Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Cardinal Health
INTRAVENOUS
PRESCRIPTION DRUG
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
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
New Drug Application
PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION CARDINAL HEALTH ---------- 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 Přečtěte si celý dokument