Pronunciation:

hye-droe-KOR-ti-sone VAL-er-ate

Brand Names:

• Westcort
• Hydroval
• Tarocort

Dosage Forms:

• Cream
• Ointment

Classifications:

Therapeutic—

Corticosteroid, Intermediate

Pharmacologic—

Hydrocortisone

Uses of This Medicine:

Hydrocortisone valerate topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of hydrocortisone valerate topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children and teenagers who must use this medicine should be checked often by their doctor since hydrocortisone valerate topical may be absorbed through the skin and can affect growth or cause other unwanted effects. Safety and effectiveness have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocortisone valerate topical in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection at or near the place of application or
• Large sores, broken skin, or severe injury at the area of application—The chance of side effects may be increased.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

Wash your hands with soap and water before and after using this medicine.

Be very careful not to get this medicine in your eyes. Wash your hands after using your finger to apply the medicine. If you accidentally get this medicine in your eyes, flush them with water.

Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.

Unless otherwise directed by your doctor, do not apply this medicine to open wounds, burns, or broken or inflamed skin.

This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap or a special patch) to be applied over this medicine, make sure you know how to apply it. Since occlusive dressings increase the amount of medicine absorbed through your skin and the possibility of side effects, use them only as directed. If you have any questions about this, check with your doctor.

Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (cream and ointment):
  • For redness, itching, and swelling of the skin:
    • Adults—Apply to the affected area of the skin two or three times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits for any problems or unwanted effects that may be caused by this medicine.

If your symptoms do not improve within 2 weeks, or if it become worse, check with your doctor.

After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. This medicine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and for patients who use large amounts for a long time. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Avoid using tight-fitting diapers or plastic pants on a child if this medicine is being used on the child's diaper area. Plastic pants and tight-fitting diapers may increase the chance of absorption of the medicine through the skin and the chance of side effects.

Do not use cosmetics or other skin care products on the treated skin areas.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

Skin rash, encrusted, scaly, and oozing

stinging

Less common

Burning, itching, redness, skin rash, swelling, or soreness at the application site

cough or hoarseness

dry skin

fever or chills

itching in the genital or other skin areas

lower back or side pain

painful or difficult urination

rash

rash with flat lesions or small raised lesions on the skin

skin irritation

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin

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 facial or intertriginous areas

Some side effects 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:

Less common

Diarrhea

indigestion

loss of appetite

nausea or vomiting

passing of gas

stomach pain, fullness, or discomfort

Incidence not known

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.