Aclovate

Name: Aclovate

What should I discuss with my healthcare provider before using Aclovate (alclometasone topical)?

You should not use alclometasone topical if you are allergic to it.

Do not use alclometasone topical to treat diaper rash.

To make sure alclometasone topical is safe for you, tell your doctor if you have:

  • bacterial, fungal, or viral skin infection.

Steroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

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

It is not known whether alclometasone topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Alclometasone topical should not be used on a child younger than 1 year old. Do not use this medicine on any child without a doctor's advice. Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects.

How should I use Aclovate (alclometasone topical)?

Alclometasone topical is usually applied 2 or 3 times per day. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

Apply a small amount to the affected area and rub it gently into the skin. Do not apply alclometasone topical over a large area of skin.

Do not cover the treated skin area unless your doctor tells you to.

Call your doctor if your symptoms do not improve after 2 weeks of treatment, or if they get worse while using alclometasone topical.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

Cautions for Aclovate

Contraindications

  • Known hypersensitivity to alclometasone, other corticosteroids, or any ingredient in the formulation.1 d

Warnings/Precautions

Sensitivity Reactions

Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.b c d

General Precautions

Hypothalamic-Pituitary-Adrenal Axis Suppression

Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.c d

Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.b c d

If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, and/or substitute a less potent corticosteroid.c d

HPA-axis function recovery generally is prompt and complete following drug discontinuance.c d

Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.b c d

Systemic Effects

Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.b c d

Adverse systemic effects may occur when corticosteroids are used on large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.b

Infants and children may be more susceptible to adverse systemic effects.c d (See Pediatric Use under Cautions.)

Local Effects

Possible adverse local reactions (e.g., burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.b

Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue;b these effects are most likely to occur (even with short-term use) in intertriginous (e.g., axilla, groin), flexor, and facial areas.b

If irritation occurs, discontinue drug and institute appropriate therapy.c d

Skin Infection

If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy.c d If infection does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.c d

When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation.b In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.b (See Occlusive Dressings under Cautions.)

Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection (including vaccinia and varicella and herpes simplex of the eye or adjacent skin).b However, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.b

Occlusive Dressings

Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly.b (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also see Systemic Effects, under Cautions.)

Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.b c d (See Local Effects under Cautions.)

Do not use occlusive dressings on weeping or exudative lesions.b

Do not use occlusive dressings in patients with primary skin infection.b

Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.b

Use plastic occlusive material with care to avoid the risk of suffocation.b

Specific Populations

Pregnancy

Category C.c d

Lactation

Not known whether topical alclometasone is distributed into milk.c d Caution advised if topical alclometasone is used.c d

Pediatric Use

Safety and efficacy not established in children <1 year of age.c d

Do not use for the treatment of diaper dermatitis; tight-fitting diapers or plastic pants should not be used on a child being treated with alclometasone in the diaper area, since such garments may constitute occlusive dressings.c d

Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio, especially when topical corticosteroids are applied to >20% of body surface area.c d The risk of adrenal suppression appears to increase with decreasing age.b (See Systemic Effects under Cautions.)

Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and lack of response to corticotropin (ACTH) stimulation.b c d

Children also are at greater risk of glucocorticoid insufficiency during and/or after withdrawal of treatment.b c d

Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.b c d

Striae have been reported in children treated inappropriately with topical corticosteroids.b c d

Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development.b

Geriatric Use

Response in limited number of patients ≥65 years of age does not appear to differ from that in younger adults.c d

Common Adverse Effects

Burning, itching, erythema, irritation,, dryness, papular rash, folliculitis, acneiform eruptions, hypopigmentationc , perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria.c d

Interactions for Aclovate

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Nitroblue-tetrazolium test for bacterial infection

Concurrent use of corticosteroids reportedly may result in false-negative resultsb

How do I store and/or throw out Aclovate?

  • Store at room temperature. Do not freeze.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

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 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 to areas 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.

The effects of Aclovate® Cream and Ointment on the HPA axis have been evaluated. In one study, Aclovate® Cream and Ointment were applied to 30% of the body twice daily for 7 days, and occlusive dressings were used in selected patients either 12 hours or 24 hours daily. In another study, Aclovate® Cream was applied to 80% of the body surface of normal subjects twice daily for 21 days with daily 12-hour periods of whole body occlusion. Average plasma and urinary free cortisol levels and urinary levels of 17-hydroxysteroids were decreased (about 10%), suggesting suppression of the HPA axis under these conditions. Plasma cortisol levels have also been demonstrated to decrease in pediatric patients treated twice daily for 3 weeks without occlusion.

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 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 area to body mass ratios (see PRECAUTIONS: Pediatric Use).

If irritation develops, Aclovate® Cream or Ointment 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 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 Aclovate® Cream or Ointment should be discontinued until the infection has been adequately controlled.

In a transgenic mouse study, chronic use of Aclovate cream led to an increased number of animals with benign neoplasms of the skin at the treatment site (see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility). The clinical relevance of the findings in animal studies to humans is not clear.

Information for Patients: 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 Aclovate® Cream or Ointment in the treatment of diaper dermatitis. Aclovate® Cream or Ointment 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 unless directed by the physician.
  7. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

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, Impairment of Fertility:

Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of alclometasone dipropionate. The effects of alclometasone dipropionate on mutagenesis or fertility have not been evaluated.

In a 26-week dermal carcinogenicity study conducted in transgenic (Tg.AC) mice, topical application once daily of both the vehicle cream and the 0.05% alclometasone dipropionate cream significantly increased the incidence of benign neoplasms of the skin in both sexes at the treatment site when compared to untreated controls. This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear.

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. There are no adequate and well-controlled studies in pregnant women. Aclovate® Cream or Ointment 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 topical 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 Aclovate® Cream or Ointment is administered to a nursing woman.

Pediatric Use: Aclovate® Cream and Ointment may be used with caution in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Use of Aclovate® Cream and Ointment is supported by results from adequate and well-controlled studies in pediatric patients with corticosteroid-responsive dermatoses. Since the safety and efficacy of Aclovate® Cream and Ointment have not been established in pediatric patients below 1 year of age, its 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 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. Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children. Pediatric patients applying Aclovate® Cream or Ointment to >20% of the body surface area are at higher risk for HPA axis suppression.

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

Aclovate® Cream or Ointment should not be used in the treatment of diaper dermatitis.

Geriatric Use: A limited number of patients at or above 65 years of age have been treated with Aclovate® Cream and Ointment in US clinical trials. The number of patients is too small to permit separate analysis of efficacy and safety. No adverse events were reported with Aclovate® Ointment in geriatric patients, and the single adverse reaction reported with Aclovate® Cream in this population was similar to those reactions reported by younger patients. Based on available data, no adjustment of dosage of Aclovate® Cream and Ointment in geriatric patients is warranted.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Change in color of skin.
  • Skin changes (pimples, stretch marks, slow healing, hair growth).
  • Skin irritation.

Alclometasone topical Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. Comments: Corticosteroids should not be used extensively in large amounts for prolonged periods of time in pregnant women. US FDA Pregnancy Category: C

Animal studies have revealed evidence of teratogenicity when corticosteroids are administered systemically or topically. There are no adequate and well-controlled studies in pregnant women. US FDA Pregnancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Administrative Information

LactMed Record Number

413

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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