NOREPINEPHRINE BITARTRATE injection, solution, concentrate

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Civica, Inc.

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 approxima

Produktbesonderheiten:

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. Supplied as: 4 mg/4 mL Single-dose Vials in boxes of 10 (NDC 72572-481-10) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store in original carton until time of administration to protect from light. Discard unused portion.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

NOREPINEPHRINE BITARTRATE- NOREPINEPHRINE BITARTRATE INJECTION,
SOLUTION,
CONCENTRATE
CIVICA, INC.
----------
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 SANDOZ INC. AT
1-800-525-8747 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: 3/2023
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 with 10 mL to 15 mL of
saline solution containing from 5
mg to 10 mg of an ad