Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C), TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)
Almirall, LLC
CLINDAMYCIN PHOSPHATE
CLINDAMYCIN 10 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
VELTIN™ (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. VELTIN 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 VELTIN Gel. VELTIN 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 VELTIN 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 recommended clinical dose assuming 100% absorption and based on body surface area comparison. For p
How Supplied VELTIN Gel is supplied as follows: Storage and Handling
New Drug Application
VELTIN- CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL ALMIRALL, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VELTIN™ GEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VELTIN GEL. VELTIN™ (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL 1.2%/0.025% FOR TOPICAL USE ONLY INITIAL U.S. APPROVAL: 2006 INDICATIONS AND USAGE • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • ADVERSE REACTIONS Observed local treatment-related adverse reactions (≥ 1%) in clinical trials with VELTIN 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 ALMIRALL AT 1-866-665-2782 OR FDA AT 1- 800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • USE IN SPECIFIC POPULATIONS • SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 6/2019 VELTIN™ Gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older. (1) 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) Topical gel: clindamycin phosphate 1.2% and tretinoin 0.025% in 30-gram and 60-gram tubes. (3) VELTIN Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. (4) 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. VELTIN 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) VE Đọc toàn bộ tài liệu