NOREPINEPHRINE BITARTRATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norepinephrine Bitartrate Injection, USP is indicated to raise blood pressure in adult patients with severe, acute hypotension. None. 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

Product summary:

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: 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NOREPINEPHRINE BITARTRATE- NOREPINEPHRINE BITARTRATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
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
with underlying heart disease. (5.3)
Allergic Reactions with Sulfite: Norepinephr