NOREPINEPHRINE BITARTRATE- norepinephrine in sodium chloride injection, solution NOREPINEPHRINE BITARTRATE- norepinephrine in s

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Par Pharmaceutical, Inc.

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Norepinephrine 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 a

Sommarju tal-prodott:

Norepinephrine in Sodium Chloride Injection (norepinephrine bitartrate) is supplied as a clear, colorless sterile solution in a 250 mL non-PVC infusion bag with single function connector system consisting of a port and cap, packaged individually in an aluminum foil pouch with an oxygen scavenger. Supplied as:         4 mg/250 mL                (16 mcg/mL)         8 mg/250 mL                (32 mcg/mL)         16 mg/250 mL                (64 mcg/mL) Store at 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. Keep in sealed overwrap until ready to use. Discard after 24 hours of opening overwrap.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

NOREPINEPHRINE BITARTRATE- NOREPINEPHRINE IN SODIUM CHLORIDE
INJECTION,
SOLUTION
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOREPINEPHRINE IN
SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION.
NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1950
INDICATIONS AND USAGE
Norepinephrine in Sodium Chloride Injection is a catecholamine
indicated for restoration of blood pressure
in adult patients with acute hypotensive states. (1)
DOSAGE AND ADMINISTRATION
No further dilution prior to infusion is required (2.1)
Initial intravenous infusion rate of 8 to 12 mcg per minute, adjust
the rate of flow to establish and
maintain a low to normal blood pressure (usually 80 to 100 mm Hg)
sufficient to maintain the
circulation of vital organs (2.2)
The average maintenance dose ranges from 2 to 4 mcg per minute. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 250-mL single dose infusion bags with
- 4 mg equivalent of norepinephrine (16 mcg /mL) in 0.9% sodium
chloride
- 8 mg equivalent of norepinephrine (32 mcg /mL) in 0.9% sodium
chloride
- 16 mg equivalent of norepinephrine (64 mcg /mL) in 0.9% sodium
chloride
CONTRAINDICATIONS
• None. (4)
WARNINGS AND PRECAUTIONS
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 in Sodium Chloride Injection
infusion rate gradually. (5.2)
Cardiac Arrhythmias: Norepinephrine in Sodium Chloride Injection may
cause arrhythmias. Monitor
cardiac function in patients with underlying heart disease. (5.3)
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 REACT