Brand Name

    US Brand Name

    Prudoxin

    Zonalon


    Description

    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.

    This product is available in the following dosage forms:

    • Cream

    Before Using

    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 this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

    Pediatric

    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.

    Geriatric

    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.

    Breastfeeding

    Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

    Drug Interactions

    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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine 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.

    • Bepridil
    • Bromopride
    • Cisapride
    • Dronedarone
    • Grepafloxacin
    • Isocarboxazid
    • Levoketoconazole
    • Levomethadyl
    • Linezolid
    • Mavorixafor
    • Mesoridazine
    • Methylene Blue
    • Metoclopramide
    • Moclobemide
    • Pimozide
    • Piperaquine
    • Potassium Citrate
    • Ranolazine
    • Safinamide
    • Saquinavir
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • Tranylcypromine
    • Ziprasidone

    Using this medicine 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.

    • Abiraterone Acetate
    • Abiraterone Acetate, Micronized
    • Acecainide
    • Aceclofenac
    • Acemetacin
    • Adagrasib
    • Albuterol
    • Alfentanil
    • Almotriptan
    • Amantadine
    • Amiodarone
    • Amisulpride
    • Amitriptyline
    • Amoxapine
    • Amphetamine
    • Amtolmetin Guacil
    • Anagrelide
    • Apomorphine
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Arsenic Trioxide
    • Aspirin
    • Astemizole
    • Atazanavir
    • Azimilide
    • Azithromycin
    • Bedaquiline
    • Benzhydrocodone
    • Benzphetamine
    • Bretylium
    • Bromfenac
    • Bufexamac
    • Buprenorphine
    • Bupropion
    • Buserelin
    • Butorphanol
    • Carbamazepine
    • Carisoprodol
    • Celecoxib
    • Ceritinib

    Using this medicine 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.

    • Acenocoumarol
    • Arbutamine
    • Bethanidine
    • Cimetidine
    • Desogestrel
    • Dicumarol
    • Dienogest
    • Drospirenone
    • Ethinyl Estradiol
    • Ethynodiol
    • Fosphenytoin
    • Gestodene
    • Guanethidine
    • Levonorgestrel
    • Mestranol
    • Nomegestrol
    • Norethindrone
    • Norgestimate
    • Norgestrel
    • Phenprocoumon
    • Phenytoin
    • Propoxyphene
    • Ramelteon
    • S-Adenosylmethionine
    • Warfarin

    Other Interactions

    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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

    Proper Use

    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 this medicine 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 this medicine. 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 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.

    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.


    Precautions

    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.


    Side Effects

    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

    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

    • 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 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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