Clobetasol Propionate
Generic: CLOBETASOL PROPIONATE
Basic Information
Manufacturer
Sun Pharmaceutical Industries, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
d8246614-757b-4e27-8c3e-37fcb401e6d9
Indications & Usage
1.
INDICATIONS AND USAGE Clobetasol Propionate Topical Spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.
( 1.1 ) Limitations of Use: Do not use on the face, axillae or groin.
( 1.2 ) Do not use if atrophy is present at the treatment site.( 1.2 ) Do not use for rosacea or perioral dermatitis.
( 1.2 ) 1.1 Indication Clobetasol Propionate Topical Spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.
The total dosage should not exceed 50 g (59 mL or 2 fl.
oz.) per week.
Do not use more than 26 sprays per application or 52 sprays per day.
Treatment should be limited to 4 consecutive weeks.
Patients should be instructed to use Clobetasol Propionate Topical Spray, 0.05% for the minimum amount of time necessary to achieve the desired results [ see Dosage and Administration (2) ].
Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations.
1.2 Limitations of Use Clobetasol Propionate Topical Spray, 0.05% should not be used on the face, axillae, or groin.
Clobetasol Propionate Topical Spray, 0.05% should not be used if there is atrophy at the treatment site.
Clobetasol Propionate Topical Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
INDICATIONS AND USAGE Clobetasol Propionate Topical Spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.
( 1.1 ) Limitations of Use: Do not use on the face, axillae or groin.
( 1.2 ) Do not use if atrophy is present at the treatment site.( 1.2 ) Do not use for rosacea or perioral dermatitis.
( 1.2 ) 1.1 Indication Clobetasol Propionate Topical Spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.
The total dosage should not exceed 50 g (59 mL or 2 fl.
oz.) per week.
Do not use more than 26 sprays per application or 52 sprays per day.
Treatment should be limited to 4 consecutive weeks.
Patients should be instructed to use Clobetasol Propionate Topical Spray, 0.05% for the minimum amount of time necessary to achieve the desired results [ see Dosage and Administration (2) ].
Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations.
1.2 Limitations of Use Clobetasol Propionate Topical Spray, 0.05% should not be used on the face, axillae, or groin.
Clobetasol Propionate Topical Spray, 0.05% should not be used if there is atrophy at the treatment site.
Clobetasol Propionate Topical Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
Adverse Reactions
6.
ADVERSE REACTIONS In controlled, clinical trials with Clobetasol Propionate Topical Spray, 0.05%, the most common adverse reactions (incidence > 2%) were burning, pruritus, nasopharyngitis, upper respiratory tract infection.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In controlled, clinical trials with Clobetasol Propionate Topical Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with Clobetasol Propionate Topical Spray, 0.05% and 47% of subjects treated with Spray Vehicle].
Other commonly reported adverse reactions for Clobetasol Propionate Topical Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1.
Table 1 - Commonly Occurring Adverse Reactions (≥1% Incidence) Adverse Reaction Clobetasol Propionate Topical Spray, 0.05% (N=120) Vehicle Spray (N=120) System Organ Class General disorders and administration site conditions 50 (42%) 56 (47%) Application site burning 48 (40%) 56 (47%) Application site dryness 2 (2%) 0 (0%) Application site irritation 1 (1%) 0 (0%) Application site pain 1 (1%) 2 (2%) Application site pigmentation changes 1 (1%) 0 (0%) Application site pruritus 4 (3%) 3 (3%) Infections and infestations 17 (14%) 12 (10%) Nasopharyngitis 6 (5%) 3 (3%) Pharyngitis streptococcal 1 (1%) 0 (0%) Upper respiratory tract infection 10 (8%) 2 (2%) Skin and subcutaneous tissue disorders 4 (3%) 2 (2%) Eczema asteatotic 2 (2%) 0 (0%) Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender.
Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients.
6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been identified during post-approval use of Clobetasol Propionate Topical Spray, 0.05%.
Skin: Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis.
ADVERSE REACTIONS In controlled, clinical trials with Clobetasol Propionate Topical Spray, 0.05%, the most common adverse reactions (incidence > 2%) were burning, pruritus, nasopharyngitis, upper respiratory tract infection.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In controlled, clinical trials with Clobetasol Propionate Topical Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with Clobetasol Propionate Topical Spray, 0.05% and 47% of subjects treated with Spray Vehicle].
Other commonly reported adverse reactions for Clobetasol Propionate Topical Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1.
Table 1 - Commonly Occurring Adverse Reactions (≥1% Incidence) Adverse Reaction Clobetasol Propionate Topical Spray, 0.05% (N=120) Vehicle Spray (N=120) System Organ Class General disorders and administration site conditions 50 (42%) 56 (47%) Application site burning 48 (40%) 56 (47%) Application site dryness 2 (2%) 0 (0%) Application site irritation 1 (1%) 0 (0%) Application site pain 1 (1%) 2 (2%) Application site pigmentation changes 1 (1%) 0 (0%) Application site pruritus 4 (3%) 3 (3%) Infections and infestations 17 (14%) 12 (10%) Nasopharyngitis 6 (5%) 3 (3%) Pharyngitis streptococcal 1 (1%) 0 (0%) Upper respiratory tract infection 10 (8%) 2 (2%) Skin and subcutaneous tissue disorders 4 (3%) 2 (2%) Eczema asteatotic 2 (2%) 0 (0%) Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender.
Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients.
6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been identified during post-approval use of Clobetasol Propionate Topical Spray, 0.05%.
Skin: Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis.