NEUAC KIT- clindamycin phosphate and benzoyl peroxide kit

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

clindamycin phosphate (UNII: EH6D7113I8) (clindamycin - UNII:3U02EL437C), benzoyl peroxide (UNII: W9WZN9A0GM) (benzoyl peroxide - UNII:W9WZN9A0GM)

Saatavilla:

Medimetriks Pharmaceuticals

INN (Kansainvälinen yleisnimi):

clindamycin phosphate

Koostumus:

clindamycin 10 mg in 1 g

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% 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 clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% [see Adverse Reactions (6.2) ]. Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or

Tuoteyhteenveto:

Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is a white, opaque gel. It is supplied as follows: Pharmacist:

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

NEUAC KIT- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
MEDIMETRIKS PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEUAC (CLINDAMYCIN PHOSPHATE AND
BENZOYL PEROXIDE) GEL, 1.2%/5% SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NEUAC
(CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL, 1.2%/5%.
NEUAC (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL, FOR TOPICAL USE.
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Neuac
(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is a
combination of clindamycin phosphate (a
lincosamide antibacterial) and benzoyl peroxide indicated for the
topical treatment of inflammatory acne vulgaris. (1.1)
Limitation of Use:
Neuac
(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% has not been
demonstrated to have any additional
benefit when compared with benzoyl peroxide alone in the same vehicle
when used for the treatment of non-inflammatory
acne. (1.2)
DOSAGE AND ADMINISTRATION
Apply a thin layer of Neuac
(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% to the face
once daily, in the
evening. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 1.2%/5%: Each gram of Neuac
(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% contains 12
mg
clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg
benzoyl peroxide. (3)
CONTRAINDICATIONS
Neuac
(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is
contraindicated in:
Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to
clindamycin, benzoyl peroxide, any components
of the formulation, or lincomycin. (4)
Patients with a history of regional enteritis, ulcerative colitis, or
antibiotic-associated colitis (including
pseudomembranous colitis). (4)
WARNINGS AND PRECAUTIONS
Colitis: Clindamycin can cause severe colitis, which may result in
death. Diarrhea, bloody diarrhea, and colitis (including
pseudomembranous colitis) have been reported with the use of
cl