Dermatop (Topical application)

Prednicarbate topical 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 that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, 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 gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a 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.

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

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. For this medicine, please keep the following points in mind:

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 provider know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies done so far have not shown any specific problems for children that would limit the use of prednicarbate topical cream in children 1 year of age and older, and the topical ointment in children 10 years of age and older. However, due to the potential toxicity of this medicine, it should be used cautiously. Children may absorb a lot of the medicine through their skin, which can lead to serious side effects. If your child is using this medicine, follow your doctor's instructions closely. The safety and effectiveness of prednicarbate topical ointment in children younger than 10 years of age, and topical cream in children younger than 1 year of age, have not been established, and use is not recommended.

Geriatric

There is no available information on how age affects the effects of prednicarbate topical in older patients.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose or take other precautions. Inform your healthcare provider 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 the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may impact the use of this medicine. Be sure to tell your doctor if you have any other medical issues, 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 of the skin at or near the application site or
• Large sores, broken skin, or severe skin injury at the application site—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 happen, but if they do, they may need medical attention.

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

Less common

• Burning, itching, drying, scaling, or cracking of the skin
• Irritation of the skin
• Pain
• Raised, dark red, or wart-like spots on the skin, especially when used on the face
• Shininess or thinness of the skin
• Thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g., between the fingers)

Rare

• Blistering, burning, crusting, dryness, or flaking of the skin
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Hives or welts
• Itching, scaling, severe redness, soreness, or swelling of the skin
• Skin rash

Incidence not known

• Irritation of the skin around the mouth
• Redness and scaling around the mouth

Some side effects may happen 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 questions about them:

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 the treated areas of dark skin
• Reddish purple lines on the arms, face, legs, trunk, or groin

Other side effects not listed may also happen 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.

In the U.S.

• Dermatop
• Dermatop E

Available Dosage Forms:

• Ointment
• Emollient Cream

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Adrenal Glucocorticoid

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, nose, mouth, or vagina. 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.

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, such as severe burns.

Do not use the topical cream on the face, groin, or underarms unless directed to do so by your doctor, and do not use this form for more than 3 weeks.

Do not allow latex-containing products (e.g., condoms, diaphragms) to come in contact with this medicine. The latex can be damaged and the product will not be effective.

To use the cream or ointment:

• 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.

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 redness, itching, and swelling of the skin: For topical dosage form (cream): Adults—Apply to the affected area of the skin two times per day. Children 1 year of age and older—Apply to the affected area of the skin two times per day. Children younger than 1 year of age—Use is not recommended. For topical dosage form (ointment): Adults—Apply to the affected area of the skin two times per day. Children 10 years of age and older—Apply to the affected area of the skin two times per day. Children younger than 10 years of age—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.