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Phenylephrine and Pramoxine

Medically reviewed by Drugs.com. Last updated on Jun 10, 2020.

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. [DSC] = Discontinued product

Cream, External:

Preparation H: Phenylephrine hydrochloride 0.25%, pramoxine hydrochloride 1%, glycerin 14.4%, and white petrolatum 15% (26 g, 51 g) [contains cetyl alcohol, edetate disodium, methylparaben, propylene glycol, propylparaben, sodium benzoate]

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

Brand Names: U.S.

  • Preparation H Totables [OTC] [DSC]
  • Preparation H [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.

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 (Topical): 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 Radiopharmaceutical Products: Alpha1-Agonists may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. 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

Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Monitor therapy

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. Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Procarbazine: May enhance the adverse/toxic effect of Sympathomimetics. Management: Consider alternatives to this combination when possible. Procarbazine prescribing information states that this combination should be avoided. Consider therapy modification

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

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 therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic 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).

Pregnancy Considerations

Refer to individual monographs.

Patient Education

What is this drug used for?

• It is used to treat signs of hemorrhoids or rectal irritation.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Rectal bleeding

• Rectal pain

• Severe rectal irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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