COMPOSITIONThe EpiPen and EpiPen Jr autoinjectors contain 2 mL of epinephrine injection for emergency intramuscular use. Each EpiPen autoinjector delivers a single dose of 0.3 mg epinephrine by injection of epinephrine, USP, 1: 1000 (0.3 mL) into a sterile solution. Each EpiPen autoinjector delivers a single dose of 0.15 mg epinephrine by injection of epinephrine, USP, 1: 1000 (0.3 mL) into a sterile solution. For stability purposes, approximately 1.7 mL remain in the autoinjector after activation and can not be used. Each 0.3 mL of EpiPen contains 0.3 mg of epinephrine, 1.8 mg of sodium chloride, 0.5 mg of sodium metabisulfite, hydrochloric acid to adjust pH and water for injection. The pH range is between 2.2 and 5.0. Each 0.3 mL of EpiPen contains 0.15 mg of epinephrine, 1.8 mg of sodium chloride, 0.5 mg of sodium metabisulfite, hydrochloric acid to adjust pH and water for injection. The pH range is between 2.2 and 5.0. Epinephrine is a sympathomimetic catecholamine.
DOSAGE AND ADMINISTRATIONThe doctor prescribing EpiPen or EpiPen Jr should take the appropriate steps to ensure that the patient (or the patient's parent) fully understands the instructions and how to use this device. The physician should review in detail with the patient, or any other person who may be in a position to administer EpiPen or EpiPen Jr to a patient experiencing anaphylaxis, the instructions and the operation of the EpiPen or EpiPen Jr. autoinjector.
PRECAUTIONSEpinephrine is essential for the treatment of anaphylaxis. Patients with a history of severe allergic reactions (anaphylaxis) to insect bites, food, medications and other allergens, or idiopathic or exercise-induced anaphylaxis should be given precise instructions on the circumstances under which this medicinal product intended to be used life. Epinephrine is usually given with extreme caution to patients suffering from heart disease.
ADVERSE REACTIONSSide effects of epinephrine may include palpitations, tachycardia, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness, tremors, headache, apprehension, nervousness, and anxiety. Cardiac arrhythmias may occur following administration of epinephrine.
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INDICATIONSEpinephrine is indicated for the emergency treatment of allergic reactions (anaphylaxis) to insect bites and stings, food, medications and other allergens, as well as for idiopathic or exercise induced anaphylaxis. The EpiPen and EpiPen Jr autoinjectors are designed for the immediate self-administration of persons with a history of anaphylactic reactions. Such reactions may occur within minutes of exposure and consist of redness, apprehension, syncope, tachycardia, filiform or undetectable pulse associated with a drop in blood pressure, convulsions, vomiting, abdominal cramps and diarrhea, involuntary evacuation, wheezing, dyspnoea Due to pharyngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen and EpiPen Jr should only be used as emergency supportive therapy and do not replace or replace immediate medical or hospital care.
WARNINGSEpinephrine is light sensitive and should be stored in the supplied tube. Store at 25 degrees Centigrade (77 degrees Fahrenheit); Momentary permanence is permitted at temperatures between 15 and 30 degrees Celsius (59 to 86 degrees Fahrenheit). Do not refrigerate. Before use, check that the solution in the autoinjector has not faded. Replace the autoinjector if the solution has changed color or contains a precipitate. Avoid any possible inadvertent intravascular administration. EpiPen and EpiPen Jr should be injected only in the anterolateral region of the thigh. DO NOT INJECT IN THE BUTTOCK.
Large doses and accidental intravenous epinephrine injections can lead to cerebral hemorrhage due to a marked elevation of blood pressure. DO NOT INJECT INTRAVENOUSLY. NATURE AND CONTENTS OF PACKAGING
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Download the product specification for more information.
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