phenylephrine (Rx)

Brand and Other Names:Vazculep, Biorphen
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable IV solution (ready-to-use)

  • 0.1 mg/mL (Biorphen)
  • Do not dilute further

injectable IV solution (concentrated)

  • 10mg/mL (Vazculep)
  • Requires further dilution

Severe Hypotension/Shock

Alpha-1 adrenergic receptor agonist indicated for treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia

IV bolus: 40-100 mcg q1-2 min PRN, not to exceed total dose of 200 mcg

Adjust dosage according to blood pressure goal

Continuous IV infusion: If blood pressure is below the target goal, start a continuous IV infusion with an infusion rate of 10-35 mcg/min; not to exceed 200 mcg/min

Dosage Modifications

Renal impairment

  • Mild-to-moderate: Consider starting at the lower end of the recommended dose range, and adjusting dose based on the target blood pressure goal
  • End-stage renal disease (ESRD): Dose-response data indicate increased responsiveness to phenylephrine

Hepatic impairment

  • Start dosing in the recommended dose range, but more phenylephrine may be needed in this population
  • Moderate-to-severe (Child-Pugh Class B or C): Dose-response data indicate decreased responsiveness to phenylephrine

Dosing considerations

Drug not recommended by The Society of Critical Care Medicine, to treat septic shock, except when first line agent epinephrine associated with causing serious arrhythmia, when cardiac output is high and blood pressure persistently low, or when combination of inotrope/vasopressor and low dose vasopressin failed to achieve desired mean arterial pressure and phenylephrine used as salvage therapy

Dosage Forms & Strengths

injectable IV solution (ready-to-use)

  • 0.1 mg/mL (Biorphen)
  • Do not dilute further

injectable IV solution (concentrated)

  • 10mg/mL (Vazculep)
  • Requires further dilution

Severe Hypotension/Shock (Off-label)

<2 years

  • Safety and efficacy not established

≥2 years

  • 5-20 mcg/kg IV once; THEN 0.1-0.5 mcg/kg/min IV; not to exceed 3-5 mcg/kg/min IV  
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Interactions

Interaction Checker

and phenylephrine

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Extravasation

            Hypertension

            Reflex bradycardia

            Anxiety

            Headache

            Burning

            Rebound congestion

            Sneezing

            Pulmonary edema

            Metabolic acidosis

            Decreased renal perfusion

            Reduced urine output

            Nausea

            Gastric irritation

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            Warnings

            Contraindications

            None

            Cautions

            Avoid extravasation; ensure proper needle or catheter placement prior to and during infusion

            IV administration may cause severe bradycardia and reduced cardiac output, resulting from increase in cardiac afterload especially in patients with preexisting cardiac dysfunction; use with caution in patients with preexisting bradycardia, partial heart block, myocardial disease, or severe coronary artery disease; may also increase pulmonary arterial pressure and precipitate angina in patients with severe coronary artery disease

            Avoid or use with extreme caution in patients with heart failure or cardiogenic shock; cardiac output may decrease with increased systemic vascular resistance

            Avoid use in patients with hypertension; monitor blood pressure closely and adjust infusion rate; use is contraindicated in severe hypertension

            May cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, especially in patients with peripheral vascular disease

            Patients with spinal cord injury or other autonomic dysfunction may experience exaggerated increase in blood pressure response to therapy

            May increase the need for renal replacement therapy in patients with septic shock; monitor renal function

            Drug interactions overview

            • Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including phenylephrine, thus increasing the risk for hemorrhagic stroke
            • Increase blood pressure effect of phenylephrine is increased in patients receiving monoamine oxidase inhibitors (MAOI); tricyclic antidepressants; angiotensin, aldosterone; atropine; steroids (eg, hydrocortisone); norepinephrine transporter inhibitors, (eg, atomoxetine), ergot alkaloids (eg, methylergonovine maleate)
            • Interactions that antagonize the pressor effect when patient receive alpha-adrenergic antagonists; phosphodiesterase type 5 inhibitors; mixed alpha- and beta-receptor antagonists; calcium channel blockers (eg, nifedipine), benzodiazepines, ACE inhibitors, centrally-acting sympatholytic agents (eg, reserpine, guanfacine)
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            Pregnancy & Lactation

            Pregnancy

            Data from randomized controlled trials and meta-analyses with 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

            There are no data on the use during the first or second trimester

            Animal data

            • In animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hr infusion at 1.2 times the human daily dose (HDD) of 10 mg/60 kg/day
            • Decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the HDD

            Disease-associated maternal and/or embryofetal risk

            • Untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting
            • A sustained decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis

            Lactation

            No data available on the presence of phenylephrine injection or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Strong alpha effects resulting in increased peripheral vascular resistance and blood pressure; decreases cardiac output and renal perfusion

            Absorption

            Bioavailability: <38%

            Onset: 10-15 min

            Duration: 15 min

            Peak plasma time: 0.75-2 hr

            Distribution

            Vdss: 340 L

            Metabolism

            Extensively metabolized in intestinal wall; moderately metabolized in liver

            Metabolites: M-hydroxymandelic acid (inactive)

            Elimination

            Half-life: 2.5 hr (terminal phase)

            Clearance: 2100 mL/min

            Excretion: Urine (~80% [16% parent drug])

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            Administration

            IV Compatibilities

            Additive: Chloramphenicol, dobutamine, lidocaine, KCl, Na bicarb

            Y-site: Amiodarone, amrinone, famotidine, haloperidol

            IV Preparation

            IV bolus (Vazculep)

            • Prepare a solution containing a final concentration of 100 mcg/mL H5
            • Withdraw 10 mg (1 mL of 10 mg/mL) of phenylephrine and dilute with 99 mL of D5W or 0.9% NaCl
            • Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus IV administration

            Continuous IV infusion (Vazculep)

            • For continuous IV infusion, prepare a solution containing a final concentration of 20 mcg/mL in D5W or 0.9% NaCl
            • Withdraw 10 mg (1 mL of 10 mg/mL) of phenylephrine and dilute with 500 mL of D5W or 0.9% NaCl

            IV administration

            Vazculep

            • Bolus: Administer every 1-2 minutes as needed
            • Continuous IV infusion: Start infusion rate of 10-35 mcg/min; not to exceed 200 mcg/min

            Biorphen

            • Do NOT dilute before administration as an IV bolus
            • It is supplied as ready-to-use formulation
            • Administer as IV bolus every 1-2 min
            • During administration, correct intravascular volume depletion; correct acidosis
            • Visually inspected for particulate matter and discoloration before administration
            • Do not use if solution appears cloudy; discard any unused drug

            Storage

            Biorphen

            • Store at 20-25ºC (68-77ºF), excursions permitted to 15-30ºC (59-86ºF)

            Vazculep

            • Vials
              • Store at 20-25ºC (68-77ºF), excursions permitted to 15-30ºC (59-86ºF)
              • Protect from light
              • Store in carton until time of use
              • 1-mL vials are for single use only; 5- and 10-mL vials are pharmacy bulk packages
            • Diluted solutions
              • Store for <4 hr at room temperature or for <24 hr under refrigerated conditions
              • Discard any unused portion
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.