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Adrenaclick (Epinephrine) - Summary

 
 



ADRENACLICK SUMMARY

Adrenaclick™ auto-injector contains 1.1 mL epinephrine injection, USP (1 mg/mL), from which one dose of either 0.15 mg (0.15 mL) or 0.3 mg (0.3 mL) each is available for use by injection. The dose is administered by autoinjection after the patient prepares and fires Adrenaclick™ as directed. The remaining volume is not available for use and should be discarded.

Adrenaclick (epinephrine injection, USP) is indicated in the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging insects (e.g. order Hymenoptera, which includes 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 anaphylaxis to unknown substances (idiopathic anaphylaxis) or exercise-induced anaphylaxis. Adrenaclick is intended for immediate administration in patients 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. Adrenaclick is designed as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.


See all Adrenaclick indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Adrenaclick (Epinephrine)

Epinephrine first and fast for a severe allergic reaction
Source: Allergy News From Medical News Today [2014.12.04]
If you are one of the millions of Americans who experiences a severe allergic reaction to food, latex or an insect sting, you should know the first line of defense in combating the reaction is...

Experts Urge Quick Use of Epinephrine for Severe Allergic Reactions
Source: MedicineNet Allergy Specialty [2014.12.03]
Title: Experts Urge Quick Use of Epinephrine for Severe Allergic Reactions
Category: Health News
Created: 12/2/2014 12:00:00 AM
Last Editorial Review: 12/3/2014 12:00:00 AM

Emergency supplies of epinephrine in schools save lives
Source: Allergy News From Medical News Today [2014.11.11]
Millions of children across the country need emergency epinephrine at school because they could suffer a severe, potentially life-threatening allergic reaction (anaphylaxis) to food or an insect...

Emergency epinephrine used 38 times in Chicago public schools
Source: Allergy News From Medical News Today [2014.10.24]
The Chicago Public School (CPS) system used emergency epinephrine in 38 cases during the 2012-2013 school year and more than half of these cases were for first-time events.

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Published Studies Related to Adrenaclick (Epinephrine)

Effect of combined dexamethasone therapy with nebulized r-epinephrine or salbutamol in infants with bronchiolitis: A randomized, double-blind, controlled trial. [2014]
bronchodilators alone for the treatment of infants with bronchiolitis... CONCLUSIONS: This study adds to a body of evidence suggesting that

Restrictive deferred hydration combined with preemptive norepinephrine infusion during radical cystectomy reduces postoperative complications and hospitalization time: a randomized clinical trial. [2014]
approach could result in reduced postoperative complication rate... CONCLUSION: A restrictive-deferred hydration combined with preemptive

Vasopressin compared with norepinephrine augments the decline of plasma cytokine levels in septic shock. [2013]
shock... CONCLUSIONS: Survivors of septic shock had greater decreases of cytokines,

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

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Clinical Trials Related to Adrenaclick (Epinephrine)

Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation [Recruiting]

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.

Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment [Recruiting]
Suppression of the adrenal function is a common, potentially dangerous and unpredictable consequence of short term high dose glucocorticoid treatment. Identification of patients at risk would be of high clinical importance. The investigators hypothesized that the dexamethasone-suppression-test predicts the subsequent development of corticosteroid induced adrenal insufficiency.

SPARTACUS: Subtyping Primary Aldosteronism: a Randomized Trial Comparing Adrenal Vein Sampling and Computed Tomography Scan. [Recruiting]
Rationale: Primary hyperaldosteronism (PA) is the most frequent form of secondary hypertension. In PA autonomous hypersecretion of aldosterone by one or both adrenal glands causes hypertension that is often refractory to treatment. PA is usually caused by either a unilateral aldosterone-producing (micro)adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction between APA and BAH is critical since the former is treated with the aim of cure by adrenalectomy, and the latter by mineralocorticoid receptor antagonists. This distinction can be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008 guideline or by CT-scanning, as is common practice in the Netherlands. AVS is invasive, demands great skill, and is expensive, while CT-scanning is non-invasive, easy and cheap, but might be less accurate. However, the advantage of AVS has never been demonstrated in prospective randomized studies. Here we propose to perform a prospective, randomized, multicenter study that compares effectiveness of AVS with effectiveness of CT-scanning for the diagnosis of PA subtype.

Objective: To assess the quantity of antihypertensive medication needed in order to normalize blood pressure in patients who have been managed for PA according to either AVS or CT-scan. Secondary objectives: to assess potassium, costs of management and quality of life.

Study design: Prospective, randomized trial in a multi-centre setting. Two hundred patients will be recruited within two years. Follow-up will be one year after (start of) treatment.

Study population: Adult patients with therapy-resistant hypertension, with or without hypokalemia, caused by PA.

Intervention: Patients will be randomized to undergo either adrenal CT-scanning or AVS (with pre-AVS adrenal CT-scanning for phlebography). The result of either of these tests will determine the course of action: adrenalectomy for adenoma or MRAs for bilateral hyperplasia.

Main study parameters/endpoints: The quantity of antihypertensive drugs patients are using to obtain target blood pressure, expressed in Daily Defined Dosages, is used as the main study parameter. There is no criterion standard for accuracy of the diagnosis of PA-subtype, but we assume that if treatment is based on a more accurate diagnosis, treatment is more effective. The most important secondary endpoints are the costs of the diagnostic course and long-term medical treatment and the quality of life as assessed by a validated questionnaire.

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Page last updated: 2014-12-04

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