pramoxine/mineral oil/zinc oxide rectal

Pramoxine/mineral oil/zinc oxide rectal is an ointment applied topically for the temporary relief of pain, soreness, burning and itching associated with hemorrhoids. The combination ointment is available over the counter (OTC) in the U.S. The three drugs combined in the formulation work in different ways to temporarily soothe the symptoms of hemorrhoids.

• Pramoxine is a local anesthetic that relieves pain and itching by locally inhibiting the conduction of pain signals by the sensory nerves in the skin. Pramoxine reduces the inflow of sodium ions into the nerve cells (neurons), blocking the initiation and conduction of nerve impulses that transmit pain signals.
• Mineral oil is a purified petroleum product, an emollient that forms a protective layer over the inflamed tissue, traps the moisture, and keeps the hemorrhoid surface soft.
• Zinc oxide is an inorganic astringent compound that constricts tissue and prevents oozing from the hemorrhoids. Zinc is a protectant, has weak antiseptic properties, and reduces itching.

• Do not use pramoxine/mineral oil/zinc oxide rectal ointment if you are hypersensitive to any component of the formulation.
• Avoid contact of ointment in the eyes.
• Do not apply the ointment on broken or blistered skin.
• Discontinue pramoxine/mineral oil/zinc oxide rectal and consult with your physician if you experience:
  • Rectal bleeding
  • Allergic reaction
  • New onset or increase of symptoms such as redness, irritation, swelling or pain
  • No improvement in your condition within 7 days or worsening of your condition

Common side effects of pramoxine/mineral oil/zinc oxide rectal include:

• Irritation
• Itching (pruritus)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Topical ointment

• 1%/46.6%/12.5%

Adult and Pediatric:

• Children below 12 years: Safety and efficacy not established

Topical Pain

• For symptomatic relief of the discomfort associated with hemorrhoids, perianal itching, or irritation in adults and children 12 years or above
• Apply externally to affected area up to 5 times daily as needed

Administration

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly and gently dry by patting or blotting with toilet tissue or a soft cloth before application
• Clean dispensing cap after every use

Overdose

Appropriate use of pramoxine/mineral oil/zinc oxide ointment is unlikely to result in overdose. There is no information on oral ingestion and overdose, however, swallowing the product is likely to be harmful.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Pramoxine/mineral oil/zinc oxide rectal has no known severe interactions with other drugs.
• Pramoxine/mineral oil/zinc oxide rectal has no known serious interactions with other drugs.
• Moderate interactions of pramoxine/mineral oil/zinc oxide rectal include:
  • beta carotene
  • digoxin
  • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate
  • vitamin D
• Pramoxine/mineral oil/zinc oxide rectal has mild interactions with at least 21 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Safety on the use of pramoxine/mineral oil/zinc oxide rectal during pregnancy has not been studied. Use with caution only if clearly needed.
• It is not known if rectal application of pramoxine/mineral oil/zinc oxide ointment can result in sufficient systemic absorption for the drug to be present in breastmilk. Use with caution if you are a nursing mother.
• Avoid using any OTC products, including pramoxine/mineral oil/zinc oxide rectal, without first checking with your healthcare provider if you are pregnant or breastfeeding.

• Use pramoxine/mineral oil/zinc oxide rectal exactly as directed.
• Pramoxine/mineral oil/zinc oxide rectal is only for external use.
• Store pramoxine/mineral oil/zinc oxide rectal safely out of reach of children.
• In case of oral ingestion and overdose, seek medical help or contact Poison Control.