In the U.S.—

In Canada—

• Antipruritic, topical

Topical doxepin (DOX-e-pin) is used to relieve itching in patients with certain types of eczema. It appears to work by preventing the effects of histamine, which is a substance produced by the body that causes itching.

Doxepin is available only with your doctor's prescription in the following dosage form:

Topical
• Cream (U.S. and Canada)

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

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.

If your skin problem does not improve after 8 days or if it becomes worse, check with your doctor.

This medicine will add to the effects of alcohol (alcoholic beverages or other alcohol-containing preparations [e.g., elixirs, cough syrups, tonics]) and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Topical doxepin may cause some people to become drowsy. Make sure you know how to react to this medicine before you drive, use machines, or do other jobs that require you to be alert. If too much drowsiness occurs, it may be necessary to use less medicine, use it less often, or stop using it completely. However, check with your doctor first before lessening your dose or stopping use of this medicine.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, or melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Burning, crawling, or tingling sensation of the skin;  swelling at the site of application;  worsening of eczema and itching 
  
  

• Rare
  • Fever 
  
  

• Symptoms of overdose
  • Abdominal pain and swelling;  blurring of vision;  convulsions (seizures);  decreased awareness or responsiveness;  difficulty in breathing;  difficulty in passing urine;  dizziness, fainting, or lightheadedness;  drowsiness;  enlarged pupils;  excessive dryness of mouth;  extremely high fever or body temperature;  extremely low body temperature ;  fast heartbeat;  increased or excessive unconscious or jerking movements;  incurable constipation;  irregular heartbeat;  unconsciousness;  vomiting;  weak pulse 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Burning and/or stinging at the site of application;  changes in taste;  dizziness;  drowsiness;  dryness and tightness of skin;  dryness of mouth and/or lips;  emotional changes;  headache;  thirst;  unusual tiredness or weakness  
  
  

• Less common
  • Anxiety;  irritation, tingling, scaling, and cracking of skin;  nausea 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.