Epipen (Epinephrine Injection) - Summary

EPIPEN SUMMARY

Each EpiPen^® Auto-Injector delivers a single dose of 0.3 mg epinephrine injection, USP, 1:1000 (0.3 mL) in a sterile solution. Each EpiPen^® Jr Auto-Injector delivers a single dose of 0.15 mg epinephrine injection, USP, 1:2000 (0.3 mL) in a sterile solution. The EpiPen^® and EpiPen^® Jr Auto-Injectors each contain 2 mL epinephrine solution. Approximately 1.7 mL remains in the auto-injector after activation and cannot be used. Each 0.3 mL in the EpiPen^® Auto-Injector 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 the EpiPen^® Jr Auto-Injector 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.

EpiPen^® and EpiPen^® Jr Auto-Injectors 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, mosquitos), 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 Auto-Injectors 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. Selection of the appropriate dosage strength is determined according to patient body weight (see DOSAGE AND ADMINISTRATION section).

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, pruritus, rashes, urticaria or angioedema.

EpiPen^® and EpiPen^® Jr Auto-Injectors are intended for immediate self-administration as emergency supportive therapy only and are not a substitute for immediate medical care.

See all Epipen indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Epipen (Epinephrine Injection)

Pfizer Did Not Investigate EpiPen Problems: FDA
Source: MedicineNet Allergy Specialty [2017.09.11]
Title: Pfizer Did Not Investigate EpiPen Problems: FDA
Category: Health News
Created: 9/8/2017 12:00:00 AM
Last Editorial Review: 9/11/2017 12:00:00 AM

Morning Break: Barcelona Attack Fails to Derail ESC; EpiPen Settlement; Drug Patent Lo$$e$
Source: MedPage Today Allergy & Immunology [2017.08.18]
(MedPage Today) -- Health news and commentary from around the Web gathered by the MedPage Today staff

EpiPen Maker Settles Government Lawsuit for $465 Million
Source: MedicineNet Allergy Specialty [2017.08.18]
Title: EpiPen Maker Settles Government Lawsuit for $465 Million
Category: Health News
Created: 8/18/2017 12:00:00 AM
Last Editorial Review: 8/18/2017 12:00:00 AM

Expired EpiPens May Still Help Save a Life: Study
Source: MedicineNet Anaphylaxis Specialty [2017.05.09]
Title: Expired EpiPens May Still Help Save a Life: Study
Category: Health News
Created: 5/9/2017 12:00:00 AM
Last Editorial Review: 5/9/2017 12:00:00 AM

Global EpiPen Recall Now Includes U.S.
Source: MedicineNet Allergy Treatment Begins At Home Specialty [2017.04.03]
Title: Global EpiPen Recall Now Includes U.S.
Category: Health News
Created: 4/2/2017 12:00:00 AM
Last Editorial Review: 4/3/2017 12:00:00 AM

more news >>

Published Studies Related to Epipen (Epinephrine Injection)

Faster onset and more comfortable injection with alkalinized 2% lidocaine with epinephrine 1:100,000. [2013]
(IANBs)... CONCLUSIONS: Alkalinizing lidocaine with epinephrine toward physiologic pH

A comparison of the efficacy of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:80,000 epinephrine in achieving pulpal anesthesia in maxillary teeth with irreversible pulpitis. [2012]
anesthesia in maxillary teeth with irreversible pulpitis... CONCLUSIONS: There was no significant difference in efficacy between 4% articaine

Effect of intravenous lidocaine associated with amitriptyline on pain relief and plasma serotonin, norepinephrine, and dopamine concentrations in fibromyalgia. [2011.05]
OBJECTIVE: The objective of this study was to evaluate the effect of intravenous lidocaine combined with amitriptyline on pain relief and plasma serotonin, norepinephrine, and dopamine levels... CONCLUSIONS: Combined administration of 240 mg intravenous lidocaine (once a week) and 25 mg amitriptyline for 4 weeks did not modify pain intensity or plasma serotonin, norepinephrine, or dopamine concentrations in fibromyalgia patients.

Anesthetic efficacy of 4% Articaine with 1:100,000 epinephrine versus 4% articaine with 1:200,000 epinephrine as a primary buccal infiltration in the mandibular first molar. [2011.04]
INTRODUCTION: No study has compared 4% articaine with 1:100,000 epinephrine with 4% articaine with 1:200,000 epinephrine in a mandibular buccal infiltration of the first molar. The authors conducted a prospective, randomized, double-blind, crossover study comparing the degree of pulpal anesthesia obtained with 4% articaine with 1:100,000 epinephrine and 4% articaine with 1:200,000 epinephrine as a primary infiltration in the mandibular first molar... CONCLUSIONS: The anesthetic efficacy of 4% articaine with 1:200,000 epinephrine is comparable to 4% articaine with 1:100,000 epinephrine in a primary mandibular buccal infiltration of the first molar. Copyright (c) 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Does preincisional injection of levobupivacaine with epinephrine have any benefits for children undergoing tonsillectomy? An intraindividual evaluation. [2010.10]
OBJECTIVE: To evaluate the effects of peritonsillar injection of levobupivacaine with epinephrine in children undergoing adenotonsillectomy, through an intraindividual study... CONCLUSION: Preincisional injection of levobupivacaine with epinephrine decreases early postoperative pain and intraoperative blood loss as well. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

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Clinical Trials Related to Epipen (Epinephrine Injection)

Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext [Completed]
The purpose of the study is to demonstrate non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection. And to evaluate and compare the handling characteristics of two auto-injectors (Jext and EpiPen).

A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine [Completed]
This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.

Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics [Completed]
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated, under augmented dose conditions.

Make up for the Epinephrine Autoinjector [Completed]
Part of the problems related with proper use of epinephrine autoinjector may be related with the design of the autoinjector itself. The aim of the study is to investigate whether minor modifications in the design of currently available epinephrine autoinjector ease its use and abrogate common use errors.

Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers [Completed]
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.

more trials >>

Reports of Suspected Epipen (Epinephrine Injection) Side Effects

Accidental Exposure (131),  Drug Ineffective (51),  Injury Associated With Device (44),  Expired Drug Administered (40),  Injection Site Pain (23),  Hypoaesthesia (19),  Pain in Extremity (16),  Contusion (13),  Injection Site Pallor (13),  Heart Rate Increased (13), more >>