ازادرم 20% كريم 30 جم

12.1 Mechanism of Action The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.

Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea ( 1 ). Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. ( 1 )

• Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of azelaic acid gel. • Apply and gently massage a thin layer of azelaic acid gel into the affected areas on the face twice daily (morning and evening). • Wash hands immediately following application of azelaic acid gel. • Cosmetics may be applied after the application of azelaic acid gel has dried. • Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy. • Avoid the use of occlusive dressings or wrappings. • Instruct patients to avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. • For topical use. • Not for oral, ophthalmic or intravaginal use. • Apply a thin layer twice daily to affected area(s). ( 2 ) • Use only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before applying azelaic acid gel. ( 2 ) • Wash hands immediately following application. ( 2 ) • Cosmetics may be applied after the application of azelaic acid gel has dried. ( 2 ) • Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. ( 2 ) • For topical use. ( 2 ) • Not for oral, ophthalmic or intravaginal use. ( 2 )

The most common are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). ( 6 ) To report SUSPECTED , contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily azelaic acid gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). In the active-controlled trial, overall (including burning, stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness) were 19.4% (24/124) for azelaic acid gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks. Table 1: Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity * Azelaic acid gel, 15% N=457 (100%) Vehicle N=331 (100%) Mild N=99 (22%) Moderate N=61 (13%) Severe N=27 (6%) Mild N=46 (14%) Moderate N=30 (9%) Severe N=5 (2%) Burning/stinging/tingling 71 (16%) 42 (9%) 17 (4%) 8 (2%) 6 (2%) 2 (1%) Pruritus 29 (6%) 18 (4%) 5 (1%) 9 (3%) 6 (2%) 0 (0%) Scaling/dry skin/ xerosis 21 (5%) 10 (2%) 5 (1%) 31 (9%) 14 (4%) 1 (<1%) Erythema/ irritation 6 (1%) 7 (2%) 2 (<1%) 8 (2%) 4 (1%) 2 (1%) Contact dermatitis 2 (<1%) 3 (1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%) Edema 3 (1%) 2 (<1%) 0 (0%) 3 (1%) 0 (0%) 0 (0%) Acne 3 (1%) 1 (<1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%) * Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event. In patients using azelaic acid formulations, the following adverse events have been reported: worsening of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis....

None. None. ( 4 )