PHENYLEPHRINE HYDROCHLORIDE injection

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Hikma Pharmaceuticals USA Inc.

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 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.

製品概要:

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.

認証ステータス:

New Drug Application

製品の特徴

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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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
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 blocking agents, α-2 adrenergic
agonists, steroids, tricyclic antidepressants, norepinephrine
transport inhibitors, e