EPIPEN- epinephrine injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH)

Available from:

Dispensing Solutions, Inc.

INN (International Name):

Epinephrine

Composition:

Epinephrine 0.3 mg in 0.3 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EpiPen® and EpiPen® Jr Auto-Injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include 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 idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen® and EpiPen® Jr Auto-Injectors are intended for immediate administration in patients, who are determined to be at increased risk for anaphylaxis, including individuals 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, convu

Product summary:

EpiPen® Auto-Injectors (epinephrine injections, USR 1:1000, 0.3 mL) are available in individual cartons, NDC 49502-500-01, and as EpiPen 2-Pak® , NDC 49502-500-02, a pack that contains two EpiPen® Auto-Injectors (epinephrine injections, USP, 1:1000, 0.3 mL) and one EpiPen® Auto-Injector trainer device. EpiPen® Jr Auto-Injectors (epinephrine injection, USP, 1:2000, 0.3 mL) are available in individual cartons, NDC 49502-501-01, and as EpiPen Jr 2-Pak® , NDC 49502-501-02, a pack that contains two EpiPen® Jr Auto-Injectors (epinephrine injections, USP, 1:2000, 0.3 mL) and one EpiPen® Auto-Injector trainer device. EpiPen 2-Pak® and EpiPen Jr 2-Pak® also includes a S-clip to clip two cases together. Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) (See USP Controlled Room Temperature). Contains no latex. Protect from light. Rx only. MANUFACTURED FOR Dey, LP., NAPA, CALIFORNIA 94558, U.S.A. by Meridian Medical Technologies, Inc., a subsidiary of King Pharmaceuticals® , Inc., Columbia, MD 21046, U.S.A. EpiPen® , EpiPen® Jr, EpiPen 2-Pak® , and EpiPen Jr 2-Pak® are registered trademarks of Mylan, Inc. licensed exclusively to its wholly-owned affiliate, Dey, LP. of Napa California, USA. 09/08 0001497 03-914-00

Authorization status:

New Drug Application

Summary of Product characteristics

EPIPEN- EPINEPHRINE INJECTION
DISPENSING SOLUTIONS, INC.
----------
EPIPEN
(EPINEPHRINE) AUTO-INJECTOR 0.3 MG
EPIPEN = ONE DOSE OF 0.30 MG EPINEPHRINE (USP, 1:1000, 0.3 ML)
EPIPEN JR
(EPINEPHRINE) AUTO-INJECTOR 0.15 MG
EPIPEN JR = ONE DOSE OF 0.15 MG EPINEPHRINE (USP, 1:2000, 0.3 ML)
DESCRIPTION
Each EpiPen Auto-Injector delivers a SINGLE DOSE of 0.3 mg epinephrine
injection, USP, 1:1000 (0.3
mL) in a sterile solution.
Each EpiPen Jr Auto-Injector delivers a SINGLE DOSE of 0.15 mg
epinephrine injection, USP, 1:2000
(0.3 mL) in a sterile solution.
The EpiPen and EpiPen Jr Auto-Injectors each contain 2 mL epinephrine
solution. Approximately 1.7
mL remains in the auto-injector after activation and cannot be used.
Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine,
1.8 mg sodium chloride, 0.5 mg
sodium metabisulfite, hydrochloric acid to adjust pH, and Water for
Injection.
The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen Jr Auto-Injector
contains 0.15 mg epinephrine, 1.8
mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to
adjust pH, and Water for
Injection. The pH range is 2.2-5.0.
Epinephrine is a sympathomimetic catecholamine. Chemically,
epinephrine is B-(3, 4-dihydroxyphenyl)-
a-methyl-aminoethanol, 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 EpiPen
and EpiPen Jr Auto-
Injectors if the epinephrine solution appears discolored.
EpiPen and EpiPen Jr Auto-Injectors do not contain latex.
CLINICAL PHARMACOLOGY
Epinephrine is the drug of choice for the emergency treatment of
severe allergic reactions (Type I) to
insect stings or bites, foods, drugs, and other allergens. It can also
be used in the treatment of
anaphylaxis of unknown cause (idiopathic anaphylaxis) or
exercise-induced anaphylaxis. When given
intramuscularly or subcutaneously it has a rapid onset and short
duration of action. Epinephrine acts on
both alpha and beta adrenerg