Epinephrine .3 mg/.3mL Injection, 1 syringe — NDC 71872-7135-1 (Billing 71872-7135-01)
This is a package of 1 syringe of Epinephrine .3 mg/.3mL Injection from Medical Purchasing Solutions, LLC, marketed since Dec 2016 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 71872-7135-1 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 71872 labeler · 7135 product · 1 package
- Package marketed since
- Apr 11, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 7187271351 1
- FDA record last changed
- Jul 24, 2026
Other active recalls for Epinephrine (different manufacturers) — 3 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1870207
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the alpha-Adrenergic Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Epinephrine injection is used along with emergency medical treatment to treat life-threatening allergic reactions caused by insect bites or stings, foods, medications, latex, and other causes. Epinephrine injection is also used to treat life-threatening low blood pressure associated with septic shock (a serious condition caused by a body-wide infection that can lead to dangerously low blood pressure and organ failure) in hospitalized patients. Epinephrine is in a class of medications called alpha- and beta-adrenergic agonists (sympathomimetic agents). It works by relaxing the muscles in the ai...
Read the full MedlinePlus article ↗- Its main use is emergency treatment of severe allergic reactions, including anaphylaxis from stings, foods or drugs. Some injections are also used for low blood pressure in septic...
- Yes. Epinephrine is emergency first aid, not a replacement for medical care. Call for help right after using it so you can be monitored and treated further if needed.
- Do I still need to go to the hospital after using it?
- Into the outer middle part of the thigh, through clothing if needed. Never inject into a vein, the buttock, or fingers, hands or feet. For young children, hold the leg firmly so th...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Epinephrine — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $136.87 | $136.87 / 1 syringe |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 71872-7135-01 You're viewing this Main listing | 1 CONTAINER in 1 BAG / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS | 2018-04-11 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Epinephrine 1 mg/mL 00093-5986-27 | Teva | 1 syringe | $133.597 | — | Availability likely | — |
| Epinephrine .3 mg/.3mL 49502-0102-02 | Viatris | 1 syringe | $141.276 | AB | Availability likely | — |
| Epipen .3 mg/.3mL 49502-0500-02 | Viatris | 1 syringe | $292.748 | AB | FDA listed | — |
| Auvi-Q .3 mg/.3mL 60842-0023-01 | kaleo, | 2 doses | $309.376 | BX | Discontinued | — |
| Epinephrine .3 mg/.3mL 50090-4543-00 | A-S | 1 ml | — | AB | FDA listed | — |
| Epinephrine .3 mg/.3mL 67296-1946-02 | Redpharm | 1 syringe | — | AB | FDA listed | — |
| Epinephrine 0.3 Adults .3 mg/.3mL 70385-2019-01 | Sina | 1 syringe | — | AB | FDA listed | — |
| Epinephrine .3 mg/.3mL 70518-2283-00 | REMEDYREPACK | 1 syringe | — | AB | FDA listed | — |
| Epinephrine .3 mg/.3mLthis 71872-7135-01 | Medical | 1 syringe | — | AB | FDA listed | — |
| Epinephrine .3 mg/.3mL 76420-0188-02 | Asclemed | 2 syringes | — | AB | FDA listed | — |
| Epipen .3 mg/.3mL 76420-0584-02 | Asclemed | 1 syringe | — | AB | FDA listed | — |
| Epinephrine .3 mg/.3mL 85766-0091-02 | Sportpharm | 1 syringe | — | AB | FDA listed | — |
| Epinephrine .3 mg/.3mL 51662-1224-01 | HF | 1 syringe | — | AB | FDA listed | — |
| Auvi-Q .3 mg/.3mL 71872-7173-01 | Medical | 1 dose | — | BX | FDA listed | — |
| Epinephrine .3 mg/.3mL 51662-1320-01 | HF | 3 ml | — | BX | FDA listed | — |
| Auvi-Q .3 mg/.3mL 71872-7329-01 | Medical | 1 dose | — | BX | FDA listed | — |
| Auvi-Q .3 mg/.3mL 85766-0277-02 | Sportpharm | 2 doses | — | BX | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Epinephrine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 4VON5FNS3C
Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Medical Purchasing Solutions, LLC labeler code 71872
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- Lidocaine Hydrochloride 10 mg/mL Injection, Solution NDC 71872-7137-1
- Ampicillin 2 g Injection, Powder, For Solution NDC 71872-7139-1
- Ondansetron 2 mg/mL Injection NDC 71872-7140-1
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- Magnesium Sulfate 500 mg/mL Injection, Solution NDC 71872-7142-1
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Epinephrine injection, USP auto-injectors 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. Epinephrine injection, USP auto-injectors 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. Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.
Epinephrine injection, USP auto-injector contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Selection of the appropriate epinephrine injection, USP auto-injector is determined according to patient body weight. Patients greater than or equal to 30 kg (approximately 66 pounds or more): epinephrine injection, USP auto-injector, 0.3 mg Patients 15 kg to 30 kg (33 pounds to 66 pounds): epinephrine injection, USP auto-injector, 0.15 mg Inject epinephrine injection, USP auto-injector intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary.
Instruct caregivers of young children who are prescribed an epinephrine injection, USP auto-injector 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 epinephrine injection, USP auto-injector contains a single dose of epinephrine for single-use injection. Since the doses of epinephrine delivered from epinephrine injection, USP auto-injector are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. With severe persistent anaphylaxis, repeat injections with an additional epinephrine injection, USP auto-injector may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [ see Warnings and Precautions (5.1) ].
The epinephrine solution in the clear window of the epinephrine injection, USP auto-injector should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light [ see How Supplied/Storage and Handling (16.2) ] . Patients greater than or equal to 30 kg (66 lbs): epinephrine injection, USP auto-injector , 0.3 mg ( 2 ) Patients 15 to 30 kg (33 lbs to 66 lbs): epinephrine injection, USP auto-injector, 0.15 mg ( 2 ) Inject intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary.
Each device is a single-use injection . ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection, 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector Injection, 0.15 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector Epinephrine injection, USP auto-injector: 0.3 mg: 0.3 mg/0.3 mL epinephrine, USP, pre-filled auto-injector ( 3 ) Epinephrine injection, USP auto-injector : 0.15 mg: 0.15 mg/0.3 mL epinephrine, USP, pre-filled auto-injector ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS In conjunction with use, seek immediate medical or hospital care. ( 5.1 ) Do not inject intravenously, into buttock, or into digits, hands, or feet. ( 5.2 ) To minimize the risk of injection related injury, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection when administering to young children.
( 5.2 ) Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop signs or symptoms of infection. ( 5.3 ) The presence of a sulfite in this product should not deter use.
( 5.4 ) Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias. ( 5.5 )
5.1Emergency Treatment Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy and are not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [ see Indications and Usage (1) , Dosage and Administration (2) and Patient Counseling Information (17) ].
5.2Injection-Related Complications Epinephrine injection, USP auto-injector should only be injected into the anterolateral aspect of the thigh [ see Dosage and Administration (2) and Patient Counseling Information (17) ]. Do not inject intravenously. Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to sharp rise in blood pressure.
Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration. Do not inject into buttock. Injection into the buttock may not provide effective treatment of anaphylaxis.
Advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis. Additionally, injection into the buttock has been associated with Clostridial infections (gas gangrene). Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower this risk.
Do not inject into digits, hands or feet. Since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection.
Treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis [ see Adverse Reactions (6) ]. Hold leg firmly during injection. Lacerations, bent needles, and embedded needles have been reported when epinephrine injection, USP auto-injector has been injected into the thigh of young children who are uncooperative and kick or move during an injection.
To minimize the risk of injection related injury when administering epinephrine injection, USP auto-injector to young children, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection.
5.3Serious Infections at the Injection Site Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores.
To decrease the risk of Clostridium infection, do not inject epinephrine injection, USP auto-injector into the buttock [see Warnings and Precautions (5.2) ]. Advise patients to seek medi… [Excerpted — this section continues on DailyMed.]
🤒 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) ]. 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) ].
Angina may occur in patients with coronary artery disease [ see Warnings and Precautions (5.5) ]. Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine. Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [ see Warnings and Precautions (5.2) ].
Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury. Lacerations, bent needles, and embedded needles have been reported when epinephrine injection, USP auto-injector has been injected into the thigh of young children who are uncooperative and kick or move during the injection [ see Warning and Precautions (5.2) ].
Injection into the buttock has resulted in cases of gas gangrene [ see Warnings and Precautions (5.2) ] . Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection, including epinephrine injection, USP auto-injector, in the thigh [ see Warnings and Precautions (5.3) ]. Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan Specialty, L.P. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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) ]. The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine. The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta- adrenergic blocking drugs, such as propranolol.
The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha- adrenergic blocking drugs, such as phentolamine. 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: potentiate effects of epinephrine. ( 7 ) Beta-adrenergic blocking drugs: antagonize cardiostimulating and bronchodilating effects of epinephrine. ( 7 ) Alpha-adrenergic blocking drugs: antagonize vasoconstricting and hypertensive effects of epinephrine.
( 7 ) Ergot alkaloids: may reverse the pressor effects of epinephrine. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Elderly patients may be at greater risk of developing adverse reactions. ( 5.5 , 8.5 )
8.1Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. Epinephrine was teratogenic in rabbits, mice and hamsters. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both).
Epinephrine has been shown to have teratogenic effects when administered subcutaneously in rabbits at approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a maternal dose of 1.2 mg/kg/day for two to three days), in mice at approximately 7 times the maximum daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1 mg/kg/day for 10 days), and in hamsters at approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days).
These effects were not seen in mice at approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).
8.3Nursing Mothers It is not known whether epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when epinephrine injection, USP auto-injector is administered to a nursing woman.
8.4Pediatric Use Epinephrine injection, USP auto-injector may be administered to pediatric patients at a dosage appropriate to body weight [ see Dosage and Administration (2) ] . Clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Since the doses of epinephrine delivered from epinephrine injection, USP auto-injectors are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
8.5Geriatric Use Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. Therefore, epinephrine injection, USP auto-injector should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [ see Warnings and Precautions (5.5) , Overdosage (10) ].
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. Epinephrine was teratogenic in rabbits, mice and hamsters. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both).
Epinephrine has been shown to have teratogenic effects when administered subcutaneously in rabbits at approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a maternal dose of 1.2 mg/kg/day for two to three days), in mice at approximately 7 times the maximum daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1 mg/kg/day for 10 days), and in hamsters at approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days).
These effects were not seen in mice at approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).
🧒 Pediatric Use ▾
8.4Pediatric Use Epinephrine injection, USP auto-injector may be administered to pediatric patients at a dosage appropriate to body weight [ see Dosage and Administration (2) ] . Clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Since the doses of epinephrine delivered from epinephrine injection, USP auto-injectors are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. Therefore, epinephrine injection, USP auto-injector should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [ see Warnings and Precautions (5.5) , Overdosage (10) ].
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.
Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block.
Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol. Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Epinephrine acts on both alpha- and beta-adrenergic receptors.
12.2Pharmacodynamics Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension. Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis. Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.
