Phenylephrine Hydrochloride Injection, Solution
Generic Name: phenylephrine hydrochloride injection, solution
Brand Names:
Phenylephrine Hydrochloride Injection, Solution
11 DESCRIPTION Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL), an alpha-1 adrenergic receptor agonist, contains the active pharmaceutical ingredient phenylephrine in the form of hydrochloride salt. Phenylephrine is a synthetic sympathomimetic agent in sterile form for parenteral injection.
Overview
11 DESCRIPTION Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL), an alpha-1 adrenergic receptor agonist, contains the active pharmaceutical ingredient phenylephrine in the form of hydrochloride salt. Phenylephrine is a synthetic sympathomimetic agent in sterile form for parenteral injection.
Uses
1 INDICATIONS AND USAGE Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection 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 )
Dosage
2 DOSAGE AND ADMINISTRATION Do NOT dilute prior to 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 ) 2.1 General Administration Instructions During Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL) administration: Correct intravascular volume depletion. Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL) is supplied as a premixed, ready to administer product that requires no further dilution prior to infusion.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Interactions
7 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 ) 7.1 Agonists The pressor effect of phenylephrine hydrochloride is increased in patients receiving: Monoamine oxidase inhibitors (MAOI), such as selegiline.
Warnings
5 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 ) 5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its pressor effects, phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. 5.2 Bradycardia Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output. 4 CONTRAINDICATIONS The use of Phenylephrine Hydrochloride Injection, 80 mcg/mL is contraindicated in patients with: Hypersensitivity to the product or any of its components Hypersensitivity to it or any of its components ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during caesarean section have not established a drug-associated risk of major birth defects and miscarriage. These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores [see Data]. There are no data on the use of phenylephrine during the first or second trimester.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is a clear, colorless solution supplied in a readyto- use single dose 250 mL infusion bag as follows: Unit of Sale Strength Each NDC 43598-182-05 Pack of 5 intravenous solution bags in a cardboard box (20 mg/250 mL) 80 mcg/mL NDC 43598-182-50 250 mL intravenous solution bag Store at 20°C to 25°C (68°...
Frequently Asked Questions
What is Phenylephrine Hydrochloride Injection, Solution used for?▼
1 INDICATIONS AND USAGE Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection 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 )
What are the side effects of Phenylephrine Hydrochloride Injection, Solution?▼
6 ADVERSE REACTIONS The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Can I take Phenylephrine Hydrochloride Injection, Solution during pregnancy?▼
8.1 Pregnancy Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during caesarean section have not established a drug-associated risk of major birth defects and miscarriage. These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores [see Data]. There are no data on the use of phenylephrine during the first or second trimester.
What are the important warnings for Phenylephrine Hydrochloride Injection, Solution?▼
5 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 ) 5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its pressor effects, phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. 5.2 Bradycardia Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output. 4 CONTRAINDICATIONS The use of Phenylephrine Hydrochloride Injection, 80 mcg/mL is contraindicated in patients with: Hypersensitivity to the product or any of its components Hypersensitivity to it or any of its components ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.