Phenylephrine and Pramoxine (Preparation H) for Hemorrhoids

Phenylephrine and Pramoxine (Preparation H) is a combination of a decongestant and local anesthetic medicine that is used for the symptomatic treatment of patients with piles. It is used to relieve soreness, itching, redness, and discomfort associated with both internal and external hemorrhoids.

Phenylephrine and pramoxine Uses:

  • Hemorrhoids:
    • It is used for the temporary relief of pain, soreness, burning, local itching, and discomfort associated with hemorrhoids.

Phenylephrine and Pramoxine (Preparation H) Dose in Adults

Phenylephrine and Pramoxine (Preparation H) Dose in the treatment of Hemorrhoids:

  • Rectal: Apply externally to the affected area up to four times a day.

Use in Children:

Refer to adults dosing.   

Pregnancy Risk Category: C

  • Pregnancy should not be prolonged with decongestants. 
  • Pregnancy has not been evaluated for the use of topical creams.
  • It can be used as an OTC medicine to treat hemorhoids in pregnancy for three days or less.

Use during pregnancy:

  • It has not been extensively studied. It may be applied topically.   

Dose in Kidney Disease:

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

Dose in Liver disease:

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

Side effects of Preparation H:

See individual agents (Phenylephrine and Pramoxine)

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

Contraindications to Phenylephrine and Pramoxine (Preparation H):

There are no contraindications listed on the label.

Warnings and precautions

  • Cardiovascular disease, which includes ischemic heart disease.
    • Be careful. Phenylephrine, an alpha-adrenergic stimulating medication, can cause vasoconstriction or angina. It can cause an increase in blood pressure.
  • Diabetes mellitus:
    • Be careful. Patients might experience impaired glucose control.
  • Hyperthyroidism:
    • Be careful. It can worsen hyperthyroidism symptoms such as tachycardia.
  • Increased intraocular pressure
    • Be careful. It can cause mydriasis, and it may increase intraocular pressure.
  • Prostatic hyperplasia
    • Be careful. Because of its sympathomimetic activity, it can cause urinary retention.

Phenylephrine and pramoxine: Drug Interaction

Risk Factor C (Monitor therapy)

Alpha1-Blockers

May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1Agonists may antagonize Alpha1-Blocker vasodilation.

AtoMOXetine

May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics.

Cannabinoid-Containing Products

May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol.

Doxofylline

Sympathomimetics may enhance the adverse/toxic effect of Doxofylline.

Guanethidine

May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics.

Methemoglobinemia Associated Agents

May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased.

Solriamfetol

Sympathomimetics may enhance the hypertensive effect of Solriamfetol.

Sympathomimetics

May enhance the adverse/toxic effect of other Sympathomimetics.

Tedizolid

May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics.

Tricyclic Antidepressants

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

Risk Factor D (Consider therapy modification)

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.

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.

Risk Factor X (Avoid combination)

Ergot Derivatives

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

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.

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.

Monitoring Parameters:

None mentioned.   

How to administer Phenylephrine and Pramoxine (Preparation H)?

  • Before applying the cream, clean the affected area by using a cleaning wipe (by patting or blotting) and then gently dry the area.
  • Apply the cream over the lower part of the external hemorrhoids.
  • When using it inside the lower part of the anal canal, attach the dispensing cap with the tube, lubricate the dispensing cap well, and then gently insert the dispensing cap partway into the anus.
  • Thoroughly cleanse the dispensing cap after the application and replace the cover.   

Mechanism of action of Phenylephrine and Pramoxine (Preparation H):

Phenylephrine

  • It is an alpha-adrenergic antagonist that has a powerful, direct-acting effect and minimal beta-adrenergic activation. 
  • When applied locally, it causes vasoconstriction.

Pramoxine

  • It acts as a local anesthetic and decreases the neuronal membrane’s permeability for sodium ions. 
  • It blocks nerve impulse initiation and conduction and inhibits neuronal depolarization.

See individual agents (phenylephrine and Pramoxine)   

International Brand Names of Phenylephrine and pramoxine:

  • Preparation H Totables
  • Preparation H
  • Preparation H Max

Phenylephrine and pramoxine Brand Names in Pakistan:

No Brands Available in Pakistan.  

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