EPSOLAY- benzoyl peroxide cream

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Pieejams no:

Sol-Gel Technologies Inc.

Ievadīšanas:

TOPICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPSOLAY [see Warnings and Precautions (5.1)]. Risk Summary The systemic exposure of benzoyl peroxide is unknown. Based on the published literature, benzoyl peroxide is metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Hence, maternal use is not expected to result in fetal exposure to the drug. Animal reproductive studies have not been conducted with EPSOLAY or benzoyl peroxide. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Risk S

Produktu pārskats:

How Supplied EPSOLAY is a white to off-white cream supplied in an airless pump as follows: 50 gram pump: NDC 79167-005-50 Storage and Handling

Autorizācija statuss:

New Drug Application

Produkta apraksts

EPSOLAY- BENZOYL PEROXIDE CREAM
SOL-GEL TECHNOLOGIES INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPSOLAY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPSOLAY.
EPSOLAY (BENZOYL PEROXIDE) CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1984
INDICATIONS AND USAGE
EPSOLAY is indicated for the treatment of inflammatory lesions of
rosacea in adults. (1)
DOSAGE AND ADMINISTRATION
Apply to the affected areas once daily. (2)
Wash hands after application. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Cream, 5%. (3)
CONTRAINDICATIONS
A history of a serious hypersensitivity reactions to benzoyl peroxide
or any component of the formulation
in EPSOLAY. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity: Severe hypersensitivity reactions, including
anaphylaxis and angioedema, have been
reported with the use of benzoyl peroxide products. (5.1)
Skin irritation/contact dermatitis: Erythema, scaling, dryness,
stinging/burning, irritation and allergic
contact dermatitis may occur with use of EPSOLAY and may necessitate
discontinuation. (5.2)
Photosensitivity: Avoid or minimize exposure to natural or artificial
sunlight and use sun protection
measures. (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 1%) are application site
reactions: pain, erythema,
pruritis and edema. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOL-GEL TECHNOLOGIES
INC. AT [1-866-SGT-
AERS (748-4377)] OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
5.2 Skin Irritation/Contact Dermatitis
5.3 Photosensitivity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
®
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5