EPINEPHRINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

EPINEPHRINE

Composition:

EPINEPHRINE 0.15 mg in 0.15 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes 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 is 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. Epine

Product summary:

How Supplied Storage and Handling Protect from light. Epinephrine is light sensitive and should be stored in the carrying-case provided to protect it from light. Store at room temperature (20°C to 25°C (68°F to 77°F)); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles. Properly dispose of all used, unwanted, or expired epinephrine injection, USP.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

EPINEPHRINE- EPINEPHRINE INJECTION
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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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 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
Patients greater than or equal to 30 kg (66 lbs): 0.3 mg (2)
Patients 15 to 30 kg (33 lbs-66 lbs): 0.15 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) (2)
DOSAGE FORMS AND STRENGTHS
Injection, 0.3 mg: 0.3 mg/0.3 mL epinephrine injection, USP,
pre-filled auto-injector (3)
Injection, 0.15 mg: 0.15 mg/0.15 mL epinephrine injection, USP,
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