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Drug overview for ZONALON (doxepin hcl):
Generic name: doxepin HCl (dox-EH-pin)
Drug class: Antihistamines
Therapeutic class: Dermatological
Doxepin is a topical antipruritic.
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). For systemic uses of doxepin, see the Tricyclic Antidepressants General Statement 28:16.04.24.
Generic name: doxepin HCl (dox-EH-pin)
Drug class: Antihistamines
Therapeutic class: Dermatological
Doxepin is a topical antipruritic.
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). For systemic uses of doxepin, see the Tricyclic Antidepressants General Statement 28:16.04.24.
DRUG IMAGES
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The following indications for ZONALON (doxepin hcl) have been approved by the FDA:
Indications:
Atopic dermatitis
Lichen simplex chronicus
Pruritus of skin
Professional Synonyms:
Atopic eczema
Circumscribed neurodermatitis
Disseminated neurodermatitis
Itchy skin eruption
Pruritic dermatitis
Vidal's disease
Indications:
Atopic dermatitis
Lichen simplex chronicus
Pruritus of skin
Professional Synonyms:
Atopic eczema
Circumscribed neurodermatitis
Disseminated neurodermatitis
Itchy skin eruption
Pruritic dermatitis
Vidal's disease
The following dosing information is available for ZONALON (doxepin hcl):
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.
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 | DOSING INSTRUCTIONS |
|---|---|---|
| ZONALON 5% CREAM | Maintenance | Adults 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 | DOSING INSTRUCTIONS |
|---|---|---|
| DOXEPIN 5% CREAM | Maintenance | Adults 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 |
The following drug interaction information is available for ZONALON (doxepin hcl):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ZONALON (doxepin hcl):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Angle-closure glaucoma |
| Urinary retention |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| CYp2c19 poor metabolizer |
| CYp2d6 poor metabolizer |
The following adverse reaction information is available for ZONALON (doxepin hcl):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Eczema |
| Rare/Very Rare |
|---|
| None. |
There are 19 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Drowsy Polydipsia Stinging of skin Xerostomia |
Anticholinergic toxicity Dizziness Dry skin Dysgeusia Fatigue Localized edema Mood changes Pruritus of skin Skin fissure Skin irritation |
| Rare/Very Rare |
|---|
|
Contact dermatitis Fever Headache disorder Nausea Symptoms of anxiety |
The following precautions are available for ZONALON (doxepin hcl):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ZONALON (doxepin hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ZONALON (doxepin hcl)'s list of indications:
| Atopic dermatitis | |
| L20 | Atopic dermatitis |
| L20.0 | Besnier's prurigo |
| L20.8 | Other atopic dermatitis |
| L20.81 | Atopic neurodermatitis |
| L20.82 | Flexural eczema |
| L20.84 | Intrinsic (allergic) eczema |
| L20.89 | Other atopic dermatitis |
| L20.9 | Atopic dermatitis, unspecified |
| Lichen simplex chronicus | |
| L28.0 | Lichen simplex chronicus |
| Pruritus of skin | |
| L29.8 | Other pruritus |
| L29.81 | Cholestatic pruritus |
| L29.89 | Other pruritus |
| L29.9 | Pruritus, unspecified |
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