CLOBETASOL PROPIONATE
Generic: CLOBETASOL PROPIONATE
Basic Information
Manufacturer
Alembic Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
91e7bf57-d236-4b9b-8241-e71e5e93617a
Indications & Usage
1 INDICATIONS AND USAGE Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older.
( 1 ) Limitations of Use: Do not use on the face, axillae or groin.
( 1.2 ) Avoid any contact with the eyes and lips.
( 1.2 ) 1.1 Indication Clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older.
Treatment should be limited to 4 consecutive weeks.
The total dosage should not exceed 50 g (50 mL or 1.75 fl.
oz.) per week.
Patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see Dosage and Administration ( 2 )].
Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [ see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 ) ].
1.2 Limitations of Use Clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae.
Avoid any contact of the drug product with the eyes and lips.
In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.
( 1 ) Limitations of Use: Do not use on the face, axillae or groin.
( 1.2 ) Avoid any contact with the eyes and lips.
( 1.2 ) 1.1 Indication Clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older.
Treatment should be limited to 4 consecutive weeks.
The total dosage should not exceed 50 g (50 mL or 1.75 fl.
oz.) per week.
Patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see Dosage and Administration ( 2 )].
Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [ see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 ) ].
1.2 Limitations of Use Clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae.
Avoid any contact of the drug product with the eyes and lips.
In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions are burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc.
at 1-866-210-9797 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 clinical trials with clobetasol propionate shampoo, 0.05%, the following adverse reactions have been reported: headache, burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.
Table 1 summarizes selected adverse reactions that occurred in at least 1% of subjects in the Phase 2 and 3 studies for scalp psoriasis.
Table 1: Summary of Selected Adverse Reactions ≥ 1% by Body System Body System Clobetasol Propionate Shampoo, 0.05% N=558 Vehicle Shampoo N=127 Skin and Appendages 49 (8.8%) 28 (22.0%) Discomfort Skin 26 (4.7%) 16 (12.6%) Pruritus 3 (0.5%) 9 (7.1%) Body as a Whole 33 (5.9%) 12 (9.4%) Headache 10 (1.8%) 1 (0.8%) Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria 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 shampoo, 0.05%.
Endocrine disorders: Cushing's syndrome, Adrenal suppression Eye: Eye pain, Vision blurred, Eye irritation CNS: Dizziness GI: Nausea Skin: Erythema, Skin exfoliation, Rash, Skin irritation, Hair color changes, Allergic contact dermatitis, Pain of skin, Skin tightness Other: Psoriasis (aggravation)
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc.
at 1-866-210-9797 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 clinical trials with clobetasol propionate shampoo, 0.05%, the following adverse reactions have been reported: headache, burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.
Table 1 summarizes selected adverse reactions that occurred in at least 1% of subjects in the Phase 2 and 3 studies for scalp psoriasis.
Table 1: Summary of Selected Adverse Reactions ≥ 1% by Body System Body System Clobetasol Propionate Shampoo, 0.05% N=558 Vehicle Shampoo N=127 Skin and Appendages 49 (8.8%) 28 (22.0%) Discomfort Skin 26 (4.7%) 16 (12.6%) Pruritus 3 (0.5%) 9 (7.1%) Body as a Whole 33 (5.9%) 12 (9.4%) Headache 10 (1.8%) 1 (0.8%) Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria 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 shampoo, 0.05%.
Endocrine disorders: Cushing's syndrome, Adrenal suppression Eye: Eye pain, Vision blurred, Eye irritation CNS: Dizziness GI: Nausea Skin: Erythema, Skin exfoliation, Rash, Skin irritation, Hair color changes, Allergic contact dermatitis, Pain of skin, Skin tightness Other: Psoriasis (aggravation)