PHENYLEPHRINE HYDROCHLORIDE injection

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Verfügbar ab:

Cardinal Health

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia. The use of phenylephrine hydrochloride is contraindicated in patients with: Pregnancy Category C Animal reproduction studies have not been conducted with intravenous phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed. The most common maternal adverse reactions reported in studies of phenylephrine use during neuraxial anesthesia during cesarean delivery include nausea and vomiting, which are commonly associated with hypotension, bradycardia, reactive hypertension, and transient arrhythmias.  Phenylephrine does not appear to cause a decrease in placental perfusion sufficient to alter

Produktbesonderheiten:

Phenylephrine Hydrochloride Injection, USP, is supplied as follows: 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 covered in carton until time of use. For single use only.  Discard unused portion. Manufactured by: WEST-WARD PHARMACEUTICALS Eatontown, NJ 07724 USA Distributed By: Cardinal Health Dublin, OH 43017 Revised: December 2012 L51227671118 462-664-01

Berechtigungsstatus:

New Drug Application

Fachinformation

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYLEPHRINE HYDROCHLORIDE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PHENYLEPHRINE
HYDROCHLORIDE.
PHENYLEPHRINE HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist
indicated for increasing blood pressure in adults
with clinically important hypotension resulting primarily from
vasodilation, in such settings as septic shock or anesthesia.
(1)
DOSAGE AND ADMINISTRATION
Dilute before administration (2.1).
_Dosing for Perioperative Hypotension_
• Intravenous bolus administration: 50 mcg to 250 mcg (2.4)
• Intravenous continuous infusion: 0.5 mcg/kg/minute to 1.4
mcg/kg/minute titrated to effect (2.4)
_Dosing for Patients with Vasodilatory Shock_
• Intravenous continuous infusion: 0.5 mcg/kg/minute to 6
mcg/kg/minute titrated to effect (2.5)
DOSAGE FORMS AND STRENGTHS
Injection: 10 mg/mL supplied as a 1 mL single dose vial (3,11,16)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions: _ _nausea and vomiting, headache,
nervousness (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD
PHARMACEUTICAL CORP. AT 1-877-845-0689
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Agonistic effects with monoamine oxidase inhibitors (MAOI),
β-adrenergic blocking agents, α-2 adrenergic agonists,
steroids, tricyclic antidepressants, norepinephrine transport
inhibitors, ergot alkaloids, centrally-acting sympatholytic
agents and atropine sulfate (7.1).
Antagonistic effects on and by α-adrenergic blocking agents (7.2)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Administration Instructions
2.2 Preparing