Doxepin Topical

In the U.S.

• Prudoxin
• Zonalon

Available Dosage Forms:

• Cream

Therapeutic Class: Dermatological Agent

Pharmacologic Class: Antidepressant, Tricyclic

Topical doxepin is for external use only. Do not use doxepin orally, do not use it on the eyes, or inside of the vagina.

Use doxepin exactly as directed. Do not use more of it, do not use it more often, and do not use it for more than 8 days. Also, do not apply it to an area of skin larger than recommended by your doctor. To do so may increase the chance of side effects.

Apply a thin layer of doxepin cream to only the affected area(s) of the skin and rub in gently.

To help clear up your skin problem it is very important that you keep using topical doxepin for the full time of treatment. Do not miss any doses.

Do not cover with a bandage or otherwise wrap the area of skin being treated. This may increase the amount of medicine that gets into the bloodstream, thereby increasing the chance of side effects.

Dosing

The dose of doxepin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of doxepin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  • For itching due to eczema:
    • Adults—Apply a thin layer to the affected area(s) of the skin four times a day. Space the doses or applications at least three or four hours apart. Treatment may be continued for up to eight days.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of doxepin, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

• It is used to treat itching.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take doxepin. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Use care when using on a large part of the skin. Talk with the doctor.
• If you are 65 or older, use doxepin with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

• Doxepin HCl
• Doxepin Hydrochloride

Taking doxepin with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking doxepin with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Before taking doxepin, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline.

You must wait at least 5 weeks after stopping fluoxetine (Prozac) before you can take doxepin.

Other drugs may interact with doxepin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

This medication is used to relieve troublesome itching from certain skin conditions (e.g., atopic dermatitis, eczema, neurodermatitis). It should be used only for a short time (no more than 8 days). Doxepin is a tricyclic antidepressant. It is not known how this medication decreases itching. Some medication is absorbed into the body when the cream is applied. This medication may work by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. The decrease in itching may be a result of drowsiness or some other effect in the brain that causes you not to notice or be bothered by the itching.

How to use Doxepin HCL Cream

Before applying the medication, clean the affected area with mild soap and water, rinse well, and pat dry. Gently rub a small amount of the medication into the affected area in a thin layer, usually 4 times a day. Wait at least 3-4 hours between applications, or use as directed by your doctor. How often the medication is applied and for how long depends on your condition and response to treatment. Usually, this medication is for short-term use only (up to 8 days).

Wash hands immediately after use unless the area being treated includes the hands. This medication is for use on the skin only. Avoid getting the product in your eyes, nose, ears, mouth, or vaginal/anal area. If the medication gets in these areas, rinse immediately with clean water.

Do not cover the area with plastic or waterproof bandages. Covering the treated area may increase the absorption of the medication through the skin and increase the risk of side effects.

Do not use more of this product, use it more often, or keep using it longer than prescribed by your doctor. Your condition will not improve faster and the risk for side effects will increase. Side effects may increase when you use the cream on a larger area of skin (e.g., more than 10 percent of your body surface). Tell your doctor if you have severe drowsiness while using this product. It may be a sign that you are absorbing too much of the medication. Your doctor may tell you to decrease how often you apply the medication, the amount of medication used, or how much skin to spread the medication over. Follow your doctor's directions carefully.

Tell your doctor if your condition does not improve or if it worsens.

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 doxepin topical 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.

Stop using doxepin topical 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 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.

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.

Doxepin topical 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.

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

Serious overdose symptoms can occur if too much of this medicine 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).

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.

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is recommended only if clearly needed and the benefit outweighs the risk. US FDA pregnancy category: B