EPINEPHRINE ABBOJECT NDC 0409-4933-01 Highlights

(Epinephrine injection, USP ABBOJECT)

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

EPINEPHRINE INJECTION, for intravenous use
Initial U.S. Approval: 1939

INDICATIONS AND USAGE

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)

DOSAGE AND ADMINISTRATION

  • Hypotension associated with septic shock:
    • Dilute epinephrine in dextrose solution prior to infusion. (2.2)
    • Infuse epinephrine into a large vein. (2.2)
    • Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated to achieve desired mean arterial pressure. (2.2)
    • Wean gradually. (2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 1 mg/10 mL (0.1 mg/mL) in ABBOJECT Syringe. (3)

CONTRAINDICATIONS

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)

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

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

USE IN SPECIFIC POPULATIONS

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

Revised: 11/2019

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

EPINEPHRINE INJECTION, for intravenous use
Initial U.S. Approval: 1939

INDICATIONS AND USAGE

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)

DOSAGE AND ADMINISTRATION

  • Hypotension associated with septic shock:
    • Dilute epinephrine in dextrose solution prior to infusion. (2.2)
    • Infuse epinephrine into a large vein. (2.2)
    • Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated to achieve desired mean arterial pressure. (2.2)
    • Wean gradually. (2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 1 mg/10 mL (0.1 mg/mL) in ABBOJECT Syringe. (3)

CONTRAINDICATIONS

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)

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

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

USE IN SPECIFIC POPULATIONS

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

Revised: 11/2019

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