FDA

Phenylephrine Hydrochloride

Approved 5 Jul 2018IntravenousSolution

The FDA lists this product in 60 strengths and forms.

Indications

Phenylephrine hydrochloride injection, 10 mg/mL is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

( 1 )

Contraindications

None None. ( 4 )

Warnings and precautions

Extravasation during intravenous administration may cause necrosis or sloughing of tissue. ( 5.3 ) Severe bradycardia and decreased cardiac output. ( 5.4 ) Allergic-type reactions : Sulfite. ( 5.5 ) Concomitant use with oxytocic drugs: Pressor effect of sympathomimetic pressor amines is potentiated. ( 5.8 )

5.1Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because

of its increasing blood pressure effects, phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.

5.2Peripheral and Visceral Ischemia

Phenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.

5.3Skin and Subcutaneous Necrosis Extravasation

of phenylephrine hydrochloride can cause necrosis or sloughing of tissue. The infusion site should be checked for free flow. Care should be taken to avoid extravasation of phenylephrine hydrochloride.

Indications

( 1 )

Warnings and precautions

5.1Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because

5.2Peripheral and Visceral Ischemia

Phenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.

5.3Skin and Subcutaneous Necrosis Extravasation

Pregnancy and breastfeeding

8.1Pregnancy Pregnancy Category C Risk Summary

There are no adequate or well-controlled studies with phenylephrine hydrochloride injection in pregnant women, nor have animal reproduction studies been conducted. Published studies in normotensive pregnant rabbits report early onset labor, increased fetal lethality, and adverse placental effects with subcutaneous phenylephrine administration during gestation at doses approximately 1.9-times the total daily human dose.

Published studies in normotensive pregnant sheep report decreased uterine blood flow and decreased PaO 2 in the fetus with intravenous phenylephrine administration during late gestation at doses less than and similar to the human dose. It is not known whether phenylephrine hydrochloride, can cause fetal harm when administered to a pregnant woman. Phenylephrine hydrochloride, should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Clinical Considerations Labor and Delivery The most common maternal adverse reactions reported in published studies of phenylephrine use during neuraxial anesthesia during Cesarean delivery include nausea and vomiting, bradycardia, reactive hypertension, and transient arrhythmias. Phenylephrine, when administered during labor or delivery, does not appear to alter either neonatal Apgar scores or umbilical artery blood-gas status.

Data Animal Data Studies in the published literature evaluating subcutaneously administered phenylephrine (0.33 mg/kg, TID) in normotensive pregnant rabbits reported fetal deaths, adverse histopathology findings in the placenta (necrosis, calcification and thickened vascular walls with narrowed lumen) and possible teratogenic effects (one incidence of clubbed feet, partial development of the intestine) when treatment was initiated during the first trimester or later; and premature labor when treatment was initiated at the second trimester or later.

The doses administered were 1.9- times the total daily human dose of 10 mg/day based on a body surface area comparison. Published studies in pregnant normotensive sheep demonstrate that intravenous phenylephrine (4 mcg/kg/min for 30 minutes, equivalent to 3.6 to 4.1 mcg/kg/min human equivalent dose based on body surface area) administered during the third trimester of pregnancy decreased uterine blood flow by 42%. This dose is 1.1- to 1.2-times the human bolus dose of 200 mcg/60 kg person based on body surface area.

Mean fetal blood pressure and heart rate fluctuated above and below controls by about 7% during the infusion. Fetal PaO 2 was significantly decreased by approximately 26% of control during the infusion. Likewise, PaCO 2 was increased and pH was decreased. The clinical significance of these findings is not clear; however, the results suggest the potential for cardiovascular effects on the fetus when phenylephrine is used during pregnancy.

Phenylephrine Hydrochloride

Indications

Contraindications

Warnings and precautions

5.1Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because

5.2Peripheral and Visceral Ischemia

5.3Skin and Subcutaneous Necrosis Extravasation

Two medicines in one question?

Phenylephrine Hydrochloride

Indications

Contraindications

Warnings and precautions

5.1Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because

5.2Peripheral and Visceral Ischemia

5.3Skin and Subcutaneous Necrosis Extravasation

Two medicines in one question?

5.4Bradycardia

5.5Allergic Reactions

5.6Renal Toxicity

5.7Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction

5.8Pressor Effect with Concomitant Oxytocic Drugs

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Pregnancy Category C Risk Summary

Adverse reactions

Composition

Strengths and forms

Official product information

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