PRUDOXIN 50 mg/g

doxepin hydrochloride · CREAM · Mylan Pharmaceuticals Inc.

No Recall History

Plain English

PRUDOXIN is a cream containing doxepin hydrochloride at 50 mg/g, taken topical. Manufactured by Mylan Pharmaceuticals Inc..

Key Facts

Brand Name: PRUDOXIN
Generic Name: doxepin hydrochloride
NDC Code (Product): 0378-8130
Manufacturer: Mylan Pharmaceuticals Inc.
Strength: 50 mg/g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: NDA020126
Marketing Start: 08/01/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

completed suicide189 reports

pain186 reports

drug ineffective174 reports

dizziness160 reports

insomnia156 reports

toxicity to various agents153 reports

fall149 reports

fatigue141 reports

anxiety139 reports

off label use123 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 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. (See DOSAGE AND ADMINISTRATION .)

Dosage & Administration

DOSAGE AND ADMINISTRATION 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 (See WARNINGS section). 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 (see WARNINGS section) affected should be particularly cautioned concerning possible drowsiness and other systemic adverse effects of doxepin. If excessive drowsiness occurs, it may be necessary to do one or more of the following: reduce the body surface area treated, reduce the number of applications per day, reduce the amount of cream applied, or discontinue the drug. Occlusive dressings may …

Warnings

WARNINGS 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.

Contraindications

CONTRAINDICATIONS 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.

Drug Interactions

Drug Interactions 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. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8-fold increase in plasma AUC of the TCA). In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dosage regimen …

Adverse Reactions

ADVERSE REACTIONS 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. 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 PRUDOXIN ® Cream withdrew from the study because of the burning and/or stinging. The table below presents the adverse events reported at an incide…

Frequently Asked Questions

What is PRUDOXIN used for?

PRUDOXIN contains doxepin hydrochloride. It is a cream taken topical. Consult your doctor for specific uses.

Is PRUDOXIN a controlled substance?

PRUDOXIN is not classified as a controlled substance by the DEA.

What is the generic name for PRUDOXIN?

The generic name for PRUDOXIN is doxepin hydrochloride. There are 12 other brand versions of doxepin hydrochloride.

What is the NDC code for PRUDOXIN 50 mg/g?

The NDC (National Drug Code) for PRUDOXIN 50 mg/g is 0378-8130, listed by Mylan Pharmaceuticals Inc..

Product NDC

0378-8130

Package NDC

0378-8130-45

Other Doxepin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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