EPINEPHRINE injection

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

可用日期:

Rebel Distributors Corp

INN（国际名称）:

EPINEPHRINE

组成:

EPINEPHRINE 0.3 mg

给药途径:

SUBCUTANEOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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.

授权状态:

New Drug Application Authorized Generic

产品特点

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