NOREPINEPHRINE BITARTRATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Baxter Healthcare Corporation

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norepinephrine Bitartrate in Dextrose 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 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 U.S. general population, the estimated background risk of major birth defects and miscarriage in 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 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 Dextrose Injection into the veins in the leg in elderly patients [see Warnings and Precautions (5.1) ].

Product summary:

Norepinephrine Bitartrate in Dextrose Injection for intravenous infusion is a colorless to slightly yellow solution available in single-dose, ready-to-use containers in an amber/foil overwrap. Each 250 mL of Norepinephrine Bitartrate in Dextrose Injection , 4 mg/250 mL, 8 mg/250 mL, and 16 mg/250 mL contains the equivalent of 4 mg, 8 mg, and 16 mg of norepinephrine, respectively (provided as norepinephrine bitartrate monohydrate). Norepinephrine Bitartrate in Dextrose Injection is available in the following: Product Description NDC Number Twenty containers of 4 mg/250 mL NDC 0338-0112-20 Twenty containers of 8 mg/250 mL NDC 0338-0108-20 Twenty containers of 16 mg/250 mL NDC 0338-0116-20 Store at room temperature [20°C to 25°C (68°F to 77°F)], excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Once the overwrap is removed, the bag can be stored at room temperature for up to 30 days.

Authorization status:

New Drug Application

Summary of Product characteristics

NOREPINEPHRINE BITARTRATE- NOREPINEPHRINE BITARTRATE INJECTION,
SOLUTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOREPINEPHRINE
BITARTRATE IN DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR NOREPINEPHRINE BITARTRATE IN DEXTROSE INJECTION.
NOREPINEPHRINE BITARTRATE IN DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1950
INDICATIONS AND USAGE
Norepinephrine Bitartrate in Dextrose Injection is a catecholamine
indicated for restoration of blood
pressure in adult patients with acute hypotensive states. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 250-mL single dose-containers with (3)
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Serious adverse reactions are described in greater detail in other
sections [see Warnings and Precautions
(5.1, 5.2, & 5.3)].
Most common adverse reactions are hypertension, bradycardia, ischemic
injury, anxiety, headache,
respiratory difficulty, pulmonary edema, and extravasation necrosis at
injection site. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAXTER HEALTHCARE AT
1-866-888-2472 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2023
No further dilution prior to infusion is required. (2.1)
Initiate at 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 equivalent of norepinephrine (16 mcg/mL) in 5% dextrose.
8 mg equivalent of norepinephrine (32 mcg/mL) in 5% dextrose.
16 mg equivalent of norepinephrine (64 mcg/mL) in 5% dextrose.
None. (4)
Tissue Ischemia: Infuse Norepinephrine Bitartrate in Dextrose
Injection into a large vein. To prevent
sloughing and necrosis in areas in with extravasation, infi