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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Allergic/ Hypersensitivity Reactions: Allergy/hypersensitivity reactions include anaphylaxis, angioedema, face edema, eyelid edema, lip swelling, and pruritis. Discontinue adapalene gel in the event of an allergic/hypersensitivity reaction. ( 5.1 ) • Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided ( 5.2 ). • Local Cutaneous Reactions: Erythema, scaling, dryness. and stinging/burning were reported with use of adapalene gel. Concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. ( 5.3 ). 5.1 Allergic/ Hypersensitivity Reactions Adverse reactions including anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritus that sometimes required medical treatment have been reported during postmarketing use of adapalene. Advise a patient to stop using Adapalene gel, 0.3% and seek medical attention if experiencing allergic or anaphylactoid/ anaphylactic reactions during treatment. 5.2 Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized during use of adapalene gel, 0.3%. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene gel, 0.3%. 5.3 Local Cutaneous Reactions Cutaneous signs and symptoms such as erythema, scaling, dryness, and stinging/ burning were reported with use of adapalene gel, 0.3%. These were most likely to occur during the first four weeks of treatment, were mostly mild to moderate in intensity, and usually lessened with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to either use a moisturizer, reduce the frequency of application of adapalene gel, 0.3% or discontinue use. Avoid application to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with adapalene. As adapalene gel, 0.3% has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution.
6 ADVERSE REACTIONS The most frequently reported (≥1%) adverse reactions were erythema,scaling, dryness, and/or burning/stinging. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 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 reactions 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 the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne subjects who used Adapalene gel, 0.3% once daily for 12 weeks. Of the subjects who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with Adapalene gel, 0.3% from the controlled clinical trial is provided in the following table: Table 1: Physician assessed local cutaneous irritation with Adapalene gel Incidence of Local Cutaneous Irritation with Adapalene gel, 0.3% (N = 253*) Maximum Severity Scores Higher Than Mild Moderate Severe Erythema 66 (26.1%) 33 (13.0%) 1 (0.4%) Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%) Dryness 113 (44.7%) 43 (17.0%) 2 (0.8%) Burning / Stinging 72 (28.5%) 36 (14.2%) 9 (3.6%) * Total number of subjects with local cutaneous data for at least one post-Baseline evaluation. Table 2: Patient reported local cutaneous adverse reactions with Adapalene Gel Adapalene Gel, 0.3% Vehicle Gel N = 258 N = 134 Related* Adverse Reactions Dry Skin Skin Discomfort 57 (22.1%) 36 (14%) 15 (5.8%) 4 (1.6%) 6 (4.5%) 2 (1.5%) 0 (0.0%) 0 (0.0%) * Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related The following adverse reactions occurred in less than 1 % of subjects: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema. In a one-year, open-label safety trial of 551 subjects with acne who received Adapalene gel, 0.3%, the pattern of adverse reactions was similar to the 12-week controlled study. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.