Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)
Medical Purchasing Solutions, LLC
INTRAMUSCULAR
PRESCRIPTION DRUG
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,
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.
New Drug Application Authorized Generic
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. Olvassa el a teljes dokumentumot