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Epinephrine 30 mg/30 ml Injection USP

Epinephrine 30 mg/30 ml Injection USP,  for intramuscular, subcutaneous,  and intravenous use Initial U.S. Approval: 1939.

Epinephrine Injection, USP is medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

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Epinephrine injection details

NDC Product Code:
76329-9060
Proprietary Name:
Epinephrine 30mg/30 ml
Non-Proprietary Name: 
Epinephrine
Substance Name: 
Epinephrine
NDC Directory Status:
Human Prescription Drug
Product Type: 
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection – A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): 
  • Intramuscular – Administration within a muscle.
  • Intravenous – Administration within or into a vein or veins.
  • Subcutaneous – Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Labeler Name: 
International Medication Systems, Limited
Labeler Code:
76329
Product Label ID:
7b6ffd77-8b25-4ff1-993e-dbfd7e0834cf
HCPCS Code:
J0171 – INJECTION, ADRENALIN, EPINEPHRINE, 0.1 MG
FDA Application Number: 
ANDA211880
Marketing Category: 
ANDA – A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: 
05-19-2020
Listing Expiration Date: 
12-31-2025
Exclude Flag: 
N

Epinephrine dosage information

Applies to the following strengths: 1 mg/mL; 0.5%; 0.15 mg; 0.3 mg; 0.1 mg/mL; 0.3 mg/inh; 5 mg/mL; 16 mg/250 mL-NaCl 0.9%; 1 mg/mL preservative/sulfite-free; 10 mcg/mL-0.9%; 10 mcg/mL-D5%; 4 mg/250 mL-NaCl 0.9%; 0.22 mg/inh; 0.125 mg/inh; 2 mg/250 mL-D5%; 4 mg/250 mL-D5%; 3 mg/250 mL-D5%; 8 mg/250 mL-NaCl 0.9%; hydrochloride; 2 mg/250 mL-NaCl 0.9%; 5 mg/250 mL-NaCl 0.9%; 10 mg/250 mL-NaCl 0.9%; bitartrate; 0.1 mg; 100 mcg/mL-NaCl 0.9%; 16 mcg/mL-NaCl 0.9%; 1 mg/250 mL-D5%; 8 mg/250 mL-D5%; 5 mg/250 mL-D5%; 16 mcg/mL-D5%; 0.2 mg/0.2 mL preservative-free; 1 mg/0.1 mL; 2 mg/0.1 mL

Usual Adult Dose for Asystole

Injectable Solution of 0.1 mg/mL (1:10,000):

  • IV: 0.5 to 1 mg (5 to 10 mL) IV once; during resuscitation effort, 0.5 mg (5 mL) should be given IV every 5 minutes
  • Intracardiac: 0.3 to 0.5 mg (3 to 5 mL) via intracardiac injection into left ventricular chamber once
  • Endotracheal: 0.5 to 1 mg (5 mL to 10 mL) via endotracheal tube directly into bronchial tree once

Comments:

  • Intracardiac injection should only be administered by personnel well trained in this technique and only if there has not been sufficient time to establish an IV route.

Use: For prophylaxis and treatment of cardiac arrest and attacks of transitory atrioventricular heart block with syncopal seizures (Stokes-Adams Syndrome)

The American Heart Association (AHA) recommends:

  • IV or intraosseous: 1 mg IV or intraosseous every 3 to 5 minutes during cardiac arrest
  • Endotracheal: 2 to 2.5 mg endotracheally every 3 to 5 minutes during cardiac arrest if IV or intraosseous route cannot be established

Use: For administration during cardiac arrest

Usual Adult Dose for Ventricular Fibrillation

Injectable Solution of 0.1 mg/mL (1:10,000):

  • IV: 0.5 to 1 mg (5 to 10 mL) IV once; during resuscitation effort, 0.5 mg (5 mL) should be given IV every 5 minutes
  • Intracardiac: 0.3 to 0.5 mg (3 to 5 mL) via intracardiac injection into left ventricular chamber once
  • Endotracheal: 0.5 to 1 mg (5 mL to 10 mL) via endotracheal tube directly into bronchial tree once

Comments:

  • Intracardiac injection should only be administered by personnel well trained in this technique and only if there has not been sufficient time to establish an IV route.

