Hemril-HC Uniserts

They also may be used along with systemic (oral or injection) corticosteroids or other medicines to treat severe disease or mild to moderate disease that has spread too far to be treated effectively by medicine inserted into the rectum alone. Rectal corticosteroids also are used to help relieve swelling, itching, and discomfort of some other rectal problems, including hemorrhoids and inflammation of the rectum caused by radiation therapy.

Rectal corticosteroids are available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Kit


• Enema


• Solution


• Suppository


• Cream


• Foam

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 and teenagers who must use this medicine should be checked often by their doctor . Rectal corticosteroids may be absorbed through the lining of the rectum and, rarely, may affect growth, especially if used in large amounts or for a long time. Before using this medicine in children, you should discuss its use with the child`s doctor .

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of rectal corticosteroids in the elderly with use in other age groups, these medicines are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Betamethasone may change the number and ability of movement of sperm in men. Budesonide crosses the placenta. It is not known whether other rectal corticosteroids cross the placenta. Studies in animals have shown that budesonide, hydrocortisone, and hydrocortisone acetate cause birth defects. Rectal corticosteroids should not be used in large amounts or for a long time by women who are pregnant or who are planning to become pregnant .

Breastfeeding

It is not known whether rectal corticosteroids pass into breast milk. However, systemic (oral and injection) corticosteroids pass 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-feeding during treatment . Be sure you have discussed with your doctor the risks and benefits of using the medicine.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Acute psychosisa€”This condition may be made worse.

• Chickenpox (including recent exposure) or


• Measles (including recent exposure)a€”Risk of severe disease affecting other parts of the body .

• Type 2 diabetes mellitusa€”Corticosteroids may cause a loss of control of diabetes by increasing blood glucose (sugar).

• Glaucomaa€”Corticosteroids may cause the pressure within the eye to increase.

• Heart disease or


• Hypertension (high blood pressure) or


• Kidney disease or


• Myasthenia gravis or


• Overactive thyroid or


• Swelling of blood vesselsa€”Corticosteroids should be used with caution.

• Herpes simplex of the eyea€”Corticosteroids may cause additional problems in the eye.

• Ileocolostomy, postsurgical or


• Infection or


• Tuberculosis (active TB, nonactive TB, or past history of)a€”Corticosteroids may cause slower healing, worsen existing infections, or cause new infections.

• Liver disease or


• Underactive thyroida€”With these conditions, the body may not eliminate the corticosteroid at the usual rate; therefore, the medicine`s effect may be increased .

• Osteoporosisa€”Corticosteroids may worsen osteoporosis because they cause the body to lose more calcium.

• Other stomach or intestine problems or


• Severe ulcerative colitisa€”Corticosteroids may cover up symptoms of a worsening stomach or intestinal condition; a patient would not know if his or her condition was getting worse and would not get medical help when needed.

• Stomach ulcera€”Corticosteroids may worsen this condition by causing an increase in the amount of acid in the stomach.

Proper Use

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 follow them 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 any part of the aerosol container into the rectum .

For patients using the suppository form of this medicine:

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the wrapper.


• To insert the suppository: First remove the wrapper and moisten the suppository with cold water . Lie down on your side and use your finger to 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 so may increase the chance of absorption through the lining of the rectum and the chance of side effects.

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 betamethasone

• For enema dosage form:
  
  
  
  • For ulcerative colitis:
    
    
    
    • Adultsa€”The usual dose is 5 milligrams (mg) (1 unit), used as directed, every night for two to four weeks.
    
    
    • Childrena€”Dose must be determined by your doctor .
    
    
    
    
  
  
  
  

For budesonide

• For enema dosage form:
  
  
  
  • For ulcerative colitis:
    
    
    
    • Adultsa€”The usual dose is 2 milligrams (mg) (1 unit), used as directed, every night for four to eight weeks.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

For hydrocortisone

• For enema dosage form:
  
  
  
  • For ulcerative colitis:
    
    
    
    • Adultsa€”The usual dose is 100 milligrams (mg) (1 unit), used as directed, every night for two or three weeks or until condition improves as determined by your doctor .
    
    
    • Childrena€”Dose must be determined by your doctor .
    
    
    
    
  
  
  
  

For hydrocortisone acetate

• For foam dosage form:
  
  
  
  • For ulcerative colitis:
    
    
    
    • Adultsa€”At first, 1 applicatorful, used as directed, one or two times a day for two or three weeks. Then, the dose may be decreased to 1 applicatorful every other day.
    
    
    • Childrena€”Dose must be determined by your doctor .
    
    
    
    
  
  
  
  


• For suppository dosage form:
  
  
  
  • For ulcerative colitis:
    
    
    
    • Adultsa€”The usual dose is 25 or 30 milligrams (mg) two times a day, in the morning and at night, for two weeks. In more severe cases, the dose may be 25 or 30 mg three times a day or 50 or 60 mg two times a day.
    
    
    • Childrena€”Dose must be determined by your doctor .
    
    
    
    
  
  
  • For inflammation of the rectum caused by radiation therapy:
    
    
    
    • Adultsa€”The usual dose is 25 or 30 mg two times a day, in the morning and at night, for six to eight weeks.
    
    
    • Childrena€”Dose must be determined by your doctor .
    
    
    
    
  
  
  • For other rectal problems:
    
    
    
    • Adultsa€”The usual dose is 20 to 30 mg a day for three days, or 40 to 80 mg a day as needed.
    
    
    • Childrena€”Dose must be determined by your doctor .
    
    
    
    
  
  
  
  

For tixocortol

• For enema dosage form:
  
  
  
  • For ulcerative colitis:
    
    
    
    • Adultsa€”The usual dose is 250 milligrams (mg) (1 unit), used as directed, at bedtime for twenty-one days in a row.
    
    
    • Childrena€”Use and dose must be determined by your 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.

Do not keep outdated medicine or medicine no longer needed.

Do not puncture, break, or burn the rectal foam aerosol container, even when it is empty .

Precautions

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

Check with your doctor if your condition does not improve within 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 irritation that 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 (including dental surgery) or emergency treatment


• If you get a serious infection or injury

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

While you are being treated with this medicine, and after you stop taking it, do not have any immunizations without your doctor`s approval.

For patients with diabetes:

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

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 .

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

• Abdominal or stomach pain


• Acne


• Backache


• Coughing


• Coughing up blood


• Decreased resistance to infection


• Dryness of mouth


• Eye pain


• Filling or rounding out of the face


• Gradual blurring or loss of vision


• Headache


• Hunchback


• Increased thirst


• Irregular heartbeat


• Loss of appetite


• Menstrual irregularities


• Mood or mental changes


• Muscle cramps or pain


• Muscle weakness


• Nausea or vomiting


• Nonelevated blue or purplish patch on the skin


• Osteoporosis or bone fractures


• Pain in joints


• Pain or discomfort 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 wound healing


• Stunting of growth (in children)


• Swelling of feet or lower legs


• Trouble in sleeping


• Unusual decrease in sexual desire or ability in men


• Tearing of eyes


• Unusual increase in hair growth (especially on the face)


• Unusual tiredness or weakness


• Unusual weight loss


• Weak pulse

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

• Dizziness


• Dry, scaly skin


• Increase in appetite


• Increased sweating


• Lightened skin color


• Passing of gas (with budesonide only)


• Sensation of spinning


• Thin, fragile skin


• Thinning hair on scalp


• Unusual weight gain

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.