alpha-Adrenergic Agonist

Epinephrine

Approved 5 Nov 2019IntravenousSolution

The FDA lists this product in 24 strengths and forms.

Indications

Epinephrine is a non-selective alpha- and beta-adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. ( 1.1 )

1.1 Hypotension associated with Septic Shock Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

Contraindications

None. None. ( 4 )

Warnings and precautions

Monitor patient for acute severe hypertension. ( 5.1 ) Potential for pulmonary edema, which may be fatal. ( 5.2 ) May induce potentially serious cardiac arrhythmias and myocardial ischemia, particularly in patients with underlying heart disease. ( 5.3 ) Avoid extravasation into tissues, which can cause local necrosis. ( 5.4 ) Potential for oliguria or renal impairment. ( 5.5 ) Presence of sulfite in this product should not deter use for hypotension associated with septic shock ( 5.6 )

5.1Hypertension

Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine.

5.2Pulmonary Edema

Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema.

5.3Cardiac Arrhythmias and Ischemia

Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients with coronary artery disease, or cardiomyopathy [see Adverse Reactions and Drug Interactions (7.3) ] .

Indications

Epinephrine is a non-selective alpha- and beta-adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. ( 1.1 )

Warnings and precautions

5.1Hypertension

5.2Pulmonary Edema

Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema.

5.3Cardiac Arrhythmias and Ischemia

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Limited published data on epinephrine use in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. However, there are risks to the mother and fetus associated with epinephrine use during labor or delivery, and risks due to untreated hypotension associated with septic shock (see Clinical Considerations ) . In animal reproduction studies, epinephrine demonstrated adverse developmental effects when administered to pregnant rabbits (gastroschisis), mice (teratogenic effects, embryonic lethality, and delayed skeletal ossification), and hamsters (embryonic lethality and delayed skeletal ossification) during organogenesis at doses approximately 15 times, 3 times and 2 times, respectively, the maximum recommended daily intramuscular or subcutaneous dose (see Data ) .

All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypotension associated with septic shock is a medical emergency in pregnancy which can be fatal if left untreated.

Delaying treatment in pregnant women with hypotension associated with septic shock may increase the risk of maternal and fetal morbidity and mortality. Do not withhold life-sustaining therapy for a pregnant woman. Labor or Delivery Epinephrine usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid epinephrine during the second stage of labor.

In dosage sufficient to reduce uterine contractions, the drug may cause a prolonged period of uterine atony with hemorrhage. Avoid epinephrine in obstetrics when maternal blood pressure exceeds 130/80 mmHg. Although epinephrine improves maternal hypotension associated with anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Data Animal Data In a study in pregnant rabbits administered 1.2 mg/kg/day epinephrine (approximately 15 times the maximum recommended intramuscular or subcutaneous dose on a mg/m 2 basis) subcutaneously during organogenesis (on days 3 to 5, 6 to 7 or 7 to 9 of gestation), epinephrine caused teratogenic effects (including gastroschisis).

Animals treated on days 6 to 7 had decreased number of implantations. In a teratology study, pregnant mice were subcutaneously administered epinephrine (0.1 to 10 mg/kg/day) on Gestation Days 6 to 15. Teratogenic effects, embryonic lethality, and delays in skeletal ossification were observed at approximately 3 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days).

These effects were not seen in mice at approximately 2 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). Subcutaneous administration of epinephrine to pregnant hamsters at a dose of 0.5 mg/kg/day (approximately 2 times the maximum recommended intramuscular or subcutaneous dose on a mg/m 2 basis) on Gestation Days 7 to 10 resulted in delayed skeletal ossification and a reduction in litter size.

Adverse reactions

The following adverse reactions are discussed elsewhere in labeling: Hypertension [see Warnings and Precautions (5.1) ] Pulmonary Edema [see Warnings and Precautions (5.2) ] Cardiac Arrhythmias and Ischemia [see Warnings and Precautions (5.3) ] Extravasation and Tissue Necrosis with Intravenous Infusion [see Warnings and Precautions (5.4) ] Renal Impairment [see Warnings and Precautions (5.5) ] Allergic Reactions associated with Sulfite [see Warnings and Precautions (5.6) ] The following adverse reactions have been associated with use of epinephrine.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiovascular disorders : tachycardia, supraventricular tachycardia, ventricular arrhythmias (including fatal ventricular fibrillation), myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema, hypertension Gastrointestinal disorders : nausea, vomiting General disorders and administrative site conditions : extravasation Metabolic : insulin resistance, hypokalemia, lactic acidosis Nervous system disorders : headache, paresthesia, tremor, stroke, central nervous system bleeding, weakness, dizziness, disorientation, impaired memory, panic, psychomotor agitation, somnolence Psychiatric disorders : excitability, anxiety, apprehensiveness, nervousness, restlessness Renal disorders : renal insufficiency Respiratory : rales Skin and subcutaneous tissue disorders : diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation.

Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; diaphoresis; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Epinephrine

Indications

Contraindications

Warnings and precautions

5.1Hypertension

5.2Pulmonary Edema

5.3Cardiac Arrhythmias and Ischemia

Two medicines in one question?

Epinephrine

Indications

Contraindications

Warnings and precautions

5.1Hypertension

5.2Pulmonary Edema

5.3Cardiac Arrhythmias and Ischemia

Two medicines in one question?

5.4Extravasation and Tissue Necrosis with Intravenous Infusion

5.5Renal Impairment

5.6Allergic

Interactions

7.2Drugs Potentiating Pressor Effects of Epinephrine

7.3Drugs Potentiating Arrhythmogenic Effects of Epinephrine

7.4Drugs Potentiating Hypokalemic Effects of Epinephrine

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance