PHENYLEPHRINE HYDROCHLORIDE injection IMMPHENTIV- phenylephrine hydrochloride injection IMMPHENTIV- phenylephrine hydrochlorid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

IMMPHENTIV injection 100 mcg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. 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 IMMPHENTIV 100 mcg/mL and 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 indicat

Product summary:

IMMPHENTIV® injection , USP, 100 mcg/mL Ready-to-Use vials 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. Discard any unused portion. Phenylephrine Hydrochloride injection , USP, 10 mg/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. Discard any 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:

New Drug Application

Summary of Product characteristics

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION
IMMPHENTIV- PHENYLEPHRINE HYDROCHLORIDE INJECTION
IMMPHENTIV- PHENYLEPHRINE HYDROCHLORIDE INJECTABLE, LIPOSOMAL
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IMMPHENTIV AND
PHENYLEPHRINE HYDROCHLORIDE SAFELY ANDEFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR IMMPHENTIV® AND PHENYLEPHRINE HYDROCHLORIDE.
IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTION FOR INTRAVENOUS
BOLUS USE ONLY
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
IMMPHENTIV injection 100 mcg/mL is an alpha-1 adrenergic receptor
agonist indicated for increasing blood
pressure in adults with clinically important hypotension resulting
primarily from vasodilation in the setting
of anesthesia. (1)
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
IMMPHENTIV Injection 100 mcg/mL:
Do NOT dilute prior to administration (2.1)
_Dosing for Perioperative Hypotension_
_- Intravenous bolus administration: 50 mcg to 250 mcg (2.2)_
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 (2.2)
Intravenous continuous infusion: 0.5 mcg/kg/minute to 1.4
mcg/kg/minute titrated to effect (2.2)
_Dosing for Patients with Vasodilatory Shock_
Intravenous continuous infusion: 0.5 mcg/kg/minute to 6 mcg/kg/minute
titrated to effect (2.2)
DOSAGE FORMS AND STRENGTHS
IMMPHENTIV Injection:
5