Hydrocortisone valerate (Topical application)

Hydrocortisone valerate (Topical application) is used to help reduce redness, itching, swelling, or other discomfort from skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

It is very important for your doctor to 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 they get worse, check with your doctor.

After applying this medicine to your child's skin, watch the child closely 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 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.

In deciding to use a medicine, you and your doctor should think about the risks and benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of hydrocortisone valerate (Topical application) in children. Because this medicine can be harmful, it should be used carefully. Children and teenagers who need to use this medicine should be regularly monitored by their doctor, as hydrocortisone valerate (Topical application) can be absorbed through the skin and might impact growth or cause other unwanted effects. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of hydrocortisone valerate (Topical application).

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others can be used together even if interactions may happen. In these cases, your doctor might adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform 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. This may worsen these conditions.

• Infection at or near the application site or
• Large sores, broken skin, or severe injuries in the area of application—This may increase the chance of side effects.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Skin rash that is encrusted, scaly, and oozing
• Stinging

Less common

• Burning, itching, redness, skin rash, swelling, or soreness at the site of application
• Cough or hoarseness
• Dry skin
• Fever or chills
• Itching in the genital area 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 the face or areas where skin rubs together

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. Your health care professional may also provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

Less common

• Diarrhea
• Indigestion
• Loss of appetite
• Nausea or vomiting
• Passing 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 hair root
• 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, consult 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.

In the U.S.

• Westcort

In Canada

• Hydroval
• Tarocort

Available Dosage Forms:

• Cream
• Ointment

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Hydrocortisone

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.