HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ADRENALIN safely and effectively. See full prescribing information for ADRENALIN.

ADRENALIN (epinephrine injection) 1 mg/mL, for
intramuscular, subcutaneous, and intravenous use
Initial U.S. Approval: 1939

RECENT MAJOR CHANGES

Indications and Usage (1.2) 01/2019

Dosage and Administration (2.3) 01/2019

Warnings and Precautions (5.3, 5.4, 5.5, 5.6, 5.7) 01/2019

INDICATIONS AND USAGE

Adrenalin® is a non-selective alpha and beta adrenergic agonist indicated for:

Emergency treatment of allergic reactions (Type 1), including anaphylaxis ( 1-1.1)
To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1-1.2)

DOSAGE AND ADMINISTRATION

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 anterolateral aspect of the thigh every 5 to 10 minutes as necessary ( 2-2.2)
Children 30 kg (66 lbs) or less: 0.01 mg/kg (0.01 mL/kg), up to 0.3 mg (0.3 mL), intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary ( 2-2.2)

Hypotension associated with septic shock:

Dilute epinephrine in dextrose solution prior to infusion ( 2-2.3)
Infuse epinephrine into a large vein ( 2-2.3)
Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated to achieve desired mean arterial pressure ( 2-2.3)
Wean gradually ( 2-2.3)
See Full Prescribing Information for instructions on dilution and administration of the injection.

DOSAGE FORMS AND STRENGTHS

Injection: 1 mg/mL single dose vial and 30 mg/30 mL (1 mg/mL) multiple dose vial ( 3)

CONTRAINDICATIONS

None ( 4)

WARNINGS AND PRECAUTIONS

Do not inject into buttocks, digits, hands, or feet ( 5-5.1)
Avoid extravasation into tissues, which can cause local necrosis ( 5-5.3)
May aggravate angina pectoris or produce ventricular arrhythmias ( 5-5.7)

ADVERSE REACTIONS

Common adverse reactions to systemically administered epinephrine include anxiety, tremor, weakness, dizziness, sweating, palpitations and pallor ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives and ergot alkaloids. ( 7-7.1)
Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, quinidine and certain antihistamines. ( 7-7.2)
Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, and cardiac glycosides. Observe for development of cardiac arrhythmias. ( 7-7.3)
Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. ( 7-7.4)

USE IN SPECIFIC POPULATIONS

Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally ( 8-8.1, 8-8.5)
Pregnancy: May cause fetal harm ( 8-8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2019