PHENYLEPHRINE HYDROCHLORIDE injection

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Eugia US LLC

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Phenylephrine hydrochloride injection 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 injection 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 decrease in placental perfusion sufficient to alter either the neonate Apgar scores or blood-gas status. It is not known whether this drug is excreted in human milk. Safety and effectiveness in pediatric patients have not been established. 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. 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. 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.

Produkt oversigt:

Phenylephrine hydrochloride injection, USP is a clear, colorless, aqueous solution and is supplied as follows: 10 mg per mL:     1 mL Single-Dose Vials     packaged in a carton of 25                                                        NDC 55150-300-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Keep covered in carton until time of use. For single-dose only. 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. The vial stoppers are not made with natural rubber latex.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

PHENYLEPHRINE HYDROCHLORIDE - PHENYLEPHRINE HYDROCHLORIDE INJECTION
EUGIA US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYLEPHRINE
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
PHENYLEPHRINE HYDROCHLORIDE INJECTION.
PHENYLEPHRINE HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
Phenylephrine hydrochloride injection 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
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 EUGIA US LLC AT
1-866-850-2876 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, cent