This medication is used to treat a certain intestinal problem known as ulcerative colitis of the rectum, also called ulcerative proctitis. It does not cure this condition but it may relieve rectal pain, diarrhea, and bloody stools caused by swelling (inflammation). Hydrocortisone belongs to a class of drugs called corticosteroids. This medication works by decreasing inflammation directly in the rectum. It is usually used in people who cannot use corticosteroid enemas.

Read the directions for use that come with this product. If you have any questions, ask your doctor or pharmacist.

Use this product in the rectum as directed by your doctor, usually once or twice daily for 2 to 3 weeks, then every other day. The dosage and length of treatment are based on your medical condition and response to treatment. To reduce the chance of side effects, your doctor will slowly lower your dose, after you have a positive response to treatment, to the lowest effective dose that controls your symptoms. If you have a worsening of your symptoms, your doctor may need to increase your dose temporarily. Follow your doctor's directions.

Do not insert any part of the container into the anus. Use the enclosed applicator to apply this drug. Leave the cap of the container on while using the product. Shake the container well for 5-10 seconds before use and hold upright. Fill the applicator with foam according to the instructions in the package. Gently insert the applicator tip into the anus, and gently push the plunger to apply the foam. Remove the applicator.

After inserting the foam, pull the applicator apart and wash all parts with warm water. Rinse the container cap and tip to prevent any blockage. Wash your hands after use.

Use this medication regularly as prescribed to get the most benefit from it. It may take 5 to 7 days to notice an improvement.

Do not apply large amounts of this product, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase. If you have been using this medication for a long time, do not stop using it without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition does not get better after 2 to 3 weeks of treatment or if it gets worse.

Itching or burning in the rectum may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, it is possible this medication will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time. Tell your doctor right away if any of the following side effects occur:

• unusual/extreme tiredness
• weight loss
• headache
• swelling ankles/feet
• increased thirst/urination
• vision problems

Tell your doctor right away if you have any serious side effects, including:

• rectal bleeding that is new or doesn't go away
• unusual bruising/bleeding
• symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds)
• bone pain
• easily broken bones
• mental/mood changes (such as depression, mood swings, agitation)
• muscle weakness/pain
• irregular heartbeat
• signs of infection (such as sore throat that doesn't go away, fever, painful urination, worsening redness/irritation near the anus)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using hydrocortisone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other stomach/intestinal problems (such as ulcers, blockage, bleeding, infection, recent surgery)
• infections (such as tuberculosis, fungal infections)
• certain eye conditions (cataracts, glaucoma, herpes infection of the eye)
• heart problems (such as heart failure, recent heart attack)
• high blood pressure
• liver disease
• kidney disease
• thyroid problems (overactive or underactive thyroid disease)
• diabetes
• bone loss (osteoporosis)
• bleeding or blood clotting problems
• mental/mood conditions (such as psychosis, depression)
• low potassium blood level

Limit alcoholic beverages while using this medication to decrease the risk of stomach/intestinal bleeding.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Tell your health care professional that you are using hydrocortisone before having any immunizations, vaccinations, or skin tests. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Rarely, this drug can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Older adults may be more sensitive to the side effects of this drug, especially bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).

Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed and not for prolonged periods. Other forms of hydrocortisone (given by mouth or by injection) may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• aldesleukin
• "blood thinners" (such as warfarin)
• desmopressin

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (including aspirin, salicylates, NSAIDs such as ibuprofen, naproxen) that may increase your risk of bleeding when taken with corticosteroids. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as sigmoidoscopy, adrenal gland function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Do not refrigerate. Do not store or use near heat or open flame. The contents of the container are under pressure. Do not puncture or burn the container. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.