CLOBETASOL PROPIONATE- clobetasol propionate lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Clobetasol Propionate (UNII: 779619577M) (Clobetasol - UNII:ADN79D536H)

Available from:

Teligent Pharma, Inc.

INN (International Name):

Clobetasol Propionate

Composition:

Clobetasol Propionate .05 mg in 100 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol Propionate Lotion 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. Treatment should be limited to 2 consecutive weeks. For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 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 Lotion 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

Product summary:

Clobetasol Propionate Lotion 0.05% is a white liquid, supplied in the following sizes: 2 fl oz/59 mL NDC  52565-055-02 high density polyethylene bottles 4 fl oz/118 mL NDC  52565-055-04 high density polyethylene bottles Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE LOTION
TELIGENT PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL PROPIONATE LOTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBETASOL
PROPIONATE LOTION.
CLOBETASOL PROPIONATE LOTION, FOR TOPICAL USE.
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Clobetasol Propionate Lotion, 0.05% is a corticosteroid indicated for
the relief of the inflammatory and pruritic
manifestations of corticosteroid-responsive dermatoses, in patients 18
years of age or older. (1.1).
Limitations of Use: (1)
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)
DOSAGE AND ADMINISTRATION
Not for oral, ophthalmic, or intravaginal use. (2)
Clobetasol Propionate Lotion 0.05% should be applied directly onto the
affected skin areas twice daily and rubbed in
gently. (2)
Clobetasol Propionate Lotion 0.05% contains a super-high potent
topical corticosteroid; therefore treatment should be
limited to 2 weeks. For moderate to severe plaque psoriasis, treatment
may be extended for additional 2 weeks for
localized lesions (<10% body surface area) that have not sufficiently
improved. (2)
Total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.
(2)
DOSAGE FORMS AND STRENGTHS
Lotion, 0.05% (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Clobetasol propionate is a highly potent topical corticosteroid that
has been shown to suppress the hypothalamic-pituitary-
adrenal (HPA) axis at the lowest doses tested. (5.1)
Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes
mellitus can also result from systemic absorption of
topical corticosteroids. (5.1)
Systemic absorption may require periodic evaluation for HPA axis
suppression. Modify use if HPA axis suppression
develops. (5.1)
Children may be more susceptible to systemic toxicity from use of
topical corticoster