Prednicarbate Emollient Cream (Dermatop Emollient Cream)
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Prednicarbate Emollient Cream (Dermatop Emollient Cream)

DERMATOP® Emollient Cream
(prednicarbate) Emollient Cream 0.1%

FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES
.

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 11β 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; 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,...

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 »

Last reviewed on RxList: 1/20/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% may be used with caution in pediatric patients 1 year of age or older. The safety and efficacy of drug use for longer than 3 weeks in this population have not been established. Since safety and efficacy of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended.

DOSAGE AND ADMINISTRATION

Apply a thin film of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% to the affected skin areas twice daily. Rub in gently.

DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1 % may be used in pediatric patients 1 year of age or older. Safety and efficacy of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% should not be used with occlusive dressings unless directed by the physician. DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

HOW SUPPLIED

DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is supplied in 15 g (NDC 0066-0507-15) and 60 g (NDC 0066-0507-60) tubes. Store between 41 and 77°F (5 and 25°C).

Dermik Laboratories., a business of sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised October 2010

Last reviewed on RxList: 1/20/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

In controlled adult clinical studies, the incidence of adverse reactions probably or possibly associated with the use of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% was approximately 4%. Reported reactions included mild signs of skin atrophy in 1% of treated patients, as well as the following reactions which were reported in less than 1% of patients: pruritis, edema, paresthesia, urticaria, burning, allergic contact dermatitis and rash.

In an uncontrolled study in pediatric patients with atopic dermatitis, the incidence of adverse reactions possibly or probably associated with the use of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1 % was limited. Mild signs of atrophy developed in 5 patients (5/59, 8%) during the clinical trial, with 2 patients exhibiting more than one sign. Two patients (2/59, 3%) developed shininess, and 2 patients (2/59, 3%) developed thinness. Three patients (3/59, 5 %) were observed with mild telangiectasia. It is unknown whether prior use of topical corticosteroids was a contributing factor in the development of telangiectasia in 2 of the patients (See PRECAUTIONS, Pediatric Use.) The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, striae and miliaria.

Read the Dermatop Emollient Cream (prednicarbate emollient cream) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 1/20/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided.

PRECAUTIONS

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or under occlusion should be evaluated periodically for evidence of HPA-axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% did not produce significant HPA-axis suppression when used at a dose of 30g/day for a week in 10 adult patients with extensive psoriasis or atopic dermatitis. DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% did not produce HPA-axis suppression in any of 59 pediatric patients with extensive atopic dermatitis when applied BID for 3 weeks to > 20% of the body surface (See PRECAUTIONS, Pediatric Use.) If HPA-axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of the application, or to substitute a less potent corticosteroid. Recovery of HPA-axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS, Pediatric Use.)

If irritation develops, DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as observed with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.

If a favorable response does not occur promptly, use of DERMATOP Emollient Cream (prednicarbate emollient cream) should be discontinued until the infection has been adequately controlled.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA-axis suppression:

ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

In a study of the effect of prednicarbate on fertility, pregnancy, and postnatal development in rats, no effect was noted on the fertility or pregnancy of the parent animals or postnatal development of the offspring after administration of up to 0.80 mg/kg of prednicarbate subcutaneously.

Prednicarbate has been evaluated in the Salmonella reversion test (Ames test) over a wide range of concentrations in the presence and absence of an S-9 liver microsomal fraction, and did not demonstrate mutagenic activity. Similarly, prednicarbate did not produce any significant changes in the numbers of micronuclei seen in erythrocytes when mice were given doses ranging from 1 to 160 mg/kg of the drug.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Prednicarbate has been shown to be teratogenic and embryotoxic in Wistar rats and Himalayan rabbits when given subcutaneously during gestation at doses 1900 times and 45 times the recommended topical human dose, assuming a percutaneous absorption of approximately 3%. In the rats, slightly retarded fetal development and an incidence of thickened and wavy ribs higher than the spontaneous rate were noted. In rabbits, increased liver weights and slight increase in the fetal intrauterine death rate were observed. The fetuses that were delivered exhibited reduced placental weight, increased frequency of cleft palate, ossification disorders in the sternum, omphalocele, and anomalous posture of the forelimbs.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects of prednicarbate. DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is administered to a nursing woman.

Pediatric Use

DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% may be used with caution in pediatric patients 1 year of age or older, although the safety and efficacy of drug use longer than 3 weeks have not been established. The use of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is supported by results of a three-week, uncontrolled study in 59 pediatric patients between the ages of 4 months and 12 years of age with atopic dermatitis. None of the 59 pediatric patients showed evidence of HPA-axis suppression. Safety and efficacy of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% in pediatric patients below 1 year of age have not been established, therefore use in this age group is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. In an uncontrolled study in pediatric patients with atopic dermatitis, the incidence of adverse reactions possibly or probably associated with the use of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% was limited.

Mild signs of atrophy developed in 5 patients (5/59, 8%) during the clinical trial, with 2 patients exhibiting more than one sign. Two patients (2/59, 3%) developed shininess, and two patients (2/59, 3%) developed thinness. Three patients (3/59, 5%) were observed with mild telangiectasia. It is unknown whether prior use of topical corticosteroids was a contributing factor in the development of telangiectasia in 2 of the patients. Adverse effects including striae have also been reported with inappropriate use of topical corticosteroids in infants and children. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk for HPA-axis suppression.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% should not be used in the treatment of diaper dermatitis.

Last reviewed on RxList: 1/20/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

CONTRAINDICATIONS

DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.

