Prudoxin label

Prudoxin

Prudoxin Recall

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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.

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FDA Safety Alerts

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

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Manufacturer Warnings

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

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FDA Labeling Changes

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

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Uses

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.)

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History

There is currently no drug history available for this drug.

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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.

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Prudoxin Manufacturers

  • Prestium Pharma, Inc.
    Prudoxin | Prestium Pharma, Inc.
    No Recall

    Prudoxin | Prestium Pharma, Inc.

    Prudoxin | Prestium Pharma, Inc.

    A thin film of PRUDOXINTM 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 PRUDOXINTM 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 PRUDOXINTM 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 PRUDOXINTM Cream (See WARNINGS section). Clinical experience has shown that drowsiness is significantly more common in patients applying PRUDOXINTM 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 increase the absorption of most topical drugs; therefore, occlusive dressings should not be utilized with PRUDOXINTM Cream.

  • Smith & Nephew, Inc.
    Prudoxin | Smith & Nephew, Inc.
    No Recall

    Prudoxin | Smith & Nephew, Inc.

    Prudoxin | Smith & Nephew, Inc.

    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 increase the absorption of most topical drugs; therefore, occlusive dressings should not be utilized with PRUDOXIN Cream.

  • Healthpoint, Ltd
    Prudoxin | Healthpoint, Ltd
    No Recall

    Prudoxin | Healthpoint, Ltd

    Prudoxin | Healthpoint, Ltd

    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 increase the absorption of most topical drugs; therefore, occlusive dressings should not be utilized with PRUDOXIN Cream.

    Rx Only.

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