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Phenylephrine (Topical)


General


Pronunciation

(fen il EF rin)


Brand Names: U.S.

  • Anu-Med [OTC]
  • GRX Hemorrhoidal [OTC]
  • Hem-Prep [OTC] [DSC]
  • Hemorrhoidal [OTC]
  • Major-Prep Hemorrhoidal [OTC]
  • Preparation H [OTC]
  • Rectacaine [OTC]

Indications


Use: Labeled Indications

For OTC use as treatment of hemorrhoids


Contraindications


Hypersensitivity to phenylephrine or any component of the formulation; hypertension; ventricular tachycardia


Dosing and Administration


Dosing: Adult

Hemorrhoids: Rectal:

Ointment: Apply to clean, dry area up to 4 times/day

Suppository: Insert 1 suppository rectally up to 4 times/day


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Hemorrhoids: Children >12 years: Refer to adult dosing.


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Ointment, Rectal, as hydrochloride:

GRX Hemorrhoidal: 0.25% (43 g) [contains benzoic acid, methylparaben, propylparaben]

Hemorrhoidal: 0.25% (57 g) [contains benzoic acid, methylparaben, propylparaben]

Major-Prep Hemorrhoidal: 0.25% (57 g) [contains methylparaben, propylparaben]

Preparation H: 0.25% (28 g, 57 g) [contains benzoic acid, methylparaben, propylparaben]

Rectacaine: 0.25% (30 g [DSC])

Suppository, Rectal, as hydrochloride:

Anu-Med: 0.25% (12 ea)

Hem-Prep: 0.25% (24 ea [DSC])

Hemorrhoidal: 0.25% (12 ea, 24 ea) [contains methylparaben, propylparaben]

Preparation H: 0.25% (12 ea, 24 ea, 48 ea) [contains methylparaben, propylparaben]

Rectacaine: 0.25% (12 ea)


Drug Interactions

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Ergot Derivatives: May enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

MAO Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Exceptions: Linezolid; Tedizolid. Avoid combination

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Tricyclic Antidepressants: May enhance the vasopressor effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the vasopressor effect of Alpha1-Agonists. Monitor therapy


Adverse Reactions


Rare systemic effects may occur.


Warnings/Precautions


Disease-related concerns:

- Cardiovascular disease, including ischemic heart disease: Use caution.

- Diabetes mellitus: Use caution.

- Hyperthyroidism: Use caution.

Special populations:

- Elderly: Use caution.

Other warnings/precautions:

- Use with caution in patients with increased intraocular pressure or prostatic hyperplasia. Notify healthcare provider if symptoms do not improve within 7 days or if bleeding occurs.


Pregnancy Considerations

When administered intravenously, phenylephrine crosses the placenta. Refer to the Phenylephrine (Systemic) monograph for details. There is limited information available supporting the use of topical agents for the treatment of hemorrhoids. Products containing phenylephrine should be used with caution in pregnant women, especially patients with hypertension or diabetes.


Actions


Pharmacology

Potent, direct-acting alpha-adrenergic agonist with virtually no beta-adrenergic activity; produces local vasoconstriction.


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Have patient report immediately to prescriber rectal bleeding or rectal pain (HCAHPS).

- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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