ADRENACLICK SUMMARY
Adrenaclick (epinephrine injection, USP) auto-injector 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components.
Each Adrenaclick 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution.
Each Adrenaclick 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution.
Adrenaclick 0.3 mg and Adrenaclick 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for Adrenaclick 0.3 mg and Adrenaclick 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded.
Each 0.3 mL in Adrenaclick 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.
Each 0.15 mL in Adrenaclick 0.15 mg contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.
Epinephrine is a sympathomimetic catecholamine.
Adrenaclick® is indicated in the emergency treatment of 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, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
Adrenaclick is 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.
Adrenaclick is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
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NEWS HIGHLIGHTS
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
Clinical Trials Related to Adrenaclick (Epinephrine)
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.
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.
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).
Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) [Completed]
The purpose of this study is to find out if your adrenal glands are normal or abnormal. This
can be determined by whether or not your adrenal gland concentrates more of a labeled
building block of adrenal hormone, norcholesterol. This labeled material had been used as an
investigative diagnostic tool for imaging adrenal glands for many years with success in our
hands. This is a diagnostic procedure. CT, MRI and Ultrasound can determine the size and
presence or absence of tumor but cannot assess the function of the adrenal glands. To
determine hormone concentrations from blood samples would involve more invasive
catherization.
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