CORTICOSTEROIDS (Rectal)

Some commonly used brand names are:

In the U.S.?

• Anucort-HC ⁴
• Anu-Med HC ⁴
• Anuprep HC ⁴
• Anusol-HC ⁴
• Anutone-HC ⁴
• Anuzone-HC ⁴
• Cort-Dome ⁴
• Cortenema ³
• Cortifoam ⁴
• Hemril-HC Uniserts ⁴
• Hemorrhoidal HC ⁴
• Proctocort ⁴
• Proctosol-HC ⁴
• Rectasol-HC ⁴

In Canada?

• Betnesol ¹
• Cortenema ³
• Cortifoam ⁴
• Cortiment-10 ⁴
• Cortiment-40 ⁴
• Entocort ²
• Hycort ³
• Rectocort ⁴
• Rectovalone ⁵

Another commonly used name for hydrocortisone is cortisol.

Category

• Anti-inflammatory, steroidal, rectal
• Corticosteroid, rectal

Description

Rectal corticosteroids (kor-ti-ko-STER-oyds) are used to treatmild or moderate ulcerative colitis. They also may be used along with systemic(oral or injection) corticosteroids or other medicines to treat severe diseaseor mild to moderate disease that has spread too far to be treated effectivelyby medicine inserted into the rectum alone. Rectal corticosteroids also areused to help relieve swelling, itching, and discomfort of some other rectalproblems, including hemorrhoids and inflammation of the rectum caused by radiationtherapy.

Rectal corticosteroids are available only with your doctor's prescriptionin the following dosage forms:

Rectal
• Betamethasone
  • Enema (Canada)
• Budesonide
  • Enema (Canada)
• Hydrocortisone
  • Enema (U.S. and Canada)
• Hydrocortisone acetate
  • Foam (U.S. and Canada)
  • Suppositories (U.S. and Canada)
• Tixocortol
  • Enema (Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of using it must be weighed against the good it will do. This isa decision you and your doctor will make. For rectal corticosteroids, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to any of the corticosteroids. Also tell your health careprofessional if you are allergic to any other substances, such as food, preservatives,or dyes.

Pregnancy?Betamethasone may change the number and ability ofmovement of sperm in men. Budesonide crosses the placenta. It is not knownwhether other rectal corticosteroids cross the placenta. Studies in animalshave shown that budesonide, hydrocortisone, and hydrocortisone acetate causebirth defects. Rectal corticosteroids should not be used in large amountsor for a long time by women who are pregnant or who are planning to becomepregnant.

Breast-feeding?It is not known whether rectal corticosteroidspass into breast milk. However, systemic (oral and injection) corticosteroidspass into breast milk and may cause problems with growth in nursing babies.It may be necessary for you to take a different medicine or to stop breast-feedingduring treatment. Be sure you have discussed with your doctor the risks andbenefits of using the medicine.

Children?Children and teenagers who must use this medicineshould be checked often by their doctor. Rectal corticosteroids may be absorbedthrough the lining of the rectum and, rarely, may affect growth, especiallyif used in large amounts or for a long time. Before using this medicine inchildren, you should discuss its use with the child's doctor.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of rectal corticosteroids in the elderly with use in otherage groups, these medicines are not expected to cause different side effectsor problems in older people than they do in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction may occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are usingrectal corticosteroids, it is especially important that your health care professionalknow if you are taking any of the following:

• Immunizations (vaccinations)?While you are being treated withthis medicine, and even after you stop using it, do not have any immunizationswithout your doctor's approval

• Skin test injections?Corticosteroids may cause false resultsin skin tests

Other medical problems?The presence of other medicalproblems may affect the use of rectal corticosteroids. Make sure you tellyour doctor if you have any other medical problems, especially:

• Acute psychosis?This condition may be made worse

• Chickenpox (including recent exposure) or
• Measles (including recent exposure)?Risk of severe diseaseaffecting other parts of the body

• Type 2 diabetes mellitus?Corticosteroids may causea loss of control of diabetes by increasing blood glucose (sugar)

• Glaucoma?Corticosteroids may cause the pressure within theeye to increase

• Heart disease or
• Hypertension (high blood pressure) or
• Kidney disease or
• Myasthenia gravis or
• Overactive thyroid or
• Swelling of blood vessels?Corticosteroids should be used withcaution

• Herpes simplex of the eye?Corticosteroids may cause additionalproblems in the eye

• Ileocolostomy, postsurgical or
• Infection or
• Tuberculosis (active TB, nonactive TB, or past history of)?Corticosteroidsmay cause slower healing, worsen existing infections, or cause new infections

• Liver disease or
• Underactive thyroid?With these conditions, the body may noteliminate the corticosteroid at the usual rate; therefore, the medicine'seffect may be increased

• Osteoporosis?Corticosteroids may worsen osteoporosis becausethey cause the body to lose more calcium

• Other stomach or intestine problems or
• Severe ulcerative colitis?Corticosteroids may cover up symptomsof a worsening stomach or intestinal condition; a patient would not know ifhis or her condition was getting worse and would not get medical help whenneeded

• Stomach ulcer?Corticosteroids may worsen this condition bycausing an increase in the amount of acid in the stomach

Proper Use of This Medicine

It is important that your doctor check your progress at regular visits.

For patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read and followthem carefully before using this medicine.

For patients using the foam form of this medicine:

• This medicine is used with a special applicator. Do not insert anypart of the aerosol container into the rectum.

