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

Use this medicine 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 topical 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 dose of topical doxepin. If your dose is different, do not change it unless your doctor tells you to do so.

The number of doses you apply each day, the time allowed between doses, and the length of time you use the medicine depend on the severity of the medical problem for which you are using topical doxepin.

• 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 this medicine, 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. Do not double doses.

Storage

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For topical doxepin, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic reaction to doxepin. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy Doxepin has not been studied in pregnant women. However, doxepin has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding Doxepin passes into the breast milk. Oral doxepin has been shown to cause unwanted effects in the breast-fed baby. Therefore, it may be necessary for you to use another medicine or to stop breast-feeding during treatment with topical doxepin. Be sure you have discussed the risk and benefits of the medicine with your doctor.

Children Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of doxepin in children with use in other age groups.

Older adults Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of doxepin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using topical doxepin, it is especially important that your health care professional know if you are taking any of the following:

• Alcohol or
• Central nervous system (CNS) depressants (medicines that cause drowsiness) or
• Tricyclic antidepressants (medicines for depression) Drinking alcohol or using these medicines with topical doxepin may cause increased CNS depressant effects such as drowsiness

• Cimetidine (e.g., Tagamet)

• Debrisoquine (e.g., Declinax)

• Dextromethorphan (e.g., Benylin DM)

• Medicines that correct heart rhythm problems, (encainide [e.g., Enkaid], flecainide [e.g., Tambocor], propafenone [e.g., Rythmol], quinidine [e.g., Cardioquin]) Using these medicines with topical doxepin may increase the chance of side effects

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) Using topical doxepin while you are taking or within 2 weeks of taking MAO inhibitors may cause sudden high body temperature, excitability, severe convulsions, and even death; however, sometimes some of these medicines may be used together under close supervision by your doctor

• Glaucoma or
• Urinary tract blockage or difficult urination Using topical doxepin may make these conditions worse