SANDOZ ADAPALENE / BENZOYL PEROXIDE FORTE

5% topical gels include mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. These reactions usually occur early in the treatment, and tend to gradually lessen over time (see WARNINGS AND PRECAUTIONS).

5% compared to adapalene or benzoyl peroxide alone. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 5% Topical Gel formulations. A total of 1470 patients with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months.

5% efficacy and safety were assessed in subjects 12 years of age or older presenting with acne vulgaris. 5% gels and their comparators were applied once daily over a treatment period of 12 weeks. 5% Topical Gel are captured in Table 1.

5% Topical Gel are summarized in Table 2. 2) a Drug-related adverse events do not include known local adverse events (local tolerability) of retinoids. b Multiple occurrences of a Preferred Term by a subject were counted once per Preferred Term.

c A subject was counted once even if the subject experienced more than one AE during the study. 9) 0 0 a Drug-related adverse events do not include known local adverse events (local tolerability) of retinoids. 5% Topical Gel, local tolerability evaluations were conducted at each study visit by assessment of erythema, scaling, dryness and stinging/burning.

Analysis over the 12-week period showed that local tolerability scores peaked at Week 1 of therapy and subsided thereafter. 5% Topical Gel were mild or moderate in severity (Table 3). 5 % Gel. 4) 0 a N = Total number of subjects with data available.

b n = Number of subjects with data worse than baseline. At the end of treatment period (12 weeks), the incidence of local signs and symptoms of […]