Prudoxin Recall

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Questions & Answers

Side Effects & Adverse Reactions

Drowsiness occurs in over 20% of patients treated with PRUDOXINTM 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 PRUDOXINTM Cream.

The sedating effects of alcoholic beverages, antihistamines, and other CNS depressants may be potentiated when PRUDOXINTM 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


PRUDOXINTM 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.)


There is currently no drug history available for this drug.

Other Information

PRUDOXINTM (doxepin hydrochloride) Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin).

Doxepin hydrochloride is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[b,e]oxepin-Δ11(6H),γ-propylamine hydrochloride. Doxepin hydrochloride has an empirical formula of C19H21NO•HCl and a molecular weight of 316.

The structural formula of doxepin hydrochloride.

PRUDOXINTM Cream also contains sorbitol, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG- 100 stearate, petrolatum, benzyl alcohol, titanium dioxide and purified water.

Prudoxin Manufacturers

  • Prestium Pharma, Inc.
    Prudoxin (Doxepin Hydrochloride) Cream [Prestium Pharma, Inc.]
  • Smith & Nephew, Inc.
    Prudoxin (Doxepin Hydrochloride) Cream [Smith & Nephew, Inc.]
  • Healthpoint, Ltd
    Prudoxin (Doxepin Hydrochloride) Cream [Healthpoint, Ltd]

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