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EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
Anaphylactic 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, pruritus, rashes, urticaria or angioedema.
EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.
DOSAGE AND ADMINISTRATION
Selection of the appropriate dosage strength (EpiPen 0.3 mg or EpiPen Jr 0.15 mg) is determined according to patient body weight.
- Patients greater than or equal to 30 kg (approximately 66 pounds or more): EpiPen 0.3 mg
- Patients 15 to 30 kg (33 pounds to 66 pounds): EpiPen Jr 0.15 mg
Inject EpiPen or EpiPen Jr intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed an EpiPen or EpiPen Jr and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see WARNINGS AND PRECAUTIONS].
Each EpiPen or EpiPen Jr contains a single dose of epinephrine for single-use injection. Since the doses of epinephrine delivered from EpiPen or EpiPen Jr are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. Wit h severe persist ent anaph yl ax is , repeat injections with an additional EpiP en or EpiPen Jr ma y be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see WARNINGS AND PRECAUTIONS].
The epinephrine solution in the clear window of t he EpiPen Auto-Injector should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light [see HOW SUPPLIED/Storage and Handling].
Dosage Forms And Strengths
- EpiPen: Injection, 0.3 mg/0.3 mL (0.3 mL, 1:1000) epinephrine injection, USP, pre-filled auto-injector
- EpiPen Jr: Injection, 0.15 mg/0.3 mL, (0.3 mL 1:2000) epinephrine injection, USP, pre-filled auto-injector
EpiPen Auto-Injectors (epinephrine injections, USP, 1:1000, 0.3 mL) are available as EpiPen 2Pak®, NDC 49502-500-02, a pack that contains two EpiPen Auto-Injectors (epinephrine injections, USP, 1:1000, 0.3 mL) and one EpiPen Auto-Injector trainer device.
EpiPen Jr Auto-Injectors (epinephrine injections, USP, 1:2000, 0.3 mL) are available 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 Auto-Injector trainer device.
Storage And Handling
Protect from light. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.
Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company. Revised: May 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/7/2016
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