Anesthetic, local (rectal route)

Brand Name

US Brand Name

AnaMantle HC

Colace

Fleet Babylax

Fleet Glycerin

Proctofoam-NS

Sani-Supp

Z-Pram

Zypram

Canadian Brand Name

Tronothane

Description

Rectal anesthetics 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.

This product is available in the following dosage forms:

Cream
Foam
Suppository

Before Using

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

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

Pregnancy

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

Breastfeeding

Rectal anesthetics have not been reported to cause problems in nursing babies.

Drug Interactions

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. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Dronedarone
Saquinavir
Vernakalant

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Alcuronium
Amifampridine
Amiodarone
Amprenavir
Arbutamine
Articaine
Atracurium
Benoxinate
Benzocaine
Benzyl Alcohol
Bretylium
Bupivacaine Liposome
Bupropion
Chloroprocaine
Cisatracurium
Cobicistat
Cocaine
Darunavir
Dasabuvir
Delavirdine
Dibucaine
Disopyramide
Dofetilide
Donepezil
Doxacurium
Dronedarone
Dyclonine
Encainide
Ethyl Chloride
Etidocaine
Etravirine
Fazadinium
Flecainide
Fosamprenavir
Fosphenytoin
Gallamine
Hexafluorenium
Hyaluronidase
Ibutilide

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use

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 medicines in this class 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.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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 you miss a dose of this medicine, take 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. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Do not keep outdated medicine or medicine no longer needed.

Precautions

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

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 taking this medicine and get emergency help immediately if any of the following effects occur:

Signs and symptoms of too much medicine being absorbed by the body

Blurred or double vision
confusion
convulsions (seizures)
dizziness or lightheadedness
drowsiness
feeling hot, cold, or numb
increased sweating
ringing or buzzing in ears
shivering or trembling
slow or irregular heartbeat
unusual anxiety, excitement, nervousness, or restlessness
unusual paleness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Burning, stinging, swelling, or tenderness not present before treatment
skin rash, redness, itching, or hives at or near place of application

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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