Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Dermatological Agent
Pharmacologic Class: Antidepressant, Tricyclic
Topical doxepin 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 deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For doxepin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to doxepin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies on doxepin 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.
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, doxepin is not expected to cause different side effects or problems in older people than it does in younger adults.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using doxepin.
Using doxepin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using doxepin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using doxepin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of doxepin. Make sure you tell your doctor if you have any other medical problems, especially:
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.
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.
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.
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.
If your skin problem does not improve after 8 days or if it becomes worse, check with your doctor.
doxepin 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 doxepin.
Topical doxepin may cause some people to become drowsy. Make sure you know how to react to doxepin 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 doxepin.
doxepin 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
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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