Alclometasone Dipropionate (Page 2 of 2)

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. Alclometasone dipropionate 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 alclometasone dipropionate cream or ointment is administered to a nursing woman.

Pediatric Use

Alclometasone dipropionate 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 alclometasone dipropionate 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 alclometasone dipropionate 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 alclometasone dipropionate 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.

Alclometasone dipropionate 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 alclometasone dipropionate 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 alclometasone dipropionate ointment in geriatric patients, and the single adverse reaction reported with alclometasone dipropionate cream in this population was similar to those reactions reported by younger patients. Based on available data, no adjustment of dosage of alclometasone dipropionate cream and ointment in geriatric patients is warranted.

ADVERSE REACTIONS

The following local adverse reactions have been reported with alclometasone dipropionate cream in approximately 2% of patients: itching and burning, erythema, dryness, irritation, and papular rashes.

The following local adverse reactions have been reported with alclometasone dipropionate 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.

OVERDOSAGE

Topically applied alclometasone dipropionate cream and ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin film of alclometasone dipropionate cream USP or alclometasone dipropionate ointment USP to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.

Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate 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.

Alclometasone dipropionate cream or ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate 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.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with alclometasone dipropionate cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

Alclometasone dipropionate cream USP, 0.05% is supplied in:

15 gram tube NDC 54868-2861-0
45 gram tube NDC 54868-2861-1

Store between 2° and 30°C (36° and 86°F).

Manufactured by:

Glenmark Generics Ltd.
Village Kishanpura, Baddi Nalagarh Road
District: Solan, Himachal Pradesh — 174101, India

Manufactured for:
Glenmark logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkgenerics.com

July 2011

Additional barcode label applied by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

Alclometasone dipropionate cream USP, 0.05%

45 gram

NDC 54868-2861-1

Alclometason Dipropionate Cream USP, 0.05% 45g Tube Label
(click image for full-size original)
ALCLOMETASONE DIPROPIONATE alclometasone dipropionate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-2861(NDC:64862-300)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCLOMETASONE DIPROPIONATE (ALCLOMETASONE) ALCLOMETASONE DIPROPIONATE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
PETROLATUM
CETOSTEARYL ALCOHOL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
CHLOROCRESOL
PHOSPHORIC ACID
WATER
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
CETETH-20
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2861-0 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (54868-2861-0)
2 NDC:54868-2861-1 1 TUBE (TUBE) in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (54868-2861-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079061 06/23/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 07/2011 Physicians Total Care, Inc.

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