VELTIN® (clindamycin phosphate and tretinoin) Gel 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Click here for Full Prescribing Information for VELTIN® Gel.Important Safety Information Regarding VELTIN® (clindamycin phosphate and tretinoin) Gel 1.2%/0.025%
- VELTIN Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis.
- Systemic absorption of clindamycin has been demonstrated following topical use. Diarrhea, bloody diarrhea (with or without mucus), and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. VELTIN Gel should be discontinued if significant diarrhea or severe abdominal cramps occur. Severe colitis has occurred following oral or parenteral clindamycin administration. Severe colitis may result in death.
- Avoid exposure to sunlight and sunlamps when using VELTIN Gel. Patients with sunburn should be advised not to use VELTIN Gel until fully recovered. Daily use of sunscreen products and protective apparel are recommended. Weather extremes (e.g., wind and cold) also may be irritating to patients using VELTIN Gel.
- Observed local treatment-related adverse reactions (≥1%) in clinical studies with VELTIN Gel were application site reactions, including dryness, irritation, exfoliation, erythema, pruritus, and dermatitis. Sunburn was also reported. Incidence of actively assessed local skin reactions peaked at week 2 and then gradually decreased.
- VELTIN Gel should not be used in combination with erythromycin-containing products due to antagonism to the clindamycin component.
- Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. VELTIN Gel should be used with caution in patients receiving such agents.
- VELTIN Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- It is not known whether either clindamycin or tretinoin is excreted in human milk following use of VELTIN Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Due to possible serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug. Exercise caution if administering VELTIN Gel to a nursing woman.
- The efficacy and safety have not been established in pediatric patients below the age of 12 years.
- VELTIN Gel is not for oral, ophthalmic, or intravaginal use.
Click here for Full Prescribing Information for VELTIN® Gel.
To report SUSPECTED ADVERSE REACTIONS, contact Aqua Pharmaceuticals at 1-866-665-2782, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.