Last reviewed on RxList: 1/20/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

In common with other topical corticosteroids, prednicarbate has anti-inflammatory, antipruritic, and vasoconstrictive properties. In general, the mechanism of the anti-inflammatory activity of topical steroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Use of occlusive dressings with hydrocortisone for up to 24 hours have not been shown to increase penetration; however, occlusion of hydrocortisone for 96 hours does markedly enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

Studies performed with DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1 % indicate that the drug product is in the medium range of potency compared with other topical corticosteroids.

Last reviewed on RxList: 1/20/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients using topical corticosteroids should receive the following information and instructions:

  1.  This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2.  This medication should not be used for any disorder other than that for which it was prescribed.
  3.  The treated skin area should not be bandaged, otherwise covered or wrapped so as to be occlusive, unless directed by the physician.
  4.  Patients should report to their physician any signs of local adverse reactions.
  5.  Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis. This medication should not be applied in the diaper area as diapers or plastic pants may constitute occlusive dressing (See DOSAGE AND ADMINISTRATION).
  6.  This medication should not be used on the face, underarms, or groin areas.
  7.  Contact between DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% and latex containing products (eg. condoms, diaphragm etc.) should be avoided since paraffin in contact with latex can cause damage and reduce the effectiveness of any latex containing products. If latex products come into contact with DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1%, patients should be advised to discard the latex products. Patients should be advised that this medication is to be used externally only, not intravaginally.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, contact the physician.

Last reviewed on RxList: 1/20/2011
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients using topical corticosteroids should receive the following information and instructions:

  1.  This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2.  This medication should not be used for any disorder other than that for which it was prescribed.
  3.  The treated skin area should not be bandaged, otherwise covered or wrapped so as to be occlusive, unless directed by the physician.
  4.  Patients should report to their physician any signs of local adverse reactions.
  5.  Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis. This medication should not be applied in the diaper area as diapers or plastic pants may constitute occlusive dressing (See DOSAGE AND ADMINISTRATION).
  6.  This medication should not be used on the face, underarms, or groin areas.
  7.  Contact between DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% and latex containing products (eg. condoms, diaphragm etc.) should be avoided since paraffin in contact with latex can cause damage and reduce the effectiveness of any latex containing products. If latex products come into contact with DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1%, patients should be advised to discard the latex products. Patients should be advised that this medication is to be used externally only, not intravaginally.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, contact the physician.

Last reviewed on RxList: 1/20/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Dermatop Emollient Cream Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PREDNICARBATE CREAM - TOPICAL

(PRED-ni-KAR-bate)

COMMON BRAND NAME(S): Dermatop

USES: This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Prednicarbate reduces the swelling, itching and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid.

HOW TO USE: Use this medication on the skin only. Do not use it on the face, groin, underarms, inside the vagina, or for diaper rash, unless directed to do so by your doctor.

Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in, usually twice daily or as directed by your doctor. Do not bandage, cover or wrap the area unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

After applying the medication, wash your hands, unless you are using this medication to treat the hands. When applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you get the medication in your eyes, nose, or mouth, rinse with plenty of water.

Use this medication only for the condition prescribed. Do not use it on a child for longer than 3 weeks in a row, unless directed to do so by your doctor.

Inform your doctor if your condition persists or worsens after 2 weeks.

Disclaimer

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.

Read the Dermatop Emollient Cream (prednicarbate emollient cream) Side Effects Center for a complete guide to possible side effects »

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.

Disclaimer

Dermatop Emollient Cream Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription or nonprescription/herbal products you may use, especially of: oral corticosteroids (e.g., prednisone), other topical corticosteroids (e.g., hydrocortisone), drugs that suppress the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medication may be harmful if swallowed.

NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.

Inform all your doctors you use or have used this medication.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the US product between 41-77 degrees F (5-25 degrees C).

Store the Canadian product between 59-86 degrees F (15-30 degrees C).

Store the medication away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition may cause complications in a medical emergency. For enrollment information in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised February 2011. Copyright(c) 2011 First Databank, Inc.

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)?

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 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; 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.

Read the Dermatop Emollient Cream (prednicarbate emollient cream) Side Effects Center for a complete guide to possible side effects »

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.

Side Effects Centers

Dermatop Emollient Cream Patient Information including How Should I Take

What should I discuss with my healthcare provider before using prednicarbate topical (Dermatop Emollient Cream)?

You should not use this medication if you are allergic to prednicarbate.

To make sure you can safely use prednicarbate topical, tell your doctor if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

FDA pregnancy category C. It is not known whether prednicarbate topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Prednicarbate topical cream or ointment contains an ingredient that can break down latex rubber, such as a condom or diaphragm. This can damage these items and make them less effective in preventing pregnancy or sexually transmitted disease. Avoid getting prednicarbate topical on a condom or diaphragm. This medication should not be used in the vagina or rectum.

It is not known whether prednicarbate topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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.

How should I use prednicarbate topical (Dermatop Emollient Cream)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Wash your hands before and after using prednicarbate topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

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.

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. It is important to use prednicarbate topical regularly to get the most benefit.

To be sure this medication is not causing harmful effects with long-term use, you may need blood tests. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat. Keep from freezing.

Side Effects Centers

Dermatop Emollient Cream Patient Information including If I Miss a Dose

What happens if I miss a dose (Dermatop Emollient Cream)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Dermatop Emollient Cream)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of prednicarbate topical is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using prednicarbate topical (Dermatop Emollient Cream)?

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.

What other drugs will affect prednicarbate topical (Dermatop Emollient Cream)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied prednicarbate. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about prednicarbate topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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