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Epinephrine (Epinephrine)

Trade Name : epinephrine

Amneal Pharmaceuticals of New York LLC

INJECTION

Strength 0.3 mg/.3mL

EPINEPHRINE Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Epinephrine (Epinephrine) which is also known as epinephrine and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 0.3 mg/.3mL per ml. Read more

Epinephrine (Epinephrine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Epinephrine injection, USP auto-injector is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
  • Epinephrine injection, USP auto-injector is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
  • Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema.
  • Epinephrine injection, USP auto-injector is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
  • Epinephrine injection, USP auto-injector contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. ()
  • Selection of the appropriate epinephrine injection, USP auto-injector dosage strength is determined according to patient body weight.
  • Inject epinephrine injection, USP auto-injector intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed an epinephrine injection, USP auto-injector and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see ].
  • Each epinephrine injection, USP auto-injector contains a single dose of epinephrine for single use injection. Since the doses of epinephrine delivered from epinephrine injection, USP auto-injector are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
  • The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated.
  • With severe persistent anaphylaxis, repeat injections with an additional epinephrine injection, USP auto-injector may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see ].
  • The epinephrine solution in the viewing window of epinephrine injection, USP auto-injector should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [see].
  • Inject epinephrine injection, USP auto-injector intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Each device is a single-use injection. ()
  • Patients greater than or equal to 30 kg (66 lbs): Epinephrine injection, USP auto-injector 0.3 mg ()
  • Patients 15 to 30 kg (33 lbs-66 lbs): Epinephrine injection, USP auto-injector 0.15 mg ()
  • No data
  • Injection, 0.3 mg: 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector ()
  • Injection, 0.15 mg: 0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector ()
  • None.
  • None. ()
  • No data
  • In conjunction with use, seek immediate medical or hospital care. ()
  • Do not inject intravenously, into buttock, or into digits, hands, or feet. ()
  • To minimize the risk of injection related injury,u00a0instruct caregivers to hold the childu2019s leg firmly in place and limit movement prior to and during injection when administering to young children. ()
  • Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop signs or symptoms of infection. ()
  • The presence of a sulfite in this product should not deter use. ()
  • Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias. ()
  • Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below.
  • Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [see].
  • Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see].
  • Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see ].
  • Angina may occur in patients with coronary artery disease [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 accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.
  • Lacerations, bent needles, and embedded needles have been reported when epinephrine injection, USP auto-injector has been injected into the thigh of young children who are uncooperative and kick or move during an injection [see n ].
  • Injection into the buttock has resulted in cases of gas gangrene [see].
  • 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 n ].
  • Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.
  • Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or .
  • Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see].
  • The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
  • The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol.
  • The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-adrenergic blocking drugs, such as phentolamine.
  • Ergot alkaloids may also reverse the pressor effects of epinephrine.
  • Cardiac glycosides or diuretics: observe for development of cardiac arrhythmias. ()
  • Tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines: potentiate effects of epinephrine. ()
  • Beta-adrenergic blocking drugs: antagonize cardiostimulating and bronchodilating effects of epinephrine. ()
  • Alpha-adrenergic blocking drugs: antagonize vasoconstricting and hypertensive effects of epinephrine. ()
  • Ergot alkaloids: may reverse the pressor effects of epinephrine. ()
  • No data
  • Elderly patients may be at greater risk of developing adverse reactions. (, )
  • Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of a rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.
  • Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.
  • Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.
  • Epinephrine injection, USP auto-injector 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components.
  • Each epinephrine injection, USP auto-injector 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution.
  • Each epinephrine injection, USP auto-injector 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution.
  • Epinephrine injection, USP auto-injector 0.3 mg and epinephrine injection, USP auto-injector 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for epinephrine injection, USP auto-injector 0.3 mg and epinephrine injection, USP auto-injector 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded.
  • Each 0.3 mL in epinephrine injection, USP auto-injector 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.
  • Each 0.15 mL in epinephrine injection, USP auto-injector 0.15 mg contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.
  • Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-u03b1-[(methylamino)methyl]benzyl alcohol with the following structure:
  • Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles.
  • Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [see].
  • No data
  • Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted.
  • Epinephrine and other catecholamines have been shown to have mutagenic potential and to be an oxidative mutagen in a bacterial reverse mutation assay.
  • Epinephrine was positive in the DNA Repair test with n (REC) assay, but was not mutagenic in the bacterial reverse mutation assay.
  • The potential for epinephrine to impair fertility has not been evaluated.
  • This should not prevent the use of epinephrine under the conditions noted under .
  • No data
  • [see ]
  • A healthcare provider should review the patient instructions and operation of epinephrine injection, USP auto-injector, in detail, with the patient or caregiver.
  • Epinephrine is essential for the treatment of anaphylaxis. Carefully instruct patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, about the circumstances under which epinephrine should be used.
  • Arrayn- Administration and Training
  • Instruct patients and/or caregivers in the appropriate use of epinephrine injection, USP auto-injector. Epinephrine injection, USP auto-injector should be injected into the middle of the outer thigh (through clothing if necessary).
  • Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection. Lacerations, bent needles, and embedded needles have been reported when epinephrine injection, USP auto-injector has been injected into the thigh of young children who are uncooperative and kick during an injection [see n ].
  • Each epinephrine injection, USP auto-injector is a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of epinephrine injection, USP auto-injector.
  • Complete patient information, including dosage, directions for proper administration and precautions can be found inside each epinephrine injection, USP auto-injector carton. A printed label on the surface of epinephrine injection, USP auto-injector shows instructions for use and a diagram depicting the injection process.
  • Instruct patients and/or caregivers to use the Trainer to familiarize themselves with the use of epinephrine injection, USP auto-injector in an allergic emergency. The Trainer may be used multiple times.
  • Arrayn- Adverse Reactions
  • Epinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These signs and symptoms usually subside rapidly, especially with rest, quiet, and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson's disease may notice a temporary worsening of symptoms [see ].
  • Arrayn- Accidental Injection
  • Advise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands or feet, treatment should be directed at vasodilation if there is such an accidental injection to these areas .
  • Arrayn- Serious Infections at the Injection Site
  • Rare cases of 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 n ].
  • Arrayn- Storage and Handling
  • Instruct patients to inspect the epinephrine solution visually through the viewing window periodically. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown), cloudy, or contains particles. Epinephrine is light sensitive, store in the outer case provided to protect it from light. Instruct patients that epinephrine injection, USP auto-injector must be properly disposed of once the blue caps have been removed or after use [see].
  • Complete patient information, including dosage, directions for proper administration and precautions are provided inside each epinephrine injection, USP auto-injector carton.
  • Manufactured by:n McPherson, KS 67460
  • Distributed by:n n Bridgewater, NJ 08807
  • u00a9 2019 Amneal Pharmaceuticals LLC. All rights reserved.
  • For inquiries call 1-877-835-5472n
  • 1871-03
  • Rev. 02-2019-00
  • EPINEPHRINE INJECTION, USP AUTO-INJECTOR (ep-in-eph-rine)
  • Authorized generic of Adrenaclickn
  • For allergic emergencies (anaphylaxis)
  • Read this Patient Information Leaflet carefully before you use the epinephrine injection, USP auto-injector, and each time you get a refill. There may be new information. You, your parent, caregiver, or others who may be in a position to administer epinephrine injection, USP auto-injector should know how to use it before you have an allergic emergency.
  • This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
  • What is the most important information I should know about epinephrine injection, USP auto-injector?
  • 1. Epinephrine injection, USP auto-injector contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Symptoms of an anaphylaxis may include:n tttttt
  • 2. Always carry your epinephrine injection, USP auto-injector with you because you may not know when anaphylaxis may happen.
  • 3. When you have an allergic emergency (anaphylaxis)
  • What is epinephrine injection, USP auto-injector?
  • What should I tell my healthcare provider before using epinephrine injection, USP auto-injector?
  • Before you use epinephrine injection, USP auto-injector, tell your healthcare provider about all your medical conditions, especially if you:
  • Tell your healthcare provider about all the medicines you take,
  • Especially tell your healthcare provider if you take certain asthma medicines.
  • Epinephrine injection, USP auto-injector and other medicines may affect each other, causing side effects. Epinephrine injection, USP auto-injector may affect the way other medicines work, and other medicines may affect how epinephrine injection, USP auto-injector works.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
  • Use your epinephrine injection, USP auto-injector for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicine you take.
  • How should I use epinephrine injection, USP auto-injector?
  • What are the possible side effects of epinephrine injection, USP auto-injector?
  • Epinephrine injection, USP auto-injector may cause serious side effects.
  • If you accidently inject epinephrine injection, USP auto-injector into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.
  • Common side effects of epinephrine injection, USP auto-injector include:
  • These side effects may go away with rest. n
  • These are not all the possible side effects of epinephrine injection, USP auto-injector. For more information, ask your healthcare provider or pharmacist.
  • Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store epinephrine injection, USP auto-injector?
  • Keep epinephrine injection, USP auto-injector and all medicines out of the reach of children.
  • General information about the safe and effective use of epinephrine injection, USP auto-injector:
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use epinephrine injection, USP auto-injector for a condition for which it was not prescribed. Do not give epinephrine injection, USP auto-injector to other people.
  • This Patient Information Leaflet summarizes the most important information about epinephrine injection, USP auto-injector. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about epinephrine injection, USP auto-injector that is written for health professionals.
  • For more information and video instructions on the use of epinephrine injection, USP auto-injector, go to or call 1-877-835-5472.
  • What are the ingredients in epinephrine injection, USP auto-injector?
  • Active Ingredient:
  • Inactive Ingredients:
  • Important Information
  • EPINEPHRINE INJECTION, USP AUTO-INJECTOR (ep-in-eph-rine)
  • For allergic emergencies (anaphylaxis)
  • Read these Instructions for Use carefully before you use epinephrine injection, USP auto-injector. Before you need to use your epinephrine injection, USP auto-injector, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer epinephrine injection, USP auto-injector should also understand how to use it well. If you have any questions, ask your healthcare provider.
  • Your epinephrine injection, USP auto-injector
  • u00a0n
  • Arrayn- Array
  • u00a0n- u00a0n- u00a0
  • STEP 1. Prepare epinephrine injection, USP auto-injector for injection
  • Note:
  • STEP 2. Administer epinephrine injection, USP auto-injector
  • Arrayn- Array
  • STEP 3. Get emergency medical help right away.
  • STEP 4. After use / Disposal
  • Carefully cover the needle with the carrying case.
  • Arrayn- Array
  • u00a0n
  • Note:
  • For more information and video instructions on the use of epinephrine injection, USP auto-injector, go to or call 1-877-835-5472.
  • This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • u00a9 2019 Amneal Pharmaceuticals LLC. All rights reserved.
  • Manufactured by:n n McPherson, KS 67460
  • Distributed by:n n Bridgewater, NJ 08807n 1872-03n Rev. 02-2019-00
  • No data
  • No data
  • No data
  • No data

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