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Epinephrine
Ingredients: Epinephrine
Indications: Rhinitis, allergic; Glaucoma open-angle; Asthma; Serum sickness; Cardiac arrest; Angioedema;
Urticaria; Anaphylaxis; Anesthesia, local adjunct; Anesthesia, spinal adjunct; Uterine contraction inhibition.
Off-label Indications: Not clinically relevant: Hemorrhage, Gastrointestinal; Hemorrhage, Renal Arterial
Pregnancy Category C
FDA Approved 1951-06-01
DRUG CLASS: Adrenergic agonists; Bronchodilators; Inotropes; Ophthalmics.
Brand Names: Adrenalin (US, Bulgaria, Canada, Finland, Norway, Sweden, Turkey); Adrenalin, Topical (US);
Adrenalina (Italy); Adrenalina Sintetica (Switzerland); Adrenaline (Greece, Russia); Adrenaline Aguettant (France);
Adrenaline Injection (Australia, New-Zealand); Adrenalini Bitarticas (Indonesia); Adrenalin Medihaler (Denmark,
Finland); Ana-Guard (South-africa); Anapen (France); Bosmin (Taiwan); Epifrin (New-zealand); Epinefrina (Chile);
Epipen (Canada, Israel, South-africa); EpiPen 2-Pak (US); EpiPen Auto Injector (US); Epipen Jr. 0.15mg Adrenaline
Auto-Injector (Australia); EpiPen JR 2-Pak (US); EpiPen JR Auto-Injector (US); Epipen Junior (Israel); Eppy
(Bulgaria, Ireland, Italy, South-africa, Sweden); Eppy "N" (Israel); Eppystabil (Austria); Glaucon (Czech-republic);
Glaufrin (Sweden); Isopto Epinal (Spain); L-Adrenalin (Austria); Medihaler-Iso (Benin, Burkina-Faso, Ethiopia, Gambia,
Ghana, Guinea, Ivory-Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Kuwait, Oman,
Qutar, Saudi-Arabia, United-Arab-Emirates, Republic of Yemen, Libya, Lebanon, Syria, Nigeria, Senegal, Seychelles,
Sierra-Leone, South-Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe); Posumin (Taiwan); Simplene
(England, Ireland, South-africa); Suprarenin (Austria); Sus-Phrine Injection (US); Weimer Adrenaline (Hong-kong,
Philippines); Weradren (Philippines). (International brand names outside U.S. in italics)
Epinephrine(IM-SC)
DESCRIPTION:
Adrenalin Injection
A sterile solution intended for subcutaneous or intramuscular injection. When diluted, it may also be administered
intracardially or intravenously. Each milliliter contains 1 mg Adrenalin (epinephrine) as the hydrochloride dissolved in
water for injection, with sodium chloride added for isotonicity. The ampoules contain not more than 0.1% sodium
bisulfite as an antioxidant, and the air in the ampoule has been displaced by nitrogen. The Steri-Vials contain 0.5%
Chlorobutanol (chloroform derivative) as a preservative and not more than 0.15% sodium bisulfite as an antioxidant.
Epinephrine is the active principle of the adrenal medulla, chemically described as (--)-3,4-dihydroxy-alpha[(methylamino)methyl] benzyl alcohol.
EpiPen and Epipen Jr
The EpiPen and Epipen Jr auto-injectors contain 2 ml epinephrine injection for emergency intramuscular use. Each
EpiPen auto-injector delivers a single dose of 0.3 mg epinephrine from epinephrine injection, 1:1000 (0.3 ml) in a
sterile solution. Each EpiPen Jr auto-injector delivers a single dose of 0.15 mg epinephrine from epinephrine injection,
1:2000 (0.3 ml) in a sterile solution.
For stability purposes, approximately 1.7 ml remains in the auto-injector after activation and cannot be used.
Each 0.3 ml in EpiPen contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric
acid to adjust pH, and water for injection. The pH range is 2.2-5.0. Each 0.3 ml in EpiPen Jr contains 0.15 mg
epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and water for
injection. The pH range is 2.2-5.0.
Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is B-(3,4-dihydroxyphenyl)-amethylaminoethanol. It deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and
brown from the formation of melanin. Epinephrine solutions which show evidence of discoloration should be replaced.
CLINICAL PHARMACOLOGY:
Adrenalin Injection
Adrenalin 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.
