Epinephrinedrug info
NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector
What it is used for
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, are non-selective alpha and beta-adrenergic receptor agonist indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 31, 2021. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Epinephrine Injection USP, 0.3 mg and Epinephrine Injection USP, 0.15 mg are single-dose auto-injectors and combination products containing drug and device components. Each Epinephrine Injection USP, 0.3 mg (Auto-Injector) delivers a single dose of 0.3 mg epinephrine, USP from epinephrine injection USP, 0.3 mg/0.3 mL in a sterile solution. Each Epinephrine Injection USP, 0.15 mg (Auto-Injector) delivers a single dose of 0.15 mg epinephrine, USP from epinephrine injection USP, 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the Epinephrine Injection USP, 0.3 mg (Auto-Injector) contains 0.3 mg epinephrine USP, 1.8 mg sodium chloride, 0.4 mg sodium metabisulfite, 0.4 mg sodium tartrate (dihydrate), hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2 to 5.0. Each 0.3 mL in the Epinephrine Injection USP, 0.15 mg (Auto-Injector) contains 0.15 mg epinephrine USP, 1.8 mg sodium chloride, 0.4 mg sodium metabisulfite, 0.2 mg sodium tartrate (dihydrate), hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2 to 5.0. Epinephrine, USP is a sympathomimetic catecholamine. Chemically, epinephrine, USP is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure: Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace Epinephrine Injection USP, 0.3 mg and Epinephrine Injection USP, 0.15 mg if the epinephrine solution appears discolored (pinkish or darker than slightly yellow), cloudy, or if it contains a precipitate. Thoroughly review the patient instructions and operation of Epinephrine Injection USP, 0.3 mg or Epinephrine Injection USP, 0.15 mg with patients and caregivers prior to use. structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 31, 2021. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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