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Basic Drug Info
Drug Name:EpiPen
Manufacturer:DEY
Other Info:

PRESCRIBING INFORMATION(PHARMACIST - PLEASE REMOVE BEFORE DISPENSING)EPIPEN® 0.3 mg EPINEPHRINE AUTO-INJECTORAuto-Injector for Intramuscular Injection of EpinephrineFor the Emergency Treatment of Allergic Reactions (Anaphylaxis)Delivers a single 0.3 mg intramuscular dose of epinephrine from epinephrine injection, USP, 1:1000 (0.3 mL).EPIPEN® JR 0.15 mg EPINEPHRINE AUTO-INJECTORAuto-Injector for Intramuscular Injection of EpinephrineFor the Emergency Treatment of Allergic Reactions (Anaphylaxis)Delivers a single 0.15 mg intramuscular dose of epinephrine from epinephrine injection, USP, 1:2000 (0.3 mL).IMPORTANT INFORMATIONDO NOT REMOVE GRAY SAFETY RELEASE UNTIL READY FOR USE.A SINGLE DOSE OF 0.3 ML OF SOLUTION IS DISPENSED.

THE MAJORITY OF THE DRUG PRODUCT, 1.7 ML, REMAINS IN THE AUTO-INJECTOR AFTER ACTIVATION AND CANNOT BE USED.THE UNIT CONTAINS NO LATEX.



Clinical Trials:


Indications and Usage

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 auto-injectors 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.
Allergic Reaction --

Syncope -- A transient loss of consciousness and postural tone caused by diminished blood flow to the brain (i.e., BRAIN ISCHEMIA). Presyncope refers to the sensation of lightheadedness and loss of strength that precedes a syncopal event or accompanies an incomplete syncope. (From Adams et al., Principles of Neurology, 6th ed, pp367-9)

Tachycardia -- Abnormally rapid heartbeat, usually with a HEART RATE above 100 beats per minute for adults. Tachycardia accompanied by disturbance in the cardiac depolarization (cardiac arrhythmia) is called tachyarrhythmia.

Convulsions -- the most dramatic type of seizure, characterized by tonic and clonic contraction of most skeletal muscles.

Vomiting -- The forcible expulsion of the contents of the STOMACH through the MOUTH.

Diarrhea -- An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.

Abdominal Cramps --

Wheezing --

Dyspnea -- Difficult or labored breathing.

LARYNGISMUS -- A disorder in which the adductor muscles of the VOCAL CORDS exhibit increased activity leading to laryngeal spasm. Laryngismus causes closure of the VOCAL FOLDS and airflow obstruction during inspiration.

Pruritus -- An intense itching sensation that produces the urge to rub or scratch the skin to obtain relief.

Exanthema -- Diseases in which skin eruptions or rashes are a prominent manifestation. Classically, six such diseases were described with similar rashes; they were numbered in the order in which they were reported. Only the fourth (Duke's disease), fifth (ERYTHEMA INFECTIOSUM), and sixth (EXANTHEMA SUBITUM) numeric designations survive as occasional synonyms in current terminology.

Angioedema -- Swelling involving the deep DERMIS, subcutaneous, or submucosal tissues, representing localized EDEMA. Angioedema often occurs in the face, lips, tongue, and larynx.

Contraindications
There are no absolute contraindications to the use of epinephrine in a life-threatening situation.
Warnings

Epinephrine is light sensitive and should be stored in the tube provided.

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) (See USP Controlled Room Temperature).

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 affectedarea 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.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.