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Prudoxin

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Prudoxin

Prudoxin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Prudoxin (doxepin hydrochloride) cream 5% is used to treat itching from certain skin conditions like atopic dermatitis and eczema. Common side effects include burning/stinging at the application site, drowsiness, dizziness, dry mouth, blurred vision, or changes in taste.

Apply a thin film of Prudoxin to afflicted area 4 times daily, with at least 3 hours between applications; for no more than 8 days. Avoid taking MAO inhibitors within 2 weeks before, during and after treatment with Prudoxin. Prudoxin may interact with antidepressants, tricyclic antidepressants, phenothiazines, carbamazepine, cimetidine, and Type 1C antiarrhythmics. Tell your doctor all medications and supplements you tale. Do not drive, use machinery, or do any activity that requires alertness or clear vision while taking Prudoxin. Avoid alcoholic beverages. Prudoxin should be used during pregnancy only if clearly needed. Prudoxin passes into breast milk. Consult your doctor if you are breastfeeding.

Our Prudoxin (doxepin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Prudoxin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Controlled Clinical Trials

Systemic Adverse Effects: In controlled clinical trials of patients treated with Doxepin HCl Cream 5%, the most common systemic adverse effect reported was drowsiness. Drowsiness occurred in 22% of patients treated with Doxepin HCl Cream 5% (and 2% of patients treated with placebo cream) and resulted in the premature discontinuation of the drug in approximately 5% of patients treated.

Other systemic adverse effects reported in approximately 1 to 10% of these patients included: Dry mouth, dry lips, thirst, headache, fatigue, dizziness, emotional changes, and taste changes.

Other systemic adverse effects reported in less than 1% of these patients included: Nausea, anxiety and fever.

Local Site Adverse Effects: In controlled clinical trials of patients treated with Doxepin HCl Cream 5%, the most common local site adverse effect reported was burning and/or stinging at the site of application. These occurred in approximately 21% of these patients. 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 Doxepin HCl Cream 5% withdrew from the study because of the burning and/or stinging.

Other local site adverse effects reported in approximately 1 to 10% of these patients included: Pruritus exacerbation, eczema exacerbation, dryness and tightness to skin, paresthesias, and edema.

Other local site adverse effects reported in less than 1% of these patients included: Irritation, tingling, scaling, and cracking.

Post Marketing Experience

Some cases of allergic contact dermatitis have been reported in patients using Doxepin HCl 5% cream.

Read the entire FDA prescribing information for Prudoxin (Doxepin) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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