Adrenalin epinephrine 1 mg/mL Injection
Other active recalls for Epinephrine (different manufacturers) — 2 · tap to view
Past resolved recalls for this product (2)
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the alpha-Adrenergic Agonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Use it at the first signs of a severe allergic reaction — things like throat tightening, difficulty breathing, widespread hives, a sudden drop in blood pressure, or feeling faint....
- When exactly should I use my epinephrine auto-injector or nasal spray?
- No — and this is really important. Even if your symptoms improve quickly, you need to go to the emergency room right away. Anaphylaxis can return hours later (called a biphasic rea...
- After I use epinephrine, can I just go home and rest if I feel better?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Epinephrine — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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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5.25 mg / 1 mL
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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0.20 mg / 1 mL
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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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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6.15 mg / 1 mL
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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0.920 mg / 1 mL
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.
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0.457 mg / 1 mL
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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2.25 mg / 1 mL
UNII W4888I119H
Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
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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.
8 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $45.44 | $45.44 / 1 vial |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0165 | $0.234 / J0165 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Adrenalin 1 mg/mL 42023-0159-25 | Par | 25 vials | $7.796 | AP | Availability likely | — |
| Epinephrine 1 mg/mL 00517-3030-01 | American | 1 vial | — | AP | FDA listed | — |
| Adrenalin 1 mg/mLthis 42023-0168-89 | Par | 1 vial | — | AP | FDA listed | — |
| epinephrine 1 mg/mL 43066-0801-02 | Baxter | 1 vial | — | — | FDA listed | — |
| Adrenalin(R) 1 mg/mL 51662-1307-01 | HF | 1 vial | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 54288-0120-01 | BPI | 1 vial | — | AP | FDA listed | — |
| Epinephrine 30 mg/30mL 54288-0152-01 | BPI | 1 vial | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 54288-0600-01 | BPI | 1 vial | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 63323-0698-30 | Fresenius | 1 vial | — | — | FDA listed | — |
| epinephrine 1 mg/mL 68083-0633-01 | Gland | 1 vial | — | AP | FDA listed | — |
| epinephrine 1 mg/mL 68083-0685-01 | Gland | 1 vial | — | AP | FDA listed | — |
| epinephrine 1 mg/mL 68462-0760-10 | GLENMARK | 1 vial | — | AP | FDA listed | — |
| epinephrine 1 mg/mL 68462-0761-30 | GLENMARK | 1 vial | — | AP | FDA listed | — |
| epinephrine 1 mg/mL 70121-1660-02 | Amneal | 1 vial | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 72572-0238-01 | CIVICA, | 1 vial | — | — | FDA listed | — |
| Epinephrine 1 mg/mL 76329-9060-00 | International | 1 vial | — | AP | FDA listed | — |
| Adrenalin 1 mg/mL 71872-7223-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Adrenalin 1 mg/mL 84549-0159-25 | ProPharma | 1 ml | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 70518-4156-00 | REMEDYREPACK | 25 vials | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 80830-1659-02 | Amneal | 25 vials | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 71872-7360-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 54288-0119-10 | BPI | 10 vials | — | AP | FDA listed | — |
| epinephrine 1 mg/mL 43066-0803-25 | Baxter | 25 vials | — | — | FDA listed | — |
| Adrenalin Vials 1 mg/mL 70385-2024-02 | Sina | 2 vials | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 00143-9476-25 | Hikma | 25 ampules | — | AP | FDA listed | — |
| Adrenalin 1 mg/mL 70518-1342-00 | REMEDYREPACK | 25 vials | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 51662-1706-01 | HF | 1 ml | — | AP | FDA listed | — |
| Epinephrine 1 mg/mL 51662-1708-01 | HF | 1 ml | — | AP | FDA listed | — |
Where does this data come from?
⏳ 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.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 9295657 ↗ | Method of use | U-1829 | Mar 13, 2035 |
| US 10130592 ↗ | Drug product | — | Mar 13, 2035 |
| US 9119876 ↗ | Drug product | — | Mar 13, 2035 |
| US 12280024 ↗ | Drug product | — | Mar 13, 2035 |
Is there a generic version of ADRENALIN 30 MG/30 ML VIAL?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 42023-0168-01 | 1 VIAL in 1 CARTON (42023-168-01) / 30 mL in 1 VIAL | 2014-03-01 | Active |
| 42023-0168-99 | 1 VIAL in 1 CARTON (42023-168-99) / 30 mL in 1 VIAL | 2020-12-04 | Active |
| 42023-0168-89 You're viewing this | 1 VIAL in 1 CARTON (42023-168-89) / 30 mL in 1 VIAL | 2020-12-04 | Active |
This pack accounts for about 1.9% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 42023-0168-89?
What NDC number is used to bill for this package of Adrenalin epinephrine 1 mg/mL Injection?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Adrenalin ® is a non-selective alpha and beta adrenergic agonist indicated for: Emergency treatment of allergic reactions (Type 1), including anaphylaxis ( 1.1 ) To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1.2 )
1.1Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
1.2Hypotension associated with Septic Shock Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Anaphylaxis : Adults and Children 30 kg (66 lbs) or more : 0.3 mg to 0.5 mg (0.3 mL to 0.5 mL) intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary ( 2.2 ) Children 30 kg (66 lbs) or less : 0.01 mg/kg (0.01 mL/kg), up to 0.3 mg (0.3 mL), intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary ( 2.2 ) Hypotension associated with septic shock : Dilute epinephrine in dextrose solution prior to infusion ( 2.3 ) Infuse epinephrine into a large vein ( 2.3 ) Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated to achieve desired mean arterial pressure ( 2.3 ) Wean gradually ( 2.3 ) See Full Prescribing Information for instructions on dilution and administration of the injection.
2.1General Considerations 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.
2.2Anaphylaxis Inject Adrenalin intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. When administering to a child, to minimize the risk of injection related injury, hold the leg firmly in place and limit movement prior to and during an injection. The injection may be repeated every 5 to 10 minutes as necessary.
For intramuscular administration, use a needle long enough (at least 1/2 inch) to ensure the injection is administered into the muscle. Monitor the patient clinically for the severity of the allergic reaction and potential cardiac effects of the drug, and repeat as needed. Do not administer repeated injections at the same site, as the resulting vasoconstriction may cause tissue necrosis.
Adults and Children 30 kg (66 lbs) or more : 0.3 to 0.5 mg (0.3 to 0.5 mL) of undiluted Adrenalin administered intramuscularly or subcutaneously in the anterolateral aspect of the thigh, up to a maximum of 0.5 mg (0.5 mL) per injection, repeated every 5 to 10 minutes as necessary. Monitor clinically for reaction severity and cardiac effects. Children less than 30 kg (66 lbs) : 0.01 mg/kg (0.01 mL/kg) of undiluted Adrenalin administered intramuscularly or subcutaneously in the anterolateral aspect of the thigh, up to a maximum of 0.3 mg (0.3 mL) per injection, repeated every 5 to 10 minutes as necessary.
Monitor clinically for reaction severity and cardiac effects.
2.3Hypotension associated with Septic Shock Dilute 1 mL (1 mg) of epinephrine from its vial to 1,000 mL of a 5 percent dextrose or 5 percent dextrose and sodium chloride solution to produce a 1 mcg per mL dilution. Administration in saline solution alone is not recommended. If indicated, administer whole blood or plasma separately.
Whenever possible, give infusions of epinephrine into a large vein. Avoid using a catheter tie-in technique, because the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug. Avoid the veins of the leg in elderly patients or in those suffering from occlusive vascular diseases.
To provide hemodynamic support in septic shock associated hypotension in adult patients, the suggested dosing infusion rate of intravenously administered epinephrine is 0.05 to 2 mcg/kg/min, and is titrated to achieve a desired mean arterial pressure (MAP). The dosage may be adjusted periodically, such as every 10 to 15 minutes, in increments of 0.05 to 0.2 mcg/kg/min, to achieve the desired blood pressure goal. After hemodynamic stabilization, wean incrementally over time, such as by decreasing doses of epinephrine every 10 minutes to determine if the patient can tolerate gradual withdrawal.
