PHENYLEPHRINE HYDROCHLORIDE injection

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

HF Acquisition Co LLC, DBA HealthFirst

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 8.1 Pregnancy 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. 8.2 Labor and Delivery 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 either the neonate Apgar scores or blood-gas status. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Hepatic Impairment In patients with liver cirrhosis [Child Pugh Class A (n=3), Class B (n=5) and Class C (n=1)], dose-response data indicate decreased responsiveness to phenylephrine. Consider using larger doses than usual in hepatic impaired subjects. 8.7 Renal Impairment In patients with end stage renal disease (ESRD) undergoing hemodialysis, dose-response data indicates increased responsiveness to phenylephrine. Consider using lower doses of phenylephrine hydrochloride in ESRD patients.

Каталог на резюме:

Phenylephrine Hydrochloride Injection, USP, is supplied as follows: NDC:51662-1576-1 PHENYLEPHRINE HYDROCHLORIDE INJECTION, USP 10mg PER mL 1mL VIAL NDC:51662-1576-2 PHENYLEPHRINE HYDROCHLORIDE INJECTION, USP 10mg PER mL 1mL VIAL in 1 Pouch NDC:51662-1576-3 PHENYLEPHRINE HYDROCHLORIDE INJECTION, USP 10mg PER mL 1mL VIAL in a Pouch, 25 Pouches/Case HF Acquisition Co LLC, DBA HealthFirst 11629 49th Pl W. Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° 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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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PHENYLEPHRINE HYDROCHLORIDE INJECTION, USP 10MG PER ML 1ML VIAL
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 per mL supplied as a 1 mL single dose 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)
ADVERSE REACTIONS
Most common adverse reactions: nausea and vomiting, headache,
nervousness ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC
at 1-800-551-7176 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