PHENYLEPHRINE HYDROCHLORIDE- 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:

Fresenius Kabi USA, LLC

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 product or any of its 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 miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data No malformations were noted when normotensive pregnant rats were treated with a single daily intravenous bolus dose of 50 mcg, 150 mcg, or 300/200 mcg/kg phenylephrine hydrochloride from Gestation Day 6 to 17 (high dose is 0.3/0.2 times the human daily dose (HDD) of 10 mg/day based on body surface area). Evidence of maternal toxicity, including mortality, was noted at the highest tested dose of 300/200 mcg/kg. Decreased fetal body weights but no clear treatment-related malformations were reported when normotensive pregnant rabbits were treated with a single daily intravenous bolus dose of 40 mcg, 100 mcg and 200 mcg/kg (0.08, 0.2, and 0.4 times the HDD based on body surface area) phenylephrine hydrochloride from Gestation Day 7 to 19. Maternal toxicity, as manifested by decreased food consumption and body weight gain at all doses. An increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was noted in all treatment groups compared to controls. No adverse effects on the offspring were reported when pregnant rats were treated via a single daily intravenous bolus dose of up to 200 mcg/day phenylephrine hydrochloride (0.2 times the HDD based on body surface area) from Gestation Day 6 to Lactation Day 20. 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.

Product summary:

Phenylephrine Hydrochloride Injection, USP, is supplied as follows: Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENYLEPHRINE HYDROCHLORIDE - PHENYLEPHRINE HYDROCHLORIDE INJECTION
FRESENIUS KABI USA, LLC
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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
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
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 per mL supplied as a 1 mL single dose vial (3)
CONTRAINDICATIONS
Hypersensitivity to the products 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)
ADVERSE REACTIONS
Most common adverse reactions: nausea and vomiting, headache,
nervousness (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FRESENIUS KABI USA, LLC
AT 1-800-551-
7176 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, centrally-acting sympatholytic agents and atropine sulfate
(7.1)
Antagonistic effects on and by α-adrenergic blocking agents (7.2)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED