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)

Dey Launches And Unveils Next-Generation, Needle-Protected EpiPen(R) (Epinephrine) Auto-Injector With Enhanced Patient-Friendly Features
Source: Allergy News From Medical News Today [2009.10.29]
Dey Pharma, L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL - News), launched a newly designed, patient-friendly EpiPen® Auto-Injector 0.3/0.15 mg. This next-generation EpiPen Auto-Injector maintains the simplicity, speed, safety and reliability of EpiPen Auto-Injector with several new, user-friendly features, including being the only auto-injector with needle-protection before and after use. Dey President Carolyn Myers, Ph.D.

Anaphylaxis
Source: MedicineNet Allergic Cascade Specialty [2007.05.30]
Title: Anaphylaxis
Category: Diseases and Conditions
Created: 4/15/2000 5:35:00 PM
Last Editorial Review: 5/30/2007

ACAAI: EMS Teams Vary on Epinephrine Policies (CME/CE, with video)
Source: MedPage Today Emergency Medicine [2009.11.11]
MIAMI BEACH (MedPage Today) -- All 50 states allow emergency medical services (EMS) teams to carry epinephrine for anaphylaxis patients, but about a third don't require responders to carry the drug, researchers said here.

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Published Studies Related to Epipen (Epinephrine Injection)

Effect of intraoperative injection of 0.25% bupivacaine with 1:200,000 epinephrine on intraoperative blood loss in FESS. [2009.07]
BACKGROUND: This study was designed to compare differences in intraoperative blood loss, mean arterial blood pressure (MABP), and duration of surgery when 0.25% bupivacaine with 1:200000 epinephrine is injected, preoperatively, versus normal saline (NS), during functional endoscopic sinus surgery (FESS)... CONCLUSION: There was no significant reduction in intraoperative blood loss during FESS when local anesthetic containing epinephrine was used compared with infiltration with NS. More importantly, Part II shows a significantly higher MABP associated with infiltration of epinephrine. Parts I and II did not show a significant difference in preoperative MABP or duration of surgery.

Comparison of bupivacaine and lidocaine with epinephrine for digital nerve blocks. [2009.05]
OBJECTIVE: This study compared the efficacy in terms of pain of injection, time of onset and duration of action of digital blocks of bupivacaine 0.5% alone and lidocaine 1% with epinephrine (1:100,000)... CONCLUSION: Lidocaine (1%) with epinephrine (1:100 000) was significantly less painful and had a shorter duration of action than bupivacaine (0.5%), which had a similar onset of action for digital nerve block. Trial registration number: ISRCTN45121950.

Oral or intravenous proton pump inhibitor in patients with peptic ulcer bleeding after successful endoscopic epinephrine injection. [2009.03]
AIMS: We aimed to assess the clinical effectiveness of oral vs. intravenous (i.v.) regular-dose proton pump inhibitor (PPI) after endoscopic injection of epinephrine in patients with peptic ulcer bleeding... CONCLUSIONS: Oral rabeprazole and i.v. regular-dose omeprazole are equally effective in preventing rebleeding in patients with high-risk bleeding peptic ulcers after successful endoscopic injection with epinephrine.

Vasopressin and epinephrine vs. epinephrine alone in cardiopulmonary resuscitation. [2008.07.03]
BACKGROUND: During the administration of advanced cardiac life support for resuscitation from cardiac arrest, a combination of vasopressin and epinephrine may be more effective than epinephrine or vasopressin alone, but evidence is insufficient to make clinical recommendations... CONCLUSIONS: As compared with epinephrine alone, the combination of vasopressin and epinephrine during advanced cardiac life support for out-of-hospital cardiac arrest does not improve outcome. (ClinicalTrials.gov number, NCT00127907.) 2008 Massachusetts Medical Society

Epinephrine/Lidocaine injection vs. saline during endoscopic sinus surgery. [2008.07]
OBJECTIVES: To assess the safety and effectiveness of an epinephrine/lidocaine mixture administered by injection versus epinephrine administered topically and to learn its pharmacokinetics following administration to the nasal mucosa. DESIGN: A double-blind randomized controlled trial... CONCLUSIONS: Injection of epinephrine/lidocaine mixture does not produce higher blood levels of epinephrine when compared to saline injection and did not induce any harmful side effects. We postulate that the combination with lidocaine 1% may reduce the patients' stress and thus prevent higher catecholamine levels.

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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.

Combined Vasopressin, Methylprednisolone, and Epinephrine for Inhospital Cardiac Arrest [Completed]
A randomized controlled trial did not show benefit of vasopressin versus epinephrine in inhospital cardiac arrest. Preceding laboratory data suggest that combined vasopressin and epinephrine ensure long-term survival and neurologic recovery. Also, postresuscitation abnormalities mimic severe sepsis. We hypothesized that combined vasopressin and epinephrine during cardiopulmonary resuscitation (CPR), and steroid supplementation during and after (when required) CPR may improve survival in cardiac arrest.

Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency [Completed]
Corticotropin Releasing Hormone (CRH) is a hypothalamic hormone made up of 41 amino acids. Amino acids are proteins that when combined make up different substances, like hormones. The order of amino acids in CRH, has been determined, meaning that the hormone can now be synthetically reproduced in a laboratory setting.

When CRH is released from the hypothalamus it stimulates the pituitary gland to secrete another hormone, ACTH. ACTH then causes the adrenal glands to make a third hormone, cortisol. This process is known as the hypothalamic-pituitary-adrenal axis. Problems can occur in any of the steps of this process and result in a variety of diseases (Cushing's Syndrome and adrenal insufficiency).

Researchers hope that CRH created in a laboratory setting, ovine CRH (oCRH) can be used to help diagnose and treat conditions of the HPA axis. This study will test the relationship for single doses of oCRH in normal volunteers and patients with disorders of the HPA axis. The oCRH will be injected into the patients vein as a single injection or slowly through an IV line over 24 hours. The participants will have blood tests taken to measure hormone levels before, during, and after receiving the oCRH.

Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening [Completed]
This is a clinical research study using I-131 Iodocholesterol which is an experimental radioactive chemical that when injected into the vein, is picked up in the adrenal glands and permits visualization with gamma imaging devices. These images are used in diagnosing a variety of adrenal abnormalities. Prior to the injection of I-131 Iodocholesterol, the patient will receive perchlorate capsules to block any uptake of I-131 by the thyroid gland if this is deemed important. The patient will continue to take these capsules throughout the period of imaging, which may last up to 1 week. The injection of I-131 Iodocholesterol will be given into a vein and the patient will return for images on at least 1 and possibly 2 occasions between 3-7 days after injection. If the case requires it, the patient may also be given a steroid in tablet form, dexamethasone, to take orally prior to and after the injection to suppress normal adrenal function so that the abnormal tissues can be more easily detected.

Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome [Completed]

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