NOREPINEPHRINE BITARTRATE injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

HF Acquisition Co LLC, DBA HealthFirst

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Norepinephrine Bitartrate Injection, USP is indicated to raise blood pressure in adult patients with severe, acute hypotension. None. 8.1 Pregnancy 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 below). 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 below). 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 below). 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). 8.2 Lactation 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. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of Norepinephrine Bitartrate 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 Injection into the veins in the leg in elderly patients [see WARNINGS AND PRECAUTIONS (5.1)].

Ürün özeti:

Norepinephrine Bitartrate Injection, USP is a sterile, colorless 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. NOREPINEPHRINE BITARTRATE INJECTION, USP 4mg PER 4mL (1 mg/mL) is supplied in the following dosage forms. NDC 51662-1528-1 NOREPINEPHRINE BITARTRATE INJECTION, USP 4mg PER 4mL (1 mg/mL) 4mL VIAL NDC 51662-1528-2 NOREPINEPHRINE BITARTRATE INJECTION, USP 4mg PER 4mL (1 mg/mL) 4mL VIAL in a Pouch NDC 51662-1528-3 NOREPINEPHRINE BITARTRATE INJECTION, USP 4mg PER 4mL (1 mg/mL) 4mL VIAL, 10 Pouches in a Case HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Supplied as: Boxes of 10 x 4 mg/4 mL in amber glass vials (NDC 0143-9318-10) Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Store in original carton until time of administration to protect from light. Discard unused portion.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

NOREPINEPHRINE BITARTRATE- NOREPINEPHRINE BITARTRATE INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
NOREPINEPHRINE BITARTRATE INJECTION, USP 4MG PER 4ML (1 MG/ML)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NOREPINEPHRINE
BITARTRATE INJECTION, USP safely and effectively. See full prescribing
information for
NOREPINEPHRINE BITARTRATE INJECTION, USP.
NOREPINEPHRINE BITARTRATE INJECTION, USP 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
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)
DOSAGE FORMS AND STRENGTHS
Injection: 4 mg/4 mL (1 mg/mL) norepinephrine base in single-dose
glass vial. ( 3)
CONTRAINDICATIONS
None. ( 4) (4)
WARNINGS AND PRECAUTIONS
Tissue Ischemia: Avoid extravasation of Norepinephrine Bitartrate
Injection into the
tissues, as local necrosis might ensue due to the vasoconstrictive
action of the drug.
Infuse Norepinephrine Bitartrate Injection 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 with 10 mL to 15 mL of saline solution containing
from 5 mg to 10
mg of an adrenergic blocking agent. ( 5.1)
Hypotension After Abrupt Discontinuation: Sudden cessation of the
infusion rate may
result in marked hypotension. Reduce the Norepinephrine Bitartrate
Injection infusion
rate gradually. ( 5.2)
Cardiac Arrhythmias: Norepinephrine Bitartrate Injection may cause
arrhythmias.
Monitor cardiac function in patients wit