Doxepin is a tricyclic antidepressant. When applied to the skin, Prudoxin can help relieve itching but it will not treat symptoms of depression.

Prudoxin (for use on skin) is used to treat itchy skin in adults with eczema or other skin conditions that can lead to repeated scratching and thickened skin.

Prudoxin may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Prudoxin is usually applied 4 times each day. Allow at least 3 hours to pass between applications.

Apply a thin layer of medication to the affected skin and rub in gently.

Do not cover treated skin area with a bandage or plastic. Bandaging can increase the amount of drug absorbed through your skin and may cause harmful effects.

Do not use this medicine for longer than 8 days. Stop using the medicine and call your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Keep the tube tightly closed when not in use.

You should not use Prudoxin if you are allergic to doxepin (Silenor, Sinequan), or if you have:

• untreated narrow-angle glaucoma; or

• urination problems.

Before using Prudoxin, tell your doctor about all your medical conditions or allergies.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Doxepin topical can pass into breast milk and may cause side effects in the nursing baby. Tell your doctor if you are breast-feeding.

Prudoxin is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Serious overdose symptoms can occur if too much of Prudoxin is absorbed through your skin. Overdose symptoms may include extreme dizziness or drowsiness, feeling hot or cold, vomiting, confusion, agitation, trouble concentrating, irregular heartbeats, hallucinations, fainting, dilated pupils, muscle stiffness, or seizure (convulsions).

Rinse with water if this medicine gets in your eyes.

Absorbing large amounts of this medicine through your skin may cause side effects that can impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when Prudoxin is applied to the skin, side effects can occur if the medicine is absorbed into your bloodstream. You may feel drowsy after applying this medicine, especially if you have treated large areas of skin.

Prudoxin may cause serious side effects. Stop using Prudoxin and call your doctor at once if you have:

• severe drowsiness;

• confusion;

• severe dry mouth;

• painful or difficult urination;

• blurred vision; or

• new or worsening skin symptoms.

Some side effects may be more likely in older adults.

Common side effects of Prudoxin may include:

• burning or stinging where the medicine was applied;

• mild drowsiness; or

• dry mouth.

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.

Using Prudoxin with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Before using Prudoxin, tell your doctor if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• cimetidine;

• heart rhythm medication; or

• any antidepressant medication you take by mouth.

This list is not complete. Other drugs may interact with doxepin topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.