EPIPEN .3 mg/.3mL

epinephrine · INJECTION · Asclemed USA, Inc.

2 Recalls on RecordCurrently in Shortage

Plain English

EPIPEN is a injection containing epinephrine at .3 mg/.3mL, taken intramuscular. Manufactured by Asclemed USA, Inc..

Key Facts

Brand Name: EPIPEN
Generic Name: epinephrine
NDC Code (Product): 76420-584
Manufacturer: Asclemed USA, Inc.
Strength: .3 mg/.3mL
Dosage Form: INJECTION
Route: INTRAMUSCULAR
Marketing Status
Application #: NDA019430
Drug Class: alpha-Adrenergic Agonist [EPC]; beta-Adrenergic Agonist [EPC]
Marketing Start: 12/22/1987

Recall History

2 Recalls on Record

Class I03/12/2017

Meridian Medical Technologies a Pfizer Company

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

OngoingVoluntary: Firm initiated

Class I03/12/2017

Meridian Medical Technologies a Pfizer Company

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective5,587 reports

headache4,215 reports

sinusitis3,971 reports

fatigue3,849 reports

dyspnoea3,273 reports

pain3,216 reports

nausea3,203 reports

product dose omission issue3,120 reports

off label use2,728 reports

covid-192,599 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE EpiPen are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care. EpiPen are non-selective alpha and beta-adrenergic…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Patients greater than or equal to 30 kg (66 lbs): EpiPen 0.3 mg ( 2 ) Inject intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Each device is a single-dose injection . ( 2 ) 2.1 Recommended Dosage According to Patient Body Weight Patients greater than or equal to 30 kg (approximately 66 pounds or more): EpiPen 0.3 mg 2.2 Administration Instructions Inject the single-dose EpiPen intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Do not inject intravenously, and do not inject into buttocks, into digits, hands or feet [see Warnings and Precautions (5.2) ]. Instruct caregivers of young children who are prescribed an EpiPen and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see Warnings and Precautions (5.2) ] . Each EpiPen is a single-dose epinephrine injection for single use. Since the doses of epinephrine delivered from EpiPen are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. With…

Contraindications

4 CONTRAINDICATIONS None None ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Cardiac Glycosides, Diuretics, and Anti-arrhythmics Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see Warnings and Precautions (5.5) ] . Antidepressants, Monoamine Oxidase Inhibitors, Levothyroxine, and Antihistamines The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine. Beta-Adrenergic Blockers The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta- adrenergic blocking drugs, such as propranolol. Alpha-Adrenergic Blockers The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha- adrenergic blocking drugs, such as phentolamine. Ergot Alkaloids Ergot alkaloids may also reverse the pressor effects of epinephrine. Cardiac glycosides or diuretics: observe for development of cardiac arrhythmias. ( 7 ) Tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines po…

Adverse Reactions

6 ADVERSE REACTIONS Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below. Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [ see Warnings and Precautions (5.5) ]. Cardiovascular Reactions Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [ see Warnings and Precautions (5.5) and Drug Interactions (7) ]. Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [ see Warnings and Precautions (5.5) ]. A…

Frequently Asked Questions

What is EPIPEN used for?

EPIPEN contains epinephrine. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is EPIPEN a controlled substance?

EPIPEN is not classified as a controlled substance by the DEA.

What is the generic name for EPIPEN?

The generic name for EPIPEN is epinephrine. There are 12 other brand versions of epinephrine.

What is the NDC code for EPIPEN .3 mg/.3mL?

The NDC (National Drug Code) for EPIPEN .3 mg/.3mL is 76420-584, listed by Asclemed USA, Inc..

Product NDC

76420-584

Package NDC

76420-584-02

Other Epinephrine Brands

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

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