INDICATIONS AND USAGE
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.
DOSAGE AND ADMINISTRATION
The physician who prescribes Adrenaclick™ should review this Prescribing Information insert in detail with the patient. This review should include the proper use of Adrenaclick to ensure that subcutaneous or intramuscular injections are given into the anterolateral aspect of the thigh, through clothing if necessary. The accompanying Patient Information Leaflet and Wrap Label should also be reviewed with the patient.
Adrenaclick is capable of delivering one dose of either 0.15 mg or 0.3 mg (0.15 mL or 0.3 mL of epinephrine). This dose is available for auto-injection by the patient.
Selection of the appropriate Adrenaclick dosage strength is determined according to patient body weight.
|Adrenaclick 0.15 mg
||For use by patients who weigh 15 - 30 kilograms (approximately 33 - 66 pounds)
|Adrenaclick 0.3 mg
||For use by patients who weigh 30 kilograms (approximately 66 pounds) or greater
The usual dose of epinephrine for allergic emergencies in patients who weigh 30 kilograms or greater is 0.3 mg (0.3 mL of epinephrine).
Since the doses of epinephrine delivered from Adrenaclick are fixed, the physician should consider other forms of injectable epinephrine if doses lower than those available from Adrenaclick are felt to be necessary. The prescribing physician 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 being prescribed.
Patients should be instructed to periodically visually inspect the epinephrine solution for particulate matter and discoloration. If the solution contains particulate matter or develops a pinkish color or becomes darker than slightly yellow, the patient should immediately contact their physician for a replacement, since these changes indicate that the effectiveness of the drug product may be decreased.
Adrenaclick is a patient (or caregiver) actuated product that contains 1.1 mL of epinephrine injection, USP (1 mg/mL), of which one dose can be delivered by auto-injection. THE REMAINING VOLUME THAT IS LEFT AFTER THIS FIXED DOSE CANNOT BE FURTHER ADMINISTERED AND SHOULD BE DISCARDED WITH THE DEVICE AS OUTLINED IN THE PATIENT INFORMATION LEAFLET.
Adrenaclick 0.15 mg is available in a single unit carton, NDC 59630-803-01, containing one Adrenaclick 0.15 mg auto-injector and in a Two-Pack, NDC 59630-803-02, containing two Adrenaclick 0.15 mg auto-injectors.
Adrenaclick 0.3 mg is available in a single unit carton, NDC 59630-804-01, containing one Adrenaclick 0.3 mg auto-injector and in a Two-Pack, NDC 59630-804-02, containing two Adrenaclick 0.3 mg auto-injectors.
PROTECT FROM LIGHT. STORE AT ROOM TEMPERATURE, 20°-25°C (68°-77°F) WITH EXCURSIONS PERMITTED TO 15°-30°C (59°-86°F). PROTECT FROM FREEZING. DO NOT REFRIGERATE.