国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)
Rebel Distributors Corp
EPINEPHRINE
EPINEPHRINE 0.3 mg
SUBCUTANEOUS
PRESCRIPTION DRUG
Epinephrine auto-injector is indicated in the emergency treatment of severe 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, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g. radiocontrast media), and other allergens, as well as anaphylaxis to unknown substances (idiopathic anaphylaxis) or exercise-induced anaphylaxis. Epinephrine auto-injector is intended for immediate administration in patients with a history of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to patient body weight (See DOSAGE AND ADMINISTRATION section). Such 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, w
Epinephrine auto-injector is a patient (or caregiver) actuated product that contains 1.1 mL of epinephrine injection, USP (1 mg/mL), of which one dose can be delivered by auto-injection. THE REMAINING VOLUME THAT IS LEFT AFTER THIS FIXED DOSE CANNOT BE FURTHER ADMINISTERED AND SHOULD BE DISCARDED WITH THE DEVICE AS OUTLINED IN THE PATIENT INFORMATION LEAFLET. Epinephrine auto-injector 0.3 mg is available in a single unit carton, NDC 21695-947-01, containing one epinephrine auto-injector 0.3 mg. PROTECT FROM LIGHT. STORE AT ROOM TEMPERATURE, 20°-25°C (68°-77°F) WITH EXCURSIONS PERMITTED TO 15°-30°C (59°-86°F). PROTECT FROM FREEZING. DO NOT REFRIGERATE.
New Drug Application Authorized Generic
EPINEPHRINE- EPINEPHRINE INJECTION REBEL DISTRIBUTORS CORP ---------- EPINEPHRINE INJECTION, USP AUTO-INJECTOR PRESCRIBING INFORMATION AVAILABLE AS 0.15 MG 0.3 MG each unit delivers 0.15 mg or 0.3 mg of epinephrine DESCRIPTION Epinephrine injection, USP auto-injector (referred to throughout as epinephrine auto-injector) contains 1.1 mL epinephrine injection, USP (1 mg/mL), from which one dose of either 0.15 mg (0.15 mL) or 0.3 mg (0.3 mL) each is available for use by injection. The dose is administered by auto-injection after the patient prepares and fires epinephrine auto-injector as directed. The remaining volume is not available for use and should be discarded. See PATIENT DIRECTIONS FOR USE on the accompanying Patient Information Leaflet. This single, available dose of epinephrine injection, USP contains either 0.15 mg or 0.3 mg l- epinephrine, sodium chloride, chlorobutanol and sodium bisulfite, all sealed under nitrogen. Epinephrine is a sympathomimetic catecholamine. Its naturally occurring l-isomer, which is twenty times as active as the d-isomer, is obtained in pure form by separation from the synthetically produced racemate. Chemically, epinephrine is 1-(3,4-dihydroxyphenyl)-2-(methylamino)ethanol with the following structure: Epinephrine deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Epinephrine solutions that show evidence of discoloration should be discarded. Epinephrine auto-injector contains no latex. CLINICAL PHARMACOLOGY Epinephrine is the drug of choice for the emergency treatment of severe allergic reactions (Type I) to allergens, such as those present in certain insect venoms, foods, or drugs. It can also be used in the treatment of anaphylaxis of unknown cause (idiopathic anaphylaxis) or exercise-induced anaphylaxis. Epinephrine, when given intramuscularly or subcutaneously, has a rapid onset and short duration of action. Epinephrine acts on both alpha and beta adrenergic receptors. Through its action on a 完全なドキュメントを読む