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epineprine
Overview
What is Adrenalin?
Adrenalin® (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL (1:1000) epinephrine, packaged as 1 mL of solution in a single-use 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, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, and water for injection. In the 30 mL vial, each 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, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, 5.25 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 (-),4-Dihydroxy-A-[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 and adrenochrome and brown from the formation of malanin.
What does Adrenalin look like?
What are the available doses of Adrenalin?
Adrenalin® 1mg/mL (1:1000) epinephrine injection , 1 mL solution in a single-use clear glass vial and 30 mL solution in a multiple-dose amber glass vial.
What should I talk to my health care provider before I take Adrenalin?
8.1 Pregnancy
Teratogenic Effects: Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women. 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 is teratogenic in rabbits, mice and hamsters dosed during organogenesis.
Epinephrine has been shown to have teratogenic effects (including gastroschisis and embryonic lethality) when administered subcutaneous in rabbits at approximately 15 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days).
In mice, teratogenic effects (including embryonic lethality) were observed at approximately 3 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 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 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).
In hamsters, teratogenic effects were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days).
8.2 Labor and Delivery
Use with caution during labor and delivery. Although epinephrine improves maternal hypotension associated with anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia.
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
How should I use Adrenalin?
Adrenalin
Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue.
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 5/8 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, with repeat doses titrated to effect. Do not administer repeated injections at the same site, as the resulting vasoconstriction may cause tissue necrosis.
Inspect visually for particulate matter and discoloration prior to administration. Do not use if the solution is colored or cloudy, or if it contains particulate matter.
Adults and Children 30 kg (66 lbs) or more
Children less than 30 kg (66 lbs)
What interacts with Adrenalin?
None.
What are the warnings of Adrenalin?
Sorry No Records found
What are the precautions of Adrenalin?
Sorry No Records found
What are the side effects of Adrenalin?
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 ]
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 by body system:
Cardiovascular
Angina may occur in patients with coronary artery disease [see
].
Arrhythmias, including fatal ventricular fibrillation, have occurred, particularly in patients with underlying organic heart disease or patients receiving drugs that sensitize the heart to arrhythmias [see ].
Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see ].
Respiratory
Neurological
Psychiatric
Gastrointestinal
Other
Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms [see ].
Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see ]. Adverse events experienced as a result of an injection into these areas include increased heart rate, local reactions including injection site pallor, coldness, hypoesthesia, and tissue loss, or injury at the injection site resulting in bruising, bleeding, discoloratio, erythema, and skeletal injury.
Injection into the buttock has resulted in cases of gas gangrene [see ].
Rare cases fo 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 ].
Skin
To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical, Inc. at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Adrenalin?
None.
What might happen if I take too much Adrenalin?
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 a-adrenergic blocking drug and respiratory support.
Epinephrine is rapidly inactivated in the body and treatment following overdose with epinephrine is primarily supportive. If necessary, pressor effects may be counteracted by rapidly acting vasodilators or a-adrenergic blocking drugs. If prolonged hypotension follows such measures, it may be necessary to administer another pressor drug.
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 due to elevated blood lactic acid levels, and kidney failure. Suitable corrective measures must be taken in such situations.
Myocardial ischemia, myocardial infarction and cardiomyopathy have been noted in the literature following overdose of epinephrine.
How should I store and handle Adrenalin?
Store at 20° to 25°C (68° to 77°F); see USP controlled room temperature.Protect from light. Do not freeze.Store at 20° to 25°C (68° to 77°F); see USP controlled room temperature.Protect from light. Do not freeze.Adrenalin® 1 mL Single-Use Vials:Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial.NDCC 42023-159-25 1 mL vialAdrenalin® 30 mL Multi-Dose Vials:Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial.NDC 42023-168-01 30 mL vialVial 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.Adrenalin® 1 mL Single-Use Vials:Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial.NDCC 42023-159-25 1 mL vialAdrenalin® 30 mL Multi-Dose Vials:Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial.NDC 42023-168-01 30 mL vialVial 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.Adrenalin® 1 mL Single-Use Vials:Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial.NDCC 42023-159-25 1 mL vialAdrenalin® 30 mL Multi-Dose Vials:Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial.NDC 42023-168-01 30 mL vialVial 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.Adrenalin® 1 mL Single-Use Vials:Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial.NDCC 42023-159-25 1 mL vialAdrenalin® 30 mL Multi-Dose Vials:Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial.NDC 42023-168-01 30 mL vialVial 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.Adrenalin® 1 mL Single-Use Vials:Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial.NDCC 42023-159-25 1 mL vialAdrenalin® 30 mL Multi-Dose Vials:Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial.NDC 42023-168-01 30 mL vialVial 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.Adrenalin® 1 mL Single-Use Vials:Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial.NDCC 42023-159-25 1 mL vialAdrenalin® 30 mL Multi-Dose Vials:Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial.NDC 42023-168-01 30 mL vialVial 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.Adrenalin® 1 mL Single-Use Vials:Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial.NDCC 42023-159-25 1 mL vialAdrenalin® 30 mL Multi-Dose Vials:Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial.NDC 42023-168-01 30 mL vialVial 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.Adrenalin® 1 mL Single-Use Vials:Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial.NDCC 42023-159-25 1 mL vialAdrenalin® 30 mL Multi-Dose Vials:Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial.NDC 42023-168-01 30 mL vialVial 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.Adrenalin® 1 mL Single-Use Vials:Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial.NDCC 42023-159-25 1 mL vialAdrenalin® 30 mL Multi-Dose Vials:Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial.NDC 42023-168-01 30 mL vialVial 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.Adrenalin® 1 mL Single-Use Vials:Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial.NDCC 42023-159-25 1 mL vialAdrenalin® 30 mL Multi-Dose Vials:Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial.NDC 42023-168-01 30 mL vialVial 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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
12.1 Mechanism of Action
Epinephrine acts on both alpha and beta-adrenergic receptors.
12.2 Pharmacodynamics
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.
Epinephrine increases blycogenolysis, reduces glucose up take by tissues, and inhibits insulin release in the pancreas, resulting in hyperglycemia and increased blood lactic acid [see ].
Epinephrine cause mydriasis when administered parenterally.
12.3 Pharmacokinetics
When administered parenterally, epinephrine has a rapid onset and short duration of action.
Non-Clinical Toxicology
None.5.1
Incorrect Locations of Injections
Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate locations 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 due to possible differences in absorption associated with this use.
Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis.
Do not inject into buttock.
Do not inject into digits, hands, or feet.
5.2 Serious Infections at the Injection Site
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. 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 spores. To decrease the risk of infection, do not inject Adrenalin® into the buttock [see 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.
5.3 Disease Interactions
Some patients may be at greater risk for developing adverse reactions after systemic epinephrine administration. Despite these concerns, the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation.
Patients with Heart Disease
Epinephrine should be administered with caution in patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, cerebrovascular disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as product ventricular arrhythmias [see ].
Other Patients and Diseases
5.4 Allergic Reactions Associated with Sulfite
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 ]
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 by body system:
Cardiovascular
Angina may occur in patients with coronary artery disease [see ].
Arrhythmias, including fatal ventricular fibrillation, have occurred, particularly in patients with underlying organic heart disease or patients receiving drugs that sensitize the heart to arrhythmias [see ].
Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see ].
Respiratory
Neurological
Psychiatric
Gastrointestinal
Other
Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms [see ].
Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see ]. Adverse events experienced as a result of an injection into these areas include increased heart rate, local reactions including injection site pallor, coldness, hypoesthesia, and tissue loss, or injury at the injection site resulting in bruising, bleeding, discoloratio, erythema, and skeletal injury.
Injection into the buttock has resulted in cases of gas gangrene [see ].
Rare cases fo 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 ].
Skin
To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical, Inc. at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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