Drugplain

ADRENALIN (EPINEPHRINE) 1 mg/mL

ADRENALIN (EPINEPHRINE) · INJECTION · HF Acquisition Co LLC, DBA HealthFirst

2 Recalls on Record
Plain English

ADRENALIN (EPINEPHRINE) is a injection containing adrenalin (epinephrine) at 1 mg/mL, taken intramuscular. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.

Key Facts

Brand Name
ADRENALIN (EPINEPHRINE)
Generic Name
ADRENALIN (EPINEPHRINE)
NDC Code (Product)
51662-1290
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Strength
1 mg/mL
Dosage Form
INJECTION
Route
INTRAMUSCULAR, SUBCUTANEOUS
Marketing Status
Application #
NDA204200
Drug Class
alpha-Adrenergic Agonist [EPC]; beta-Adrenergic Agonist [EPC]
Marketing Start
09/21/2018

Recall History

2 Recalls on Record
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated
Class II01/17/2024

Henry Schein Inc. and Glove Club HSI Gloves Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.

CompletedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1. INDICATIONS AND USAGE Adrenalin ® 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 Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

Dosage & Administration

2. DOSAGE AND ADMINISTRATION No further dilution prior to infusion is required ( 2.1 ) Infuse epinephrine into a large vein ( 2.2 ) Titrate 0.05 mcg/kg/min to 2 mcg/kg/min to achieve desired blood pressure ( 2.2 ) Wean gradually ( 2.2 ) See Full Prescribing Information for instructions on administration of the injection. 2.1. General Considerations Administration Adrenalin is a ready to administer product that requires no further dilution prior to infusion. Inspect visually for particulate matter and discoloration prior to administration; solution should be clear and colorless. Do not use if the solution is colored or cloudy, or if it contains particulate matter. Do not open the aluminum overwrap until time of use. The premixed, ready-to-use infusion bag has a single port for insertion of the infusion set only. This port should not be used to remove content from the bag or add another medication. Once the infusion bag has been connected to the infusion set, it is stable for 24 hours, as long as the bag stays connected to the infusion set. Single dose only. Discontinuation When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal. Discard unused portio

Contraindications

4. CONTRAINDICATIONS None. None ( 4 )

Drug Interactions

7. 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, antihistamines, exogenous thyroid hormones, diuretics, cardiac glycosides and quinidine. Observe for development of cardiac arrhythmias. ( 7.3 ) Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. ( 7.4 ) 7.1. Drugs Antagonizing Pressor Effects of Epinephrine α-blockers, such as phentolamine Vasodilators, such as nitrates Diuretics Antihypertensives Ergot alkaloids Phenothiazine antipsychotics 7.2. Drugs Potentiating Pressor Effects of Epinephrine Sympathomimetics β-blockers, such as propranolol Tricyclic anti-depressants Monoamine oxidase (MAO

Adverse Reactions

6. 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 )] The following adverse reactions associated with the infusion of epinephrine were identified in the literature. 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, myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema Gastrointestinal disorders : Nausea, vomiting General disorders and administrative site conditions : Chest pain, extravasation Metabolic : hypoglycemia, hyperglycemia, insulin resistance, hypokalemia, lactic acidosis Nervous system disorders : Headache, nervousness, paresthesia, tremor, st

Frequently Asked Questions

What is ADRENALIN (EPINEPHRINE) used for?

ADRENALIN (EPINEPHRINE) contains ADRENALIN (EPINEPHRINE). It is a injection taken intramuscular. Consult your doctor for specific uses.

Is ADRENALIN (EPINEPHRINE) a controlled substance?

ADRENALIN (EPINEPHRINE) is not classified as a controlled substance by the DEA.

What is the generic name for ADRENALIN (EPINEPHRINE)?

The generic name for ADRENALIN (EPINEPHRINE) is ADRENALIN (EPINEPHRINE). There are no other listed brand versions of ADRENALIN (EPINEPHRINE).

What is the NDC code for ADRENALIN (EPINEPHRINE) 1 mg/mL?

The NDC (National Drug Code) for ADRENALIN (EPINEPHRINE) 1 mg/mL is 51662-1290, listed by HF Acquisition Co LLC, DBA HealthFirst.

Product NDC

51662-1290

Package NDC

51662-1290-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)