Hydrocortisone and pramoxine (topical/rectal)

Hydrocortisone is a type of steroid. It helps lower the effects of chemicals in the body that lead to inflammation.

Pramoxine is a numbing medicine, also known as an anesthetic. It works by blocking pain signals that travel from the nerves to the brain.

Hydrocortisone and pramoxine topical (for the skin) is a combination medicine used to relieve itching and discomfort caused by allergic reactions, eczema, minor burns, insect bites, or other skin conditions.

Hydrocortisone and pramoxine rectal (for the rectum) is used to relieve itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone and pramoxine topical may also be used for other reasons not mentioned in this medication guide.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are using.

You should not use hydrocortisone and pramoxine if you are allergic to hydrocortisone or pramoxine, or to any other anesthetics or "numbing medicines."

To make sure hydrocortisone and pramoxine is safe for you, tell your doctor if you have:

• liver disease;
• diabetes;
• problems with your eyes;
• a stomach or intestinal disorder;
• a rectal sore or infection; or
• if you use any drugs that weaken the immune system, including steroids.

Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and cleared up.

FDA pregnancy category C. It is not known whether hydrocortisone and pramoxine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether hydrocortisone and pramoxine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not use this medicine on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone.

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.

Stop using this medication and call your doctor right away if you show signs of absorbing too much of the medicine through your skin, such as:

• blurred vision, eye pain, or seeing halos around lights;
• mood changes;
• sleep problems (insomnia);
• high blood sugar (increased thirst or urination, hunger, dry mouth, fruity breath odor, weight loss);
• weight gain, puffiness in your face; or
• muscle weakness, feeling tired.

Stop using the medicine and call your doctor if you have rectal bleeding or severe irritation in any treated skin.

Common side effects of hydrocortisone and pramoxine may include:

• mild redness or swelling of treated skin;
• thinning of treated skin; or
• numbness on areas where the medicine is accidentally applied.

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.

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.

Since hydrocortisone and pramoxine is used as needed, you might not have a regular dosing schedule. If you do have a schedule and miss a dose, take it as soon as you remember. If it’s almost time for your next scheduled dose, skip the missed dose. Do not use extra medicine to make up for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone and pramoxine (topical/rectal) is not expected to cause life-threatening symptoms. However, using high doses of steroids for a long time can result in symptoms such as thinning skin, easy bruising, changes in body fat distribution (especially in your face, neck, back, and waist), increased facial hair, menstrual problems, impotence, or loss of interest in sex.

Do not apply this medication to swollen skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion. Avoid using it on body areas with skin folds or thin skin unless your doctor has instructed you to.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If this occurs, rinse with water.

It is not likely that other drugs you take orally or inject will affect hydrocortisone and pramoxine when applied to the skin. However, many drugs can interact with each other. Inform all your health care providers about all the medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.