Adrenalin diluted in 5 percent dextrose solutions or 5 percent dextrose and sodium chloride solutions are stable for 4 hours at room temperature or 24 hours under refrigerated conditions.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Adrenalin injection: clear, colorless solution supplied as 1 mg/1 mL in a single dose clear glass vial and as 30 mg/30 mL (1 mg/mL) in a multiple dose amber glass vial. Injection: 1 mg/mL single dose vial and 30 mg/30 mL (1 mg/mL) multiple dose vial ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Do not inject into buttocks, digits, hands, or feet ( 5.1 ) Avoid extravasation into tissues, which can cause local necrosis ( 5.3 ) May aggravate angina pectoris or produce ventricular arrhythmias ( 5.7 )
5.1Incorrect Locations of Injection for Anaphylaxis Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate location for administration because of its location, size, and available blood flow. Injection into (or near) smaller muscles, such as in the deltoid, is not recommended. Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis.
Do not inject into buttock. Injection into the buttock may not provide effective treatment of anaphylaxis and has been associated with the development of Clostridial infections (gas gangrene). Do not inject into digits, hands, or feet.
Epinephrine is a strong vasoconstrictor. Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area and tissue necrosis.
5.2Serious 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.
5.3Extravasation and Tissue Necrosis with Intravenous Infusion Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When Adrenalin is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage.
This also may progress on rare occasions to superficial slough. Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein.
Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine , an adrenergic blocking agent. Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours.
5.4Hypertension Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine.
5.5Pulmonary Edema Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema.
5.6Renal Impairment Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment.
5.7Cardiac Arrhythmias and Ischemia Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy.
5.8Allergic Reactions Associated with Sulfite Adrenalin contains sodium bisulfite which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes in susceptible individuals. However, the presence of bisulfite in this product should not preclude its use for the treatment of…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Common adverse reactions to systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism [ see Warnings and Precautions (5.7) ] . 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 by body system: Cardiovascular : angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy and stress cardiomyopathy. Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [ see Warnings and Precautions (5.7) ] . Neurological : disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling.
Psychiatric : anxiety, apprehensiveness, restlessness. Other : Patients with Parkinson’s disease may experience psychomotor agitation or a temporary worsening of symptoms [ see Warnings and Precautions (5.7) ] . Diabetic patients may experience transient increases in blood sugar.
Injection into the buttock has resulted in cases of gas gangrene [ see Warnings and Precautions (5.1) ] . 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 and Precautions (5.2) ]. Common adverse reactions to systemically administered epinephrine include anxiety, tremor, weakness, dizziness, sweating, palpitations and pallor ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 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, quinidine 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, and cardiac glycosides.
Observe for development of cardiac arrhythmias. ( 7.3 ) Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. ( 7.4 )
7.1Drugs Antagonizing Pressor Effects of Epinephrine α-blockers, such as phentolamine Vasodilators, such as nitrates Diuretics Antihypertensives Ergot alkaloids Phenothiazine antipsychotics
7.2Drugs Potentiating Pressor Effects of Epinephrine Sympathomimetics β-blockers, such as propranolol Tricyclic anti-depressants Monoamine oxidase (MAO) inhibitors Catechol-O-methyl transferase (COMT) inhibitors, such as entacapone Clonidine Doxapram Oxytocin
7.3Drugs Potentiating Arrhythmogenic Effects of Epinephrine Cardiac arrhythmias are more common among patients receiving any of the following drugs [ see Warnings and Precautions (5.7) and Adverse Reactions (6) ] . β-blockers, such as propranolol Cyclopropane or halogenated hydrocarbon anesthetics, such as halothane Antihistamines Thyroid hormones Diuretics Cardiac glycosides, such as digitalis glycosides Quinidine
7.4Drugs Potentiating Hypokalemic Effects of Epinephrine Potassium depleting diuretics Corticosteroids Theophylline
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally ( 8.1 , 8.5 ) Pregnancy: May cause fetal harm ( 8.1 )
8.1Pregnancy Risk Summary Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, do not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, there are risks to the mother and fetus associated with epinephrine use during labor or delivery (see Clinical Considerations) . In animal reproduction studies, epinephrine administered by the subcutaneous route to pregnant rabbits, mice, and hamsters, during the period of organogenesis, resulted in adverse developmental effects (including gastroschisis, and embryonic lethality, and delayed skeletal ossification) at doses approximately 2 times the maximum recommended daily intramuscular, subcutaneous, or intravenous dose (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk During pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. The prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. Management of anaphylaxis during pregnancy is similar to management in the general population.
Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. Hypotension associated with septic shock is a medical emergency in pregnancy which can be fatal if left untreated.
Delaying treatment in pregnant women with hypotension associated with septic shock may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of epinephrine on the fetus. Labor or Delivery Epinephrine usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labor.
Avoid epinephrine during the second stage of labor. In dosage sufficient to reduce uterine contractions, the drug may cause a prolonged period of uterine atony with hemorrhage. Avoid epinephrine in obstetrics when maternal blood pressure exceeds 130/80 mmHg.
Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Data Animal Data In an embryofetal development study with pregnant rabbits dosed during the period of organogenesis (on days 3 to 5, 6 to 7 or 7 to 9 of gestation), epinephrine caused teratogenic effects (including gastroschisis) at doses approximately 15 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days).
Animals treated on days 6 to 7 had decreased number of implantations. In an embryofetal development study, pregnant mice were administered epinephrine (0.1 to 10 mg/kg/day) on Gestation Days 6 to 15. Teratogenic effects, embryonic lethality, and delays in skeletal ossification were observed at approximately 3 times the maximum recommended intramuscular, subcuta…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, do not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, there are risks to the mother and fetus associated with epinephrine use during labor or delivery (see Clinical Considerations) . In animal reproduction studies, epinephrine administered by the subcutaneous route to pregnant rabbits, mice, and hamsters, during the period of organogenesis, resulted in adverse developmental effects (including gastroschisis, and embryonic lethality, and delayed skeletal ossification) at doses approximately 2 times the maximum recommended daily intramuscular, subcutaneous, or intravenous dose (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk During pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. The prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. Management of anaphylaxis during pregnancy is similar to management in the general population.
Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. Hypotension associated with septic shock is a medical emergency in pregnancy which can be fatal if left untreated.
Delaying treatment in pregnant women with hypotension associated with septic shock may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of epinephrine on the fetus. Labor or Delivery Epinephrine usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labor.
Avoid epinephrine during the second stage of labor. In dosage sufficient to reduce uterine contractions, the drug may cause a prolonged period of uterine atony with hemorrhage. Avoid epinephrine in obstetrics when maternal blood pressure exceeds 130/80 mmHg.
Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Data Animal Data In an embryofetal development study with pregnant rabbits dosed during the period of organogenesis (on days 3 to 5, 6 to 7 or 7 to 9 of gestation), epinephrine caused teratogenic effects (including gastroschisis) at doses approximately 15 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days).
Animals treated on days 6 to 7 had decreased number of implantations. In an embryofetal development study, pregnant mice were administered epinephrine (0.1 to 10 mg/kg/day) on Gestation Days 6 to 15. Teratogenic effects, embryonic lethality, and delays in skeletal ossification were observed at approximately 3 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m 2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days).
These effects were not seen in mice at approximately 2 times the maximum recommended daily intramuscular or subcutan…
🧒 Pediatric Use ▾
8.4Pediatric Use Clinical use data support weight-based dosing for treatment of anaphylaxis in pediatric patients, and other reported 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. Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established.
🧓 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, for the treatment of anaphylaxis, consider starting with a lower dose to take into account potential concomitant disease or other drug therapy.
Clinical studies of epinephrine for the treatment of hypotension associated with septic shock did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 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. 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. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported.
Epinephrine is rapidly inactivated in the body and treatment following overdose with epinephrine is primarily supportive. Treatment of pulmonary edema consists of a rapidly acting alpha-adrenergic blocking drug (such as phentolamine mesylate) and respiratory support. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug (such as propranolol).
If necessary, pressor effects may be counteracted by rapidly acting vasodilators or α-adrenergic blocking drugs. If prolonged hypotension follows such measures, it may be necessary to administer another pressor drug.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Epinephrine acts on both alpha and beta-adrenergic receptors. The mechanism of the rise in blood pressure is 3-fold: a direct myocardial stimulation that increases the strength of ventricular contraction (positive inotropic action), an increased heart rate (positive chronotropic action), and peripheral vasoconstriction.
12.2Pharmacodynamics Epinephrine increases glycogenolysis, reduces glucose up take by tissues, and inhibits insulin release in the pancreas, resulting in hyperglycemia and increased blood lactic acid. Intramuscular and subcutaneous use for anaphylaxis 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. Intravenous use for hypotension associated with septic shock When administered parenterally, epinephrine has a rapid onset and short duration of action. Following intravenous administration of epinephrine, increases in systolic blood pressure and heart rate are observed.
