EPINEPHRINE injection

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Medical Purchasing Solutions, LLC

Via di somministrazione:

INTRAMUSCULAR

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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,

Dettagli prodotto:

Epinephrine Injection, USP Auto-Injectors, 0.3 mg (epinephrine injections, USP 0.3 mg/0.3 mL) are available as NDC 49502-102-02, a pack that contains two Epinephrine Injection, USP Auto-Injectors, 0.3 mg (epinephrine injections, USP 0.3 mg/0.3 mL) and one Epinephrine Injection, USP Auto-Injector Trainer device. Epinephrine Injection, USP Auto-Injectors, 0.15 mg (epinephrine injections, USP 0.15 mg/0.3 mL) are available as NDC 49502-101-02, a pack that contains two Epinephrine Injection, USP Auto-Injectors, 0.15 mg (epinephrine injections, USP 0.15 mg/0.3 mL) and one Epinephrine Injection, USP Auto-Injector Trainer device. Epinephrine Injection, USP Auto-Injectors also include an S-clip to clip two carrier tubes together. Rx only Protect from light. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. Store at 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.

Stato dell'autorizzazione:

New Drug Application Authorized Generic

Scheda tecnica

EPINEPHRINE- EPINEPHRINE INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
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, 0.15 MG, 0.3 MG, FOR
INTRAMUSCULAR OR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
RECENT MAJOR CHANGES
Dosage and Administration ( 2) 05/2016
Warnings and Precautions ( 5.2, 5.3) 05/2016
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
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)
Inject 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
EPINEPHRINE INJECTION, USP AUTO-INJECTOR: 0.3 mg: 0.3 mg/0.3 mL
epinephrine, USP, pre-filled auto-
injector ( 3)
EPINEPHRINE INJECTION, USP AUTO-INJECTOR: 0.15 mg: 0.15 mg/0.3 mL
epinephrine, 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, instruct caregivers
to 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.