EPINEPHRINE injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

A-S Medication Solutions

Administreringssätt:

SUBCUTANEOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. Epinephrine injection is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care. None. Risk Summary There are no available human data on the use of epinephrine injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, epinephrine administered by the subcutaneous route to rabbits, mice, and hamsters during the period of organogenesis was teratogenic at doses 7 times and higher than the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis (see Data ). Epinephrine is the first-line medication of choice for the treatment of anaphylaxis during pregnancy in humans. Epinephrine should be used for treatment of anaphylaxis during pregnancy in the same manner as it is used in non-pregnant patients. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and embryo/fetal risk: During pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate.  The prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. Management of anaphylaxis during pregnancy is similar to management in the general population.  Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients.  In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. Data Animal Data In an embryofetal development study with rabbits dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including gastroschisis and embryonic lethality) at doses approximately 40 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). In an embryofetal development study with mice dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including embryonic lethality) at doses approximately 8 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). These effects were not seen in mice at approximately 4 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). In an embryofetal development study with hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine was shown to be teratogenic at doses approximately 7 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day). Risk Summary There are no data on the presence of epinephrine in human milk, or the effects of epinephrine on the breastfed infant or on milk production. Epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and no-breastfeeding patients. Epinephrine injection may be administered to pediatric patients at a dosage appropriate to body weight [see Dosage and Administration (2.1)] . Clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Since the dose of epinephrine delivered from epinephrine injection is fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. Therefore, epinephrine injection should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [see Warnings and Precautions (5.5) and Overdosage (10)] . EPINEPHRINE injection (ep-in-eph-rine) for intramuscular or subcutaneous use For allergic emergencies (anaphylaxis) Read this Instructions for Use carefully before you use epinephrine injection and each time you get a refill. There may be new information. Before you need to use your epinephrine injection, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer epinephrine injection should also understand how to use it well. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions, ask your healthcare provider.  Your epinephrine injection         Step 1. Prepare epinephrine injection for injection - Remove epinephrine injection from its protective carrying case. - Pull off blue end caps . You will now see a red tip. Grasp the epinephrine injection in your fist with the red tip pointing downward. See Figure A . Note: - The needle comes out of the red tip. - To avoid an accidental injection, never put your thumb, fingers, or hand over the red tip. If an accidental injection happens, get medical help right away. Step 2. Administer epinephrine injection - If you are administering epinephrine injection to a young child, hold the leg firmly in place and limit movement prior to and while administering an injection. - Put the red tip against the middle of the outer thigh (upper leg) at a 90° angle (perpendicular) to the thigh. - Press down hard and hold firmly against the thigh for approximately 10 seconds to deliver the medicine. See Figure B.   - Only inject into the middle of the outer thigh. Do not inject into any other part of the body. - Remove epinephrine injection from the thigh. - Massage the area for 10 seconds. - Check the red tip. The injection is complete and you have received the correct dose of the medicine if you see the needle sticking out of the red tip. If you do not see the needle repeat Step 2. Step 3. Get emergency medical help right away. You may need further medical attention. You may need to use a second epinephrine injection if symptoms continue or recur. Step 4. After use Disposal Carefully cover the needle with the carrying case. - Lay the labeled half of the carrying case cover down on a flat surface. Use one hand to carefully slide the end of the epinephrine injection needle first, into the labeled carrying case cover. See Figure C. - After the needle is inside the labeled cover, push the unlabeled half of the carrying case cover firmly over the non-needle end of the epinephrine injection . See Figure D.   - Take your used epinephrine injection with you when you go to see a healthcare provider. - Tell the healthcare provider that you have received an injection of epinephrine. Show the healthcare provider where you received the injection. - Give your used epinephrine injection to the healthcare provider for inspection and proper disposal. - Ask for a refill, if needed. Note: - Epinephrine injection is a single-use injectable device that delivers a fixed dose of epinephrine. Epinephrine injection cannot be reused. Do not attempt to reuse epinephrine injection after the device has been activated. It is normal for most of the medicine to remain in the auto-injector after the dose is injected. The correct dose has been administered if you see the needle sticking out of the red tip. - A separate epinephrine injection Trainer is available. The epinephrine injection Trainer has a beige color. The beige epinephrine injection Trainer contains no medicine and no needle. Practice with your epinephrine injection Trainer, but always carry your real epinephrine injection in case of an allergic emergency. - If you will be administering epinephrine injection to a young child, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose. - Do not try to take epinephrine injection. For more information and video instructions on the use of epinephrine injection, go to www.epinephrineautoinject.com or call 1-877-835-5472. This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. © 2021 Amneal Pharmaceuticals LLC. All rights reserved. Manufactured by: Hospira, Inc. McPherson, KS 67460 Distributed by: Amneal  Pharmaceuticals LLC Bridgewater, NJ 08807 1872-03 Revised 02-2021-03

Produktsammanfattning:

Product: 50090-3155 NDC: 50090-3155-0 1 mL in a CASE / 2 in a CARTON

Bemyndigande status:

New Drug Application Authorized Generic

Produktens egenskaper

EPINEPHRINE- EPINEPHRINE INJECTION
A-S MEDICATION SOLUTIONS
----------
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 and vomiting,