Clobetasol Propionate (Page 2 of 2)
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 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 either clobetasol propionate gel, cream or ointment is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of clobetasol propionate gel, cream, and ointment in pediatric patients have not been established. Use in children under 12 years of age 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 or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children (see PRECAUTIONS).
HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Geriatric Use
Clinical studies of clobetasol propionate drug products in US clinical trials did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.
Adverse Reactions to Clobetasol Propionate
In a controlled clinical trial with clobetasol propionate gel, the only reported adverse reaction that was considered to be drug related was a report of burning sensation (1.8% of treated patients). In controlled clinical trials, the most frequent adverse reactions reported for clobetasol propionate cream were burning and stinging sensation in 1% of treated patients. Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin. In controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia.
Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.
OVERDOSAGE
Topically applied clobetasol propionate gel, cream or ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
DOSAGE AND ADMINISTRATION
Apply a thin layer of clobetasol propionate gel, cream or ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE.)
Clobetasol propionate gel, cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Clobetasol propionate gel, cream or ointment should not be used with occlusive dressings.
HOW SUPPLIED
Clobetasol Propionate Gel, 0.05% is supplied in tamper-evident tubes:15 g (NDC 51672-1294-1), 30 g (NDC 51672-1294-2), and 60 g (NDC 51672-1294-3).
Clobetasol Propionate Cream USP, 0.05% is supplied in tamper-evident tubes: 15 g (NDC 51672-1258-1), 30 g (NDC 51672-1258-2), 45 g (NDC 51672-1258-6), and 60 g (NDC 51672-1258-3).
Clobetasol Propionate Ointment USP, 0.05% is supplied in tamper-evident tubes: 15 g (NDC 51672-1259-1), 30 g (NDC 51672-1259-2), 45 g (NDC 51672-1259-6), and 60 g (NDC 51672-1259-3).
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist by: Taro Pharmaceuticals U.S.A. , Inc., Hawthorne, NY 10532
Revised: October, 2019
PK-6540-2 11
PRINCIPAL DISPLAY PANEL — 60 g Tube Carton
NDC 51672-1294-3
Clobetasol Propionate Gel 0.05%
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.
60 g
Rx only
TARO
PRINCIPAL DISPLAY PANEL — 15 g Tube Carton
NDC 51672-1258-1
15 g
Clobetasol Propionate
Cream USP, 0.05%
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.
Rx only
TARO
PRINCIPAL DISPLAY PANEL — 15 g Ointment Tube Carton
NDC 51672-1259-1
15 g
Clobetasol Propionate
Ointment USP, 0.05%
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.
Rx only
TARO
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| CLOBETASOL PROPIONATE clobetasol propionate cream | |||||||||||||||||||||||||||||||||||||||||
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| CLOBETASOL PROPIONATE clobetasol propionate ointment | |||||||||||||||||||||||||||||||||||||||||
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| Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE (51672-1259), MANUFACTURE (51672-1294), MANUFACTURE (51672-1258) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Taro Pharmaceutical Industries Ltd. | 600072078 | MANUFACTURE (51672-1259), MANUFACTURE (51672-1258) | |
Revised: 05/2023 Taro Pharmaceuticals U.S.A., Inc.
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