Hemmorex-HC

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.

Hemmorex-HC™ suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.

Do not use Hemmorex-HC™ suppositories unless adequate proctologic examination is made. If irritation develops, the product should be discontinued and appropriate therapy instituted. In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, Hemmorex-HC™ should be discontinued until the infection has been adequately controlled.

Carcinogenesis:

No long term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

Pregnancy Category C:

In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. There are no adequate and well controlled studies in pregnant women. Hemmorex-HC™ suppositories should only be used during pregnancy if the potential benefit justifies the risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

It is not known whether this drug is excreted in human milk and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Hemmorex-HC™ suppositories, a decision should be

made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The following local adverse reactions have been reported with corticosteroid suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.

Hemmorex-HC™ (hydrocortisone acetate suppositories), 30mg are off-white, smooth surfaced and bullet shaped with one pointed end.

Box of 12 suppositories, NDC 16477-202-12.

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 Hemmorex-HC) 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