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Drug Catalog - Product Detail

EPINEPHRINE INJ SOL 0.1MG/ML 10ML X 10

NDC Mfr Size Str Form
00409-4921-34 HOSPIRA 10 1MG/10ML SOLUTION
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Generic Name
EPINEPHRINE
Substance Name
EPINEPHRINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ENDOTRACHEAL
Application Number
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
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
Indications & 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.
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 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.