DIPROLENE- betamethasone dipropionate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Merck Sharp & Dohme Corp.

INN (International Name):

betamethasone dipropionate

Composition:

betamethasone 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DIPROLENE® 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. DIPROLENE 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 DIPROLENE 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 DIPROLENE Ointment may increase the risk of having a low birthweight infant and to use DIPROLENE Ointment on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, increased malformations, including umbilical he

Product summary:

DIPROLENE Ointment 0.05% is a white ointment supplied in 15-g (NDC 0085-0575-02) and 50-g (NDC 0085-0575-05) tubes. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

DIPROLENE- BETAMETHASONE DIPROPIONATE OINTMENT
MERCK SHARP & DOHME CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIPROLENE OINTMENT SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DIPROLENE OINTMENT.
DIPROLENE (AUGMENTED BETAMETHASONE DIPROPIONATE) OINTMENT, FOR TOPICAL
USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
DIPROLENE 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: DIPROLENE 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: DIPROLENE 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%) are: erythema, folliculitis,
pruritus, and vesiculation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MERCK SHARP & DOHME
COR