Country: United States
Language: English
Source: NLM (National Library of Medicine)
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)
Physicians Total Care, Inc.
EPINEPHRINE
EPINEPHRINE 0.3 mg in 0.3 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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
EpiPen® Auto-Injectors (epinephrine injections, USR 1:1000, 0.3 mL) are available as an EpiPen 2-Pak® , NDC 54868-2804-1, 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 as an EpiPen Jr 2-Pak® , NDC 54868-4819-0, 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. Manufactured 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 Additional barcode labeled by: Physicians Total Care, Inc. Tulsa, OK 74146
New Drug Application
EPIPEN - EPINEPHRINE INJECTION EPIPEN JR - EPINEPHRINE INJECTION PHYSICIANS TOTAL CARE, 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 Read the complete document