ACANYA- clindamycin phosphate and benzoyl peroxide gel

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

Clindamycin Phosphate (UNII: EH6D7113I8) (Clindamycin - UNII:3U02EL437C), Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)

Pieejams no:

Bausch Health US, LLC

SNN (starptautisko nepatentēto nosaukumu):

Clindamycin Phosphate

Kompozīcija:

Clindamycin 10 mg in 1 g

Ievadīšanas:

TOPICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

ACANYA® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ACANYA Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with ACANYA Gel [see Postmarketing Experience (6.2)] . ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1)] . Risk Summary There are no available data on ACANYA Gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The limited published data on use of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes (see Data) .In limited published cli

Produktu pārskats:

ACANYA Gel, 1.2%/2.5%, a white to off-white smooth gel is supplied as: NDC 13548-132-50                   50 g pump

Autorizācija statuss:

New Drug Application

Produkta apraksts

ACANYA- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL
BAUSCH HEALTH US, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACANYA GEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ACANYA GEL.
ACANYA
(CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
ACANYA Gel is a combination of clindamycin phosphate (a lincosamide
antibacterial) and benzoyl peroxide indicated for
the topical treatment of acne vulgaris in patients 12 years or older.
(1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Gel, 1.2% clindamycin phosphate/2.5% benzoyl peroxide (3)
CONTRAINDICATIONS
ACANYA Gel is contraindicated in:
•
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The following selected adverse reactions occurred in less than 0.2% of
patients: application site pain (0.1%); application
site exfoliation (0.1%); and application site irritation (0.1%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH HEALTH US, LLC
AT 1-800-321-4576 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Colitis/Enteritis
®
Apply a pea-sized amount of ACANYA Gel to the face once daily. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to
clindamycin, benzoyl peroxide, any
components of the formulation, or lincomycin. (4.1)
Patients with a history of regional enteritis, ulcerative colitis, or
antibiotic-associated colitis. (4.2)
_Colitis:_ Orally and parenterally administered clindamycin has been
associated with severe colitis, which may result in
death. Diarrhea, bloody diarrhea, and colitis (including
pseudomembranous colitis) have b