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Name:Epinephrine
Manufacturer:General Injectables And Vaccines, Inc.
Category:Prescription Marketed Drugs


EPINEPHRINE  - epinephrine injection, solution 
GENERAL INJECTABLES AND 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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DESCRIPTION

Each mL contains Epinephrine 1 mg (as the hydrochloride), Sodium Chloride 9 mg,
and Water for Injection q.s. Contains no Sulfites. pH adjusted with Hydrochloric Acid and/or
Sodium Hydroxide.
Epinephrine is the active principle of the adrenal medulla. Chemically described as (-)-3,4-
Dihydroxy-α-[(methylamino)methyl] benzyl alcohol.

Formula

CLINICAL PHARMACOLOGY

Epinephrine is a sympathomimetic drug. It activates an
adrenergic receptive mechanism on effector cells and imitates all actions of the sympathetic
nervous system except those on the arteries of the face and sweat glands. Epinephrine acts on
both alpha and beta receptors and is the most potent alpha receptor activator.

INDICATIONS AND USAGE

In general, the most common uses of epinephrine are to relieve
respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to
drugs and other allergens, and to prolong the action of infiltration anesthetics. Its cardiac effects
may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not
used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock.
Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay
fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to
complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness,
urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents;
in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine
contractions. Epinephrine injection can be utilized to prolong the action of intraspinal and local
anesthetics (see CONTRAINDICATIONS).

CONTRAINDICATIONS

Epinephrine is contraindicated in narrow-angle (congestive) glaucoma,
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; in labor because it may delay the second stage; in cardiac dilatation and
coronary insufficiency.

WARNINGS SECTION

Administer with caution to elderly people; to those with cardiovascular disease,
hypertension, diabetes, or hyperthyroidism; in psychoneurotic individuals; and in pregnancy.
Patients with long-standing bronchial asthma and emphysema who have developed
degenerative heart disease should be administered the drug with extreme caution.
Overdosage or inadvertent intravenous injection of epinephrine may cause cerebrovascular
hemorrhage resulting from the sharp rise in blood pressure.
Fatalities may also result from pulmonary edema because of the peripheral constriction and
cardiac stimulation produced. Rapidly acting vasodilators such as nitrites, or alpha-blocking
agents may counteract the marked pressor effects of epinephrine.

PRECAUTIONS

Epinephrine Injection should be protected from exposure to light. Do not
remove ampules from carton until ready to use. The solution should not be used if its color is
pinkish or darker than slightly yellow or if it contains a precipitate.
Epinephrine is readily destroyed by alkalies and oxidizing agents. In the latter category are
oxygen, chlorine, bromine, iodine, permanganates, chromates, nitrites, and salts of easily
reducible metals, especially iron.

Drug Interactions: Use of epinephrine with excessive doses of digitalis, mercurial diuretics, or
other drugs that sensitize the heart to arrhythmias is not recommended. Anginal pain may be
induced when coronary insufficiency is present.
The effects of epinephrine may be potentiated by tricyclic antidepressants; certain
antihistamines, e.g., diphenhydramine, tripelennamine, d-chlorpheniramine; and sodium Ithyroxine.
Pregnancy: Teratogenic effects: Pregnancy Category C: Safety for use in pregnancy has not
been established. Use of epinephrine in women of childbearing potential requires that anticipated
benefits be weighed against possible hazards.

ADVERSE REACTIONS

Transient and minor side effects of anxiety, headache, fear, and
palpitations often occur with therapeutic doses, especially in hyperthyroid individuals. Repeated
local injections can result in necrosis at sites of injection from vascular constriction. “Epinephrinefastness”
can occur with prolonged use.

DOSAGE AND ADMINISTRATION

Intramuscularly or subcutaneously — 0.2 to 1 mL. Start with
a small dose and increase if required.
Note: The subcutaneous is the preferred route of administration. If given intramuscularly,
injection into the buttocks should be avoided.
For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum
sickness, anaphylactic shock, use epinephrine subcutaneously. For bronchial asthma in pediatric
patients, administer 0.01 mL/kg or 0.3 mL/m2 to a maximum of 0.5 mL subcutaneously, repeated
every four hours if required.
For cardiac resuscitation — A dose of 0.5 mL diluted to 10 mL with sodium chloride injection can
be administered intravenously or intracardially to restore myocardial contractility. External
cardiac massage should follow intracardial administration to permit the drug to enter coronary
circulation. The drug should be used secondarily to unsuccessful attempts with physical or
electromechanical methods.
Intraspinal use — Usual dose is 0.2 to 0.4 mL added to anesthetic spinal fluid mixture (may
prolong anesthetic action by limiting absorption). For use with local anesthetic - Epinephrine
1:100,000 to 1:20,000 is the usual concentration employed with local anesthetics.
Ophthalmologic use (for producing conjunctival decongestion, to control hemorrhage, produce
mydriasis and reduce intraocular pressure) — Use concentration of 1:10,000 to 1:1,000.
Store below 23°C (73°F). Do not freeze.
Protect from light (see PRECAUTIONS).
Parenteral drug products should be inspected visually for particulate matter and discoloration,
whenever solution and container permit.

HOW SUPPLIED

Sterile solution containing Epinephrine 1 mg (as the hydrochloride) in each
1 mL ampule. Supplied in a box of 25 Ampules.

SAMPLE OUTER PACKAGE LABEL

Image of package Label


EPINEPHRINE 
epinephrine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-019(NDC:0517-1130)
Route of Administration INTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Epinephrine (Epinephrine) Epinephrine 1 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-019-05 1 VIAL, MULTI-DOSE ( VIAL) in 1 BAG contains a VIAL, MULTI-DOSE
1 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the BAG (52584-019-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/01/2010

Labeler - GENERAL INJECTABLES AND VACCINES, INC. (108250663)

Revised: 07/2010 GENERAL INJECTABLES AND VACCINES, INC.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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