EPINEPHRINE injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

BPI Labs, LLC

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Epinephrine Injection, USP 1 mg/mL  is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue. None Risk Summary Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, does not identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are risks to the mother and fetus associated with epinephrine use during labor or delivery (see Clinical Considerations ). In animal reproduction studies, epinephrine administered by the subcutaneous route to pregnant rabbits, mice, and hamsters, during the period of organogenesis, resulted in adverse developmental effects (including gastroschisis, embryonic lethality, and delayed skeletal ossification) at doses approximately 2 times the maximum recommended daily intramuscular, subcutaneous, or intravenous dose (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States 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/or 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. Hypotension associated with septic shock is a medical emergency in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic shock may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of epinephrine on the fetus. Labor or Delivery Epinephrine usually inhibits spontaneous or oxytocin-induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid epinephrine during the second stage of labor. In dosage sufficient to reduce uterine contractions, the drug may cause a prolonged period of uterine atony with hemorrhage. Avoid epinephrine in obstetrics when maternal blood pressure exceeds 130/80 mmHg. Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Data Animal Data In an embryofetal development study with pregnant rabbits dosed during the period of organogenesis (on days 3 to 5, 6 to 7, or 7 to 9 of gestation), epinephrine caused teratogenic effects (including gastroschisis) at doses approximately 15 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m2  basis at a maternal subcutaneous dose of 1.2 mg/kg/day for 2 to 3 days). Animals treated on days 6 to 7 had decreased number of implantations. In an embryofetal development study, pregnant mice were administered epinephrine (0.1 to 10 mg/kg/day) on Gestation Days 6 to 15. Teratogenic effects, embryonic lethality, and delays in skeletal ossification were observed at approximately 3 times the maximum recommended intramuscular, subcutaneous, or intravenous 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 2 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 pregnant hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine produced reductions in litter size and delayed skeletal ossification at doses approximately 2 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m2  basis at a maternal subcutaneous dose of 0.5 mg/kg/day). Risk Summary There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production. However, due to its poor oral bioavailability and short half-life, epinephrine exposure is expected to be very low in the breastfed infant. Epinephrine is the first-line medication of choice for treatment of anaphylaxis; it should be used in the same manner for anaphylaxis in breastfeeding and non-breastfeeding patients.  Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established. Clinical use data support weight-based dosing for treatment of anaphylaxis in pediatric patients, and other reported 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. Clinical studies of epinephrine for the treatment of hypotension associated with septic shock did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 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, for the treatment of anaphylaxis, consider starting with a lower dose to take into account potential concomitant disease or other drug therapy.

leaflet_short:

Epinephrine Injection supplied as a clear colorless solution available as follows: 1 mL Single-dose Vial: Each carton contains 10 single-dose vials containing 1 mL of a 1 mg/mL epinephrine injection, USP solution in a clear glass vial. NDC 54288-119-10                  Box of 10 × 1 mL Single-Dose Vials Each carton contains 25 single-dose vials containing 1 mL of a 1 mg/mL epinephrine injection, USP solution in a clear glass vial. NDC 54288-119-25                 Box of 25 × 1 mL Single-Dose Vials 10 mL Multiple dose Vial: Each carton contains 1 multiple dose vial containing 10 mg/10 mL (1 mg/mL) epinephrine injection, USP solution in an amber glass vial. NDC 54288-120-01               10 mL Multiple Dose Vial Multiple Dose Vial and contents must be discarded 30 days after initial use. 30 mL Multiple dose Vial: Each carton contains 1 multiple dose vial containing 30 mg/30 mL (1 mg/mL) epinephrine injection, USP solution in an amber glass vial. NDC 54288-152-01               30 mL Multiple Dose Vial Multiple Dose Vial and contents must be discarded 30 days after initial use. Epinephrine is light sensitive. Protect from light until ready to use. Do not refrigerate. Protect from freezing. Vial and contents must be discarded 30 days after initial use. Store at room temperature, between 20°C to 25°C (68°F to 77°F). (See USP Controlled Room Temperature.) Protect from alkalis and oxidizing agents.

מצב אישור:

New Drug Application

מאפייני מוצר

EPINEPHRINE- EPINEPHRINE INJECTION
BPI LABS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPINEPHRINE INJECTION
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
EPINEPHRINE INJECTION
USP.
EPINEPHRINE INJECTION, USP FOR INTRAVENOUS, INTRAMUSCULAR AND
SUBCUTANEOUS USE ONLY
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
Epinephrine is a non-selective alpha and beta adrenergic agonist
indicated: (1)
To increase mean arterial blood pressure in adult patients with
hypotension associated with septic
shock (1.1)
For emergency treatment of allergic reactions (Type 1), including
anaphylaxis (1.2)
DOSAGE AND ADMINISTRATION
Hypotension associated with septic shock (2.2):
Dilute epinephrine in dextrose solution prior to infusion.
Infuse epinephrine into a large vein.
Titrate 0.05 mcg/kg/min to 2 mcg/kg/min to achieve desired blood
pressure.
Wean gradually.
Anaphylaxis (2.3):
Administer intramuscularly or subcutaneously into anterolateral thigh
every 5-10 minutes as needed
Adults and children over 30 kg (66 lb): 0.3-0.5 mg (0.3-0.5 mL)
Children under 30 kg (66 lb): 0.01 mg/kg (0.01 mL/kg)
DOSAGE FORMS AND STRENGTHS
Injection solution: 1 mg/mL Single-Dose Vial (3)
Injection solution: 10 mg/10 mL (1 mg/mL) Multiple Dose Vial (3)
Injection solution: 30 mg/30 mL (1 mg/mL) Multiple Dose Vial (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Monitor patient for acute severe hypertension. (5.1)
Avoid extravasation into tissues, which can cause local necrosis.
(5.2)
Do not inject into buttocks, digits, hands, or feet. (5.3)
Potential for pulmonary edema, which may be fatal. (5.4)
May constrict renal blood vessels and decrease urine formation. (5.5)
May induce potentially serious cardiac arrhythmias or aggravate angina
pectoris, particularly in patients
with underlying heart disease. (5.6)
Presence of sulfite in this product should not deter use. (5.9)
ADVERSE REACTIONS
Most common adverse reactions to systemically administered epinephrin