CLINDAMYCIN PHOSPHATE AND TRETINOIN gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C), TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Tilgængelig fra:

Solaris Pharma Corporation

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older. Clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. Pregnancy Category C. There are no well-controlled studies in pregnant women treated with clindamycin phosphate and tretinoin gel. Clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A limit teratology study performed in Sprague Dawley rats treated topically with clindamycin phosphate and tretinoin gel or 0.025% tretinoin gel at a dose of 2 mL/kg during gestation days 6 to 15 did not result in teratogenic effects. Although no systemic levels of tretinoin were detected, craniofacial and heart abnormalities were described in drug-treated groups. These abnormalities are consistent with retinoid effects and occurred at 16 times the recomm

Produkt oversigt:

How Supplied Clindamycin phosphate and tretinoin gel, 1.2%/0.025% is supplied as follows: Storage and Handling

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CLINDAMYCIN PHOSPHATE AND TRETINOIN - CLINDAMYCIN PHOSPHATE AND
TRETINOIN GEL
SOLARIS PHARMA CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLINDAMYCIN
PHOSPHATE AND TRETINOIN GEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL.
CLINDAMYCIN PHOSPAHTE AND TRETINOIN GEL, FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Clindamycin phosphate and tretinoin gel is a lincosamide antibiotic
and retinoid combination product
indicated for the topical treatment of acne vulgaris in patients 12
years and older. (1)
DOSAGE AND ADMINISTRATION
Apply a pea-sized amount once daily in the evening lightly covering
the entire affected area. Avoid the
eyes, lips, and mucous membranes. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Topical gel: clindamycin phosphate 1.2% and tretinoin 0.025% in
30-gram and 60-gram tubes. (3)
CONTRAINDICATIONS
Clindamycin phosphate and tretinoin gel is contraindicated in patients
with regional enteritis, ulcerative
colitis, or history of antibiotic-associated 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 clindamycin.
Clindamycin phosphate and tretinoin gel should be discontinued if
significant diarrhea occurs. (5.1)
Ultraviolet Light and Environmental Exposure: Avoid exposure to
sunlight, sunlamps, and weather
extremes. Wear sunscreen daily. (5.2)
ADVERSE REACTIONS
Observed local treatment-related adverse reactions (≥ 1%) in
clinical studies with clindamycin
phosphate and tretinoin gel were application site reactions, including
dryness, irritation, exfoliation,
erythema, pruritus, and dermatitis. Sunburn was also reported. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLARIS PHARMA
CORPORATION AT 1-833-
919-0527 OR FDA AT 1-800-FDA-