PHENYLEPHRINE HYDROCHLORIDE injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Civica, Inc.

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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: - Hypersensitivity to it or any of its components 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 de

Termék összefoglaló:

Phenylephrine Hydrochloride Injection, USP, 10 mg/mL, 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. The 1 mL vials are for single use only; the 10 mL vial is a pharmacy bulk package. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.

Engedélyezési státusz:

New Drug Application

Termékjellemzők

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
CIVICA, INC.
----------
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
RECENT MAJOR CHANGES
Dosage and Administration, Pharmacy Bulk Vials (2.6) 6/2019
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)
10 mL pharmacy bulk package vial (3, 11, 16)
CONTRAINDICATIONS
Hypersensitivity to it or any of its components (4)
WARNINGS AND PRECAUTIONS
_Severe bradycardia and decreased cardiac output:_ (5.2)
_Extravasation:_ during intravenous administration may cause necrosis
or sloughing of tissue (5.4)
_Concomitant use with oxytocic drugs:_ pressor effect of
sympathomimetic pressor amines is
potentiated (5.5)
_Allergic-type reactions:_ Sulfite (5.6)
ADVERSE REACTIONS
Most common adverse reactions: _ _nausea and vomiting, headache,
nervousness (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. 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 blockin