ProCort topical / rectal

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not use hydrocortisone and pramoxine to treat any condition that has not been checked by your doctor.

Wash your hands before and after applying this medicine, unless you are using hydrocortisone and pramoxine to treat a hand condition.

Use only a small amount of hydrocortisone and pramoxine topical on the affected area and rub it gently into the skin.

Do not cover the treated skin area unless your doctor tells you to. Covering the skin that is treated with this medicine can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

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

Shake the hydrocortisone and pramoxine rectal foam before each use.

For best results from the rectal medication, use only the applicator provided with the medication. Otherwise, follow the directions provided with your medicine.

Clean the rectal area with mild soap and water before applying the medicine, or use any cleansing wipes provided with your medicine.

Your body may absorb too much of this medication if you use a large amount, if you apply it over large skin areas, or if you cover treated skin with heat, bandages, or plastic wrap. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Call your doctor if your symptoms do not improve, if they get worse, or if you develop signs of infection (redness, swelling, oozing) while using hydrocortisone and pramoxine. This medicine will not treat a bacterial, fungal, or viral skin infection.

Store at room temperature away from moisture and heat.

Do not refrigerate the rectal aerosol foam. Keep the rectal foam canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone and pramoxine. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Applies to hydrocortisone / pramoxine topical: external cream, external foam, external gel, external lotion, external ointment

Other dosage forms:

• rectal cream, rectal foam, rectal kit, rectal lotion

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Irritation where this drug is used.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Thinning of the skin.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry skin.
• Burning.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.