EPIPEN JR- epinephrine injection

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

A-S Medication Solutions

INN (International ime):

EPINEPHRINE

Sastav:

EPINEPHRINE 0.15 mg in 0.3 mL

Administracija rute:

INTRAMUSCULAR

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

EpiPen and EpiPen Jr 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, mosquitoes), 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 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. Anaphylactic 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, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen an

Proizvod sažetak:

Product: 50090-1243 NDC: 50090-1243-0 1 mL in a CONTAINER

Status autorizacije:

New Drug Application

Svojstava lijeka

EPIPEN JR- EPINEPHRINE INJECTION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPIPEN AND EPIPEN JR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPIPEN AND EPIPEN
JR.
EPIPEN (EPINEPHRINE INJECTION, USP), AUTO-INJECTOR 0.3 MG, EPIPEN JR (EPINEPHRINE INJECTION, USP) AUTO-
INJECTOR 0.15 MG, FOR INTRAMUSCULAR OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
RECENT MAJOR CHANGES
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INDICATIONS AND USAGE
EpiPen and EpiPen Jr contain epinephrine, a non-selective alpha and
beta-adrenergic receptor agonist, indicated in the
emergency treatment of allergic reactions (Type I) including
anaphylaxis. (1)
DOSAGE AND ADMINISTRATION
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Inject EpiPen and EpiPen Jr intramuscularly or subcutaneously into the
anterolateral aspect of the thigh, through clothing if
necessary. Each device is a single-use injection. (2)
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse reactions to epinephrine include anxiety, apprehensiveness,
restlessness, tremor, weakness, dizziness, sweating,
palpitations, pallor, nausea and vomiting, headache, and/or
respiratory difficulties. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN SPECIALTY, L.P.
AT 1-877-446-3679 (1-877-4-
INFO-RX) OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
DRUG INTERACTIONS
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Dosage and Administration (2) 05/2016
Warnings and Precautions (5.2, 5.3) 05/2016
Patients greater than or equal to 30 kg (66 lbs): EpiPen 0.3 mg (2)
Patients 15 to 30 kg (33 lbs to 66 lbs): EpiPen Jr 0.15 mg (2)
EpiPen: Injection, 0.3 mg: 0.3 mg/0.3 mL epinephrine, USP, pre-filled
auto-injector (3)
EpiPen Jr: Injection, 0.15 mg: 0.15 mg/0.3 mL epinephrine, USP,
pre-filled auto-injector (3)
In conjunction with use, seek immediate medical or hospital care.
(5.1)
Do not inject intravenously, into buttock, or into digits, hands, or
feet. (5.2)
To minimize the risk of inje