Adrenalin (epinephrine in sodium chloride) 16 ug/mL Injection
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the alpha-Adrenergic Agonist class.
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🏭 Manufacturer & labeler
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🩺 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
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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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10 ug / 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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9 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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13.1 ug / 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.
3 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0163 | $0.605 / J0163 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| epinephrine 16 ug/mL 00338-0006-20 | Baxter | 250 ml | — | — | FDA listed | — |
| Adrenalin (epinephrine in sodium chloride) 16 ug/mLthis 42023-0315-10 | Par | 250 ml | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
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 11083698 ↗ | Method of use | U-3567 | Mar 21, 2039 |
| US 11083698 ↗ | Method of use | U-3567 | Mar 21, 2039 |
| US 11083698 ↗ | Method of use | U-3567 | Mar 21, 2039 |
| US 11083698 ↗ | Method of use | U-3567 | Mar 21, 2039 |
| US 11083698 ↗ | Method of use | U-3567 | Mar 21, 2039 |
| US 10653646 ↗ | Drug product | — | Mar 21, 2039 |
| US 11207280 ↗ | Drug product | — | Mar 21, 2039 |
| US 10653646 ↗ | Drug product | — | Mar 21, 2039 |
| US 12133837 ↗ | Drug product | — | Mar 21, 2039 |
| US 11207280 ↗ | Drug product | — | Mar 21, 2039 |
| US 11207280 ↗ | Drug product | — | Mar 21, 2039 |
| US 10653646 ↗ | Drug product | — | Mar 21, 2039 |
| US 12133837 ↗ | Drug product | — | Mar 21, 2039 |
| US 12133837 ↗ | Drug product | — | Mar 21, 2039 |
| US 11207280 ↗ | Drug product | — | Mar 21, 2039 |
| US 10653646 ↗ | Drug product | — | Mar 21, 2039 |
| US 12133837 ↗ | Drug product | — | Mar 21, 2039 |
| US 11207280 ↗ | Drug product | — | Mar 21, 2039 |
| US 12133837 ↗ | Drug product | — | Mar 21, 2039 |
| US 10653646 ↗ | Drug product | — | Mar 21, 2039 |
Is there a generic version of ADRENALIN 4 MG/250ML-0.9% NACL?
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 42023-0315-10 You're viewing this | 10 BAG in 1 CARTON (42023-315-10) / 250 mL in 1 BAG (42023-315-01) | 2024-10-04 | Active |
🧭 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1. INDICATIONS AND USAGE Adrenalin ® is a non-selective alpha and beta adrenergic agonist indicated to: Increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1.1 ) 1.1. Hypotension associated with Septic Shock Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
⏱️ Dosage and Administration ▾
2. DOSAGE AND ADMINISTRATION No further dilution prior to infusion is required ( 2.1 ) Infuse epinephrine into a large vein ( 2.2 ) Titrate 0.05 mcg/kg/min to 2 mcg/kg/min to achieve desired blood pressure ( 2.2 ) Wean gradually ( 2.2 ) See Full Prescribing Information for instructions on administration of the injection. 2.1.
General Considerations Administration Adrenalin is a ready to administer product that requires no further dilution prior to infusion. Inspect visually for particulate matter and discoloration prior to administration; solution should be clear and colorless. Do not use if the solution is colored or cloudy, or if it contains particulate matter.
Do not open the aluminum overwrap until time of use. The premixed, ready-to-use infusion bag has a single port for insertion of the infusion set only. This port should not be used to remove content from the bag or add another medication.
Once the infusion bag has been connected to the infusion set, it is stable for 24 hours, as long as the bag stays connected to the infusion set. Single dose only. Discontinuation When discontinuing the infusion, reduce the flow rate gradually.
Avoid abrupt withdrawal. Discard unused portion. 2.2.
Hypotension associated with Septic Shock 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 mcg/kg/min 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 mcg/kg/min 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.
💊 Dosage Forms and Strengths ▾
3. DOSAGE FORMS AND STRENGTHS Injection: Epinephrine in sodium chloride is a clear, colorless solution in a ready-to-use, single-dose container available as: 2 mg/250 mL (8 mcg/mL) 4 mg/250 mL (16 mcg/mL) 5 mg/250 mL (20 mcg/mL) 8 mg/250 mL (32 mcg/mL) 10 mg/250 mL (40 mcg/mL) Injection: 250 mL single-dose container with: ( 3 ) - 2 mg epinephrine (8 mcg/mL) in 0.9% sodium chloride - 4 mg epinephrine (16 mcg/mL) in 0.9% sodium chloride - 5 mg epinephrine (20 mcg/mL) in 0.9% sodium chloride - 8 mg epinephrine (32 mcg/mL) in 0.9% sodium chloride - 10 mg epinephrine (40 mcg/mL) in 0.9% sodium chloride
⛔ Contraindications ▾
4. CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5. WARNINGS AND PRECAUTIONS Monitor blood pressure frequently ( 5.1 ) Increases cardiac output and causes peripheral vasoconstriction ( 5.2 ) May induce cardiac arrhythmias and myocardial ischemia. ( 5.3 ) Avoid extravasation into tissues, which can cause local necrosis ( 5.4 ) May aggravate angina pectoris or produce ventricular arrhythmias ( 5.5 ) Constricts Renal blood vessels which may result in oliguria or renal impairment ( 5.5 ) 5.1.
Hypertension 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. 5.2.
Pulmonary Edema Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. 5.3. Cardiac Arrhythmias and Ischemia Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy.
5.4. Extravasation 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. 5.5. Renal Impairment Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment.
🤒 Adverse Reactions ▾
6. ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in labeling: Hypertension [see Warnings and Precautions ( 5.1 )] Pulmonary Edema [see Warnings and Precautions ( 5.2 )] Cardiac Arrhythmias and Ischemia [see Warnings and Precautions ( 5.3 )] Extravasation and Tissue Necrosis with Intravenous Infusion [see Warnings and Precautions ( 5.4 )] Renal Impairment [see Warnings and Precautions ( 5.5 )] The following adverse reactions associated with the infusion of epinephrine were identified in the literature.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiovascular disorders : tachycardia, supraventricular tachycardia, ventricular arrhythmias, myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema Gastrointestinal disorders : Nausea, vomiting General disorders and administrative site conditions : Chest pain, extravasation Metabolic : hypoglycemia, hyperglycemia, insulin resistance, hypokalemia, lactic acidosis Nervous system disorders : Headache, nervousness, paresthesia, tremor, stroke, central nervous system bleeding Psychiatric disorders : Excitability Renal disorders : Renal insufficiency Respiratory : Pulmonary edema, rales Skin and subcutaneous tissue disorders : Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties.
Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred. ( 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, and certain antihistamines.
( 7.2 ) Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, cardiac glycosides and quinidine. Observe for development of cardiac arrhythmias. ( 7.3 ) Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine.
( 7.4 ) 7.1. Drugs Antagonizing Pressor Effects of Epinephrine α-blockers, such as phentolamine Vasodilators, such as nitrates Diuretics Antihypertensives Ergot alkaloids Phenothiazine antipsychotics 7.2. Drugs Potentiating Pressor Effects of Epinephrine Sympathomimetics β-blockers, such as propranolol Tricyclic anti-depressants Monoamine oxidase (MAO) inhibitors Catechol-O-methyl transferase (COMT) inhibitors, such as entacapone Clonidine Doxapram Oxytocin 7.3.
Drugs Potentiating Arrhythmogenic Effects of Epinephrine Patients who are concomitantly receiving any of the following drugs should be observed carefully for the development of cardiac arrhythmias [see Warnings and Precautions ( 5.5 ) 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 7.4. Drugs 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 ) 8.1. Pregnancy Risk Summary Limited published data on epinephrine use in pregnant women are not sufficient to determine a drug-associated risk of major birth defects or miscarriage.
However, there are risks to the mother and fetus associated with epinephrine use during labor or delivery and risks due to untreated hypotension associated with septic shock ( see Clinical Considerations ). In animal reproduction studies, epinephrine demonstrated adverse developmental effects when administered to pregnant rabbits (gastroschisis), mice (teratogenic effects, embryonic lethality, and delayed skeletal ossification), and hamsters (embryonic lethality and delayed skeletal ossification) during organogenesis at doses approximately 15 times, 3 times and 2 times, respectively, the maximum recommended daily 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 2-4% and 15-20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk 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. Do not withhold life-sustaining therapy for a pregnant woman.
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, 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 subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). In an embryofetal development study with pregnant hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine produced reductions in litter size and delayed skeletal ossification at doses approximately 2 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day).
8.2. Lactation Risk Summary There is no information regarding the presence of epinephrine in human milk or the effects of epin…
🤰 Pregnancy ▾
8.1. Pregnancy Risk Summary Limited published data on epinephrine use in pregnant women are not sufficient to determine a drug-associated risk of major birth defects or miscarriage. However, there are risks to the mother and fetus associated with epinephrine use during labor or delivery and risks due to untreated hypotension associated with septic shock ( see Clinical Considerations ).
In animal reproduction studies, epinephrine demonstrated adverse developmental effects when administered to pregnant rabbits (gastroschisis), mice (teratogenic effects, embryonic lethality, and delayed skeletal ossification), and hamsters (embryonic lethality and delayed skeletal ossification) during organogenesis at doses approximately 15 times, 3 times and 2 times, respectively, the maximum recommended daily 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 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk 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. Do not withhold life-sustaining therapy for a pregnant woman. 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, 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 subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). In an embryofetal development study with pregnant hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine produced reductions in litter size and delayed skeletal ossification at doses approximately 2 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day).
🧒 Pediatric Use ▾
8.4. Pediatric Use Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established.
🧓 Geriatric Use ▾
8.5. Geriatric Use 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 and failure 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 (such as nitrates) 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 12.1. Mechanism 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. 12.2. Pharmacodynamics Intravenous use for hypotension associated with septic shock 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. 12.3. Pharmacokinetics 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 10-15 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 ▾
12.1. Mechanism 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 (epinephrine in sodium chloride injection) is supplied as a clear, colorless sterile solution in a single-dose 250 mL non-PVC infusion bag with a single function connector system consisting of a port and cap, packaged individually in an aluminum overwrap with an oxygen scavenger. Supplied as: Unit of Sale Strength Pack Factor NDC 42023-273-10 2 mg/250 mL (8 mcg/mL) 10 units NDC 42023-315-10 4 mg/250 mL (16 mcg/mL) 10 units NDC 42023-434-10 5 mg/250 mL (20 mcg/mL) 10 units NDC 42023-500-10 8 mg/250 mL (32 mcg/mL) 10 units NDC 42023-721-10 10 mg/250 mL (40 mcg/mL) 10 units Store between 20°C to 25°C (68°F to 77°F) [ See USP Controlled Room Temperature ].
Epinephrine is light sensitive. Protect from light and freezing. Keep in foil overwrap until ready to use.
Discard after 24 hours of opening overwrap. Manufactured for: Par Health USA Rochester, MI 48307 © 2025 Par Health, Inc. or one of its affiliates. R12/2025
📋 Description ▾
11. DESCRIPTION Adrenalin (epinephrine in sodium chloride injection) 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. Adrenalin (epinephrine in sodium chloride injection) is a clear, colorless, sterile solution administered by intravenous infusion, supplied in a 250 mL infusion bag.
It is provided in five (5) ready-to-use concentrations containing: Ingredient Concentration 8 mcg/mL 16 mcg/mL 20 mcg/mL 32 mcg/mL 40 mcg/mL Epinephrine, USP 8 mcg 16 mcg 20 mcg 32 mcg 40 mcg Sodium chloride, USP 9 mg 9 mg 9 mg 9 mg 9 mg Disodium Edetate Dihydrate (EDTA), USP 10 mcg 10 mcg 10 mcg 10 mcg 10 mcg L (+) Tartaric Acid, NF 6.6 mcg 13.1 mcg 16.4 mcg 26.2 mcg 32.8 mcg It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. It has a pH range of 3.7 - 4.3. The headspace in the containers has been displaced with nitrogen gas. chemical structure