alclometasone dipropionate 0.05 % Topical Ointment
OVERDOSAGE
: Topically applied alclometasone dipropionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
DESCRIPTION
: Alclometasone dipropionate ointment contains 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 C 28 H 37 ClO 7 .
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 alclometasone dipropionate ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum.
StructuralFormula
HOW SUPPLIED
: Alclometasone dipropionate ointment USP, 0.05% is supplied in 15 gram tube NDC 0168-0264-15 45 gram tube NDC 0168-0264-45 60 gram tube NDC 0168-0264-60 Store between 2° and 30°C (36° and 86°F).
E.
FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747 I2264D R09/12 #77
GERIATRIC USE
Geriatric Use: A limited number of patients at or above 65 years of age have been treated with alclometasone dipropionate 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.
Based on available data, no adjustment of dosage of alclometasone dipropionate ointment in geriatric patients is warranted.
INDICATIONS AND USAGE
: Alclometasone dipropionate ointment is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Alclometasone dipropionate 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 PRECAUTIONS: Pediatric Use ).
Since the safety and efficacy of alclometasone dipropionate ointment have not been established in pediatric patients below 1 year of age, the use in this age-group is not recommended.
PEDIATRIC USE
Pediatric Use: Alclometasone dipropionate 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 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 ointment has 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’s 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 ointment to >20% of the body surface area are at higher risk for HPA axis suppression.
HPA axis suppression, Cushing’s 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 ointment should not be used in the treatment of diaper dermatitis.
NUSRING MOTHERS
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 ointment is administered to a nursing woman.
INFORMATION FOR PATIENTS
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 alclometasone dipropionate ointment in the treatment of diaper dermatitis.
Alclometasone dipropionate 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.
DOSAGE AND ADMINISTRATION
: Apply a thin film of alclometasone dipropionate ointment to the affected skin areas two or three times daily; massage gently until the medication disappears.
Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older.
Safety and effectiveness of alclometasone dipropionate 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 ointment should not be used with occlusive dressings unless directed by a physician.
Alclometasone dipropionate 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 ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.