well as unusually elevated blood pressure. (see warnings .) toxic effects of overdosage can be counteracted by injection of an alpha-adrenergic blocker and a beta-adrenergic blocker. in the event of a sharp rise in blood pressure, rapid-acting vasodilators such as the nitrites, or alpha-adrenergic blocking agents can be given to counteract the marked pressor effect of large doses of epinephrine.
Description:
Description epinephrine injection, usp is a sterile, nonpyrogenic solution administered parenterally by the intravenous or intracardiac (left ventricular chamber) routes, or via endotracheal tube into the bronchial tree. each milliliter (ml) contains epinephrine 0.1 mg; sodium chloride 8.16 mg; sodium metabisulfite added 0.46 mg; citric acid, anhydrous 2 mg and sodium citrate, dihydrate 0.6 mg added as buffers. may contain additional citric acid and/or sodium citrate for ph adjustment. ph 3.3 (2.2 to 5.0). epinephrine injection, usp is oxygen sensitive. the solution contains no bacteriostat or antimicrobial agent and is intended for use only as a single-dose injection. when smaller doses are required the unused portion should be discarded. epinephrine injection, usp is a parenteral adrenergic (sympathomimetic) agent and cardiac stimulant. the drug belongs to the group of endogenous compounds known as catecholamines. sodium chloride, usp is chemically designated nacl, a white crystalline powder freely soluble in water. epinephrine, usp is chemically designated 4-[1-hydroxy-2-(methylamino) ethyl]-1, 2 benzenediol, a white, microcrystalline powder. with acids, it forms salts that are freely soluble in water. epinephrine has the following structural formula: structural formula epinephrine
Clinical Pharmacology:
Clinical 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 intravenous injection, it produces a rapid rise in blood pressure, mainly systolic, by (1) direct stimulation of cardiac muscle which increases the strength of ventricular contraction, (2) increasing the heart rate and (3) constriction of the arterioles in the skin, mucosa and splanchnic areas of the circulation. when given by slow intravenous injection, epinephrine usually produces only a moderate rise in systolic and a fall in diastolic pressure. although some increase in pulse pressure occurs, there is usually no great elevation in mean blood pressure. accordingly, the compensatory reflex mechanisms that come into play with a pronounced increase in blood pressure
Read more... 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 decreases by action of epinephrine on beta receptors of the skeletal muscle vasculature and blood flow is thereby enhanced. usually this vasodilator effect of the drug on the circulation predominates so that the modest rise in systolic pressure which follows slow injection or absorption is mainly 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. epinephrine relaxes the smooth muscles 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. intravenous injection produces an immediate and intensified response. following intravenous injection epinephrine disappears rapidly from the blood stream. epinephrine is rapidly inactivated in the body and is degraded by enzymes in the liver and other tissues. the larger portion of injected doses is excreted in the urine as inactivated compounds and the remainder either partly unchanged or conjugated. the drug becomes fixed in the tissues and is inactivated chiefly by enzymatic 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 (vanillyl-mandelic acid: vma) which also is detectable in the urine. sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (na + ) and chloride (cl â ) ions.
How Supplied:
How supplied epinephrine injection, usp is supplied in single-dose containers as follows: unit of sale total strength/ total volume (concentration) each ndc 0409-4901-18 bundle of 10 1 mg/10 ml (0.1 mg/ml) ndc 0409-4901-10 10 ml single-dose abboject⢠glass syringe (18 g x 3 1/2 inch) ndc 0409-4921-34 bundle of 10 1 mg/10 ml (0.1 mg/ml) ndc 0409-4921-20 10 ml single-dose lifeshield⢠abboject⢠glass syringe abboject⢠lifeshield⢠unit of use syringe with protected needle and male luer lock adapter. (20 g x 1 1/2 inch) store at 20 to 25ºc (68 to 77ºf). [see usp controlled room temperature.] protect from light. to prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand. hospira, inc., lake forest, il 60045 usa abboject⢠is a trademark of abbott laboratories. lab-1136-1.0 revised: 09/2017 hospira logo
Package Label Principal Display Panel:
Principal display panel - 10 ml syringe label - 4921 10 ml single-dose ndc 0409-4921-20 epinephrine injection., usp 1 mg/10 ml (0.1 mg/ml) rx only ph 3.3 (2.2 to 5.0). for intravenous use. see insert for dosage and administration. sterile, nonpyrogenic. hospira, inc. lake forest, il 60045 usa rl - 5185 principal display panel - 10 ml syringe label - 4921
Ca-4216 carton ndc 0409-4921-20
Outer package label ndc 71872-7120-1 pdp