openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Drowsiness occurs in over 20% of patients treated with Zonalon ® Cream, especially in patients receiving treatment to greater than 10% of their body surface area. Patients should be warned about the possibility of sedation and cautioned against driving a motor vehicle or operating hazardous machinery while being treated with Zonalon ® Cream. The sedating effects of alcoholic beverages, antihistamines, and other CNS depressants may be potentiated when Zonalon ® Cream is used. If excessive drowsiness occurs it may be necessary to reduce the frequency of applications, the amount of cream applied, and/or the percentage of body surface area treated, or discontinue the drug. However, the efficacy with reduced frequency of applications has not been established. Keep this product away from the eyes.
ADVERSE REACTIONS Controlled Clinical Trials Systemic Adverse Effects In controlled clinical trials of patients treated with Zonalon ® Cream, the most common systemic adverse event reported was drowsiness. Drowsiness occurred in 71 of 330 (22%) of patients treated with Zonalon ® Cream compared to 7 of 334 (2%) of patients treated with vehicle cream. Drowsiness resulted in the premature discontinuation of the drug in approximately 5% of patients treated with Zonalon ® Cream in controlled clinical trials. Local Site Adverse Effects In controlled clinical trials of patients treated with Zonalon ® Cream, the most common local site adverse event reported was burning and/or stinging at the site of application. These occurred in 76 of 330 (23%) of patients treated with Zonalon ® Cream compared to 54 of 334 (16%) of patients treated with vehicle cream. Most of these reactions were categorized as "mild"; however, approximately 25% of patients who reported burning and/or stinging reported the reaction as "severe". Four patients treated with Zonalon ® Cream withdrew from the study because of the burning and/or stinging. The table below presents the adverse events reported at an incidence of ≥ 1% in either Zonalon ® or vehicle cream treatment groups during the trials: Adverse Event Zonalon ® N=330 Vehicle N=334 Burning/Stinging 76 (23.0%) 54 (16.2%) Drowsiness 71 (21.5%) 7 (2.1%) Dry Mouth Includes reports of "dry lips", "dry throat", and "thirst" 32 (9.7%) 4 (1.2%) Pruritus Includes reports of "pruritus exacerbated" 13 (3.9%) 20 (6.0%) Fatigue/Tiredness 10 (3.0%) 5 (1.5%) Exacerbated Eczema 10 (3.0%) 8 (2.4%) Other Application Site Reaction Includes report of "increased irritation at application site" 10 (3.0%) 16 (4.8%) Dizziness Includes reports of "lightheadedness" and "dizziness/vertigo" 7 (2.1%) 3 (0.9%) Mental/Emotional Changes 6 (1.8%) 1 (0.3%) Taste Perversion Includes reports of "bitter taste" and "metallic taste in mouth" 5 (1.5%) 1 (0.3%) Edema 4 (1.2%) 1 (0.3%) Headache 3 (0.9%) 14 (4.2%) Adverse events occurring in 0.5% to < 1.0% of Zonalon ® Cream treated patients in the controlled clinical trials included: nervousness/anxiety, tongue numbness, fever, and nausea. Post-Marketing Experience Twenty-six cases of allergic contact dermatitis have been reported in patients using Zonalon ® Cream, twenty of which were documented by positive patch test to doxepin 5% cream.