Application Nr Approved Date Route Status External Links
ANDA090589 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Epinephrine Injection, 0.3 Mg And Epinephrine Injection, 0.15 Mg Are Indicated In The Emergency Treatment Of Allergic Reactions (Type I) Including Anaphylaxis To Stinging Insects (E.g., Order Hymenoptera, Which Include 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. Epinephrine Injection, 0.3 Mg And Epinephrine Injection, 0.15 Mg Are 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. Epinephrine Injection, 0.3 Mg And Epinephrine Injection, 0.15 Mg Are Intended For Immediate Administration As Emergency Supportive Therapy Only And Are Not A Substitute For Immediate Medical Care. Epinephrine Injection, 0.3 Mg And Epinephrine Injection, 0.15 Mg Contain Epinephrine, A Non-Selective Alpha And Beta-Adrenergic Receptor Agonist, Indicated In The Emergency Treatment Of Allergic Reactions (Type I) Including Anaphylaxis. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Epinephrine EPINEPHRINE ZINC39089

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