Mode
Text Size
Log in / Sign up

FDA approved Adrenalin (epinephrine) for Anaphylaxis and Septic Shock HypotensionFDA approved Adrenalin for severe allergic reactions and septic shock.

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Consider Adrenalin for emergency anaphylaxis treatment and as a vasopressor for septic shock hypotension.

The FDA has approved Adrenalin (epinephrine) for two distinct indications: emergency treatment of Type I allergic reactions including anaphylaxis, and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. For anaphylaxis, the drug is administered intramuscularly or subcutaneously into the anterolateral thigh, with dosing based on weight. For septic shock, it is given as a continuous intravenous infusion after dilution. The approval provides a standardized formulation for these critical care settings.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Epinephrine is a non-selective alpha and beta adrenergic agonist. It acts on both alpha and beta receptors to produce vasoconstriction, bronchodilation, and increased heart rate and contractility.

Indication & Patient Population

Adrenalin is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. It is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

Dosing & Administration

For anaphylaxis: Adults and children 30 kg or more: 0.3 to 0.5 mg (0.3 to 0.5 mL) intramuscularly or subcutaneously into the anterolateral aspect of the thigh every 5 to 10 minutes as necessary. Children less than 30 kg: 0.01 mg/kg (0.01 mL/kg) up to 0.3 mg (0.3 mL) intramuscularly or subcutaneously every 5 to 10 minutes as necessary. For septic shock: Dilute 1 mg in 1000 mL of 5% dextrose solution to produce 1 mcg/mL. Infuse into a large vein at 0.05 to 2 mcg/kg/min, titrated to desired mean arterial pressure. Wean gradually.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

No contraindications listed. Drug interactions include drugs that counter pressor effects (alpha blockers, vasodilators, diuretics, antihypertensives, ergot alkaloids), drugs that potentiate effects (sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin, levothyroxine, quinidine, certain antihistamines), and drugs that increase arrhythmogenic potential (beta blockers, cyclopropane, halogenated anesthetics, antihistamines, thyroid hormones, diuretics, cardiac glycosides). Potassium-depleting drugs potentiate hypokalemic effects.

Place in Therapy

Adrenalin is a first-line treatment for anaphylaxis and a vasopressor option for septic shock hypotension. Its use in anaphylaxis is standard of care. In septic shock, it is one of several vasopressors available for hemodynamic support.

The FDA has approved Adrenalin (epinephrine) for two serious conditions: emergency treatment of severe allergic reactions (including anaphylaxis) and to raise blood pressure in adults with septic shock. For allergic reactions, it is injected into the thigh muscle or under the skin. For septic shock, it is given continuously through an IV after being diluted. This approval standardizes the formulation for use in hospitals and emergency settings.

Adrenalin is for people experiencing a severe allergic reaction or those with dangerously low blood pressure due to an infection. It works by narrowing blood vessels and opening airways, which can be life-saving. The approval means there is now a consistent, FDA-approved version of epinephrine for these critical uses.

This approval does not change how patients currently use epinephrine auto-injectors like EpiPen. Those devices remain available and are still the standard for at-home use. The new approval is mainly for healthcare providers in hospitals or emergency situations.

If you have questions about using epinephrine for allergies or septic shock, talk to your doctor. They can help you understand the best treatment for your specific condition.

What this means for you:
Adrenalin is now FDA-approved for severe allergies and septic shock, but does not change how you use your current epinephrine auto-injector.

Study Details

Study typeFda approval
PublishedDec 2013
View Original Abstract ↓
1 INDICATIONS AND USAGE Adrenalin ® is a non-selective alpha and beta adrenergic agonist indicated for: Emergency treatment of allergic reactions (Type 1), including anaphylaxis ( 1.1 ) To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1.2 ) 1.1 Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. 1.2 Hypotension associated with Septic Shock Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.