EPINEPHRINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH)

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

Epinephrine

Composition:

Epinephrine 0.1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 anesthetiz

Product summary:

Epinephrine Injection, USP is supplied in single-dose containers as follows: 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 Hospira Logo Abboject™ is a trademark of Abbott Laboratories. LAB-1136-1.0 Revised: 09/2017

Authorization status:

unapproved drug other

Summary of Product characteristics

EPINEPHRINE- EPINEPHRINE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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EPINEPHRINE 1:10,000 0.1 MG/ML INJECTION, USP 10 ML PREFILLED SYRINGE
DESCRIPTION
EPINEPHRINE
INJECTION, USP
1 MG/10 ML (0.1 MG/ML)
ABBOJECT™ SYRINGE
FLIPTOP VIAL
PROTECT SOLUTION FROM LIGHT;
DO NOT USE THE INJECTION IF ITS COLOR IS
PINKISH OR DARKER THAN SLIGHTLY YELLOW
OR IF IT CONTAINS A PRECIPITATE.
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:
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