FDA approved Adrenalin (epinephrine) for Anaphylaxis and Septic Shock HypotensionFDA approved Adrenalin for Severe Allergic Reactions and Septic Shock

Epinephrine is a non-selective alpha and beta adrenergic agonist. Its pressor effects are mediated by alpha-adrenergic receptor stimulation, while beta-adrenergic effects contribute to bronchodilation and cardiac stimulation.

Adrenalin is indicated for: (1) Emergency treatment of allergic reactions (Type 1), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, other allergens, as well as idiopathic or exercise-induced anaphylaxis. (2) To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

For anaphylaxis: Adults and children 30 kg (66 lbs) or more: 0.3 mg to 0.5 mg (0.3 mL to 0.5 mL) intramuscularly or subcutaneously into the anterolateral aspect of the thigh every 5 to 10 minutes as necessary. Children 30 kg or less: 0.01 mg/kg (0.01 mL/kg), up to 0.3 mg (0.3 mL), intramuscularly or subcutaneously into the anterolateral aspect of the thigh every 5 to 10 minutes as necessary. For intramuscular administration, use a needle at least 1/2 inch long. Do not administer repeated injections at the same site due to risk of tissue necrosis from vasoconstriction.

For hypotension associated with septic shock: Dilute epinephrine in 5% dextrose solution or 5% dextrose and sodium chloride solution to produce a 1 mcg/mL dilution (1 mL of 1 mg/mL vial to 1,000 mL). Administration in saline alone is not recommended. Infuse into a large vein. Avoid catheter tie-in technique and veins of the leg in elderly patients or those with occlusive vascular diseases. Suggested infusion rate: 0.05 mcg/kg/min to 2 mcg/kg/min, titrated to achieve desired mean arterial pressure. Adjust dosage every 10 to 15 minutes in increments of 0.05 to 0.2 mcg/kg/min. Wean gradually after stabilization. Diluted solutions are stable for 4 hours at room temperature or 24 hours refrigerated.

Trial data not available in label.

Contraindications: None.

Drug interactions: Drugs that counter pressor effects include alpha blockers, vasodilators (e.g., nitrates), diuretics, antihypertensives, and ergot alkaloids. Drugs that potentiate effects include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, quinidine, and certain antihistamines. Drugs that increase arrhythmogenic potential include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, and cardiac glycosides. Observe for cardiac arrhythmias. Potassium-depleting drugs (corticosteroids, diuretics, theophylline) potentiate hypokalemic effects.

Epinephrine is the first-line treatment for anaphylaxis and a vasopressor option for septic shock hypotension. The label provides specific dosing for both emergency settings, emphasizing intramuscular or subcutaneous administration for anaphylaxis and intravenous infusion for septic shock. Clinicians should monitor for cardiac effects and repeat dosing as needed.