EPINEPHRINE .15 mg/.15mL Injection, 1 syringe — NDC 51662-1222-1 (Billing 51662-1222-01)
This is a package of 1 syringe of EPINEPHRINE .15 mg/.15mL Injection from HF Acquisition Co LLC, DBA HealthFirst, marketed since Sep 2018 and currently FDA-listed. It is this product's only package size.
Other active recalls for Epinephrine (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1870225
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 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 ↗- Epinephrine works fast but wears off quickly — sometimes in as little as 15 to 20 minutes. Anaphylaxis can come back (this is called a biphasic reaction), and you may need addition...
- Why do I need to go to the ER after using my EpiPen or Auvi-Q if I already feel better?
- Yes, it absolutely matters. Inject into the outer thigh — you can even go through your clothing if needed. Never inject into the buttocks (that spot carries a risk of serious infec...
- Where exactly do I inject it, and does it matter?
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 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 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 | $128.60 | $128.60 / 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 3, 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 |
|---|---|---|---|---|
| 51662-1222-01 You're viewing this Main listing | 1 SYRINGE, GLASS in 1 CASE / .15 mL in 1 SYRINGE, GLASS | 2018-09-14 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| epinephrine .15 mg/.15mL 00115-1695-30 | Amneal | 1 syringe | $117.966 | BX | Availability likely | — |
| Epinephrine .15 mg/.15mLthis 51662-1222-01 | HF | 1 syringe | — | BX | FDA listed | — |
| Epinephrine Pediatrics .15 mg/.15mL 70385-2038-01 | Sina | 1 syringe | — | BX | FDA listed | — |
| epinephrine .15 mg/.15mL 70518-4573-00 | REMEDYREPACK | 1 syringe | — | BX | FDA listed | — |
| epinephrine .15 mg/.15mL 76420-0835-01 | Asclemed | 1 syringe | — | BX | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 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 Sep 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII HM4YQM8WRC
Chlorobutanol is a colorless crystalline chemical used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and shelf life.
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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 TZX5469Z6I
Sodium bisulfite is a chemical salt used as a preservative and antioxidant in medicines. It prevents discoloration and degradation of active ingredients, especially in liquid formulations and injectables.
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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 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
5 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 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Epinephrine injection, USP auto-injector is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes 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-injector is 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-injector is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Selection of the appropriate epinephrine injection, USP auto-injector dosage strength 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 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 & 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 & PRECAUTIONS (5.1)].
The epinephrine solution in the viewing window of epinephrine injection, USP auto-injector should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [see HOW SUPPLIED/STORAGE & HANDLING (16.2)].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Injection, 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector Injection, 0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector
⛔ Contraindications ▾
4 CONTRAINDICATIONS None.
⚠️ Warnings and Cautions ▾
5 WARNINGS & PRECAUTIONS
5.1Emergency Treatment Epinephrine injection, USP auto-injector is intended for immediate administration as emergency supportive therapy and is 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 & USAGE (1), DOSAGE & 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 & 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 a 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 the development of Clostridial infections (gas gangrene). Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower the 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 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 medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.
5.4Allergic Reactions Associated with Sulfite The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive. Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.
The alternatives to using epinephrine in a life-threatening… [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 & 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 & 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 & PRECAUTIONS (5.5)].
Angina may occur in patients with coronary artery disease [see WARNINGS & PRECAUTIONS (5.5)]. Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see WARNINGS & 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 an injection [see WARNINGS & PRECAUTIONS (5.2)]. Injection into the buttock has resulted in cases of gas gangrene [see WARNINGS & 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 in the thigh [see WARNINGS & PRECAUTIONS (5.3)].
Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.
🔄 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 & 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
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/m2 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/m2 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/m2 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/m2 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 dose of epinephrine delivered from epinephrine injection, USP auto-injector is 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 & PRECAUTIONS (5.5) and 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 a 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 CLINICALPHARMACOLOGY
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 intramuscularly or subcutaneously, epinephrine has a rapid onset and short duration of action.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE & HANDLING EPINEPHRINE INJECTION, USPis supplied in the following dosage forms. NDC 51662-1222-1 EPINEPHRINE INJECTION, USP AUTO INJECTOR 0.15mg NDC 51662-1223-1 EPINEPHRINE INJECTION, USP AUTO INJECTOR 0.30mg HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms
16.1How Supplied Carton containing two epinephrine injection, USP auto-injectors 0.3 mg: NDC 0115-1694-49. Carton containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 0115-1694-30. Carton containing two epinephrine injection, USP auto-injectors 0.15 mg: NDC 0115-1695-49. Carton containing one epinephrine injection, USP auto-injector 0.15 mg: NDC 0115-1695-30. Rx only
16.2Storage and Handling Protect from light. Epinephrine is light sensitive and should be stored in the carrying-case provided to protect it from light. Store at room temperature (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-injector 0.3 mg and 0.15 mg is an auto-injector and a combination product 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 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 mL) in a sterile solution.
Epinephrine injection, USP auto-injector 0.3 mg and epinephrine injection, USP auto-injector 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for epinephrine injection, USP auto-injector 0.3 mg and epinephrine injection, USP auto-injector 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded.
