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ZIANA ® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZIANA Gel safely and effectively. See full prescribing information for ZIANA Gel.
ZIANA ® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel
For topical use only
Initial U.S. Approval: 2006
INDICATIONS AND USAGE
ZIANA Gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older. (1)
DOSAGE AND ADMINISTRATION
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Apply a pea-sized amount to the entire face once daily at bedtime. Do not apply to eyes, mouth, angles of the nose, or mucous membranes. ( 2)
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ZIANA Gel is not for oral, ophthalmic, or intravaginal use. ( 2)
DOSAGE FORMS AND STRENGTHS
Topical gel: Clindamycin phosphate 1.2% and tretinoin 0.025% gel in 30 and 60 gram tubes. (3)
CONTRAINDICATIONS
ZIANA Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic–associated colitis. (4)
WARNINGS AND PRECAUTIONS
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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)
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Ultraviolet Light and Environmental Exposures: Avoid exposure to sunlight and sunlamps. Wear sunscreen daily. ( 5.2)
ADVERSE REACTIONS
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 Medicis, The Dermatology Company at 1-800-900-6389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
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Concomitant use of topical medications with a strong drying effect can increase skin irritation. Use with caution. ( 7.1)
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ZIANA Gel should not be used in combination with erythromycin-containing products because of its clindamycin component. ( 7.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 3/2012
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
ZIANA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
2 DOSAGE AND ADMINISTRATION
At bedtime, squeeze a pea-sized amount of medication onto one fingertip, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face. ZIANA Gel should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes.
ZIANA Gel is not for oral, ophthalmic, or intravaginal use.
3 DOSAGE FORMS AND STRENGTHS
ZIANA Gel, a combination of a lincosamide antibiotic and a retinoid, contains clindamycin phosphate 1.2% and tretinoin 0.025%, formulated as a topical gel. Each gram of ZIANA Gel contains, as dispensed, 10 mg (1%) clindamycin as phosphate, and 0.25 mg (0.025%) tretinoin in an aqueous based gel. ZIANA Gel is available in 30 gram and 60 gram tubes.
4 CONTRAINDICATIONS
ZIANA Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis.
5 WARNINGS AND PRECAUTIONS
5.1 Colitis
Systemic absorption of clindamycin has been demonstrated following topical use of this product. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. When significant diarrhea occurs, ZIANA Gel should be discontinued.
Severe colitis has occurred following oral or parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.
Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
5.2 Ultraviolet Light and Environmental Exposure
Exposure to sunlight, including sunlamps, should be avoided during the use of ZIANA Gel, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Daily use of sunscreen products and protective apparel (e.g., a hat) are recommended. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with ZIANA Gel.
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use |
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