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|Pramoxine Rectal

ANESTHETICS (Rectal)

Some commonly used brand names are:

In the U.S.—

• Americaine Hemorrhoidal ¹
• Nupercainal ²
• Fleet Relief ³
• Pontocaine Cream † ⁴
• Pontocaine Ointment ⁵
• ProctoFoam/non-steroid ³
• Tronolane ³
• Tronothane ³

In Canada—

• Nupercainal ²
• Tronothane ³

Other commonly used names are: amethocaine cinchocaine ethyl aminobenzoate pramocaine

Category

• Anesthetic (mucosal-local)—Benzocaine; Dibucaine; Pramoxine; Tetracaine; Tetracaine and Menthol

† Not commercially available in Canada.

Description

Rectal anesthetics (an-ess-THET-iks) are used to relieve the pain and itching of hemorrhoids (piles) and other problems in the rectal area. However, if you have hemorrhoids that bleed, especially after a bowel movement, check with your doctor before using this medicine. Bleeding may mean that you have a condition that needs other treatment.

These medicines are available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.

These medicines are available in the following dosage forms:

• Rectal
• Benzocaine
  • Ointment (U.S.)
• Dibucaine
  • Ointment (U.S. and Canada)
• Pramoxine
  • Aerosol foam (U.S.)
  • Cream (U.S. and Canada)
  • Ointment (U.S.)
• Tetracaine
  • Cream (U.S.)
• Tetracaine and Menthol
  • Ointment (U.S.)

Before Using This Medicine

If you are using this medicine without a prescription, carefully read and follow any precautions on the label. For rectal anesthetics, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to a local anesthetic, especially one that was applied to any part of the body as a liquid, cream, ointment, or spray. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Rectal anesthetics have not been reported to cause birth defects or other problems in humans.

Breast-feeding—Rectal anesthetics have not been reported to cause problems in nursing babies.

Children—Children may be especially sensitive to the effects of local anesthetics. This may increase the chance of side effects during treatment.

Older adults—Elderly people are especially sensitive to the effects of local anesthetics. This may increase the chance of side effects during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Before you use a rectal anesthetic, check with your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of rectal anesthetics. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection at or near place of treatment or
• Large sores, broken skin, or severe injury at or near place of treatment—The chance of unwanted effects may be increased

Proper Use of This Medicine

For safe and effective use of this medicine:

• Rectal anesthetics usually come with patient directions. Read them carefully before using the medicine, even if it was prescribed by your doctor. Check with your pharmacist if you have any questions about how to use the product.
• Follow your doctor"s instructions if this medicine was prescribed.
• Follow the manufacturer"s package directions if you are treating yourself.
• Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed . To do so may increase the chance of absorption into the body and the chance of unwanted effects.

This medicine should be used only for conditions being treated by your doctor or for problems listed on the package label. Do not use it for other problems without first checking with your doctor . This medicine should not be used if certain kinds of infections are present.

For applying a rectal anesthetic to the area around the rectum :

• First, clean the area, using mild soap and water or a cleansing wipe. Rinse the area carefully and dry it gently with a soft towel or toilet paper.
• Apply a small amount of medicine to the sore area, using a piece of gauze, a tissue, or a ``finger cot.""

For inserting a rectal cream or ointment inside the rectum :

• Use only products that come packaged in pre-filled applicators or that come packaged with a special inserter called a rectal tube.
• If you are using a product that has an inserter (rectal tube) packaged separately from the tube of cream or ointment:
  • Remove the cap from the tube of cream or ointment. Attach the inserter to the top of the tube. Squeeze the tube until a little cream or ointment comes out on the inserter. Then spread the cream or ointment over the inserter.
  • Place the inserter into your rectum and squeeze the tube until a small amount of medicine comes out. Then remove the inserter from your body.
  • Remove the inserter from the tube and replace the cap. Then wash the applicator carefully.
• If you are using the product that comes in pre-filled applicators:
  • Follow the manufacturer"s directions for using the applicator and inserting the medicine. Each applicator is meant to be used only once. Throw the applicator away after using it.

For inserting the rectal aerosol foam (e.g., Proctofoam/nonsteroid) into the rectum :

• Do not insert the container itself into your rectum. Use the applicator provided.
• To fill the container—First, shake the container hard for several seconds. Then, holding the container upright, insert it into the applicator. Press the cap of the container until the foam reaches the fill line of the applicator. Remove the applicator from the container.
• To use the medicine—Place a small amount of foam on the tip of the applicator. Insert the applicator into your rectum, then push the plunger as far as possible. Remove the applicator. Then take it apart and wash it carefully.

Dosing—The dose of rectal anesthetics will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

• For benzocaine
• For pain and itching of hemorrhoids or other problems in the rectal area:
  • For rectal ointment dosage form:
    • Adults—Apply a small amount of ointment to the area around the rectum up to six times a day.
    • Children—Use and dose must be determined by the doctor.

• For dibucaine
• For pain and itching of hemorrhoids or other problems in the rectal area:
  • For rectal ointment dosage form:
    • Adults—Insert a small amount of ointment into the rectum three or four times a day, in the morning, in the evening, and after bowel movements. Or, apply a small amount of ointment to the area around the rectum three or four times a day.
    • Children—Use and dose must be determined by the doctor.

• For pramoxine
• For pain and itching of hemorrhoids or other problems in the rectal area:
  • For rectal cream dosage form:
    • Adults—Apply a small amount to the area around the rectum up to five times a day, in the morning, in the evening, and after bowel movements.
    • Children—Use and dose must be determined by the doctor.
  • For rectal ointment dosage form:
    • Adults—Insert a small amount of ointment into the rectum up to five times a day, in the morning, in the evening, and after bowel movements. Or, apply a small amount to the area around the rectum up to five times a day, in the morning, in the evening, and after bowel movements.
  • For the rectal aerosol foam dosage form:
    • Adults—Insert 1 applicatorful into the rectum two or three times a day. Or, apply a small amount to the area around the rectum two or three times a day.
    • Children—Use and dose must be determined by the doctor.

• For tetracaine and for tetracaine and menthol
• For pain and itching of hemorrhoids or other problems in the rectal area:
  • For the rectal cream or rectal ointment dosage form:
    • Adults—Insert a small amount into the rectum up to six times a day. Or, apply a small amount to the area around the rectum up to six times a day.
    • Children—Use and dose must be determined by the doctor.

Missed dose—If your doctor has directed you to use this medicine on a regular schedule and you miss a dose, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not puncture, break, or burn the pramoxine aerosol foam container, even after it is empty.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your doctor:

• If your condition does not improve after you have been using this medicine regularly for 7 days, or if it becomes worse.
• If any bleeding from the rectum occurs.
• If you notice any rash, redness, or irritation that was not present before you started using this medicine.

False test results may occur if benzocaine or tetracaine is present in your body when a certain laboratory test is done. This test uses a medicine called bentiromide (e.g., Chymex) to show how well your pancreas is working. You should not use any products containing benzocaine or tetracaine for about 72 hours (3 days) before this test is done.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop using this medicine and check with your doctor immediately if any of the following side effects occur:

Also, check with your doctor as soon as possible if any of the following side effects occur:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 09/01/1994

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