CLOBETASOL PROPIONATE shampoo

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Akorn

INN (nume internaţional):

CLOBETASOL PROPIONATE

Compoziție:

CLOBETASOL PROPIONATE .5 mg in 1 mL

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 Teratogenic e

Rezumat produs:

Clobetasol Propionate Shampoo, 0.05%, is a translucent, colorless to pale yellow viscous liquid, supplied in 4 fl. oz. (118 mL) bottles. NDC 50383-979-04 Storage: Keep tightly closed. Store at USP controlled room temperature 68˚ to 77˚F (20˚ to 25˚C), with excursions permitted between 59˚ and 86˚F (15˚ to 30˚C).

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SHAMPOO
AKORN
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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, FOR TOPICAL USE ONLY
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) (1)
Limitations of Use: (1) (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Shampoo, 0.05% (3) (3)
CONTRAINDICATIONS
None (4) (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) (5)
Cushing’s syndrome, hyperglycemia and unmasking of latent diabetes
mellitus can also result from
systemic absorption of topical corticosteroids. (5.1) (5)
Systemic absorption may require periodic evaluation for HPA axis
suppression. Modify use if HPA axis
suppression develops. (5.1) (5)
Children may be more susceptible to systemic toxicity from use of
topical corticosteroids. (5.1, 8.4) (5)
If irritation develops in the presence of dermatological infections,
the use of an appropriate antifungal or
antibacterial agent should be instituted. If a favorable response does
not occur promptly, use of clobetasol
propionate shampoo should be discontinued until the infection has been
adequately controlled. (5.3) (5)
Local adverse reactions with topical corticosteroids may occur more
frequently with the use of occlusive
dressings and higher potency corticosteroids, including clobetasol
propionate. These reactions include:
folliculitis, acneiform eruptions, hypopigmentation, perioral
dermatitis, allergic contact dermatitis,
secondary infection, striae and miliaria. (5.4) (5) (5)
ADVERSE REACTIONS
The most