CLODAN- clobetasol propionate shampoo

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

clobetasol propionate (UNII: 779619577M) (clobetasol - UNII:ADN79D536H)

Commercializzato da:

Medimetriks Pharmaceuticals

INN (Nome Internazionale):

clobetasol propionate

Composizione:

clobetasol propionate 0.5 mg in 1 mL

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Clodan® (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 Clodan® (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)] . Clodan® (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 th

Dettagli prodotto:

Clodan® (clobetasol propionate) Shampoo, 0.05% is a translucent, colorless viscous liquid, supplied in 4 fl. oz. (118 mL) bottles. NDC 43538-950-04 Storage: Keep bottle 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).

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CLODAN- CLOBETASOL PROPIONATE SHAMPOO
MEDIMETRIKS PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLODAN (CLOBETASOL
PROPIONATE) SHAMPOO, 0.05% SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
CLODAN (CLOBETASOL PROPIONATE) SHAMPOO, 0.05%.
CLODAN (CLOBETASOL PROPIONATE) SHAMPOO, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Clodan (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)
Clodan (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.
Clodan (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 (50 mL or 1.75 fl. oz.) per week.
(2)
Clodan (clobetasol propionate) Shampoo, 0.05% 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
Clodan (clobetasol propionate) Shampoo, 0.05% 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