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Phenylephrine and pramoxine: Drug information

Phenylephrine and pramoxine: Drug information
(For additional information see "Phenylephrine and pramoxine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Avedana Hemorrhoid Pain Relief [OTC];
  • Hemorrhoidal [OTC];
  • Preparation H [OTC]
Pharmacologic Category
  • Alpha-Adrenergic Agonist;
  • Antihemorrhoidal Agent;
  • Local Anesthetic
Dosing: Adult
Hemorrhoids

Hemorrhoids: Topical, Rectal: Apply externally to affected area up to 4 times daily (eg, morning, night, and after bowel movements).

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Hemorrhoids

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

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. See individual agents. There are no adverse reactions listed in the manufacturer’s labeling.

Warnings/Precautions

Other warnings/precautions:

• Self-medication (OTC use): For external use only. When used for self-medication (OTC), notify health care provider prior to use if you have diabetes, heart disease, high BP, thyroid disease, difficulty in urination due to enlargement of the prostate gland, or are currently taking medications for high BP or depression. Discontinue use and notify health care provider if condition worsens or does not improve within 7 days or if bleeding occurs; or if accompanied by additional symptoms (eg, irritation, pain, redness, swelling).

Dosage Forms: US

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

Cream, External:

Avedana Hemorrhoid Pain Relief: Phenylephrine hydrochloride 0.25%, pramoxine hydrochloride 1%, glycerin 14.4%, and white petrolatum 15% (25.5 g) [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben]

Hemorrhoidal: Phenylephrine hydrochloride 0.25%, pramoxine hydrochloride 1%, glycerin 14.4%, and white petrolatum 15% (51 g) [contains cetyl alcohol, methylparaben, polysorbate 80, propylene glycol, propylparaben]

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

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Avedana Hemorrhoid Pain Relief External)

1-0.25-14.4-15% (per gram): $0.10

Cream (Preparation H External)

1-0.25-14.4-15% (per gram): $0.27

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical or rectal: For external and/or intrarectal use only. Prior to use, cleanse affected area by patting or blotting with cleansing wipe, and gently dry. 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; do not insert cream into rectum by using fingers or other mechanical device. Thoroughly cleanse dispensing cap after each use and replace cover.

Administration: Pediatric

Topical: Cleanse affected rectal 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. Wash hands after application.

Use: Labeled Indications

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

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Atropine (Systemic): May enhance the hypertensive effect of Alpha1-Agonists. Risk C: Monitor therapy

Bromocriptine: May enhance the hypertensive effect of Alpha1-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider therapy modification

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: 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. Risk D: Consider therapy modification

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

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May enhance the vasoconstricting effect of Alpha1-Agonists. Risk X: Avoid combination

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: 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. Risk X: Avoid combination

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider therapy modification

Lisuride: May enhance the hypertensive effect of Alpha1-Agonists. Risk X: Avoid combination

Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: 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. Risk X: Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Pergolide: May enhance the hypertensive effect of Alpha1-Agonists. Risk C: Monitor therapy

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

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

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

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

Pregnancy Considerations

Refer to individual monographs.

Breastfeeding Considerations

Refer to individual monographs.

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Anusol f;
  • (MX) Mexico: Preparation h max;
  • (TR) Turkey: Pramofen
  1. Preparation H Multi-Symptom (phenylephrine and pramoxine) [prescribing information]. Pfizer Consumer Healthcare; received August 2022.
Topic 112902 Version 105.0

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