July 26, 2016
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Adrenaclick

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Adrenaclick

Indications
Dosage
How Supplied

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

Selection of the appropriate Adrenaclick dosage strength is determined according to patient body weight.

  • Patients greater than or equal to 30 kg (approximately 66 pounds or more): Adrenaclick 0.3 mg
  • Patients 15 to 30 kg (33 pounds to 66 pounds): Adrenaclick 0.15 mg

Inject Adrenaclick intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed an Adrenaclick and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see WARNINGS AND PRECAUTIONS].

Each Adrenaclick contains a single dose of epinephrine for single use injection. Since the doses of epinephrine delivered from Adrenaclick are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated.

With severe persistent anaphylaxis, repeat injections with an additional Adrenaclick may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see WARNINGS AND PRECAUTIONS].

The epinephrine solution in the viewing window of Adrenaclick should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [see HOW SUPPLIED/Storage and Handling].

HOW SUPPLIED

Dosage Forms And Strengths

  • Injection, 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector
  • Injection, 0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector

Carton containing two Adrenaclick (epinephrine injection, USP) 0.3 mg auto-injectors: NDC 52054-804-02.

Carton containing two Adrenaclick (epinephrine injection, USP) 0.15 mg auto-injectors: NDC 52054-803-02.

Storage And Handling

Protect from light. Epinephrine is light sensitive and should be stored in the carrying-case provided to protect it from light. Store at room temperature (20° to 25°C (68° to 77°F)); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.

Manufactured for and Distributed by: Amedra Pharmaceuticals LLC, Horsham, PA 19044. Revised: May 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/1/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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