EPINEPHRINE injection, solution, concentrate

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

BPI Labs, LLC

INN (Nama Antarabangsa):

Epinephrine

Komposisi:

Epinephrine 1 mg in 1 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Epinephrine Injection USP, 1 mg/mL is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue. Induction and maintenance of mydriasis during intraocular surgery. None. Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Epinephrine crosses the placenta. E

Ringkasan produk:

Epinephrine Injection USP, 1 mg/mL is a sterile solution containing 1 mg/1 mL epinephrine in a 2 mL clear glass ampule. Supplied in a box of 10 single-use ampules (NDC 54288-103-10). Epinephrine is light sensitive. Protect from light until ready to use. Do not refrigerate. Protect from freezing. Store at room temperature, between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from alkalis and oxidizing agents. Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter.

Status kebenaran:

New Drug Application

Ciri produk

EPINEPHRINE- EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE
BPI LABS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPINEPHRINE INJECTION
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
EPINEPHRINE INJECTION
USP.
EPINEPHRINE INJECTION USP, 1 MG/ML AMPULE, FOR INTRAVENOUS,
INTRAMUSCULAR,
SUBCUTANEOUS AND INTRAOCULAR USE
INITIAL U.S. APPROVAL: 1939
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.8) 5/2016
INDICATIONS AND USAGE
Epinephrine is a non-selective alpha and beta adrenergic agonist
indicated:
To increase mean arterial blood pressure in adult patients with
hypotension associated with septic
shock. ( 1.1)
For emergency treatment of allergic reactions (Type 1), including
anaphylaxis. ( 1.2)
For induction and maintenance of mydriasis during intraocular surgery.
( 1.3)
DOSAGE AND ADMINISTRATION
• Hypotension associated with septic shock:
Dilute epinephrine in dextrose solution prior to infusion. ( 2.2)
Infuse epinephrine into a large vein. ( 2.2)
Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated
to achieve desired mean arterial
pressure ( 2.2)
Wean gradually. ( 2.2)
• Anaphylaxis:
_Adults and Children 30 kg (66 lbs) or more:_0.3 to 0.5 mg (0.3 to 0.5
mL) intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary. ( 2.3)
_Children 30 kg (66 lbs) or less:_0.01 mg/kg (0.01 mL/kg), up to 0.3
mg (0.3 mL), intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary. ( 2.3)
• Intraocular surgery:
Dilute 1 mL with 100 to 1000 mL of an ophthalmic irrigation fluid, for
ophthalmic irrigation or
intracameral injection. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Injection solution: 1 mg/1 mL, 2 mL single-use ampule. ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Monitor patient for acute severe hypertension. ( 5.1)
Avoid extravasation into tissues, which can cause local necrosis. (
5.2)
Do not inject into butto