Aclovate Information
Aclovate (Alclometasone) Description
Aclovate (Alclometasone) (alclometasone dipropionate cream) Cream, 0.05% and Aclovate (Alclometasone) (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 (Alclometasone) 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 (Alclometasone) Ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum.
Aclovate (Alclometasone) Clinical 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.
Aclovate (Alclometasone) Indications And Usage
Aclovate (Alclometasone) Cream and Ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Aclovate (Alclometasone) 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 (Alclometasone) Cream and Ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
Aclovate (Alclometasone) Contraindications
Aclovate (Alclometasone) Cream and Ointment are contraindicated in those patients with a history of hypersensitivity to any of the components in these preparations.
Aclovate (Alclometasone) Precautions
General:
The effects of Aclovate (Alclometasone) Cream and Ointment on the HPA axis have been evaluated. In one study, Aclovate (Alclometasone) 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 (Alclometasone) 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 (Alclometasone) 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 (Alclometasone) Cream or Ointment should be discontinued until the infection has been adequately controlled.
In a transgenic mouse study, chronic use of Aclovate (Alclometasone) 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.
Information for Patients:
Laboratory Tests:
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:
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Nursing Mothers:
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Pediatric Use:
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 (Alclometasone) Cream or Ointment should not be used in the treatment of diaper dermatitis.
Geriatric Use:
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Aclovate (Alclometasone) Adverse Reactions
The following local adverse reactions have been reported with Aclovate (Alclometasone) 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 (Alclometasone) 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.
Aclovate (Alclometasone) Overdosage
Topically applied Aclovate (Alclometasone) Cream and Ointment can be absorbed in sufficient amounts to produce systemic effects (see ).
Aclovate (Alclometasone) Dosage And Administration
Apply a thin film of Aclovate (Alclometasone) Cream or Ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.
Aclovate (Alclometasone) Cream and Ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of Aclovate (Alclometasone) 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 (Alclometasone) Cream or Ointment should not be used with occlusive dressings unless directed by a physician. Aclovate (Alclometasone) 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.
Aclovate (Alclometasone) How Supplied
Aclovate (Alclometasone) (alclometasone dipropionate cream) Cream, 0.05% is supplied in:
Aclovate (Alclometasone) (alclometasone dipropionate ointment) Ointment, 0.05% is supplied in:
PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com
R4/11
Aclovate (Alclometasone) Package Label – Principal Display Panel – G Label
PHARMADERM
Aclovate (Alclometasone) Cream, 0.05%
(alclometasone dipropionate cream)
For dermatologic use only – Not for ophthalmic use.
Rx only 60 g
Aclovate (Alclometasone) Package Label – Principal Display Panel – G Carton
PHARMADERM
Aclovate (Alclometasone) Cream, 0.05%
(alclometasone dipropionate cream)
For dermatologic use only – Not for ophthalmic use.
Rx only 60 g
Aclovate (Alclometasone)
Aclovate (Alclometasone)
