PHENYLEPHRINE HYDROCHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)

Available from:

BE Pharmaceuticals Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenylephrine Hydrochloride Injection 10 mg/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/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 miscarri

Product summary:

Phenylephrine Hydrochloride Injection, USP, 10 mg/mL, is a clear colorless solution, free from visible particulate matter and 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. Discard Unused Portion. The 5 mL and 10 mL vials are pharmacy bulk packages. 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°C – 8°C). Discard any unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENYLEPHRINE HYDROCHLORIDE - PHENYLEPHRINE HYDROCHLORIDE INJECTION
BE PHARMACEUTICALS 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
(2.1)………………………………03/2023
INDICATIONS AND USAGE
Phenylephrine Hydrochloride Injection 10 mg/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/mL:
MUST BE DILUTED 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
Phenylephrine Hydrochloride Injection:
10 mg in 1 mL (10 mg/mL) of Phenylephrine hydrochloride in a
single-dose vial (3)
50 mg in 5 mL (10 mg/mL) of Phenylephrine hydrochloride in a pharmacy
bulk package vial (3)
100 mg in 10 mL (10 mg/mL) of Phenylephrine hydrochloride in a
pharmacy bulk package 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/mL: Sulfite (5.6)
ADV