Brand Name(s):

    
  • Silenor®Tablets
  • Sinequan®Capsules¶
  • Sinequan®Concentrated Solution¶
  • IMPORTANT WARNING

    A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as doxepin during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take doxepin, but in some cases, a doctor may decide that doxepin is the best medication to treat a child's condition.

    You should know that your mental health may change in unexpected ways when you take doxepin or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied, abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

    Your healthcare provider will want to see you often while you are taking doxepin, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

    The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with doxepin. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: Web Site.

    No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

    WHY is this medicine prescribed?

    Doxepin is used to treat depression and anxiety. Doxepin is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed for mental balance.

    HOW should this medicine be used?

    Doxepin comes as a capsule, a tablet, or concentrate (liquid) to take by mouth. It is usually taken one to three times a day and may be taken with or without food. Try to take doxepin at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take doxepin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

    Doxepin concentrate (oral liquid) comes with a specially marked dropper for measuring the dose. Ask your pharmacist to show you how to use the dropper. Dilute the concentrate in 4 ounces (120 mL) of water; whole or skim milk; or orange, grapefruit, tomato, prune, or pineapple juice just before taking it. Do not mix it with carbonated beverages (soft drinks).

    It may take several weeks or longer for you to feel the full effect of doxepin. Continue to take doxepin even if you feel well. Do not stop taking doxepin without talking to your doctor. Your doctor will probably want to decrease your dose gradually.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking doxepin,

        
  • tell your doctor and pharmacist if you are allergic to doxepin, amoxapine, or any other medications.
  • tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take doxepin. If you stop taking doxepin, you should wait at least 14 days before you start to take an MAO inhibitor.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; anticoagulants (blood thinners) such as warfarin (Coumadin); cimetidine (Tagamet); flecainide (Tambocor); levodopa (Larodopa, Sinemet); lithium (Eskalith, Lithobid); medication for high blood pressure, seizures, Parkinson's disease, diabetes, asthma, colds, or allergies; methylphenidate (Ritalin); muscle relaxants; propafenone (Rythmol); quinidine; sedatives; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sleeping pills; thyroid medications; tolazamide (Tolinase); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Your doctor may tell you not to take doxepin if you have taken fluoxetine in the past 5 weeks.
  • tell your doctor if you have or have ever had glaucoma (an eye condition) or difficulty urinating. Your doctor will probably tell you not to take doxepin.
  • tell your doctor if you have or have ever had an enlarged prostate (a male reproductive gland), diabetes, seizures, an overactive thyroid gland, or liver, kidney, or heart disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking this medication, call your doctor.
  • talk to your doctor about the risks and benefits of taking doxepin if you are 65 years of age or older. Older adults should not usually take doxepin because it is not as safe or effective as other medications that can be used to treat the same condition.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking doxepin.
  • you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • remember that alcohol can add to the drowsiness caused by this medication.
  • What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet

    What should I do IF I FORGET to take a dose?

    Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Doxepin may cause side effects. Call your doctor if any of these symptoms are severe or do not go away:

        
  • nausea
  • drowsiness
  • weakness or tiredness
  • nightmares
  • dry mouth
  • skin more sensitive to sunlight than usual
  • changes in appetite or weight
  • constipation
  • difficulty urinating
  • frequent urination
  • blurred vision
  • changes in sex drive or ability
  • excessive sweating
  • If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

        
  • jaw, neck, and back muscle spasms
  • slow or difficult speech
  • shuffling walk
  • uncontrollable shaking of a part of the body
  • fever
  • difficulty breathing or swallowing
  • rash
  • yellowing of the skin or eyes
  • irregular heartbeat
  • If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].

    Doxepin may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.

    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    ¶This branded product is no longer on the market. Generic alternatives may be available.

    AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

    Selected Revisions: October 1, 2010.