EPINEPHRINE injection, solution, concentrate

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

REMEDYREPACK INC.

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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. Induction and maintenance of mydriasis during intraocular surgery. None. Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Epinephrine crosses the placenta. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both). Epinephrine is teratogenic in rabbits, mice, and hamsters dosed during organogenesis. Epinephrine has been shown to have teratogenic effects (including gastroschisis and embryonic lethality) when administered subcutaneous in rabbits at approximately 15 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). In mice, teratogenic effects (including embryonic lethality) were observed at approximately 3 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 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/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). In hamsters, teratogenic effects were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days). 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. Use with caution during labor and delivery. Although epinephrine improves maternal hypotension associated with anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. It is not known whether epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when epinephrine is administered to a nursing woman. 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. The safety and effectiveness of epinephrine (at a dilution of 1:100,000 to 1:400,000) for induction and maintenance of mydriasis during intraocular surgery have been established in pediatric patients. Use of epinephrine for induction and maintenance of mydriasis during intraocular surgery in pediatric patients is supported by adequate and well controlled studies in adults and uncontrolled studies in pediatric patients. 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. For induction and maintenance of mydriasis during intraocular surgery, no overall differences have been observed between elderly and other patients.

Tóm tắt sản phẩm:

Epinephrine Injection USP, 1 mg/mL is a sterile solution containing 1 mg/1 mL epinephrine in a 2 mL clear glass ampule. Supplied in NDC: 70518-1215-00 NDC: 70518-1215-01 PACKAGING: 10 in 1 BOX PACKAGING: 1 mL in 1 AMPULE, TYPE 0 Epinephrine is light sensitive. Protect from light until ready to use. Do not refrigerate. Protect from freezing. Store at room temperature, between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from alkalis and oxidizing agents. Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

EPINEPHRINE- EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE
REMEDYREPACK INC.
----------
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, 1 MG/ML AMPULE, FOR INTRAVENOUS,
INTRAMUSCULAR,
SUBCUTANEOUS AND INTRAOCULAR USE
INITIAL U.S. APPROVAL: 1939
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.8) 5/2016
INDICATIONS AND USAGE
Epinephrine is a non-selective alpha and beta adrenergic agonist
indicated:
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)
For induction and maintenance of mydriasis during intraocular surgery.
( 1.3)
DOSAGE AND ADMINISTRATION
• Hypotension associated with septic shock:
Dilute epinephrine in dextrose solution prior to infusion. ( 2.2)
Infuse epinephrine into a large vein. ( 2.2)
Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated
to achieve desired mean arterial
pressure ( 2.2)
Wean gradually. ( 2.2)
• Anaphylaxis:
_Adults and Children 30 kg (66 lbs) or more:_0.3 to 0.5 mg (0.3 to 0.5
mL) intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary. ( 2.3)
_Children 30 kg (66 lbs) or less:_0.01 mg/kg (0.01 mL/kg), up to 0.3
mg (0.3 mL), intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary. ( 2.3)
• Intraocular surgery:
Dilute 1 mL with 100 to 1000 mL of an ophthalmic irrigation fluid, for
ophthalmic irrigation or
intracameral injection. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Injection solution: 1 mg/1 mL, 2 mL single-use ampule. ( 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 b