Procto-Pak 1% cream, ointment, suppository

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Hydrocortisone rectal is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling short of breath, even with mild exertion;

• swelling of your ankles or feet;

• muscle weakness;

• rapid weight gain, especially in your face and midsection;

• severe rectal pain or burning;

• bleeding from your rectum;

• severe stomach pain;

• sudden and severe headache or pain behind your eyes; or

• seizure (convulsions).

Less serious side effects may include:

• mild rectal pain or burning;

• acne;

• changes in your menstrual periods;

• increased sweating; or

• increased facial or body hair growth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before using hydrocortisone rectal, tell your doctor if you also use insulin or take oral diabetes medication.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Applies to hydrocortisone topical: topical application cream, topical application foam, topical application gel/jelly, topical application kit, topical application liquid, topical application lotion, topical application ointment, topical application pad, topical application paste, topical application solution, topical application spray, topical application stick

Other dosage forms:

• topical application cream, topical application lotion, topical application ointment, topical application solution
• topical application cream
• topical application cream, topical application ointment

Along with its needed effects, hydrocortisone topical (the active ingredient contained in Procto-Pak 1%) 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 immediately if any of the following side effects occur while taking hydrocortisone topical:

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• thinning, weakness, or wasting away of the skin

Some side effects of hydrocortisone topical 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:

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin