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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.
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DOSAGE AND ADMINISTRATION
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, USP, 1:1000) or the EpiPen Jr auto injector (0.3 mL epinephrine injection, USP. 1:2000) intramuscularly into the anterolateral aspect of the thigh, through clothing if necessary. See detailed Directions for Use on the accompanying Patient Instructions.
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.
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HOW SUPPLIED
EpiPen® auto-injectors (epinephrine injections, USP, 1:1000, 0.3 mL) are available in individual cartons, NDC 49502-500-01, and as EpiPen 2-Pak®, NDC 49502-500-02, a pack that contains two EpiPen auto-injectors (epinephrine injections, USP, 1:1000, 0.3 mL) and one EpiPen trainer device.
EpiPen® Jr auto-injectors (epinephrine injection, USP, 1:2000, 0.3 mL) are available in individual cartons, NDC 49502-501-01, and as EpiPen Jr 2-Pak®, NDC 49502-501-02, a pack that contains two EpiPen Jr auto-injectors (epinephrine injections, USP, 1:2000, 0.3 mL) and one EpiPen trainer device.
Each EpiPen and EpiPen Jr auto-injector comes in an individual carrying case that provides built-in needle protection after use. EpiPen 2-Pak and EpiPen Jr 2-Pak also include a S-clip to clip two cases together.
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) (See USP Controlled Room Temperature). Contains no latex. Protect from light.
Rx only.
MANUFACTURED FOR DEY ® , NAPA, CALIFORNIA 94558, U.S.A.
by Meridian Medical Technologies, Inc., a subsidiary of
King Pharmaceuticals, Inc., Columbia, MD 21046, U.S.A.
7/05 03-500-04
0001297
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