Decreases in systemic vascular resistance and diastolic blood pressure are observed at low doses of epinephrine because of β2-mediated vasodilation, but are overtaken by α1-mediated peripheral vasoconstriction at higher doses leading to increase in diastolic blood pressure. The onset of blood pressure increase following an intravenous dose of epinephrine is < 5 minutes and the time to offset blood pressure response occurs within 15 minutes. Most vascular beds are constricted including renal, splanchnic, mucosal and skin.
Epinephrine causes mydriasis when administered parenterally.
12.3Pharmacokinetics Following intravenous injection, epinephrine is rapidly cleared from the plasma with an effective half-life of < 5 minutes. A pharmacokinetic steady state following continuous intravenous infusion is achieved within 10 to 15 minutes. In patients with septic shock, epinephrine displays dose-proportional pharmacokinetics in the infusion dose range of 0.03 to 1.7 mcg/kg/min.
Epinephrine is extensively metabolized with only a small amount excreted unchanged. Epinephrine is rapidly degraded to vanillylmandelic acid, an inactive metabolite, by monoamine oxidase and catechol-O-methyltransferase that are abundantly expressed in the liver, kidneys and other extraneuronal tissues. The tissues with the highest contribution to removal of circulating exogenous epinephrine are the liver (32%), kidneys (25%), skeletal muscle (20%), and mesenteric organs (12%).
Specific Populations Elderly In a pharmacokinetic study of 45-minute epinephrine infusions given to healthy men aged 20 to 25 years and healthy men aged 60 to 65 years, the mean plasma metabolic clearance rate of epinephrine at steady state was greater among the older men (144.8 versus 78 mL/kg/min for a 0.0143 mcg/kg/min infusion). Body Weight Body weight has been found to influence epinephrine pharmacokinetics. Higher body weight was associated with a higher plasma epinephrine clearance and a lower concentration plateau.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Epinephrine acts on both alpha and beta-adrenergic receptors. The mechanism of the rise in blood pressure is 3-fold: a direct myocardial stimulation that increases the strength of ventricular contraction (positive inotropic action), an increased heart rate (positive chronotropic action), and peripheral vasoconstriction.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Adrenalin 1 mg/mL Single Dose Vials: Each carton contains 25 single dose vials containing 1 mg/mL Adrenalin (epinephrine injection, USP) solution in a 3 mL clear glass vial. NDC 42023-159-01 1 mL Single Dose Vial NDC 42023-159-25 25 Single Dose Vials x 1 mL each Discard unused portion. Adrenalin 30 mg/30 mL (1 mg/mL) Multiple Dose Vials: Each carton contains 1 multiple dose vial containing 30 mg/30 mL (1 mg/mL) Adrenalin (epinephrine injection, USP) solution in a 36 mL amber glass vial.
NDC 42023-168-01 30 mL Multiple Dose Vial Vial and contents must be discarded 30 days after initial use. Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Epinephrine is light sensitive.
Protect from light and freezing. Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter.
📦 Storage and Handling ▾
Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Epinephrine is light sensitive. Protect from light and freezing. Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter.
📋 Description ▾
11 DESCRIPTION Adrenalin (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL epinephrine, packaged as 1 mL of solution in a single dose clear glass vial or 30 mL of solution in a multiple dose amber glass vial. In the 1 mL vial, each 1 mL of Adrenalin solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.18 mg edetate disodium, 5.32 mg of 4% hydrochloric acid to adjust pH, and water for injection.
In the 30 mL vial, each 1 mL of Adrenalin solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.18 mg edetate disodium, 5.18 mg of 4% hydrochloric acid to adjust pH, 5.0 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine.
The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is: The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. description
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients or their caregivers about common adverse reactions associated with the use of epinephrine including 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 symptoms and signs usually subside rapidly, especially with rest, quiet and recumbent positioning. Warn patients with a good response to initial treatment about the possibility of recurrence of symptoms and instruct patients to obtain proper medical attention if symptoms return.
Warn patients with diabetes that they may develop increased blood glucose levels following epinephrine administration. 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 (5.2) ] .