TWYNEO- tretinoin and benzoyl peroxide cream

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Հասանելի է:

Sol-Gel Technologies, Inc.

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is contraindicated in patients with a history of hypersensitivity reaction to benzoyl peroxide or any components of TWYNEO [see Warnings and Precautions (5.1)] . Risk Summary Available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Studies conducted with topical benzoyl peroxide have not demonstrated systemic absorption and maternal use is not expected to result in fetal exposure to benzoyl peroxide. There are no data on TWYNEO use in pregnant women. There are reports of major birth defects reported with maternal use of topical tretinoin similar to those seen in infants exposed to oral retinoids, but these case reports do not establish a pattern or association with tretinoin-related embryopathy (see Data ). Animal reproductive stu

Ապրանքի ամփոփագիր:

How Supplied TWYNEO (tretinoin and benzoyl peroxide) cream, 0.1%/3%, is a yellow cream and is supplied as: Storage and Handling

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

TWYNEO- TRETINOIN AND BENZOYL PEROXIDE CREAM
SOL-GEL TECHNOLOGIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TWYNEO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TWYNEO.
TWYNEO (TRETINOIN AND BENZOYL PEROXIDE) CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2021
INDICATIONS AND USAGE
TWYNEO is a combination of tretinoin, a retinoid, and benzoyl peroxide
indicated for the topical treatment
of acne vulgaris in adults and pediatric patients 9 years of age and
older. (1)
DOSAGE AND ADMINISTRATION
Apply a thin layer of TWYNEO to the affected areas once daily. (2)
Avoid contact with the eyes, lips, paranasal creases, and mucous
membranes. (2)
Wash hands after application. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
_Cream_: 0.1% tretinoin/3% benzoyl peroxide (3)
CONTRAINDICATIONS
History of serious hypersensitivity reaction to benzoyl peroxide or
any component of TWYNEO. (4)
WARNINGS AND PRECAUTIONS
_Hypersensitivity_: Severe hypersensitivity reactions, including
anaphylaxis and angioedema, have been
reported with use of benzoyl peroxide products. (4, 5.1)
_Skin Irritation_: Pain, dryness, exfoliation, erythema, and
irritation may occur with use of TWYNEO. Avoid
application of TWYNEO to cuts, abrasions, eczematous or sunburned
skin. (5.2)
_Photosensitivity_: Minimize unprotected exposure to sunlight and
sunlamps. Use sunscreen and
protective clothing when sun exposure cannot be avoided. (5.3)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 1%) are pain,
dryness, exfoliation, erythema,
dermatitis, pruritus and irritation (all at the application site).
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOL-GEL TECHNOLOGIES
INC. AT 1-866-748-
2377 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRA