EPINEPHRINE- epinephrine injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Belcher Pharmaceuticals, LLC

INN (International Name):

EPINEPHRINE

Composition:

EPINEPHRINE 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Risk Summary Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, does not identify a d

Product summary:

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 62250-103-10). 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.

Authorization status:

New Drug Application

Summary of Product characteristics

EPINEPHRINE - EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE
BELCHER PHARMACEUTICALS, 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
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:
o Dilute epinephrine in dextrose solution prior to infusion. ( 2.2)
o Infuse epinephrine into a large vein. ( 2.2)
o Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min,
titrated to achieve desired mean arterial
pressure ( 2.2)
o Wean gradually. ( 2.2)
• Anaphylaxis:
o Administer intramuscularly or subcutaneously into anterolateral
thigh every 5-10 minutes as needed
_o Adults and Children over 30 kg (66 lbs):_ 0.3 to 0.5 mg (0.3 to 0.5
mL) ( 2.3)
o _Children under 30 kg (66 lbs):_ 0.01 mg/kg (0.01 mL/kg) ( 2.3)
• Intraocular surgery:
o 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 buttocks, digits, hands, or feet. ( 5.3)
• Potential for pulmonary edema, which may be fatal. ( 5.4)
• May constrict renal blood vessels and decrease ur