CLOBETASOL PROPIONATE shampoo

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Sandoz Inc.

INN (International Name):

CLOBETASOL PROPIONATE

রচনা:

CLOBETASOL PROPIONATE 0.05 g in 100 mL

প্রশাসন রুট:

TOPICAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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) ]. 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. None Terat

পণ্য সারাংশ:

Clobetasol Propionate Shampoo, 0.05%, is a translucent, colorless to pale yellow viscous liquid, supplied in 4 fl. oz. (118 mL) bottles. NDC 0781-7137-04 Storage: Keep tightly closed. Store at USP controlled room temperature 68˚ to 77˚F (20˚ - 25˚C), with excursions permitted between 59˚ and 86˚F (15˚ - 30˚C).

অনুমোদন অবস্থা:

New Drug Application Authorized Generic

পণ্য বৈশিষ্ট্য

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE SHAMPOO
SANDOZ INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL PROPIONATE SHAMPOO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBETASOL
PROPIONATE SHAMPOO. CLOBETASOL PROPIONATE
SHAMPOO, 0.05% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1985
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)
DOSAGE AND ADMINISTRATION
Not for oral, ophthalmic, or intravaginal use. (2)
Clobetasol Propionate Shampoo, 0.05% should be applied onto dry (not
wet) scalp once a day in a thin film to the
affected areas only, and left in place for 15 minutes before lathering
and rinsing. Clobetasol Propionate Shampoo,
0.05% contains a super-high potent topical corticosteroid; therefore
treatment should be limited to 4 weeks. (2)
As with other corticosteroids, therapy should be discontinued when
control is achieved. (2).
Total dosage should not exceed 50 g (50mL or 1.75 fl. oz.) per week.
(2)
Clobetasol Propionate Shampoo should not be used with a shower cap or
bathing cap. (2)
DOSAGE FORMS AND STRENGTHS
Shampoo, 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 corticosteroids (5.1, 8.4)
If irritation develops in the p