PHENYLEPHRINE HYDROCHLORIDE injection

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Meitheal Pharmaceuticals Inc.

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Phenylephrine Hydrochloride Injection 10 mg per mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. The use of phenylephrine hydrochloride injection 10 mg per mL is contraindicated in patients with: - Hypersensitivity to the products or any of their components Risk Summary In animal reproductive and developmental studies, decreased fetal body weights were noted at 0.4 times the human daily dose (HDD) of 10 mg. No malformations were reported, however, an increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was reported at levels as low as 0.08 times the HDD. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and misca

제품 요약:

Phenylephrine Hydrochloride Injection, USP, 10 mg per 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-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 (2° to 8°C). Discard any unused portion. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
MEITHEAL PHARMACEUTICALS INC.
----------
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
RECENT MAJOR CHANGES
Indications and Usage (1)
03/2023
Dosage and Administration (2.1, 2.2)
03/2023
INDICATIONS AND USAGE
Phenylephrine Hydrochloride Injection 10 mg per mL is alpha-1
adrenergic receptor agonist indicated for
increasing blood pressure in adults with clinically important
hypotension resulting primarily from
vasodilation in the settings of anesthesia and septic shock. (1)
DOSAGE AND ADMINISTRATION
Phenylephrine Hydrochloride Injection 10 mg per mL:
MUST BE DILUTED before administration. (2.1)
_Dosing for Perioperative Hypotension_
–
–
_Dosing for Patients with Vasodilatory Shock_
–
DOSAGE FORMS AND STRENGTHS
Phenylephrine Hydrochloride Injection:
10 mg in 1 mL (10 mg per mL) of phenylephrine hydrochloride in a
single-dose vial (3)
CONTRAINDICATIONS
Hypersensitivity to the products or any of their 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 with phenylephrine hydrochloride injection 10
mg per mL: Sulfite (5.6)
ADVERSE REACTIONS
Most common adverse reactions: nausea and vomiting, headache,
nervousness (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MEITHEAL
PHARMACEUTICALS INC. AT 1-844-
824-8426 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, t