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doxepin hydrochloride

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Overview

What is Zonalon?

Zonalon (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[]oxepin-Δ-propylamine hydrochloride. Doxepin hydrochloride has an empirical formula of CHNO•HCl and a molecular weight of 316.

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



What does Zonalon look like?



What are the available doses of Zonalon?

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What should I talk to my health care provider before I take Zonalon?

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How should I use Zonalon?

Zonalon 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 .)

A thin film of Zonalon 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 Zonalon 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 Zonalon 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 Zonalon Cream (See section). Clinical experience has shown that drowsiness is significantly more common in patients applying Zonalon Cream to over 10% of body surface area; therefore, patients with greater than 10% of body surface area (see 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 Zonalon Cream.


What interacts with Zonalon?

Because doxepin HCl has an anticholinergic effect and because significant plasma levels of doxepin are detectable after topical Zonalon Cream application, the use of Zonalon Cream is contraindicated in patients with untreated narrow angle glaucoma or a tendency to urinary retention.


Zonalon Cream is contraindicated in individuals who have shown previous sensitivity to any of its components.



What are the warnings of Zonalon?

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.

Drowsiness occurs in over 20% of patients treated with Zonalon Cream, especially in patients receiving treatment to greater than 10% of their body surface area.

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


What are the precautions of Zonalon?

General

Drowsiness

Since drowsiness may occur with the use of Zonalon Cream, patients should be warned of the possibility and cautioned against driving a car or operating dangerous machinery while using this drug. Patients should also be cautioned that their response to alcohol may be potentiated.

Sedating drugs may cause confusion and oversedation in the elderly; elderly patients generally should be observed closely for confusion and oversedation when started on Zonalon Cream. (See .)

Use under occlusion

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

Contact sensitization

Use of Zonalon Cream can cause Type IV hypersensitivity reactions (contact sensitization) to doxepin.

Drug Interactions

Studies have not been performed examining drug interactions with Zonalon Cream. However, since plasma levels of doxepin following topical application of Zonalon Cream can reach levels obtained with oral doxepin HCl therapy, the following drug interactions are possible following topical Zonalon 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 of a TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.

MAO Inhibitors

Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Therefore, MAO inhibitors should be discontinued at least two weeks prior to the cautious initiation of therapy with Zonalon Cream. The exact length of time may vary and is dependent upon the particular MAO inhibitor being used, the length of time it has been administered, and the dosage involved.

Cimetidine

Serious anticholinergic symptoms (i.e., severe dry mouth, urinary retention and blurred vision) have been associated with elevations in the serum levels of tricyclic antidepressants when cimetidine therapy is initiated. Additionally, higher than expected tricyclic antidepressant levels have been observed when they are begun in patients already taking cimetidine.

Alcohol

Alcohol ingestion may exacerbate the potential sedative effects of Zonalon Cream. This is especially important in patients who may use alcohol excessively.

Tolazamide

A case of severe hypoglycemia has been reported in a type II diabetic patient maintained on tolazamide (1 gm/day) 11 days after the addition of oral doxepin (75 mg/day).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis, mutagenesis, and impairment of fertility studies have not been conducted with doxepin hydrochloride.

Reproduction studies have been performed in which doxepin was orally administered to rats and rabbits at doses up to 0.6 and 1.2 times, respectively, the estimated exposure to doxepin that results from use of 16 grams of Zonalon Cream per day (four applications of four grams of cream per day; dose multiples reflect comparisons made following normalization of the data on the basis of body surface area estimates) and have revealed no evidence of harm to rat or rabbit fetuses due to doxepin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Doxepin is excreted in human milk after oral administration. It is possible that doxepin may also be excreted in human milk following topical application of Zonalon Cream.

One case has been reported of apnea and drowsiness in a nursing infant whose mother was taking an oral dosage form of doxepin HCl.

Because of the potential for serious adverse reactions in nursing infants from doxepin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The use of Zonalon Cream in pediatric patients is not recommended. Safe conditions for use of Zonalon Cream in children have not been established. One case has been reported of a 2.5-year-old child who developed somnolence, grand mal seizure, respiratory depression, ECG abnormalities, and coma after treatment with Zonalon Cream. A total of 27 grams had been applied over three days for eczema. He was treated with supportive care, activated charcoal, and systemic alkalization and recovered.

Geriatric Use

Clinical studies of Zonalon Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

The extent of renal excretion of doxepin has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

Sedating drugs may cause confusion and oversedation in the elderly; elderly patients generally should be observed closely for confusion and oversedation when started on Zonalon Cream. (See .) An 80-year-old male nursing home patient developed probable systemic anticholinergic toxicity which included urinary retention and delirium after Zonalon Cream had been applied to his arms, legs and back three times daily for two days.


What are the side effects of Zonalon?

Controlled Clinical Trials

Systemic Adverse Effects

In controlled clinical trials of patients treated with Zonalon Cream, the most common systemic adverse event reported was drowsiness. Drowsiness occurred in 71 of 330 (22%) of patients treated with Zonalon 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 Zonalon Cream in controlled clinical trials.

Local Site Adverse Effects



Adverse EventZonalon N=330VehicleN=334
Burning/Stinging76(23.0%)54(16.2%)
Drowsiness71(21.5%)7(2.1%)
Dry Mouth 32(9.7%)4(1.2%)
Pruritus 13(3.9%)20(6.0%)
Fatigue/Tiredness10(3.0%)5(1.5%)
Exacerbated Eczema10(3.0%)8(2.4%)
Other Application Site Reaction 10(3.0%)16(4.8%)
Dizziness 7(2.1%)3(0.9%)
Mental/Emotional Changes6(1.8%)1(0.3%)
Taste Perversion 5(1.5%)1(0.3%)
Edema4(1.2%)1(0.3%)
Headache3(0.9%)14(4.2%)


Post-Marketing Experience

Twenty-six cases of allergic contact dermatitis have been reported in patients using Zonalon Cream, twenty of which were documented by positive patch test to doxepin 5% cream.


What should I look out for while using Zonalon?

Because doxepin HCl has an anticholinergic effect and because significant plasma levels of doxepin are detectable after topical Zonalon Cream application, the use of Zonalon Cream is contraindicated in patients with untreated narrow angle glaucoma or a tendency to urinary retention.

Zonalon Cream is contraindicated in individuals who have shown previous sensitivity to any of its components.

Drowsiness occurs in over 20% of patients treated with Zonalon Cream, especially in patients receiving treatment to greater than 10% of their body surface area.

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


What might happen if I take too much Zonalon?

Deaths may occur from overdosage with this class of drugs. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose; therefore, hospital monitoring is required as soon as possible.


How should I store and handle Zonalon?

Unopened vials of gemcitabine for injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . ZONALON Cream is available in 30 g (NDC 40076-715-30) and 45 g (NDC 40076-715-45) tubes. Store at or below 27°C (80°F).


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Although doxepin HCl does have H and H histamine receptor blocking actions, the exact mechanism by which doxepin exerts its antipruritic effect is unknown. Zonalon Cream can produce drowsiness which may reduce awareness, including awareness of pruritic symptoms. In 19 pruritic eczema patients treated with Zonalon Cream, plasma doxepin concentrations ranged from nondetectable to 47 ng/mL from percutaneous absorption. Plasma levels from topical application of Zonalon Cream can result in CNS and other systemic side effects.

Once absorbed into the systemic circulation, doxepin undergoes hepatic metabolism that results in conversion to pharmacologically-active desmethyldoxepin. Further glucuronidation results in urinary excretion of the parent drug and its metabolites. Desmethyldoxepin has a half-life that ranges from 28 to 52 hours and is not affected by multiple dosing. Plasma levels of both doxepin and desmethyldoxepin are highly variable and are poorly correlated with dosage. Wide distribution occurs in body tissues including lungs, heart, brain, and liver. Renal disease, genetic factors, age, and other medications affect the metabolism and subsequent elimination of doxepin. (See .)

Non-Clinical Toxicology
Because doxepin HCl has an anticholinergic effect and because significant plasma levels of doxepin are detectable after topical Zonalon Cream application, the use of Zonalon Cream is contraindicated in patients with untreated narrow angle glaucoma or a tendency to urinary retention.

Zonalon Cream is contraindicated in individuals who have shown previous sensitivity to any of its components.

Drowsiness occurs in over 20% of patients treated with Zonalon Cream, especially in patients receiving treatment to greater than 10% of their body surface area.

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

Studies have not been performed examining drug interactions with Zonalon Cream. However, since plasma levels of doxepin following topical application of Zonalon Cream can reach levels obtained with oral doxepin HCl therapy, the following drug interactions are possible following topical Zonalon Cream application:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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