NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE- norepinephrine bitartrate injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

WG Critical Care, LLC

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Norepinephrine Bitartrate in Sodium Chloride 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 2–4% and 15–20%, 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 2–4 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 7–10). 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 in Sodium Chloride Injection 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 in Sodium Chloride Injection into the veins in the leg in elderly patients [see Warnings and Precautions (5.1)] .

Обзор продуктов:

Norepinephrine Bitartrate in Sodium Chloride Injection is filled in 250 mL transparent intravenous Nexcel bags as: NDC Configuration Packaging Configuration Total Norepinephrine Bitartrate 44567-640-01 1 single-dose bag 4 mg per 250 mL (16 mcg per mL) 44567-640-10 10 bags per carton 44567-641-01 1 single-dose bag 8 mg per 250 mL (32 mcg per mL) 44567-641-10 10 bags per carton 44567-642-01 1 single-dose bag 16 mg per 250 mL (64 mcg per mL) 44567-642-10 10 bags per carton Each filled bag is packed in an overwrap with a transparent band and oxygen absorber and oxygen indicator placed inside the overwrapping to prevent deterioration of drug product. Product should be used within 7 days of removal from overwrap. Do not use the product if the oxygen indicator has changed color to green or blue before opening the overwrap. Normal color is yellow or orange. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] in the original carton to protect from light. Do not freeze.

Статус Авторизация:

New Drug Application

Характеристики продукта

NOREPINEPHRINE BITARTRATE- NOREPINEPHRINE BITARTRATE INJECTION,
SOLUTION
WG CRITICAL CARE, LLC
REFERENCE LABEL SET ID: 2E0570E7-D28F-4936-CBA8-81EE0C4C3547
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOREPINEPHRINE
BITARTRATE IN SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE
INJECTION.
NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE INJECTION, FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1950
INDICATIONS AND USAGE
Norepinephrine Bitartrate in Sodium Chloride 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:
•
•
•
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 WG CRITICAL CARE, LLC
AT 1-866-562-
4708, OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2023
Initiate 8 to 12 mcg/min and adjust the rate to maintain blood
pressure sufficient to maintain the
circulation of vital organs. (2.2)
The average maintenance dose ranges from 2 to 4 mcg/min. (2.2)
4 mg/250 mL (16 mcg per mL) of norepinephrine, single-dose bags (3)
8 mg/250 mL (32 mcg per mL) of norepinephrine, single-dose bags. (3)
16 mg/250 mL (64 mcg per mL) of norepinephrine, single-dose bags (3)
Tissue Ischemia: Avoid extravasation into tissues, which can cause
local necrosis. (5.1)
Hypotension After Abrupt Discontinuation: Sudden cessation of the
infusion rate may result in marked
hypotension. Reduce the Norepinephrine Bitartrate in Sodium Chloride
Injection infusion rate
gradually. (5.2)
Cardiac Arr