EPINEPHRINE injection

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Mylan Specialty L.P.

INN (Nama Internasional):

EPINEPHRINE

Komposisi:

EPINEPHRINE 0.3 mg in 0.3 mL

Rute administrasi :

INTRAMUSCULAR

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Epinephrine injection, USP 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, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP 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. 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,

Ringkasan produk:

How Supplied Epinephrine Injection, USP Auto-Injectors also include an S-clip to clip two carrier tubes together. Storage and Handling

Status otorisasi:

New Drug Application Authorized Generic

Karakteristik produk

EPINEPHRINE- EPINEPHRINE INJECTION
MYLAN SPECIALTY L.P.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPINEPHRINE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
EPINEPHRINE INJECTION.
EPINEPHRINE INJECTION, FOR INTRAMUSCULAR OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
EPINEPHRINE INJECTION, USP AUTO-INJECTOR is 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
•
•
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
•
•
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
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 INTERACTIONS
•
•
•
•
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
Patients greater than or equal to 30 kg (66 lbs): EPINEPHRINE
INJECTION, USP AUTO-INJECTOR, 0.3
mg (2)
Patients 15 to 30 kg (33 lbs to 66 lbs): EPINEPHRINE INJECTION, USP
AUTO-INJECTOR, 0.15 mg (2)
Injection: 0.3 mg (0.3 mg/0.3 mL) single-dose pre-filled auto-injector
(3)
Injection: 0.15 mg (0.15 mg/0.3 mL) single-dose 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 injection related injury, hold the child’s
leg firmly in place and limit movement
prior to and during injection