Each 0.3 mL in epinephrine injection, USP auto-injector 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0. Each 0.15 mL in epinephrine injection, USP auto-injector 0.15 mg contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 sodium bisulfite, hydrochloric acid and sodium hydroxide 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)]. STRUCTURE
💬 Patient Medication Information ▾
PATIENT INFORMATION EPINEPHRINE INJECTION, USP AUTO-INJECTOR (ep-in-eph-rine) Authorized generic of Adrenaclick® For allergic emergencies (anaphylaxis) Read this Patient Information Leaflet carefully before you use 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 epinephrine injection, USP auto-injector? 1.
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 other unknown causes. Symptoms of an 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) 2.
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. 3. 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 is epinephrine injection, USP auto-injector? Epinephrine injection, USP auto-injector is a disposable, prefilled automatic injection device (auto-injector) 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-injector is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency medical help right away after using epinephrine injection, USP auto-injector.
Epinephrine injection, USP auto-injector is for people who have been prescribed this medicine by their healthcare provider. The epinephrine injection, USP auto-injector 0.3 mg auto-injector is for patients who weigh 66 pounds or more (30 kilograms or more). The epinephrine injection, USP auto-injector 0.15 mg auto-injector 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 epinephrine injection, USP auto-injector? Before you use epinephrine injection, USP auto-injector, tell your healthcare provider about all your medical conditions, especially if you: have heart problems or high blood pressure have diabetes have thyroid problems have asthma have a history of depression have Parkinson's disease have any other medical conditions are pregnant or plan to become pregnant.
It is not… [Excerpted — this section continues on DailyMed.]
🧪 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 & USAGE (1).
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE EPINEPHRINE INJECTION, USP AUTO-INJECTOR (ep-in-eph-rine) For allergic emergencies (anaphylaxis) Read these Instructions for Use carefully before you use epinephrine injection, USP auto-injector. Before you need to use your epinephrine injection, USP auto-injector, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer epinephrine injection, USP auto-injector should also understand how to use it well.
If you have any questions, ask your healthcare provider. Your epinephrine injection, USP auto-injector STEP 1. Prepare epinephrine injection, USP auto-injector for injection Remove epinephrine injection, USP auto-injector from its protective carrying case.
Pull off blue end caps; you will now see a red tip. Grasp the auto-injector in your fist with the red tip pointing downward. See Figure A.
Note: The needle comes out of the red tip. To avoid an accidental injection, never put your thumb, fingers, or hand over the red tip. If an accidental injection happens, get medical help right away.
STEP 2. Administer epinephrine injection, USP auto-injector If you are administering epinephrine injection, USP auto-injector to a young child, hold the leg firmly in place and limit movement prior to and while administering an injection. Put the red tip against the middle of the outer thigh (upper leg) at a 90° angle (perpendicular) to the thigh.
Press down hard and hold firmly against the thigh for approximately 10 seconds to deliver the medicine. See Figure B. Only inject into the middle of the outer thigh.
Do not inject into any other part of the body. Remove epinephrine injection, USP auto-injector from the thigh. Massage the area for 10 seconds.
Check the red tip. The injection is complete and you have received the correct dose of the medicine if you see the needle sticking out of the red tip. If you do not see the needle repeat Step 2.
STEP 3. 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. STEP 4. After use / Disposal Carefully cover the needle with the carrying case.
Lay the labeled half of the carrying case cover down on a flat surface. Use one hand to carefully slide the end of the auto-injector, needle first, into the labeled carrying case cover. See Figure C.
After the needle is inside the labeled cover, push the unlabeled half of the carrying case cover firmly over the non-needle end of the auto-injector. See Figure D. Take your used epinephrine injection, USP auto-injector with you when you go to see a healthcare provider.
Tell the healthcare provider that you have received an injection of epinephrine. Show the healthcare provider where you received the injection. Give your used epinephrine injection, USP auto-injector to the healthcare provider for inspection and proper disposal.
Ask for a refill, if needed. Note: Epinephrine injection, USP auto-injector is a single-use injectable device that delivers a fixed dose of epinephrine. The auto-injector cannot be reused.
Do not attempt to reuse epinephrine injection, USP auto-injector after the device has been activated. It is normal for most of the medicine to remain in the auto-injector after the dose is injected. The correct dose has been administered if you see the needle sticking out of the red tip.
A separate epinephrine injection, USP auto-injector Trainer is available. The epinephrine injection, USP auto-injector Trainer has a beige color. The beige epinephrine injection, USP auto-injector Trainer contains no medicine and no needle.
Practice with your epinephrine injection, USP auto-injector Trainer, but always carry your real epinephrine injection, USP auto-injector in case of an allergic emergency. If you will be administering epinephrine injection, USP auto-injector to a young child, ask your healthcare provider to show you how to properly h… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPLE DISPLAY PANEL, 0.15 mL CASE LABEL PRINCIPAL DISPLAY PANEL - 0.15 mg CASE LABEL epinephrine injection, USP auto-injector 0.15 mg Impax Generics CASE LABEL
PRINCIPLE DISPLAY PANEL, .15 mL SERIALIZED LABEL SERIALIZED LABEL
PRINCIPLE DISPLAY PANEL, 0.3mL SERIALIZED LABEL 0.3mL SERIALIZED LABEL
PRINCIPLE DISPLAY PANEL, 0.3 ml case label PRINCIPAL DISPLAY PANEL - 0.3 mg CASE LABEL epinephrine injection, USP auto-injector 0.3 mg Impax Generics 0.3 mL CASELABEL
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