EPIPEN- epinephrine injection

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Asclemed USA, Inc.

Administracija rute:

INTRAMUSCULAR

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

EpiPen 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 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 are intended for immediate adm

Proizvod sažetak:

How Supplied EpiPen 2-Pak ® also include an S-clip to clip two carrier tubes together. Storage and Handling

Status autorizacije:

New Drug Application

Svojstava lijeka

EPIPEN- EPINEPHRINE INJECTION
ASCLEMED USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPIPEN
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPIPEN.
EPIPEN
(EPINEPHRINE INJECTION), FOR INTRAMUSCULAR OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
EpiPen are non-selective alpha and beta-adrenergic receptor agonist
indicated in the emergency
treatment of allergic reactions (Type I) including anaphylaxis. ( 1)
DOSAGE AND ADMINISTRATION
Patients greater than or equal to 30 kg (66 lbs): EpiPen 0.3 mg ( 2)
Inject intramuscularly or subcutaneously into the anterolateral aspect
of the thigh, through clothing if
necessary. Each device is a single-dose injection .( 2)
DOSAGE FORMS AND STRENGTHS
Injection: 0.3 mg (0.3 mg/0.3 mL) single-dose pre-filled auto-injector
( 3)
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
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 injection related injury, hold the child’s
leg firmly in place and limit movement
prior to and during injection when administering to young children. (
5.2)
Rare cases of serious skin and soft tissue infections have been
reported following epinephrine injection.
Advise patients to seek medical care if they develop signs or symptoms
of infection. ( 5.3)
The presence of a sulfite in this product should not deter use. ( 5.4)
Administer with caution in patients with heart disease; may aggravate
angina pectoris or produce
ventricular arrhythmias. ( 5.5)
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 AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG I