Dermatop Emollient Cream

DRUG DESCRIPTION

DERMATOP® Emollient Cream (prednicarbate emollient cream) 0.1% contains prednicarbate, a synthetic corticosteroid for topical dermatologic use. The chemical name of prednicarbate is 11? 17, 21-trihydroxypregna-1,4-diene- 3,20-dione 17-(ethyl carbonate) 21-propionate. Prednicarbate has the empirical formula C27H36O8 and a molecular weight of 488.58. Topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

The CAS Registry Number is 73771-04-7. The chemical structure is:

DERMATOP® (prednicarbate) Structural Formula Illustration

Prednicarbate is a practically odorless white to yellow-white powder insoluble to practically insoluble in water and freely soluble in ethanol.

Each gram of DERMATOP Emollient Cream 0.1% contains 1.0 mg of prednicarbate in a base consisting of white petrolatum USP, purified water USP, isopropyl myristate NF, lanolin alcohols NF, mineral oil USP, cetostearyl alcohol NF, aluminum stearate, edetate disodium USP, lactic acid USP, and magnesium stearate DAB 9.

What are the possible side effects of prednicarbate topical (Dermatop)?

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

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing prednicarbate topical through your skin, such as:

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

Read All Potential Side Effects and See Pictures of Dermatop Emollient Cream »

What are the precautions when taking prednicarbate emollient cream (Dermatop Emollient Cream)?

Before using prednicarbate, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, immune system problems, other skin conditions (e.g., rosacea, perioral dermatitis).

Do not use if there is an infection or sore in the area to be treated.

This medication may reduce the effectiveness of latex-containing products (such as condoms).

Rarely, using corticosteroid medications for a long time or...

Read All Potential Precautions of Dermatop Emollient Cream »


Dermatop Emollient Cream Consumer (continued)

SIDE EFFECTS: Stinging, burning, itching, irritation, dryness, or redness of the skin may occur when first applied to the skin. This should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, excessive hair growth, hair bumps (folliculitis).

Skin infections can become worse when using this medication. Notify your doctor promptly if redness, swelling or irritation does not improve.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using prednicarbate, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, immune system problems, other skin conditions (e.g., rosacea, perioral dermatitis).

Do not use if there is an infection or sore in the area to be treated.

This medication may reduce the effectiveness of latex-containing products (such as condoms).

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.


Dermatop Emollient Cream Patient Information Including Side Effects

Brand Names: Dermatop

Generic Name: prednicarbate topical (Pronunciation: pred ni KAR bate)

  • What is prednicarbate topical (Dermatop Emollient Cream)?
  • What are the possible side effects of prednicarbate topical (Dermatop Emollient Cream)?
  • What is the most important information I should know about prednicarbate topical (Dermatop Emollient Cream)?
  • What should I discuss with my healthcare provider before using prednicarbate topical (Dermatop Emollient Cream)?
  • How should I use prednicarbate topical (Dermatop Emollient Cream)?
  • What happens if I miss a dose (Dermatop Emollient Cream)?
  • What happens if I overdose (Dermatop Emollient Cream)?
  • What should I avoid while using prednicarbate topical (Dermatop Emollient Cream)?
  • What other drugs will affect prednicarbate topical (Dermatop Emollient Cream)?
  • Where can I get more information?

What is prednicarbate topical (Dermatop Emollient Cream)?

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

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 other purposes not listed in this medication guide.

What are the possible side effects of prednicarbate topical (Dermatop Emollient Cream)?

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

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing prednicarbate topical through your skin, 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about prednicarbate topical (Dermatop Emollient Cream)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with prednicarbate topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

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