epinephrine
Generic: EPINEPHRINE
Basic Information
Manufacturer
Amneal Pharmaceuticals of New York LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
e13f05f1-7d21-49bb-b8d5-24bf9301c3d7
Indications & Usage
1 INDICATIONS AND USAGE Epinephrine Injection is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis in adult and pediatric patients who weigh 15 kg or greater.
Epinephrine Injection is a alpha and beta-adrenergic receptor agonist, indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 15 kg or greater.
( 1 )
Epinephrine Injection is a alpha and beta-adrenergic receptor agonist, indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 15 kg or greater.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Injection-Related Complications [see Warnings and Precautions (5.1) ] Serious Infections at the Injections [see Warnings and Precautions (5.2) ] Risks Associated with Use of Epinephrine in Certain Coexisting Conditions [see Warnings and Precautions (5.3) ] Allergic Reactions Associated with Sulfite [see Warnings and Precautions (5.4) ] The following adverse reactions associated with the use of epinephrine were identified in observational trials, case reports, studies, or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular : angina, arrhythmias (including fatal ventricular fibrillation), cerebral hemorrhage, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy Gastrointestinal Disorders : nausea and vomiting Infections : Clostridial infections (gas gangrene) Metabolism and Nutrition Disorders : transient hyperglycemia, sweating Neurological: disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling, weakness, tremor, hypoesthesia, dizziness, headache Psychiatric : anxiety, apprehensiveness, restlessness Respiratory : respiratory difficulties Skin and Subcutaneous Tissue Disorders: bruising, bleeding, discoloration, erythema, necrotizing fasciitis, myonecrosis Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular : angina, arrhythmias (including fatal ventricular fibrillation), cerebral hemorrhage, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy Gastrointestinal Disorders : nausea and vomiting Infections : Clostridial infections (gas gangrene) Metabolism and Nutrition Disorders : transient hyperglycemia, sweating Neurological: disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling, weakness, tremor, hypoesthesia, dizziness, headache Psychiatric : anxiety, apprehensiveness, restlessness Respiratory : respiratory difficulties Skin and Subcutaneous Tissue Disorders: bruising, bleeding, discoloration, erythema, necrotizing fasciitis, myonecrosis Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .