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Phenylephrine and Pramoxine

Pronunciation

(fen il EF rin) and (pra MOKS een)

Index Terms

  • Phenylephrine HCl and pramoxine HCl
  • Phenylephrine hydrochloride and pramoxine hydrochloride
  • Pramoxine and phenylephrine

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, Rectal:

Preparation H Totables: Phenylephrine hydrochloride 0.25%, pramoxine hydrochloride 1%, glycerin 14.4%, and white petrolatum 15% (5.7 g) [contains cetyl alcohol, edetate disodium, methylparaben, propylene glycol, propylparaben, sodium benzoate]

Brand Names: U.S.

  • Preparation H Totables [OTC]

Pharmacologic Category

  • Alpha-Adrenergic Agonist
  • Antihemorrhoidal Agent
  • Local Anesthetic

Pharmacology

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

Pramoxine: Like other anesthetics, it decreases the neuronal membrane's permeability to sodium ions; both initiation and conduction of nerve impulses are blocked, thus depolarization of the neuron is inhibited.

Use: Labeled Indications

Hemorrhoids: Temporary relief of pain, soreness, burning, local itching, and discomfort associated with hemorrhoids.

Dosing: Adult

Hemorrhoids: Rectal: Apply externally to affected area up to 4 times daily.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

Cleanse affected area by patting or blotting with cleansing wipe, and gently dry before applying cream. Apply externally or in the lower portion of the anal canal only. For application in the lower anal canal, remove cover from dispensing cap and attach dispensing cap to tube; lubricate dispensing cap well, then gently insert dispensing cap partway into the anus. Thoroughly cleanse dispensing cap after each use and replace cover.

Storage

Store at 20°C to 25°C (68°F to 77°F).

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

Cocaine: May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

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

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

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

Monoamine Oxidase 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

See individual agents. There are no adverse reactions listed in the manufacturer’s labeling.

Warnings/Precautions

Disease-related concerns:

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

• Diabetes mellitus: Use caution.

• Hyperthyroidism: Use caution.

• Intraocular pressure (increased): Use caution.

• Prostatic hyperplasia: Use caution.

Special populations:

• Elderly: Use caution.

Other warnings/precautions:

• Self-medication (OTC use): For external use only. When used for self-medication, notify healthcare provider if condition worsens or does not improve within 7 days or if bleeding occurs; clears up and occurs again within a few days; or if accompanied by additional symptoms (eg, swelling, rash, irritation).

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, rectal pain, or severe rectal irritation (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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