Doxepin

PRUDOXIN ® Cream is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus.

A thin film of PRUDOXIN ® Cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of PRUDOXIN ® Cream when used for greater than 8 days. Chronic use beyond eight days may result in higher systemic levels and should be avoided. Use of PRUDOXIN ® Cream for longer than 8 days may result in an increased likelihood of contact sensitization. The risk for sedation may increase with greater body surface area application of PRUDOXIN ® Cream. Clinical experience has shown that drowsiness is significantly more common in patients applying PRUDOXIN ® Cream to over 10% of body surface area, therefore, patients with greater than 10% of body surface area affected should be particularly cautioned concerning possible drowsiness and other systemic adverse effects of doxepin.

Because doxepin HCl has an anticholinergic effect and because significant plasma levels of doxepin are detectable after topical PRUDOXIN ® Cream application, the use of PRUDOXIN ® Cream is contraindicated in patients with untreated narrow angle glaucoma or a tendency to urinary retention. PRUDOXIN ® Cream is contraindicated in individuals who have shown previous sensitivity to any of its components.

Drowsiness occurs in over 20% of patients treated with PRUDOXIN ® 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 PRUDOXIN ® Cream. The sedating effects of alcoholic beverages, antihistamines, and other CNS depressants may be potentiated when PRUDOXIN ® 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.

Controlled Clinical Trials Systemic Adverse Effects: In controlled clinical trials of patients treated with PRUDOXIN ® Cream, the most common systemic adverse event reported was drowsiness. Drowsiness occurred in 71 of 330 (22%) of patients treated with PRUDOXIN ® 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 PRUDOXIN ® Cream in controlled clinical trials. Local Site Adverse Effects: In controlled clinical trials of patients treated with PRUDOXIN ® 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 PRUDOXIN ® Cream compared to 54 of 334 (16%) of patients treated with vehicle cream.

Studies have not been performed examining drug interactions with PRUDOXIN ® Cream. However, since plasma levels of doxepin following topical application of PRUDOXIN ® Cream can reach levels obtained with oral doxepin HCl therapy, the following drug interactions are possible following topical PRUDOXIN ® Cream application: Drugs Metabolized by P450 2D6: The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7-10% of Caucasians are so-called "poor metabolizers"), reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses.

Store below 27° C (80° F).