FULL PRESCRIBING INFORMATION
1INDICATIONS AND USAGEEpiPen®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.
2DOSAGE AND ADMINISTRATIONSelection 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 (5.2)].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. With severe persistent anaphylaxis, repeat injections with an additional EpiPen® or EpiPen Jr® may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Warnings and Precautions (5.1)].
The epinephrine solution in the clear window of the 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 (16.2)].
3DOSAGE 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