Phenylephrine and Pramoxine (Preparation H) for Hemorrhoids

Phenylephrine and pramoxine are two different medications with distinct mechanisms of action and uses.

  • Phenylephrine:
    • Type: Phenylephrine is a sympathomimetic amine, which means it mimics the effects of the sympathetic nervous system (fight or flight response).
    • Use: It is commonly used as a decongestant to relieve nasal congestion caused by conditions like the common cold, hay fever, or allergies. It works by narrowing the blood vessels in the nasal passages, reducing blood flow and swelling.
    • Formulations: Phenylephrine can be found in various forms, including oral tablets, nasal sprays, and eye drops.
  • Pramoxine:
    • Type: Pramoxine is a local anesthetic.
    • Use: It is primarily used topically to relieve itching and minor skin irritations. It works by numbing the skin or mucous membranes, providing temporary relief from itching and discomfort.
    • Formulations: Pramoxine is commonly found in creams, ointments, and lotions designed for external use.

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 to provide short-term relief from hemorrhoid-related pain, soreness, burning, local itching, and discomfort.

Phenylephrine and Pramoxine (Preparation H) Dose in Adults

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

For treating hemorrhoids:

  • Phenylephrine: Put it on the outside of the sore area up to four times a day.
  • Pramoxine: Use it externally on 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 hemorrhoids 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:

  • The instructions from the manufacturer don't mention any changes in the dose for people with kidney problems.

Dose in Liver disease:

  • The instructions from the maker don't say to change the dose for people with liver problems.

Side effects of Preparation H:

See individual agents (Phenylephrine and Pramoxine)

The labeling provided by the manufacturer does not indicate any negative effects.

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

might make local anesthetics more harmful or poisonous. In particular, there may be an elevated risk for methemoglobinemia.

Solriamfetol

Sympathomimetics may intensify Solriamfetol's hypertensive effects.

Sympathomimetics

might intensify the hazardous or harmful effects of other sympathomimetics.

Tedizolid

might make sympathomimetics' hypertensive effects stronger. The tachycardic impact of sympathomimetics may be increased by tedizolid.

Tricyclic Antidepressants

Alpha1-Agonists' potential therapeutic effects could be improved. The therapeutic benefit of Alpha1-Agonists may be diminished by Tricyclic Antidepressants.

Risk Factor D (Consider therapy modification)

Cocaine (Topical) 

May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to the 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 an 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

Alpha1-Agonists' hypertensive effects could be amplified. Although this is the predicted mode of action for linezolid, treatment guidelines are different from those for other monoamine oxidase inhibitors. Details can be found in linezolid-specific monographs. Linezolid and Tedizolid are exceptions.

Monitoring Parameters:

None mentioned.   

How to administer Phenylephrine and Pramoxine (Preparation H)?

How to Apply Hemorrhoid Cream:

Cleanse the Area:

  • Use a cleansing wipe to gently pat or blot the affected area.
  • Ensure the area is dry before applying the cream.

Application:

  • Apply the cream externally or in the lower part of the anal canal only.

For Lower Anal Canal Application:

  • Remove the cover from the dispensing cap.
  • Attach the dispensing cap to the tube.
  • Lubricate the dispensing cap well.
  • Gently insert the dispensing cap partway into the anus.

After Use:

  • Thoroughly cleanse the dispensing cap after each use.
  • Replace the cover on the cream tube.

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

Phenylephrine:

  • Type and Action:
    • Potent, direct-acting alpha-adrenergic agonist.
    • Virtually no beta-adrenergic activity.
  • Effect:
    • Produces local vasoconstriction.

Pramoxine:

  • Mechanism of Action:
    • Decreases the neuronal membrane's permeability to sodium ions.
  • Result:
    • Blocks both initiation and conduction of nerve impulses.
    • Inhibits depolarization of the neuron.

Note:

  • For more details on each agent, refer to the information specific to each one.

International Brand Names of Phenylephrine and pramoxine:

  • Preparation H Totables
  • Preparation H Max
  • Preparation H

Phenylephrine and pramoxine Brand Names in Pakistan:

Not available.