NOREPINEPHRINE BITARTRATE
Generic: NOREPINEPHRINE BITARTRATE
Basic Information
Manufacturer
Civica, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
4408987e-690a-41ac-9677-e24604fa9793
Indications & Usage
1 INDICATIONS AND USAGE Norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.
Norepinephrine bitartrate injection is a catecholamine, indicated for restoration of blood pressure in adult patients with acute hypotensive states.
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Norepinephrine bitartrate injection is a catecholamine, indicated for restoration of blood pressure in adult patients with acute hypotensive states.
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Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Tissue Ischemia [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.2 )] • Cardiac Arrhythmias [see Warnings and Precautions ( 5.3 )] The most common adverse reactions are hypertension and bradycardia.
The following adverse reactions can occur: Nervous system disorders: Anxiety, headache Respiratory disorders: Respiratory difficulty, pulmonary edema 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.
The following adverse reactions can occur: Nervous system disorders: Anxiety, headache Respiratory disorders: Respiratory difficulty, pulmonary edema 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.