EPINEPHRINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

EPINEPHRINE

Composition:

EPINEPHRINE 0.3 mg in 0.3 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Epinephrine injection, USP auto-injector 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, USP auto-injector 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, r

Product summary:

Carton containing two epinephrine injection, USP auto-injectors 0.3 mg: NDC 68788-6376-2. Rx only 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° to 25°C (68° to 77°F)); excursions permitted to 15° to 30°C (59° 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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

EPINEPHRINE- EPINEPHRINE INJECTION
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPINEPHRINE INJECTION, USP AUTO-
INJECTOR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
EPINEPHRINE INJECTION, USP AUTO-
INJECTOR.
EPINEPHRINE INJECTION, USP AUTO-INJECTOR 0.3 MG, 0.15 MG, FOR
INTRAMUSCULAR OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
Epinephrine injection, USP auto-injector contains epinephrine, 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
1.
2.
Inject epinephrine injection, USP auto-injector intramuscularly or
subcutaneously into the anterolateral aspect of the thigh,
through clothing if necessary. Each device is a single-use injection.
(2)
DOSAGE FORMS AND STRENGTHS
1.
2.
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
1.
2.
3.
4.
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 LINEAGE THERAPEUTICS
INC. AT 1-888-894-6528 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
1.
2.
3.
4.
5.
USE IN SPECIFIC POPULATIONS
1.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2016
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-66 lbs): Epinephrine injection, USP
auto-injector 0.15 mg (2)
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)
In conjunction with use, seek immediate medical or hospital care.
(5.1)
Do not inject intravenously, into buttock, or into d