EpiPen and Epipen Jr
Epinephrine is a sympathomimetic drug, acting on both alpha and beta receptors. It is the drug of choice for the
emergency treatment of severe allergic reactions (Type I) to insect stings or bites, foods, drugs, and other allergens. It
can also be used in the treatment of idiopathic or exercise-induced anaphylaxis. Epinephrine when given
subcutaneously or intramuscularly has a rapid onset and short duration of action. The strong vasoconstrictor action of
epinephrine through its effect on alpha adrenergic receptors acts quickly to counter vasodilation and increased
vascular permeability which can lead to loss of intravascular fluid volume and hypotension during anaphylactic
reactions. Epinephrine through its action on beta receptors on bronchial smooth muscle causes bronchial smooth
muscle relaxation which alleviates wheezing and dyspnea. Epinephrine also alleviates pruritis, urticaria, and
angioedema and may be effective in relieving gastrointestinal and genitourinary symptoms associated with
anaphylaxis.
INDICATIONS AND USAGE:
Adrenalin Injection
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, Adrenalin Injection).
EpiPen and Epipen Jr
Epinephrine is indicated in the emergency treatment of allergic reactions (anaphylaxis) to insect stings or bites, foods,
drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis. The EpiPen and EpiPen Jr autoinjectors are intended for immediate self-administration by a person with a history of an anaphylactic reaction. Such
reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia,
thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal
cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritis, rashes, uticaria or angioedema. The
EpiPen and EpiPen Jr are designed as emergency supportive therapy only and are not a replacement or substitute for
immediate medical or hospital care.
CONTRAINDICATIONS:
Adrenalin Injection
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.
EpiPen and Epipen Jr
There are no absolute contraindications to the use of epinephrine in a life-threatening situation.
WARNINGS:
Adrenalin Injection
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.
Epinephrine is the preferred treatment for serious allergic or other emergency situations even though this product
contains sodium bisulfite, 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 in this product should
not deter administration of the drug for treatment of serious allergic or other emergency situations.
EpiPen and Epipen Jr
Epinephrine is light sensitive and should be stored in the tube provided. Store at room temperature (15-30°C/59-86°F).
Do not refrigerate. Before using, check to make sure the solution in the auto-injector is not discolored. Replace the
auto-injector if the solution is discolored or contains a precipitate. Avoid possible inadvertent intravascular
administration. EpiPen and EpiPen Jr should only be injected into the anterolateral aspect of the thigh. DO NOT
INJECT INTO BUTTOCK.
Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to sharp rise in
blood pressure. DO NOT INJECT INTRAVENOUSLY. Rapidly acting vasodilators can counteract the marked pressor
effects of epinephrine.
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 in this product should
not deter administration of the drug for treatment of serious allergic or other emergency situations.
Accidental injection into the hands or feet may result in loss of blood flow to the affected area and should be avoided. If
there is an accidental injection into these areas, advise the patient to go immediately to the nearest emergency room
for treatment. EpiPen and EpiPen Jr should only be injected into the anterolateral aspect of the thigh.
PRECAUTIONS:
Adrenalin Injection General
Adrenalin should be protected from exposure to light. Do not remove ampoules or syringes from carton until ready to
use. The solution should not be used if it 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.
Usage in Pregnancy, Pregnancy Category C
Adrenalin has been shown to be teratogenic in rats when given in doses about 25 times the human dose. There are no
adequate and well-controlled studies in pregnant women. Adrenalin should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
EpiPen and Epipen Jr
Epinephrine is essential for the treatment of anaphylaxis. Patients with a history of severe allergic reactions
(anaphylaxis) to insect stings or bites, foods, drugs, and other allergens as well as idiopathic and exercise-induced
anaphylaxis should be carefully instructed about the circumstances under which this life-saving medication should be
used. It must be clearly determined that the patient is at risk of future anaphylaxis, since the following risks may be
associated with epinephrine administration (see DOSAGE AND ADMINISTRATION, EpiPen and Epipen Jr).
Epinephrine is ordinarily administered with extreme caution to patients who have heart disease. Use of epinephrine
with drugs that may sensitize the heart to arrhythmias, e.g., digitalis, mercurial diuretics, or quinidine, ordinarily is not
recommended. Anginal pain may be induced by epinephrine in patients with coronary insufficiency.
The effects of epinephrine may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors.
Some patients may be at greater risk of developing adverse reactions after epinephrine administration. These include:
hyperthyroid individuals, individuals with cardiovascular disease, hypertension, or diabetes, elderly individuals,
pregnant women, pediatric patients under 30 kg (66 lb) body weight using EpiPen, and pediatric patients under 15 kg
(33 lb) body weight using EpiPen Jr.
Despite these concerns, epinephrine is essential for the treatment of anaphylaxis. Therefore, patients with these
conditions, and/or any other person who might be in a position to administer EpiPen or EpiPen Jr to a patient
experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which this life-saving
medication should be used.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Studies of epinephrine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not
been conducted. This should not prevent the use of this life-saving medication under the conditions noted under
INDICATIONS AND USAGE, EpiPen and Epipen Jr and as indicated under PRECAUTIONS , EpiPen and Epipen Jr.
Usage in Pregnancy, Pregnancy Category C
Epinephrine has been shown to be teratogenic in rats when given in doses about 25 times the human dose. There are
no adequate and well-controlled studies in pregnant women. Epinephrine should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Pediatric Use
Epinephrine may be given safely to pediatric patients at a dosage appropriate to body weight (see DOSAGE AND
ADMINISTRATION, EpiPen and Epipen Jr).
INTERACTIONS:
Adrenalin Injection
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 l-thyroxine.
ADVERSE REACTIONS:
Adrenalin Injection
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. "Epinephrine-fastness" can occur with prolonged use.
EpiPen and Epipen Jr
Side effects of epinephrine may include palpitations, tachycardia, sweating, nausea and vomiting, respiratory difficulty,
pallor, dizziness, weakness, tremor, headache, apprehension, nervousness and anxiety. Cardiac arrhythmias may
follow administration of epinephrine.
OVERDOSAGE:
EpiPen and Epipen Jr
Overdosage or inadvertent intravascular injection of epinephrine may cause cerebral hemorrhage resulting from a
sharp rise in blood pressure. Fatalities may also result from pulmonary edema because of peripheral vascular
constriction together with cardiac stimulation.
DOSAGE AND ADMINISTRATION:
Adrenalin Injection
Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and
container permit. Vial and contents must be discarded 30 days after initial use.
Subcutaneously or intramuscularly: 0.2 to 1 ml (mg). 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 mg/kg or 0.3
mg/m2 to a maximum of 0.5 mg subcutaneously, repeated every 4 hours if required.
For cardiac resuscitation: A dose of 0.5 ml (0.5 mg) 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.
Ophthalmologic use (for producing conjunctival decongestion, to control hemorrhage, produce mydriasis and
reduce intraocular pressure): Use a concentration of 1:10,000 (0.1 mg/ml) to 1:1,000 (1 mg/ml).
Intraspinal use (Amp 88): Usual dose is 0.2-0.4 ml (0.2-0.4 mg) added to anesthetic spinal fluid mixture (may prolong
anesthetic action by limiting absorption).
For use with local anesthetic: Epinephrine 1:100,000 (0.01 mg/ml) to 1:20,000 (0.05 mg/ml) is the usual
concentration employed with local anesthetics.
EpiPen and Epipen Jr
A physician who prescribes EpiPen or EpiPen Jr should take appropriate steps to insure that the patient (or parent)
understands the indications and use of this device thoroughly. The physician should review with the patient or any
other person who might be in a position to administer EpiPen or EpiPen Jr to a patient experiencing anaphylaxis, in
detail, the patient instructions and operation of the EpiPen or EpiPen Jr auto-injector. Inject the delivered dose of the
EpiPen auto-injector (0.3 ml epinephrine injection, 1:1000) or the EpiPen Jr auto injector (0.3ml epinephrine injection,
1:2000) intramuscularly into the anterolateral aspect of the thigh, through clothing if necessary. See detailed Directions
for Use on the Patient Instructions which are distributed with the prescription.
Usual epinephrine adult dose for allergic emergencies is 0.3 mg. For pediatric use, the appropriate dosage may be
0.15 or 0.30 mg depending upon the body weight of the patient. A dosage of 0.01 mg/kg body weight is recommended.
EpiPen Jr, which provides a dosage of 0.15 mg, may be more appropriate for patients weighing less than 30 kg.
However, the prescribing physician has the option of prescribing more or less than these amounts, based on careful
assessment of each individual patient and recognizing the life-threatening nature of the reactions for which this drug is
being prescribed. The physician should consider using other forms of injectable epinephrine if doses lower than 0.15
mg are felt to be necessary.
Each EpiPen or EpiPen Jr contains a single dose of epinephrine. With severe persistent anaphylaxis, repeat injections
with an additional EpiPen may be necessary.
Parenteral drug products should be periodically inspected visually by the patient for particulate matter or discoloration
and should be replaced if these are present.
HOW SUPPLIED:
Adrenalin Injection
Amp 88: Sterile solution containing 1 mg Adrenalin (epinephrine) as the hydrochloride in each 1 ml ampoule (1:1000).
For intramuscular or subcutaneous use. When diluted, it may also be administered intracardially, intravenously, or
intraspinally.
S.V. 11: Sterile solution containing 1 mg Adrenalin (epinephrine) as the hydrochloride (1:1000). For intramuscular or
subcutaneous use. When diluted, it may also be administered intracardially or intravenously. Supplied in a 30 ml SteriVial (rubber-diaphragm-capped vial).
Storage
Store between 15 and 25°C (59 and 77°F). Protect from light and freezing.
EpiPen and Epipen Jr
EpiPen auto-injectors (epinephrine injections, 1:1000, 0.3 ml) are available in individual cartons, and as EpiPen 2-Pak,
a pack that contains two EpiPen auto-injectors (epinehrine injections, 1:1000, 0.3 ml) and one EpiPen trainer device.
EpiPen Jr auto-injectors (epinephrine injection, 1:2000, 0.3 ml) are available in individual cartons, and as EpiPen Jr 2Pak, a pack that contains two EpiPen Jr auto-injectors (epinehrine injections, 1:2000, 0.3 ml) and one EpiPen trainer
device.
Storage:
Store in a dark place at room temperature (15-30°C/59-86°F). Do not refrigerate. Contains no latex.
Epinephrine(Inhalation)
DESCRIPTION:
Note: The trade names have been used throughout this monograph for clarity.
Each ml contains 10 mg Adrenalin (epinephrine) as the hydrochloride, dissolved in sodium chloride-citrate buffer
solution with 0.2 mg Phemerol (benzethonium chloride) as a preservative and not more than 0.2% sodium bisulfite as
an antioxidant.
INDICATIONS AND USAGE:
For temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma. The inhalation of
Adrenalin Chloride solution 1:100 eases breathing for asthma patients by reducing spasms of bronchial muscles.
WARNINGS:
Adrenalin Chloride solution 1:100 is supplied for use by oral (not nasal) inhalation only. Because of the relatively high
concentration, Adrenalin Chloride solution 1:100 is not suitable for hypodermic injection.
Do not use this product unless a diagnosis of asthma has been made by a physician.
Do not use this product if you have heart disease, high blood pressure, thyroid disease, or difficulty in urination due to
enlargement of the prostate gland unless directed by a physician.
Do not use this product if you have ever been hospitalized for asthma or if you are taking any prescription drug for
asthma unless directed by a physician.
Drug interaction precaution: Do not use this product if you are presently taking a prescription drug for high blood
pressure or depression without first consulting your physician.
Do not use this product more frequently or at higher doses than recommended unless directed by a physician.
Excessive use may cause nervousness and rapid heart beat and, possibly, adverse effects on the heart.
Do not continue to use this product but seek medical assistance immediately if symptoms are not relieved
within 20 minutes or become worse.
Do not use the inhalation solution if it is pinkish or darker than slightly yellow or if it contains a precipitate.
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this
product.
DOSAGE AND ADMINISTRATION:
For relief of bronchial congestion in asthma, Adrenalin Chloride solution 1:100 should be applied with a glass or plastic
nebulizer capable of delivering a very fine spray, and which will work with a very small amount of solution.
Approximately 10 drops (not more) of Adrenalin Chloride solution 1:100 are placed in the reservoir of the nebulizer, the
nozzle of which is placed just inside the partially opened mouth. As the bulb is squeezed once or twice the patient
inhales deeply, drawing the vaporized solution into the lungs. Treatment should be started at the first symptoms.
Rinsing the mouth with water immediately after using Adrenalin Chloride solution 1:100 will help prevent the sensation
of dryness of mouth and throat which may otherwise follow.
Inhalation dosage for adults, children, and adolescents 4 years of age and older: 1-3 inhalations not more often
than every 3 hours. The use of this product by children and adolescents should be supervised by an adult.
Pediatric patients under 4 years of age: Consult a physician.
When the nebulizer contains any liquid and is not in use, it should be stoppered and kept in an upright position.
Because of oxidation, Adrenalin Chloride solution 1:100 will turn pink to brown when exposed to air. Light, heat,
alkalies, and certain metals (e.g., copper, iron, zinc) will also promote deterioration. A discolored inhalation solution or
one containing a precipitate should not be used.
HOW SUPPLIED:
Adrenalin Chloride solution 1:100 (epinephrine inhalation solution), for oral inhalation use. Supplied in bottles
containing ¼ fluid ounce (7.5 ml) each.
Storage: Store between 15 and 25°C (59 and 77°F). Protect from light and freezing.
Epinephrine(Ophthalmic)
DESCRIPTION:
Note: The trade names have been used throughout this monograph for clarity.
Epifrin (epinephrine) sterile ophthalmic solution is a topical sympathomimetic agent for ophthalmic use.
Chemical Name: 1,2-benzenediol,4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-.
Contains:
Active: Epinephrine, 0.5%, 1%, 2%
Preservative: Benzalkonium chloride
Inactives: Sodium metabisulfite; edetate disodium; hydrochloric acid; and purified water.
CLINICAL PHARMACOLOGY:
Epinephrine is an adrenergic agonist that stimulates α- and β-adrenergic receptors. The capacity of Epifrin to decrease
the aqueous inflow in open-angle glaucoma has been well documented. Studies have also shown that prolonged
topical epinephrine therapy offers significant improvement in the coefficient of aqueous outflow.
Epifrin is effective alone in reducing intraocular pressure and is particularly useful in combination with miotics or betaadrenergic blocking agents for the difficult-to-control patients. The addition of Epifrin to the patient's regimen often
provides better control of intraocular pressure than the original agent alone.
INDICATIONS AND USAGE:
Epifrin is indicated for the treatment of chronic simple glaucoma.
CONTRAINDICATIONS:
Epifrin should not be used in patients who have had an attack of narrow-angle glaucoma, since dilation of the pupil
may trigger an acute attack. Do not use if hypersensitive to any ingredient.
WARNINGS:
Epifrin should be used with caution in patients with a narrow angle, since dilation of the pupil may trigger an acute
attack of narrow-angle glaucoma.
Use with caution in patients with hypertensive cardiovascular disease or coronary artery disease.
Epinephrine has been reported to produce reversible macular edema in some aphakic patients and should be used
with caution in these patients.
Contains sodium metabisulfite, 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 than in nonasthmatic people.
PRECAUTIONS:
General
Epinephrine in any form is relatively uncomfortable upon instillation. However, discomfort lessens as the concentration
of epinephrine decreases. Epifrin is not for injection.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
No studies have been conducted in animals or in humans to evaluate the potential of these effects.
Pregnancy Category C
Animal reproduction studies have not been conducted with epinephrine. It is also not known whether epinephrine can
cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Epinephrine should
be given to a pregnant woman only if clearly needed.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS:
Undesirable reactions to topical epinephrine include eye pain or ache, browache, headache, conjunctival hyperemia
and allergic lid reactions.
Adrenochrome deposits in the conjunctiva and cornea after prolonged epinephrine therapy have been reported.
Topical epinephrine has been reported to produce reversible macular edema in some aphakic patients.
OVERDOSAGE:
Accidental ingestion will not cause problems because pharmacologically active concentrations of epinephrine cannot
be achieved orally in man. Should accidental overdosage in the eye(s) occur, flush eye(s) with water or normal saline.
DOSAGE AND ADMINISTRATION:
The usual dosage is 1 drop in the affected eye(s) once or twice daily. However, the dosage should be adjusted to meet
the needs of the individual patients. This is made easier with Epifrin sterile ophthalmic solution available in three
strengths.
HOW SUPPLIED:
Epifrin is available on prescription only in plastic dropper bottles containing 15 ml of a 0.5%, 1% or 2% solution.
Note: Protect from light and excessive heat. If the solution discolors or a precipitate forms, it should be discarded.