CLOBETASOL PROPIONATE spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Available from:

Paddock Laboratories, LLC.

INN (International Name):

CLOBETASOL PROPIONATE

Composition:

CLOBETASOL PROPIONATE 0.5 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol Propionate 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. Patients should be instructed to use Clobetasol Propionate 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 [see Use in Specific Populations (8.4) ]. Clobetasol Propionate Spray, 0.05% should not be used on the face, axillae, or groin. Clobetasol Propionate Spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol Propionate Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis. None. Risk Summary There are no available data on

Product summary:

Clobetasol Propionate Spray, 0.05% is a clear, colorless liquid, supplied in a white HDPE bottle with a white polypropylene cap and HDPE liner in the following sizes: 2 fl oz/59 mL NDC 0574-2063 -02 4.25 fl oz/125 mL NDC 0574-2063 -04 Storage: Keep tightly closed. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Do not freeze, refrigerate or store above 86°F (30°C). Spray is flammable; avoid heat, flame or smoking when using this product.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SPRAY
PADDOCK LABORATORIES, LLC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL PROPIONATE SPRAY SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBETASOL
PROPIONATE SPRAY.
CLOBETASOL PROPIONATE SPRAY, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Clobetasol Propionate 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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Spray, 0.05% w/w (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
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ADVERSE REACTIONS
In controlled, clinical trials with Clobetasol Propionate 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 PERRIGO AT
1-866-634-9120 OR FDA AT 1-800-FDA-1088
O RWWW.FDA.G O V/ME DWATC H.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2020
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)
Not for oral, ophthalmic, or intravaginal use. (1.2)
Spray directly onto the affected skin areas twice daily and rub in
gently. (2)
The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per
week. Do not use more than 26 sprays per
application or 52 sprays per day. (2)
Treatment beyond 2 weeks should be limited to localized lesions of
moderate to severe plaque psoriasis that have
not sufficiently improved after the initial 2 weeks of treatment with
Clobetasol Propionate Spray, 0.05%. (2)
Do not use for more than 4 weeks. (2)
Clobetasol propionate is a highly potent topical corticosteroid that