When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Epinephrine acts on both alpha- and beta-adrenergic receptors.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Epinephrine Injection, USP Auto-Injectors, 0.3 mg (epinephrine injections, USP 0.3 mg/0.3 mL) are available as NDC 49502-102-02, a pack that contains two Epinephrine Injection, USP Auto-Injectors, 0.3 mg (epinephrine injections, USP 0.3 mg/0.3 mL) and one Epinephrine Injection, USP Auto-Injector Trainer device. Epinephrine Injection, USP Auto-Injectors, 0.15 mg (epinephrine injections, USP 0.15 mg/0.3 mL) are available as NDC 49502-101-02, a pack that contains two Epinephrine Injection, USP Auto-Injectors, 0.15 mg (epinephrine injections, USP 0.15 mg/0.3 mL) and one Epinephrine Injection, USP Auto-Injector Trainer device.
Epinephrine Injection, USP Auto-Injectors also include an S-clip to clip two carrier tubes together. Rx only
16.2Storage and Handling Protect from light. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.
📋 Description ▾
11 DESCRIPTION Epinephrine injection, USP auto-injectors, 0.3 mg and 0.15 mg, are auto-injectors and combination products containing drug and device components. Each epinephrine injection, USP auto-injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each epinephrine injection, USP auto-injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution.
The epinephrine injection, USP auto-injector contains 2 mL epinephrine solution. Approximately 1.7 mL remains in the auto-injector after activation, but is not available for future use, and should be discarded. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.3 mg contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection.
The pH range is 2.2-5.0. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.15 mg contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0.
Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure: Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles.
Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [ see Patient Counseling Information (17) ]. Epinephrine Structrual Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION [ See FDA-Approved Patient Labeling ( Patient Information and Instructions for Use ). ] A healthcare provider should review the patient instructions and operation of epinephrine injection, USP auto-injector in detail, with the patient or caregiver. Epinephrine is essential for the treatment of anaphylaxis. Patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, should be carefully instructed about the circumstances under which epinephrine should be used.
Administration and Training Instruct patients and/or caregivers in the appropriate use of epinephrine injection, USP auto-injector. Epinephrine injection, USP auto-injector should be injected into the middle of the outer thigh (through clothing, if necessary). Each device is a single-use injection.
Advise patients to seek immediate medical care in conjunction with administration of epinephrine injection, USP auto-injectors. Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection. Lacerations, bent needles, and embedded needles have been reported when epinephrine injection, USP auto-injector has been injected into the thigh of young children who are uncooperative and kick or move during an injection [ see Warnings and Precautions (5.2) ].
Complete patient information, including dosage, directions for proper administration and precautions can be found inside each epinephrine injection, USP auto-injector carton. A printed label on the surface of epinephrine injection, USP auto-injector shows instructions for use and a diagram depicting the injection process. Instruct patients and/or caregivers to use and practice with the Trainer to familiarize themselves with the use of epinephrine injection, USP auto-injector in an allergic emergency.
The Trainer may be used multiple times. A Trainer device is provided in epinephrine injection, USP auto-injector cartons. Adverse Reactions Epinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety.
These signs and symptoms usually subside rapidly, especially with rest, quiet and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration.
Patients with Parkinson’s disease may notice a temporary worsening of symptoms [ see Warnings and Precautions (5.5) ] . Accidental Injection Advise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands, or feet, treatment should be directed at vasodilatation if there is such an accidental injection to these areas [ see Warnings and Precautions (5.2) ].
Serious Infections at the Injection Site Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [ see Warnings and Precautions (5.3) ]. Storage and Handling Instruct patients to inspect the epinephrine solution visually through the clear window of the auto-injector periodically.
Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Epineph… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
8.3Nursing Mothers It is not known whether epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when epinephrine injection, USP auto-injector is administered to a nursing woman.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension. Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis. Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.
When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted. Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro and to be an oxidative mutagen in a WP2 bacterial reverse mutation assay. Epinephrine was positive in the DNA Repair test with B. subtilis (REC) assay, but was not mutagenic in the Salmonella bacterial reverse mutation assay.
The potential for epinephrine to impair fertility has not been evaluated. This should not prevent the use of epinephrine under the conditions noted under Indications and Usage (1) .
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted. Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro and to be an oxidative mutagen in a WP2 bacterial reverse mutation assay. Epinephrine was positive in the DNA Repair test with B. subtilis (REC) assay, but was not mutagenic in the Salmonella bacterial reverse mutation assay.
The potential for epinephrine to impair fertility has not been evaluated. This should not prevent the use of epinephrine under the conditions noted under Indications and Usage (1) .
📄 Patient Package Insert ▾
PATIENT INFORMATION and INSTRUCTIONS FOR USE Epinephrine Injection, USP Auto-Injector 0.3 mg one dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL Epinephrine Injection, USP Auto-Injector 0.15 mg one dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL Authorized generic for EpiPen® and EpiPen Jr® Auto-Injectors For allergic emergencies (anaphylaxis) Patient Information Read this Patient Information Leaflet carefully before using the epinephrine injection, USP auto-injector and each time you get a refill. There may be new information.
You, your parent, caregiver, or others who may be in a position to administer epinephrine injection, USP auto-injector, should know how to use it before you have an allergic emergency. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about the Epinephrine Injection, USP Auto-Injector?
Epinephrine injection, USP auto-injector contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. Symptoms of anaphylaxis may include: trouble breathing wheezing hoarseness (changes in the way your voice sounds) hives (raised reddened rash that may itch) severe itching swelling of your face, lips, mouth, or tongue skin rash, redness, or swelling fast heartbeat weak pulse feeling very anxious confusion stomach pain losing control of urine or bowel movements (incontinence) diarrhea or stomach cramps dizziness, fainting, or “passing out” (unconsciousness) Always carry your epinephrine injection, USP auto-injector with you because you may not know when anaphylaxis may happen.
Talk to your healthcare provider if you need additional units to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your epinephrine injection, USP auto-injector and how to use it before you need it. You may be unable to speak in an allergic emergency.
When you have an allergic emergency (anaphylaxis) Use epinephrine injection, USP auto-injector right away. Get emergency medical help right away. You may need further medical attention.
You may need to use a second epinephrine injection, USP auto-injector if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode. What are epinephrine injection, USP auto-injectors?
Epinephrine injection, USP auto-injectors are disposable, prefilled automatic injection devices (auto-injectors) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine. Epinephrine injection, USP auto-injectors are for immediate self (or caregiver) administration and do not take the place of emergency medical care.
You should get emergency help right away after using epinephrine injection, USP auto-injector. Epinephrine injection, USP auto-injectors are for people who have been prescribed this medicine by their healthcare provider. The epinephrine injection, USP auto-injector (0.3 mg) is for patients who weigh 66 pounds or more (30 kilograms or more).
The epinephrine injection, USP auto-injector (0.15 mg) is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms). It is not known if epinephrine injection, USP auto-injector is safe and effective in children who weigh less than 33 pounds (15 kilograms). What should I tell my healthcare provider before using the epinephrine injection, USP auto-injector?
Before you use epinephrine injection, USP auto-injector, tell your healthcare provider about all your medical conditions, but especially if you: have heart problems or high blood pressure have dia… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Dosage and Administration ( 2 ) 05/2016 Warnings and Precautions ( 5.2 , 5.3 ) 05/2016
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL – OUTER PACKAGE LABEL NDC 71872-7135-1 Rx only For Allergic Emergencies (Anaphylaxis) Epinephrine Injection, USP 1 - Auto-Injector 0.3 mg Authorized generic for EpiPen ® Auto-Injector For more information about your Epinephrine Injection, USP Auto-Injectors visit MyGenericEAI.com Never put your thumb, fingers or hand over the orange tip. Never put thumb, fingers or hand over orange tip. Do not remove blue safety release until ready to use.
Each Epinephrine Injection, USP Auto-Injector delivers one 0.3 mg intramuscular dose of epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL. Discard unit after use. The Trainer contains no medicine and no needle.
Replace if discolored. Store at 68° to 77°F (20° to 25°C). Do not refrigerate.
Protect from light. epilabel
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