For patients using the suppository form ofthis medicine:

• If the suppository is too soft to insert, chill it in the refrigeratorfor 30 minutes or run cold water over it before removing the wrapper.
• To insert the suppository: First remove the wrapper and moistenthe suppository with cold water. Lie down on your side and use your fingerto push the suppository well up into the rectum.

Do not use rectal corticosteroids in larger amounts,more often, or for a longer time than your doctor ordered. To do somay increase the chance of absorption through the lining of the rectum andthe chance of side effects.

Dosing?The dose of rectal corticosteroids may be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of corticosteroids. If your dose isdifferent, do not change it unless your doctor tells you to do so.

For betamethasone
• For enema dosage form:
  • For ulcerative colitis:
    • Adults?The usual dose is 5 milligrams (mg) (1 unit), used asdirected, every night for two to four weeks.
    • Children?Dose must be determined by your doctor.

For budesonide
• For enema dosage form:
  • For ulcerative colitis:
    • Adults?The usual dose is 2 milligrams (mg) (1 unit), used asdirected, every night for four to eight weeks.
    • Children?Use and dose must be determined by your doctor.

For hydrocortisone
• For enema dosage form:
  • For ulcerative colitis:
    • Adults?The usual dose is 100 milligrams (mg) (1 unit), usedas directed, every night for two or three weeks or until condition improvesas determined by your doctor.
    • Children?Dose must be determined by your doctor.

For hydrocortisone acetate
• For foam dosage form:
  • For ulcerative colitis:
    • Adults?At first, 1 applicatorful, used as directed, one ortwo times a day for two or three weeks. Then, the dose may be decreased to1 applicatorful every other day.
    • Children?Dose must be determined by your doctor.
• For suppository dosage form:
  • For ulcerative colitis:
    • Adults?The usual dose is 25 or 30 milligrams (mg) two timesa day, in the morning and at night, for two weeks. In more severe cases, thedose may be 25 or 30 mg three times a day or 50 or 60 mg two times a day.
    • Children?Dose must be determined by your doctor.
  • For inflammation of the rectum caused by radiation therapy:
    • Adults?The usual dose is 25 or 30 mg two times a day, in themorning and at night, for six to eight weeks.
    • Children?Dose must be determined by your doctor.
  • For other rectal problems:
    • Adults?The usual dose is 20 to 30 mg a day for three days,or 40 to 80 mg a day as needed.
    • Children?Dose must be determined by your doctor.

For tixocortol
• For enema dosage form:
  • For ulcerative colitis:
    • Adults?The usual dose is 250 milligrams (mg) (1 unit), usedas directed, at bedtime for twenty-one days in a row.
    • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, use it assoon as you remember. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store suppositories in the bathroom medicine cabinet becausethe heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing.
• Do not puncture, break, or burn the rectal foam aerosol container,even when it is empty.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Do not stop using this medicine without first checking withyour doctor. Your doctor may want you to reduce gradually the amountyou are using before you completely stop using it.

Check with your doctor if your condition does not improvewithin 2 or 3 weeks or if it becomes worse.

Check with your doctor if you notice rectal bleeding,pain, burning, itching, blistering, or any other sign of irritationthat you did not have before you started using this medicine.

Use of suppositories may cause staining of clothing or fabric.

Tell the doctor in charge that you are using this medicine:

• Before having skin tests.
• Before having any kind of surgery (includingdental surgery) or emergency treatment.
• If you get a serious infection or injury.

Avoid close contact with anyone who has chickenpoxor measles. This is especially important for children. Tell your doctor right away if you think you have been exposed to chickenpoxor measles.

While you are being treated with this medicine, and after you stop takingit, do not have any immunizations without your doctor'sapproval.

For patients with diabetes:

• This medicine may affect blood glucose (sugar) levels. If you noticea change in the results of your blood or urine sugar tests or if you haveany questions, check with your doctor.

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 mayneed medical attention.

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

Less common or rare

Burning and itching of skin; chills; depression; diarrhea; false sense of well-being; fever; infection; mood swings; painful, red or itchy, pus-containing blisters in hair follicles; personality changes; rectal bleeding, burning, dryness, itching, or pain not present before therapy; sensation of pins and needles; stabbing pain; straining while passing stool (withtixocortol only)

Additional side effects may occur if you use this medicine for a long time.Check with your doctor as soon as possible if any of the following side effectsoccur:

Abdominal or stomach pain; acne; backache; coughing; coughing up blood; decreased resistance to infection; dryness of mouth; eyepain; filling or rounding out of the face; gradual blurring or loss of vision; headache; hunchback; increasedthirst; irregular heartbeat; loss of appetite; menstrual irregularities; mood or mental changes; muscle crampsor pain; muscle weakness; nausea or vomiting; nonelevated blue or purplishpatch on the skin; osteoporosis or bone fractures; pain in joints; pain ordiscomfort in the area of a vein; rapid weight gain; reddish purple lines on arms, face, legs, trunk,or groin; redness of eye; sensitivity of eye to light; shortness of breath; skin rash; slow woundhealing; stunting of growth (in children); swelling of feet or lower legs; troublein sleeping; unusual decrease in sexual desire orability in men; tearing of eyes; unusual increase in hair growth (especially on the face); unusual tiredness or weakness; unusual weight loss; weak pulse

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

Less common or rare

Dizziness; dry, scaly skin; increase in appetite; increased sweating; lightened skin color; passing of gas (with budesonide only); sensationof spinning; thin, fragile skin; thinning hair on scalp; unusual weight gain

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.