Preparation H

Phenylephrine/pramoxine/glycerin/petrolatum rectal is an over-the-counter (OTC) product used to treat hemorrhoids.

Phenylephrine/pramoxine/glycerin/petrolatum rectal is available under the following different brand names: Preparation H Cream Maximum Strength Pain Relief.

Dosages of Phenylephrine/Pramoxine/Glycerin/Petrolatum Rectal:

Dosage Forms and Strengths

Rectal Ointment

• 0.25%/1%/14.4%/15%

Dosage Considerations – Should be Given as Follows:

Hemorrhoids

• Adults and children 12 years and older: May apply up to 4 times/day, especially at night, in the morning, or after bowel movement that may exacerbate hemorrhoid(s)
• Apply to cleansed area externally or in the lower portion of the anal canal
• Children under 12 years: Use is dependent on the patient and if the benefit outweighs the risk
• Administration
• For application in the lower anal canal, remove the cover from dispensing cap and attach the dispensing cap to the tube
• Intrarectal use: Remove cover from the applicator and attach applicator to ointment tube, lubricate applicator well and gently insert the applicator into the rectum; clean applicator after each use and replace the cover.

Side effects of phenylephrine/pramoxine/glycerin/petrolatum rectal include:

• Allergic reaction

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Phenylephrine/pramoxine/glycerin/petrolatum rectal has no listed severe interactions with other drugs.
• Phenylephrine/pramoxine/glycerin/petrolatum rectal has no listed serious interactions with other drugs.
• Phenylephrine/pramoxine/glycerin/petrolatum rectal has no listed moderate interactions with other drugs.
• Phenylephrine/pramoxine/glycerin/petrolatum rectal has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains phenylephrine/pramoxine/glycerin/petrolatum rectal. Do not take Preparation H Cream Maximum Strength Pain Relief if you are allergic to phenylephrine/pramoxine/glycerin/petrolatum rectal or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Phenylephrine/Pramoxine/Glycerin/Petrolatum Rectal?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Phenylephrine/Pramoxine/Glycerin/Petrolatum Rectal?”

Cautions

• For external use only
• Contains phenylephrine, caution with heart disease, high blood pressure (hypertension), hyperthyroidism, diabetes, or prostatic hypertrophy
• Discontinue and contact physician if hemorrhoids worsen or do not improve within 7 days
• Discontinue if bleeding, allergic reaction, redness, irritation, swelling, pain, or other symptoms develop or increase

Pregnancy and Lactation

• Use phenylephrine/pramoxine/glycerin/petrolatum rectal with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• It is unknown if phenylephrine/pramoxine/glycerin/petrolatum rectal is distributed in breast milk.
• Pregnant or breastfeeding patients should seek the advice of a health professional before using over-the-counter (OTC) drugs.