NOREPINEPHRINE BITARTRATE injection

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

NOREPINEPHRINE BITARTRATE (UNII: IFY5PE3ZRW) (NOREPINEPHRINE - UNII:X4W3ENH1CV)

Sẵn có từ:

Baxter Healthcare Corporation

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Norepinephrine Bitartrate Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. None. Risk Summary Limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see Clinical Considerations) . In animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. Clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see Data). Increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m3 basis for four days during organogenesis (see Data). The estimated background risk for 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 U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke 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 norepinephrine on the fetus. Data Animal Data A study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2 to 4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. Decreases in fetal oxygenation, urine and lung liquid flow were also observed. Norepinephrine administration to pregnant rats on Gestation Day 16 or 17 resulted in cataract production in rat fetuses. In hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from Gestation Day 7 to 10). Risk Summary There are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine. Safety and effectiveness in pediatric patients have not been established. Clinical studies of norepinephrine bitartrate 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. Avoid administration of norepinephrine bitartrate into the veins in the leg in elderly patients [see Warnings and Precautions (5.1)] .

Tóm tắt sản phẩm:

Norepinephrine Bitartrate Injection, USP, is a sterile, colorless to pale yellow solution for injection intended for intravenous use. It contains the equivalent of 1 mg of norepinephrine base per 1 mL (4 mg/4 mL). It is available as 4 mg/4 mL in single-dose amber glass vials. Supplied as: Unit of Sale Concentration NDC 43066-997-10 Single-dose vials in boxes of 10 4 mg/4 mL (1 mg/mL) 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.] Store in original carton until time of administration to protect from light. Discard unused portion.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

NOREPINEPHRINE BITARTRATE- NOREPINEPHRINE BITARTRATE INJECTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOREPINEPHRINE
BITARTRATE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
NOREPINEPHRINE BITARTRATE INJECTION.
NOREPINEPHRINE BITARTRATE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1950
INDICATIONS AND USAGE
Norepinephrine Bitartrate Injection is a catecholamine indicated for
restoration of blood pressure in adult
patients with acute hypotensive states. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Injection: 4 mg/4 mL (1 mg/mL) norepinephrine base in single-dose
glass vial. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions are ischemic injury, bradycardia,
anxiety, transient headache, respiratory
difficulty, and extravasation necrosis at injection site. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAND PHARMA LIMITED AT
866-770-7144
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
USE IN SPECIFIC POPULATIONS
Elderly patients may be at greater risk of developing adverse
reactions. (8.5)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2021
Initial dose of 0.25 mL to 0.375 mL (from 8 mcg to 12 mcg of base) per
minute, adjust the rate of flow
to establish and maintain a low to normal blood pressure (usually 80
mm Hg to 100 mm Hg systolic)
sufficient to maintain the circulation of vital organs. (2.2)
The average maintenance dose ranges from 0.0625 mL to 0.125 mL per
minute (from 2 mcg to 4
mcg of base). (2.2)
Tissue Ischemia: Avoid extravasation of norepinephrine bitartrate into
the tissues, as local necrosis
might ensue due to the vasoconstrictive action of the drug. Infuse
norepinephrine bitartrate into a
large vein. To prevent sloughing and necrosis in areas in which
extravasation has taken place, the
area should be infiltrated as soon as possible wit