BETAMETHASONE DIPROPIONATE ointment

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

betamethasone dipropionate (UNII: 826Y60901U) (betamethasone - UNII:9842X06Q6M)

Disponibil de la:

Prasco Laboratories

INN (nume internaţional):

betamethasone dipropionate

Compoziție:

betamethasone 0.5 mg in 1 g

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Augmented Betamethasone Dipropionate Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. Augmented Betamethasone Dipropionate Ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Risk Summary There are no available data on Augmented Betamethasone Dipropionate Ointment use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that Augmented Betamethasone Dipropionate Ointment may increase the risk of having a low birthweight infant and to use Augmented Betamethasone Dipropionate Ointment on the smallest

Rezumat produs:

Augmented Betamethasone Dipropionate Ointment 0.05% is a white ointment supplied in 15-g (NDC 66993-897-15) and 50-g (NDC 66993-897-49) tubes. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Statutul autorizaţiei:

New Drug Application Authorized Generic

Caracteristicilor produsului

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AUGMENTED
BETAMETHASONE DIPROPIONATE OINTMENT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR AUGMENTED BETAMETHASONE DIPROPIONATE OINTMENT.
AUGMENTED BETAMETHASONE DIPROPIONATE OINTMENT, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
Augmented Betamethasone Dipropionate Ointment is a corticosteroid
indicated for the relief of the
inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses in patients 13 years of
age and older. (1)
DOSAGE AND ADMINISTRATION
Apply a thin film to the affected skin areas once or twice daily. (2)
Discontinue therapy when control is achieved. (2)
Limit therapy to no more than 2 consecutive weeks. (2)
Use no more than 50 g per week. (2)
Do not use with occlusive dressings unless directed by a physician.
(2)
Avoid use on the face, groin, or axillae, or if skin atrophy is
present at the treatment site. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Ointment, 0.05% (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medicine. (4)
WARNINGS AND PRECAUTIONS
Effects on endocrine system: Augmented Betamethasone Dipropionate
Ointment can cause reversible
HPA axis suppression with the potential for glucocorticosteroid
insufficiency during and after withdrawal
of treatment. Risk factor(s) include the use of high-potency topical
corticosteroids, use over a large
surface area or to areas under occlusion, prolonged use, altered skin
barrier, liver failure, and use in
pediatric patients. Modify use should HPA axis suppression develop.
(5.1, 8.4)
Ophthalmic Adverse Reactions: Augmented Betamethasone Dipropionate
Ointment may increase the
risk of cataracts and glaucoma. If visual symptoms occur, consider
referral to an ophthalmologist for
evaluation. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (<1%)