ZIANA (clindamycin phosphate)

In an open-label, multiple-dose study treating 12 subjects with moderate to severe acne, the percutaneous absorption of tretinoin following 14 consecutive daily applications of approximately 4 g of ZIANA Gel was minimal. Quantifiable tretinoin plasma concentrations ranged from 1.0 to 1.6 ng/mL, with unquantifiable plasma concentrations in 50% to 92% of subjects at any given timepoint following administration. The plasma concentrations of the key tretinoin metabolites, 13-cis-retinoic acid and 4-...

The safety and efficacy of once daily use of ZIANA Gel for treatment of acne vulgaris were assessed in three 12-week prospective, multi-center, randomized, blinded studies in patients 12 years and older. Studies 1 and 2 were of identical design, and compared ZIANA Gel to clindamycin in the vehicle gel, tretinoin in the vehicle gel, and the vehicle gel alone. Patients with mild, moderate, or severe acne were enrolled in the studies. The co-primary efficacy variables were: 1. Mean percent change from baseline at Week 12 in 1. inflammatory lesion counts, 2. non-inflammatory lesion counts, and 3. ...

Observed local adverse reactions in patients treated with ZIANA Gel were skin erythema, scaling, itching, burning, and stinging. Other most commonly reported adverse events (≥1% in patients treated with ZIANA Gel) were nasopharyngitis, pharyngolaryngeal pain, dry skin, cough, and sinusitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clin...

ZIANA Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. ZIANA 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. ZIANA Gel should be discontinued if significant diarrhea occurs. ( 5.1 )
• Ultraviolet Light and Environmental Exposures: Avoid exposure to sunlight and sunlamps. Wear sunscreen daily. ( 5.2 ) 5.1 Colitis Systemic absorption of clindamycin has been demonstrated following topical use of this product....

7 DRUG INTERACTIONS

• Concomitant use of topical medications with a strong drying effect can increase skin irritation. Use with caution. ( 7.1 )
• ZIANA Gel should not be used in combination with erythromycin-containing products because of its clindamycin component. ( 7.2 ) 7.1 Concomitant Topical Medication Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosme...