CABTREO- clindamycin phosphate/benzoyl peroxide/adapalene gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM), ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)

Available from:

Bausch Health US LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. CABTREO is contraindicated in patients with: - Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any other components of CABTREO, or lincomycin [see Warnings and Precautions ( 5.1)]. - A history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions ( 5.2)]. Risk Summary Available data with CABTREO use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with CABTREO. Clindamycin In published clinical trials and observational studies with pregnant women, oral or IV administration of clindamycin has not been associated with an increased frequency of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction stud

Product summary:

How Supplied CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque topical gel. CABTREO contains 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide and is supplied as follows: Storage and Handling

Authorization status:

New Drug Application

Summary of Product characteristics

CABTREO- CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE GEL
BAUSCH HEALTH US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CABTREO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CABTREO.
CABTREO (CLINDAMYCIN PHOSPHATE, ADAPALENE, AND BENZOYL PEROXIDE) TOPICAL GEL
INITIAL U.S. APPROVAL: 2023
INDICATIONS AND USAGE
CABTREO is a combination of clindamycin phosphate (a lincosamide
antibacterial), adapalene (a retinoid),
and benzoyl peroxide indicated for the topical treatment of acne
vulgaris in adult and pediatric patients 12
years of age and older.
( 1)
DOSAGE AND ADMINISTRATION
Apply a thin layer of CABTREO to the affected areas once daily. ( 2)
Avoid the eyes, mouth, paranasal creases, mucous membranes, and areas
of broken, eczematous, or
sunburned skin. ( 2)
Not for oral, ophthalmic, or intravaginal use. ( 2)
DOSAGE FORMS AND STRENGTHS
Topical gel: 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1%
benzoyl peroxide. CABTREO is
supplied in 20-gram and 50-gram pumps. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide,
any components of the
formulation, or lincomycin. ( 4)
History of regional enteritis, ulcerative colitis, or
antibiotic-associated colitis. ( 4)
WARNINGS AND PRECAUTIONS
_Hypersensitivity_: If a serious hypersensitivity reaction occurs,
discontinue CABTREO immediately and
initiate appropriate therapy. ( 5.1)
_Colitis_: Clindamycin can cause severe colitis, which may result in
death. Discontinue CABTREO if
diarrhea occurs. ( 5.2)
_Photosensitivity_: Avoid or minimize exposure to sunlight and
sunlamps. Wear sunscreen and protective
clothing when sun exposure cannot be avoided. ( 5.3)
_Skin Irritation and Allergic Contact Dermatitis_: Erythema, scaling,
dryness, stinging/burning, irritant and
allergic contact dermatitis may occur with use of CABTREO and may
necessitate discontinuation ( 5.4)
ADVERSE REACTIONS
The most common adverse reactions (occurring in >1% of the CABTREO