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doxepin hydrochloride
Overview
What is PRUDOXIN?
PRUDOXIN (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.
PRUDOXIN Cream also contains sorbitol, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG- 100 stearate, petrolatum, benzyl alcohol, titanium dioxide and purified water.
What does PRUDOXIN look like?
What are the available doses of PRUDOXIN?
Sorry No records found.
What should I talk to my health care provider before I take PRUDOXIN?
Sorry No records found
How should I use PRUDOXIN?
PRUDOXIN 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 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 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 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.
What interacts with PRUDOXIN?
Sorry No Records found
What are the warnings of PRUDOXIN?
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What are the precautions of PRUDOXIN?
Sorry No Records found
What are the side effects of PRUDOXIN?
Sorry No records found
What should I look out for while using PRUDOXIN?
Because doxepin HCl has an anticholinergic effect and because significant plasma levels of doxepin are detectable after topical PRUDOXIN Cream application, the use of PRUDOXIN Cream is contraindicated in patients with untreated narrow angle glaucoma or a tendency to urinary retention.
PRUDOXIN Cream is contraindicated in individuals who have shown previous sensitivity to any of its components.
Drowsiness occurs in over 20% of patients treated with PRUDOXIN 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 PRUDOXIN 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 PRUDOXIN?
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 PRUDOXIN?
PRUDOXIN Cream is available in a 45 g (NDC 40076-511-45) tube. Store at or below 27° C (80° F). Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940Manufactured by:DPT Laboratories, Ltd. San Antonio, TX 78215PRUDOXIN is a registered trademark of Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.©2/2015140475PRUDOXIN Cream is available in a 45 g (NDC 40076-511-45) tube. Store at or below 27° C (80° F). Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940Manufactured by:DPT Laboratories, Ltd. San Antonio, TX 78215PRUDOXIN is a registered trademark of Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.©2/2015140475PRUDOXIN Cream is available in a 45 g (NDC 40076-511-45) tube. Store at or below 27° C (80° F). Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940Manufactured by:DPT Laboratories, Ltd. San Antonio, TX 78215PRUDOXIN is a registered trademark of Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.©2/2015140475PRUDOXIN Cream is available in a 45 g (NDC 40076-511-45) tube. Store at or below 27° C (80° F). Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940Manufactured by:DPT Laboratories, Ltd. San Antonio, TX 78215PRUDOXIN is a registered trademark of Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.©2/2015140475PRUDOXIN Cream is available in a 45 g (NDC 40076-511-45) tube. Store at or below 27° C (80° F). Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940Manufactured by:DPT Laboratories, Ltd. San Antonio, TX 78215PRUDOXIN is a registered trademark of Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.©2/2015140475PRUDOXIN Cream is available in a 45 g (NDC 40076-511-45) tube. Store at or below 27° C (80° F). Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940Manufactured by:DPT Laboratories, Ltd. San Antonio, TX 78215PRUDOXIN is a registered trademark of Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.©2/2015140475PRUDOXIN Cream is available in a 45 g (NDC 40076-511-45) tube. Store at or below 27° C (80° F). Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940Manufactured by:DPT Laboratories, Ltd. San Antonio, TX 78215PRUDOXIN is a registered trademark of Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.©2/2015140475PRUDOXIN Cream is available in a 45 g (NDC 40076-511-45) tube. Store at or below 27° C (80° F). Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940Manufactured by:DPT Laboratories, Ltd. San Antonio, TX 78215PRUDOXIN is a registered trademark of Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.©2/2015140475
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Although doxepin HCl does have H1 and H2 histamine receptor blocking actions, the exact mechanism by which doxepin exerts its antipruritic effect is unknown. PRUDOXIN Cream can produce drowsiness which may reduce awareness, including awareness of pruritic symptoms. In 19 pruritic eczema patients treated with PRUDOXIN Cream, plasma doxepin concentrations ranged from nondetectable to 47 ng/mL from percutaneous absorption. Plasma levels from topical application of PRUDOXIN 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 PRUDOXIN Cream application, the use of PRUDOXIN Cream is contraindicated in patients with untreated narrow angle glaucoma or a tendency to urinary retention.PRUDOXIN Cream is contraindicated in individuals who have shown previous sensitivity to any of its components.
Drowsiness occurs in over 20% of patients treated with PRUDOXIN 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 PRUDOXIN 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 PRUDOXIN Cream. However, since plasma levels of doxepin following topical application of PRUDOXIN Cream can reach levels obtained with oral doxepin HCl therapy, the following drug interactions are possible following topical PRUDOXIN Cream application:
Drugs Metabolized by P450 2D6:
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:
Cimetidine:
Alcohol:
Tolazamide:
General Drowsiness:
Sedating drugs may cause confusion and oversedation in the elderly; elderly patients generally should be observed closely for confusion and oversedation when started on PRUDOXIN Cream. (See .)
Use under occlusion:
Contact sensitization:
Controlled
Clinical
Trials
Systemic Adverse Effects:
Local Site Adverse Effects:
These occurred in 76 of 330 (23%) of patients treated with PRUDOXIN Cream compared to 54 of 334 (16%) of patients treated with vehicle cream. Most of these reactions were categorized as "mild"; however, approximately 25% of patients who reported burning and/or stinging reported the reaction as "severe". Four patients treated with PRUDOXIN Cream withdrew from the study because of the burning and/or stinging.
The table below presents the adverse events reported at an incidence of ≥ 1 % in either PRUDOXIN or vehicle cream treatment groups during the trials:
Adverse events occurring in 0.5% to < 1.0% of PRUDOXIN Cream treated patients in the controlled clinical trials included: nervousness/anxiety, tongue numbness, fever, and nausea.
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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