País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
Tretinoin (UNII: 5688UTC01R) (Tretinoin - UNII:5688UTC01R), Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)
Galderma Laboratories, L.P.
TOPICAL
PRESCRIPTION DRUG
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 s
How Supplied TWYNEO (tretinoin and benzoyl peroxide) cream, 0.1%/3% is a yellow cream and is supplied as: Storage and Handling
New Drug Application
TWYNEO- TRETINOIN AND BENZOYL PEROXIDE CREAM GALDERMA LABORATORIES, L.P. ---------- 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, 0.1%/3%, FOR TOPICAL USE. INITIAL U.S. APPROVAL: 2021 INDICATIONS AND USAGE TWYNEO is a combination 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 eyes, lips, paranasal creases, and mucous membranes. (2) Wash hand 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 GALDERMA LABORATORIES, L.P. AT 1-866- 735-4137 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 8/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINIST Leer el documento completo