Prednicarbate Ointment (Dermatop Ointment)
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Prednicarbate Ointment (Dermatop Ointment)

DERMATOP® Ointment
(prednicarbate) Ointment 0.1%

DRUG DESCRIPTION

DERMATOP® Ointment (prednicarbate ointment) 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents.

Each gram of DERMATOP Ointment 0.1% contains 1.0mg of prednicarbate in a base consisting of white petrolatum, octyldodecanol, glyceryl oleate, propylene glycol, citric acid, and propyl gallate.

Prednicarbate has the empirical formula C27H36O8 and a molecular weight of 488.58. The CAS Registry Number is 73771-04-7. The chemical structure is:

DERMATOP®  Ointment (prednicarbate) Structural Formula Illustration

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 Ointment »

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

INDICATIONS

DERMATOP Ointment (prednicarbate ointment) 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

DOSAGE AND ADMINISTRATION

Apply a thin film of DERMATOP Ointment (prednicarbate ointment) 0.1% to the affected skin areas twice daily. Rub in gently.

HOW SUPPLIED

DERMATOP Ointment (prednicarbate ointment) 0.1% is supplied in 15 gram (NDC 0066-0508-15) and 60 gram (NDC 0066-0508-60) tubes.

Store at controlled room temperature (59 to 86°F or 15 to 30°C).

Dermik Laboratories a business of sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised November 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 clinical studies, the incidence of adverse reactions associated with the use of DERMATOP Ointment (prednicarbate ointment) 0.1% was approximately 1.5%. Reported reactions including burning, pruritis, drying, scaling, cracking and pain and irritant dermatitis.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings and especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae and miliaria.

Read the Dermatop Ointment (prednicarbate ointment) 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 receiving a large dose of a higher potency topical steroid applied 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 Ointment (prednicarbate ointment) 0.1% did not produce significant HPA-axis suppression when used at a dose of 60 grams per day for a week in patients with extensive psoriasis or atopic dermatitis.

However, if HPA-axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA-axis function is generally prompt and complete 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 Ointment (prednicarbate ointment) 0.1% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as 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 Ointment (prednicarbate ointment) 0.1% 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 1900times and 45times, respectively, 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 which was higher than the spontaneous rate were noted.

In rabbits, there was noted increased liver weights and slight increase in the fetal intrauterine death rate. The fetuses 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. Therefore, DERMATOP Ointment (prednicarbate ointment) 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 Ointment (prednicarbate ointment) 0.1% is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of DERMATOP Ointment (prednicarbate ointment) 0.1% in pediatric patients below the age of 10 years have not been established. 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 when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in pediatric patients. (See PRECAUTIONS.)

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

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 Ointment (prednicarbate ointment) 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

Like other topical corticosteroids, prednicarbate has anti-inflammatory, anti-pruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, 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. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin while inflammation and/or other disease processes in the skin increase percutaneous absorption.

Studies performed with DERMATOP Ointment (prednicarbate ointment) 0.1% indicate that it is in the medium range of potency as 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 or 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. This medication should not be used on the face, underarms, or groin areas.
  6. Contact between Dermatop Ointment (prednicarbate ointment) 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 Ointment (prednicarbate ointment) 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.

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 or 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. This medication should not be used on the face, underarms, or groin areas.
  6. Contact between Dermatop Ointment (prednicarbate ointment) 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 Ointment (prednicarbate ointment) 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.

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

DERMATOP® Ointment
(prednicarbate) Ointment 0.1%

DRUG DESCRIPTION

DERMATOP® Ointment (prednicarbate ointment) 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents.

Each gram of DERMATOP Ointment 0.1% contains 1.0mg of prednicarbate in a base consisting of white petrolatum, octyldodecanol, glyceryl oleate, propylene glycol, citric acid, and propyl gallate.

Prednicarbate has the empirical formula C27H36O8 and a molecular weight of 488.58. The CAS Registry Number is 73771-04-7. The chemical structure is:

DERMATOP®  Ointment (prednicarbate) Structural Formula Illustration

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

DERMATOP® Ointment
(prednicarbate) Ointment 0.1%

DRUG DESCRIPTION

DERMATOP® Ointment (prednicarbate ointment) 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents.

Each gram of DERMATOP Ointment 0.1% contains 1.0mg of prednicarbate in a base consisting of white petrolatum, octyldodecanol, glyceryl oleate, propylene glycol, citric acid, and propyl gallate.

Prednicarbate has the empirical formula C27H36O8 and a molecular weight of 488.58. The CAS Registry Number is 73771-04-7. The chemical structure is:

DERMATOP®  Ointment (prednicarbate) Structural Formula Illustration

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

DERMATOP® Ointment
(prednicarbate) Ointment 0.1%

DRUG DESCRIPTION

DERMATOP® Ointment (prednicarbate ointment) 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents.

Each gram of DERMATOP Ointment 0.1% contains 1.0mg of prednicarbate in a base consisting of white petrolatum, octyldodecanol, glyceryl oleate, propylene glycol, citric acid, and propyl gallate.

Prednicarbate has the empirical formula C27H36O8 and a molecular weight of 488.58. The CAS Registry Number is 73771-04-7. The chemical structure is:

DERMATOP®  Ointment (prednicarbate) Structural Formula Illustration

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

Dermatop Ointment Patient Information Including Side Effects

Brand Names: Dermatop

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

What is prednicarbate topical (Dermatop Ointment)?

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 Ointment)?

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 Ointment (prednicarbate ointment) Side Effects Center for a complete guide to possible side effects »

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

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 Ointment Patient Information including How Should I Take

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

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 Ointment)?

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 Ointment Patient Information including If I Miss a Dose

What happens if I miss a dose (Dermatop Ointment)?

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 Ointment)?

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 Ointment)?

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 Ointment)?

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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.01. Revision date: 9/20/2011.

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