Prudoxin (doxepin HCl)
Antihistamines Topical Cream (Gram)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Doxepin is a topical antipruritic.
Doxepin, a dibenzoxepin-derivative tricyclic compound, is a topical antipruritic. While the exact mechanism of antipruritic activity is unknown, doxepin exhibits potent histamine H1- and H2-receptor antagonist activity. Although the sedative effect of systemically absorbed doxepin may contribute to the drug's antipruritic activity, the antipruritic efficacy of doxepin reportedly does not appear to depend on a sedative effect.
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information.
The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Doxepin hydrochloride is used topically for the short-term (up to 8 days of therapy) relief of moderately severe pruritus associated with various forms of eczematous dermatitis, including atopic dermatitis and lichen simplex chronicus (circumscribed or localized neurodermatitis).
Generic name: doxepin HCl
Pronunciation: (dox-EH-pin)
Drug class: Antihistamines
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Prudoxin
Indications
The following indications are listed for Prudoxin:
- Atopic Dermatitis
- Lichen Simplex Chronicus
- Pruritus Of Skin
Also known as: Atopic Eczema, Circumscribed Neurodermatitis, Disseminated Neurodermatitis, Itchy Skin Eruption, Pruritic Dermatitis, Vidal's Disease.
Dosing
The manufacturer states that safety and efficacy of topical doxepin hydrochloride in children have not been established but that topical therapy with the drug in a limited number of children 12-18 years of age revealed no evidence of unusual adverse effect.
For the short-term relief of pruritus associated with various eczematous conditions in adults, a thin film of doxepin hydrochloride 5% cream is applied topically to affected areas of the skin 4 times daily, with an interval of at least 3-4 hours between applications.
Because clinically important amounts of the drug may be absorbed percutaneously into systemic circulation following topical application, patients should be cautioned about the risk of adverse systemic effects of doxepin, particularly drowsiness, and warned that CNS depressant effects of the drug can be exacerbated by alcohol, and the usual precautions of tricyclic antidepressant therapy should be considered. If excessive drowsiness occurs, it may be necessary to reduce the number of daily applications, the amount of cream applied, and/or the percentage of body surface area treated or to discontinue therapy with the drug. The risk of systemic toxicity is increased when the cream is applied to more than 10% of body surface area, and it is particularly important that patients receiving such dosages be cautioned about sedation and other potential adverse systemic effects of doxepin.
The manufacturer states that safety and efficacy of topical doxepin hydrochloride therapy have not been established beyond 8 days. Exceeding an 8-day course of topical therapy may result in increased systemic concentrations of the drug.
Doxepin hydrochloride is applied topically to the skin as a cream. The topical cream is intended for external use only and should not be applied to the eyes nor administered orally or intravaginally.
Because of the potential risk of enhanced percutaneous absorption, doxepin hydrochloride cream should not be used with occlusive dressings and patients should be warned that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Prudoxin 5% Cream | Maintenance | Apply a thin layer to the affected area(s) by topical route 4 times per day with an interval of at least 3-4 hours between applications. |
| Drug label | Dosing type | Instructions |
|---|---|---|
| Doxepin 5% Cream | Maintenance | Apply a thin layer to the affected area(s) by topical route 4 times per day with an interval of at least 3-4 hours between applications. |
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
There is no enhanced messaging for this drug.
- Lactation
- Angle-closure glaucoma
- Urinary retention
- CYp2c19 poor metabolizer
- CYp2d6 poor metabolizer
Adverse reactions
There is no enhanced messaging for this drug.
Less Frequent
- Eczema
More Frequent
- Drowsy
- Polydipsia
- Stinging of skin
- Xerostomia
Less Frequent
- Anticholinergic toxicity
- Dizziness
- Dry skin
- Dysgeusia
- Fatigue
- Localized edema
- Mood changes
- Pruritus of skin
- Skin fissure
- Skin irritation
Rare or Very Rare
- Contact dermatitis
- Fever
- Headache disorder
- Nausea
- Symptoms of anxiety
Precautions
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
ICD codes
| Code | Type | Description |
|---|---|---|
| Atopic dermatitis | ||
| L20 | ICD10CM | Atopic dermatitis |
| L20.0 | ICD10CM | Besnier's prurigo |
| L20.8 | ICD10CM | Other atopic dermatitis |
| L20.81 | ICD10CM | Atopic neurodermatitis |
| L20.82 | ICD10CM | Flexural eczema |
| L20.84 | ICD10CM | Intrinsic (allergic) eczema |
| L20.89 | ICD10CM | Other atopic dermatitis |
| L20.9 | ICD10CM | Atopic dermatitis, unspecified |
| Lichen simplex chronicus | ||
| L28.0 | ICD10CM | Lichen simplex chronicus |
| Pruritus of skin | ||
| L29.8 | ICD10CM | Other pruritus |
| L29.81 | ICD10CM | Cholestatic pruritus |
| L29.89 | ICD10CM | Other pruritus |
| L29.9 | ICD10CM | Pruritus, unspecified |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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