Use: For prophylaxis and treatment of cardiac arrest and attacks of transitory atrioventricular heart block with syncopal seizures (Stokes-Adams Syndrome)

The American Heart Association (AHA) recommends:

  • IV or intraosseous: 1 mg IV or intraosseous every 3 to 5 minutes during cardiac arrest
  • Endotracheal: 2 to 2.5 mg endotracheally every 3 to 5 minutes during cardiac arrest if IV or intraosseous route cannot be established

Use: For administration during cardiac arrest

Usual Adult Dose for Ventricular Tachycardia

Injectable Solution of 0.1 mg/mL (1:10,000):

  • IV: 0.5 to 1 mg (5 to 10 mL) IV once; during resuscitation effort, 0.5 mg (5 mL) should be given IV every 5 minutes
  • Intracardiac: 0.3 to 0.5 mg (3 to 5 mL) via intracardiac injection into left ventricular chamber once
  • Endotracheal: 0.5 to 1 mg (5 mL to 10 mL) via endotracheal tube directly into bronchial tree once

Comments:

  • Intracardiac injection should only be administered by personnel well trained in this technique and only if there has not been sufficient time to establish an IV route.

Use: For prophylaxis and treatment of cardiac arrest and attacks of transitory atrioventricular heart block with syncopal seizures (Stokes-Adams Syndrome)

The American Heart Association (AHA) recommends:

  • IV or intraosseous: 1 mg IV or intraosseous every 3 to 5 minutes during cardiac arrest
  • Endotracheal: 2 to 2.5 mg endotracheally every 3 to 5 minutes during cardiac arrest if IV or intraosseous route cannot be established

Use: For administration during cardiac arrest

Usual Adult Dose for Cardiac Arrest

Injectable Solution of 0.1 mg/mL (1:10,000):

  • IV: 0.5 to 1 mg (5 to 10 mL) IV once; during resuscitation effort, 0.5 mg (5 mL) should be given IV every 5 minutes
  • Intracardiac: 0.3 to 0.5 mg (3 to 5 mL) via intracardiac injection into left ventricular chamber once
  • Endotracheal: 0.5 to 1 mg (5 mL to 10 mL) via endotracheal tube directly into bronchial tree once

Comments:

  • Intracardiac injection should only be administered by personnel well trained in this technique and only if there has not been sufficient time to establish an IV route.

Use: For prophylaxis and treatment of cardiac arrest and attacks of transitory atrioventricular heart block with syncopal seizures (Stokes-Adams Syndrome)

The American Heart Association (AHA) recommends:

  • IV or intraosseous: 1 mg IV or intraosseous every 3 to 5 minutes during cardiac arrest
  • Endotracheal: 2 to 2.5 mg endotracheally every 3 to 5 minutes during cardiac arrest if IV or intraosseous route cannot be established

Use: For administration during cardiac arrest

Usual Adult Dose for Asthma – Acute

Injectable Solution of 0.1 mg/mL (1:10,000):
0.1 to 0.25 mg (1 to 2.5 mL) IV slowly once

Use: For the treatment of acute asthmatic attacks to relieve bronchospasm not controlled by inhalation or subcutaneous administration of other solutions of the drug

Usual Adult Dose for Allergic Reaction

Auto-Injector:
30 kg or greater: 0.3 mg IM or subcutaneously into anterolateral aspect of thigh; repeat as needed

Comments:

  • The manufacturer product information for the specific auto-injector being used should be consulted for administration instructions.
  • More than 2 sequential doses should only be administered under direct medical supervision.
  • The auto-injectors are intended for immediate administration as emergency supportive therapy only and not as a replacement or substitute for immediate medical care.

Injectable Solution of 1 mg/mL (1:1000):
30 kg or greater: 0.3 to 0.5 mg (0.3 to 0.5 mL) of undiluted drug IM or subcutaneously into anterolateral aspect of the thigh; repeat every 5 to 10 minutes as needed

  • Maximum dose per injection: 0.5 mg (0.5 mL)

Comments:

  • For IM administration, use a long enough needle (at least 1/2 inch to 5/8 inch) to ensure injection into the muscle.
  • Repeated injections should not be administered at the same site as resulting vasoconstriction may cause tissue necrosis.
  • The patient should be monitored clinically for reaction severity and cardiac effects with repeat doses titrated to effect.

Injectable Solution of 0.1 mg/mL (1:10,000):
0.1 to 0.25 mg (1 to 2.5 mL) IV slowly once

Convenience Kit 1 mg/mL (1:1000):
0.2 to 1 mg IM or subcutaneous

Uses: For the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging or biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis; and for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including those with a history of anaphylactic reactions

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