Epipen (Epinephrine Injection) - Summary

EPIPEN SUMMARY

EPIPEN^®
Auto-Injector for Intramuscular Injection of Epinephrine

The EpiPen® and Epipen® Jr auto-injectors contain 2 mL epinephrine injection for emergency intramuscular use. Each EpiPen® auto-injector delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP, 1:1000 (0.3 mL) in a sterile solution.

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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NEWS HIGHLIGHTS

Media Articles Related to Epipen (Epinephrine Injection)

Idiopathic anaphylaxis: The hidden allergy?
Source: Allergy News From Medical News Today [2014.02.24]
Most people have heard of severe allergies, or anaphylaxis, to food, insect stings, drugs and other common substances, but sometimes no cause at all can be found for a person's reaction - a condition called Idiopathic anaphylaxis. But does this really mean they are reacting to nothing?

Anaphylaxis
Source: MedicineNet Allergic Cascade Specialty [2013.10.22]
Title: Anaphylaxis
Category: Diseases and Conditions
Created: 4/15/2000 5:35:00 PM
Last Editorial Review: 10/22/2013 12:00:00 AM

'More likely to be murdered' than die from food allergies
Source: Allergy News From Medical News Today [2013.12.01]
The CDC estimates that around 4-6% of children in the US suffer from food allergies. Severe food allergies can lead to anaphylaxis - a reaction that causes swelling and breathing difficulties. Although a serious condition, a new study suggests that a person is more likely to be murdered than die from a food allergy.

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Published Studies Related to Epipen (Epinephrine Injection)

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.

Prophylactic injection of hypertonic saline-epinephrine oral to the papilla for prevention of postsphincterotomy bleeding. [2010.09]
CONCLUSIONS: Prophylactic injection of HSE solution oral to the papilla before ES is a simple and inexpensive method, and is effective for prevention of post-ES bleeding.

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Clinical Trials Related to Epipen (Epinephrine Injection)

Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest [Completed]
Recent studies have suggested that arginine-vasopressin could be more effective in the treatment of cardiac arrests. The last published study did not outline obvious improvements in the prognosis of all cardiac arrests but pointed out a possible increased survival rate when arginine-vasopressin is associated with epinephrine. The aim of this study is to compare the efficacy of two successive injections of epinephrine (1 mg) with two successive injections of epinephrine associated with arginine-vasopressin (40 UI) in out-of-hospital cardiac arrests occurring in adult patients. The primary endpoint is the survival rate at hospital admission. The inclusion period lasts 18 months and 2416 patients are planned to be enrolled.

Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation [Recruiting]

Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation [Recruiting]
Cardiac arrest has a very poor prognosis, especially with prolonged efforts at resuscitation, and unfortunately, survivors are often severely neurologically impaired. CPA in children is often the result of a prolonged illness rather than a sudden, primary cardiac event as is frequent in adults. This necessitates that resuscitation research must be conducted separately for pediatric and adult patients. Authorities currently endorse the use of epinephrine for restoring spontaneous circulation based on its ability to maintain diastolic blood pressure and subsequent blood flow to the heart during resuscitation. However, human studies have shown no clear survival benefit of epinephrine and have elucidated concerning adverse effects. Recently, both the European Resuscitation Council and the American Heart Association have recognized the use of vasopressin as a promising vasoconstrictor and an alternative or adjunct to epinephrine in the resuscitation of adults. Vasopressin causes profound vasoconstriction without the adverse effects of epinephrine and is associated with improved blood flow to the heart and brain. This increased cerebral blood flow has been associated with better neurologic outcome in animal studies. In light of compelling animal and human studies of combined vasopressin and epinephrine, pediatric trials are indicated for vasopressin usage in pediatric CPR. This study will evaluate the addition of the administration of vasopressin to standard advanced CPR therapy (epinephrine alone) for pediatric patients that experience in-intensive care unit CPA to assess for improved time to return of spontaneous circulation (ROSC), survival to 24 hours, survival to hospital discharge, and neurologic outcome. When a patient experiences a CPA, standard Pediatric Advanced Life Saving (PALS) protocols as endorsed by the American Heart Association will be initiated. This will include receiving epinephrine as the first vasopressor medication. Patients will then be randomized to receive vasopressin (treatment group) or epinephrine (control group) as the second vasopressor medication, if needed. If more then two doses of vasopressor medication is required in either group, epinephrine will be administered according to the PALS algorithm until the end of the event. All CPA events meeting inclusion criteria will be entered into the National Registry of Cardiopulmonary Resuscitation (NRCPR) Database, which tracts all CPA events at Children's Medical Center Dallas. Prior to commencement of the RCT, a pilot trial of 10 patients will be completed to assess preliminary safety, feasibility, and effectiveness of combination epinephrine-vasopressin for pediatric in-intensive care unit CPA refractory to initial epinephrine dosing. All pilot patients will receive vasopressin as the second vasopressor medication.

Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics [Recruiting]
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.

Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients [Recruiting]
This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.

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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 >>