hydrocortisone and pramoxine (topical/rectal)

What is the most important information I should know about hydrocortisone and pramoxine topical?

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.

What is hydrocortisone and pramoxine topical?

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation.

Pramoxine is an anesthetic, or "numbing medicine." It works by interfering with pain signals sent from the nerves to the brain.

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

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

What should I discuss with my health care provider before using hydrocortisone and pramoxine topical?

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 clears up.

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

How should I use hydrocortisone and pramoxine topical?

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

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

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.

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.

What happens if I miss a dose?

Since hydrocortisone and pramoxine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of hydrocortisone and pramoxine topical is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone and pramoxine topical?

What are the possible side effects of hydrocortisone and pramoxine topical?

• 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.

Common side effects 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.

What other drugs will affect hydrocortisone and pramoxine topical?

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.

Where can I get more information?

Your pharmacist can provide more information about hydrocortisone and pramoxine topical.