"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
Adverse Reactions in Clinical Studies
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
The safety data reflect exposure to VELTIN (clindamycin phosphate and tretinoin gel) Gel in 1,104 patients with acne vulgaris. Patients were 12 years or older and were treated once daily in the evening for 12 weeks. Adverse reactions that were reported in ≥ 1% of patients treated with VELTIN (clindamycin phosphate and tretinoin gel) Gel are presented in Table 1.
Table 1: Treatment-Related Adverse Reactions Reported by
≥ 1% of Subjects
| VELTIN (clindamycin phosphate and tretinoin gel) Gel
|Patients with at least one adverse reaction||140(13)||38(3)||141 (13)||17(3)|
|Application site dryness||64(6)||12(1)||62(6)||3(1)|
|Application site irritation||50(5)||4( < 1)||57(5)||5(1)|
|Application site exfoliation||50(5)||2( < 1)||56(5)||2( < 1)|
|Application site erythema||40(4)||6(1)||39(4)||3(1)|
|Application site pruritus||26(2)||7(1)||23(2)||6(1)|
|Application site dermatitis||6(1)||0(0)||8(1)||1( < 1)|
Local skin reactions actively assessed at baseline and end of treatment with a score > 0 are presented in Table 2.
Table 2: VELTIN (clindamycin phosphate and tretinoin gel) GEL-Treated Patients with Local Skin Reactions
|VELTIN GEL||VEHICLE GEL|
|Local Reaction|| Baseline
| End of Treatment
| End of Treatment
During the twelve weeks of treatment, each local skin reaction peaked at week 2 and gradually reduced thereafter.
Read the Veltin (clindamycin phosphate and tretinoin gel) Side Effects Center for a complete guide to possible side effects
VELTIN™ (clindamycin phosphate and tretinoin gel) Gel should not be used in combination with erythromycin-containing products due to possible antagonism to the clindamycin component. In vitro studies have shown antagonism between these 2 antimicrobials. The clinical significance of this in vitro antagonism is not known.
Neuromuscular Blocking Agents
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, VELTIN (clindamycin phosphate and tretinoin gel) Gel should be used with caution in patients receiving such agents.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/5/2010
Additional Veltin Information
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