Dermatop

Dosage Forms & Strengths

cream/ointment

• 0.1%

Dermatoses

Apply cream/ointment q12hr; discontinue therapy when control achieved

If no improvement within 2 weeks, reassess diagnosis

Not for use >3 weeks

Dosage Forms & Strengths

cream/ointment

• 0.1%

Dermatoses

<12 months: Safety & efficacy not established

>12 months: Apply cream q12hr

>10 years: Apply ointment q12hr

Not for use >3 weeks

Limit to minimum amount necessary for therapeutic efficacy

If no improvement within 2 weeks, reassess diagnosis

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using prednicarbate topical and call your doctor at once if you have a serious side effect such as:

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

Less serious side effects may include:

• mild skin rash, itching, burning, swelling, or dryness;
• thinning or softening of your skin;
• skin rash or irritation around your mouth;
• swollen hair follicles;
• numbness or tingling;
• changes in color of treated skin;
• blisters, pimples, or crusting of treated skin; or
• stretch marks.

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.

• Dermik Laboratories, Inc.

• Ortho-McNeil Pharmaceutical Corporation

• Valeant Pharmaceuticals North America LLC

Prednicarbate is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation.

Prednicarbate topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Prednicarbate topical may also be used for purposes not listed in this medication guide.

Prednicarbate topical should not be used to treat any skin condition your doctor has not prescribed it for.

Avoid using prednicarbate topical to treat skin on your face, underarms, or groin area without your doctor's advice.

Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. If this does happen, rinse with water. Do not use prednicarbate topical on broken or infected skin. Also avoid using this medication in open wounds.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using prednicarbate topical and call your doctor at once if you have a serious side effect such as:

• blurred vision, or seeing halos around lights;

• mood changes;

• sleep problems (insomnia);

• weight gain, puffiness in your face; or

• muscle weakness, feeling tired.

Less serious side effects may include:

• mild skin rash, itching, burning, swelling, or dryness;

• thinning or softening of your skin;

• skin rash or irritation around your mouth;

• swollen hair follicles;

• numbness or tingling;

• changes in color of treated skin;

• blisters, pimples, or crusting of treated skin; or

• stretch marks.

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.

Absorption

Bioavailability

Topically applied prednicarbate can be absorbed through normal intact skin.1 b c

Percutaneous penetration of corticosteroids following topical application to the skin varies among individuals and may be increased by occlusive dressings, high corticosteroid concentrations, and certain vehicles.b

Only minimal amounts of topical corticosteroid reach the dermis and subsequently the systemic circulation after application to most normal skin areas; more absorption occurs from the scrotum, axilla, eyelid, face, and scalp than from the forearm, knee, elbow, palm, and sole.b

Absorption is markedly increased by loss of the skin’s keratin layer and by inflammation and/or diseases of the epidermal barrier (e.g., psoriasis, eczema).1 b c

Distribution

Extent

Not known whether topical prednicarbate is distributed into milk.1 b c

Elimination

Metabolism

Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.b

Elimination Route

Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in bile.b

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

• If you have an allergy to prednicarbate or any other part of Dermatop (prednicarbate).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Dermatop, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Dermatop. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Dermatop.

Review Date: October 4, 2017