INDICATIONS AND USAGE Doxepin HCl cream, 5% is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus (see DOSAGE AND ADMINISTRATION ).

WARNINGS Drowsiness occurs in over 20% of patients treated with doxepin HCl 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 doxepin HCl cream.

The sedating effects of alcoholic beverages, antihistamines, and other CNS depressants may be potentiated when doxepin HCl 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 doxepin HCl cream, the most common systemic adverse event reported was drowsiness.

Drowsiness occurred in 71 of 330 (22%) of patients treated with doxepin HCl 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 doxepin HCl cream in controlled clinical trials.

Local Site Adverse Effects In controlled clinical trials of patients treated with doxepin HCl 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 doxepin HCl 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 doxepin HCl 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 doxepin HCl cream or vehicle cream treatment groups during the trials: Adverse Event Doxepin HCl Cream N=330 Vehicle N=334 Burning /Stinging 76 (23.0%) 54 (16.2%) Drowsiness 71 (21.5%) 7 (2.1%) Dry Mouth 1 32 (9.7%) 4 (1.2%) Pruritus 2 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 3 10 (3.0%) 16 (4.8%) Dizziness 4 7 (2.1%) 3 (0.9%) Mental Emotional Changes 6 (1.8%) 1 (0.3%) Taste Perversion 5 5 (1.5%) 1 (0.3%) Edema 4 (1.2%) 1 (0.3%) Headache 3 (0.9%) 14 (4.2%) 1 Includes reports of “dry lips”, “dry throat”, and “thirst” 2 Includes reports of “Pruritus Exacerbated” 3 Includes report of “increased irritation at application site” 4 Includes reports of “lightheadedness” and “dizziness/vertigo” 5 Includes reports of “bitter taste” and “metallic taste in mouth” Adverse events occurring in 0.5% to < 1.0% of doxepin HCl 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 doxepin HCl cream, twenty of which were documented by positive patch test to doxepin 5% cream.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.