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Aclovate
Overview
What is Aclovate?
ACLOVATE (alclometasone dipropionate cream) Cream, 0.05% and ACLOVATE (alclometasone dipropionate ointment) Ointment, 0.05% contain alclometasone dipropionate (7α-chloro-11β,17,21 -trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21 -dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.
Chemically, alclometasone dipropionate is CHCIO. It has the following structural formula:
Alclometasone dipropionate has the molecular weight of 521. It is a white powder insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol.
Each gram of ACLOVATE Cream contains 0.5 mg of alclometasone dipropionate in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, glyceryl stearate, PEG 100 stearate, Ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water.
Each gram of ACLOVATE Ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum.
What does Aclovate look like?
What are the available doses of Aclovate?
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What should I talk to my health care provider before I take Aclovate?
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How should I use Aclovate?
ACLOVATE Cream and Ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ACLOVATE Cream and Ointment may be used 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 (see ). Since the safety and efficacy of ACLOVATE Cream and Ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
Apply a thin film of ACLOVATE Cream or Ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.
ACLOVATE Cream and Ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of ACLOVATE Cream or Ointment 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 diagnosis may be necessary.
ACLOVATE Cream or Ointment should not be used with occlusive dressings unless directed by a physician. ACLOVATE Cream or Ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
What interacts with Aclovate?
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What are the warnings of Aclovate?
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What are the precautions of Aclovate?
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What are the side effects of Aclovate?
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What should I look out for while using Aclovate?
ACLOVATE Cream and Ointment are contraindicated in those patients with a history of hypersensitivity to any of the components in these preparations.
What might happen if I take too much Aclovate?
Topically applied ACLOVATE Cream and Ointment can be absorbed in sufficient amounts to produce systemic effects (see ).
How should I store and handle Aclovate?
Store bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (USP).ACLOVATE (alclometasone dipropionate cream) Cream, 0.05% is supplied in: ACLOVATE (alclometasone dipropionate ointment) Ointment, 0.05% is supplied in: Store between 2° and 30°C (36° and 86°F).PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com R4/11 ACLOVATE (alclometasone dipropionate cream) Cream, 0.05% is supplied in: ACLOVATE (alclometasone dipropionate ointment) Ointment, 0.05% is supplied in: Store between 2° and 30°C (36° and 86°F).PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com R4/11 ACLOVATE (alclometasone dipropionate cream) Cream, 0.05% is supplied in: ACLOVATE (alclometasone dipropionate ointment) Ointment, 0.05% is supplied in: Store between 2° and 30°C (36° and 86°F).PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com R4/11 ACLOVATE (alclometasone dipropionate cream) Cream, 0.05% is supplied in: ACLOVATE (alclometasone dipropionate ointment) Ointment, 0.05% is supplied in: Store between 2° and 30°C (36° and 86°F).PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com R4/11 ACLOVATE (alclometasone dipropionate cream) Cream, 0.05% is supplied in: ACLOVATE (alclometasone dipropionate ointment) Ointment, 0.05% is supplied in: Store between 2° and 30°C (36° and 86°F).PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com R4/11
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Like other topical corticosteroids, alclometasone dipropionate has anti-inflammatory, antipruritic, 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 A 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 A.
Non-Clinical Toxicology
ACLOVATE Cream and Ointment are contraindicated in those patients with a history of hypersensitivity to any of the components in these preparations.Propafenone is metabolized by CYP2D6 (major pathway) and CYP1A2 and CYP3A4. Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, sertraline), CYP1A2 (such as amiodarone), and CYP3A4 (such as ketaconazole, ritonavir, saquinavir, erythromycin, and grapefruit juice) can be expected to cause increased plasma levels of propafenone. Appropriate monitoring is recommended when propafenone ER capsules are used together with such drugs. In addition, propafenone is an inhibitor of CYP2D6. Coadministration of propafenone with drugs metabolized by CYP2D6 (such as desipramine, imipramine, haloperidol, venlafaxine) might lead to increased plasma concentrations of these drugs. The effect of propafenone on the P-Glycoprotein transporter has not been studied.
General:
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 ).
If irritation develops, ACLOVATE Cream or Ointment should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing 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 (). The clinical relevance of the findings in animal studies to humans is not clear.
The following local adverse reactions have been reported with ACLOVATE Cream in approximately 2% of patients: itching and burning, erythema, dryness, irritation, and papular rashes.
The following local adverse reactions have been reported with ACLOVATE Ointment in approximately 1% of patients: itching, burning, and erythema. 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 approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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