Cloderm

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.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Stop using clocortolone topical and call your doctor if you have:

• blurred vision, or seeing halos around lights;
• uneven heartbeats;
• sleep problems (insomnia);
• weight gain, puffiness in your face; or
• tired feeling.

Also stop using clocortolone topical and call your doctor at once if you have:

• severe skin irritation where the medicine was applied; or
• signs of skin infection (swelling, redness, warmtth, oozing).

Common side effects may include:

• burning or itching of treated skin;
• skin dryness or irritation;
• increased hair growth;
• acne, skin rash;
• folliculitis (redness or crusting around your hair follicles);
• stretch marks;
• lightened color of treated skin; or
• white or "pruned" appearance of the skin (caused by leaving wound dressings on for long periods of time).

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.

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

It is not likely that other drugs you take orally or inject will have an effect on topically applied clocortolone. 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.

• It is used to treat skin irritation.
• It is used to treat skin rashes.

• Tell all of your health care providers that you take Cloderm. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use to treat diaper rash.
• Do not use tight-fitting diapers or plastic pants if treated part is in the diaper area. This may cause more drug to get into the body.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not put on cuts, scrapes, or damaged skin.
• Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
• Do not use longer than you have been told by the doctor.
• Use with care in children. Talk with the doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.

Applies to clocortolone topical: external cream

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:

• Skin irritation.
• Dry skin.
• Itching.
• Burning.

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.