Hydrocortisone probutate (Topical application)

Hydrocortisone probutate (Topical application) is used to relieve 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 that your doctor check your progress at regular visits for any unwanted effects that may be caused by this medicine.

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

Using too much of this medicine or using it for a long time may increase your risk of having adrenal or pituitary gland problems. The risk is greater for children and for patients who cover the treated skin area, use large amounts for a long time, or have liver failure. Talk to your doctor if you have blurred vision, darkening of the skin, diarrhea, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, loss of appetite, mental depression, nausea, skin rash, or unusual tiredness or weakness, or vomiting.

This medicine may cause serious skin reactions. Check with your doctor right away if you have blistering, burning, crusting, dryness, flaking, itching, scaling, severe redness, soreness, or swelling of the skin.

Check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation on the skin. Do not use cosmetics or other skin care products on the treated skin areas.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine versus the benefits it will provide. 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 any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how hydrocortisone probutate topical affects children and teenagers. Safety and effectiveness have not been established. Because this medicine can be toxic, it should be used cautiously. Children and teenagers may absorb too much through the skin, leading to serious side effects. If your child is using this medicine, follow your doctor's instructions carefully.

Geriatric

There is no information available on how hydrocortisone probutate topical affects older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together with caution. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or 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 some medicines can also lead to interactions. Talk to your healthcare professional about how to use 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 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. These conditions may worsen.

• Infection at or near the application site or
• Large sores, broken skin, or severe injury at the application area or
• Liver disease—Using this medicine 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 may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Backache
• blistering, burning, crusting, dryness, flaking, irritation, itching, scaling, severe redness, soreness, stinging, or swelling of the skin
• burning, itching, and pain in the hairy areas, pus at the root of the hair
• burning and itching of the skin with pinhead-sized red blisters
• darkening of the skin
• blurred vision
• diarrhea
• dizziness
• dry mouth
• facial hair growth in females
• fainting
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• increased hunger or thirst
• increased urination
• increased hair growth on the forehead, back, arms, and legs
• irritability
• lightening of the normal skin color
• lightening of treated areas of the dark skin
• loss of appetite
• loss of sexual desire or ability
• menstrual irregularities
• mental depression
• muscle wasting
• nausea
• reddish purple lines on the arms, face, legs, trunk, or groin
• redness and scaling around the mouth
• softening of the skin
• stomach pain
• sweating
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g., between the fingers)
• thinning, weakness, or wasting away of the skin
• trouble breathing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting

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 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, are bothersome, or if you have any questions about them:

Incidence not known

• Acne or pimples
• burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• flushing, redness of the skin
• unusually warm skin

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

• Pandel

In Canada

• Barriere-Hc
• Cortate
• Cort-Eze
• Cortoderm Mild Ointment
• Cortoderm Regular Ointment
• Emo-Cort
• Emo-Cort Scalp Solution
• Hydrocortisone Cream
• Novo-Hydrocort
• Novo-Hydrocort Cream
• Prevex Hc
• Sarna Hc

Available Dosage Forms:

• Cream

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Hydrocortisone

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

Do not use the this medicine on the face, groin, or underarms unless directed to do so by your doctor, and do not use these forms for more than 2 weeks.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, including severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with 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 form (cream):For corticosteroid-responsive dermatoses: Adults—Apply to the affected area of the skin 1 or 2 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.