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Prudoxin

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Since 2009, the Food and Drug Administratio"...

Prudoxin

PATIENT INFORMATION

PRUDOXIN™
(DOXEPIN HYDROCHLORIDE CREAM), 5%

Stop the Itch Fast

What is PRUDOXIN™ Cream?

PRUDOXIN™ Cream (doxepin hydrochloride cream), 5% is a non-steroidal, moisturizing, topical anti-itch cream.

How does PRUDOXIN™ Cream (doxepin) relieve itching?

The exact way PRUDOXIN™ Cream (doxepin) works to relieve itching is unknown. However, it does have potent histamine-blocking actions.

How quickly does PRUDOXIN™ Cream (doxepin) begin to work?

PRUDOXIN™ Cream (doxepin) 's targeted delivery begins to relieve itching within minutes. In one clinical study, 75% of patients reported they began to feel relief in 15 minutes.1

How should I use PRUDOXIN™ Cream (doxepin) ?

PRUDOXIN™ Cream (doxepin) should be applied in a thin film to the affected areas four times each day with at least a 3 to 4 hour interval between applications.

Can I use PRUDOXIN™ Cream (doxepin) with other medications?

Studies have not been performed examining drug interactions with PRUDOXIN (doxepin) ™ Cream. However, data are available regarding potentially significant drug interactions regarding the active ingredient, so certain drug interactions could be possible following topical PRUDOXIN™ Cream (doxepin) application. Please see complete prescribing information.

To minimize the possibility of any drug interactions, be sure to talk with your doctor about all prescription and/or over-the-counter medications you are taking before you begin using PRUDOXIN™ Cream (doxepin) .

What are the possible side effects of PRUDOXIN™ Cream (doxepin) ?

Most common side effects, including burning and/or stinging, drowsiness (more common when applied to greater than 10% of body surface area), and dry mouth, are generally mild.

Be sure and tell your doctor if you are experiencing any side effects.

What are the contraindications of PRUDOXIN™ Cream (doxepin) ?

The use of PRUDOXIN™ Cream (doxepin) is contraindicated in patients with untreated narrow angle glaucoma, tendency to urinary retention, and in individuals who have shown previous sensitivity to any of its components.

PRUDOXIN™ Cream (doxepin) is for topical dermatologic use only. It should not be used in or around the eyes, the mouth or any mucous membrane.

How should I store PRUDOXIN™ Cream (doxepin) ?

PRUDOXIN™ Cream (doxepin) should be stored at or below 27° C (80° F).

General advice about prescription medicines:

This medicine is for your use only. Never give it to other people. It may harm them even if their skin problem appears to be the same as yours. Do not use PRUDOXIN™ Cream (doxepin) for any condition for which it was not prescribed.

REFERENCE:

1. Breneman DL, Dunlap FE, Monroe EW, Schupbach CW, Shmunes E, Phillips SB. Doxepin cream relieves eczema-associated pruritus within 15 minutes and is not accompanied by a risk of rebound upon discontinuation. J Dermatol Treat. 1997; 8:161-168.

Last reviewed on RxList: 11/21/2008
This monograph has been modified to include the generic and brand name in many instances.

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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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