Doxepin (Depression, Anxiety)

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: https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

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.

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.

Doxepin is also available as a tablet to treat insomnia. This monograph only gives information about doxepin for depression or anxiety. If you are using this medication for insomnia, read the monograph entitled doxepin (insomnia).

Doxepin comes as a capsule, 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.

Doxepin is also sometimes used to treat chronic hives without a known cause. Talk to your doctor about the risks of using this medication for your condition.

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

Before taking doxepin,

• tell your doctor and pharmacist if you are allergic to doxepin, amoxapine, loxapine, any other medications, or any of the ingredients in doxapine capsules, or concentrate.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking doxepin. 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.
• the following nonprescription products may interact with doxepin: cimetidine (Tagamet). Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking doxepin. Do not start this medication while taking doxepin without discussing with your healthcare provider.
• tell your doctor if you have glaucoma or difficulty urinating. Your doctor will probably tell you not to take doxepin.
• tell your doctor if you have or have ever drunk large amounts of alcohol, , or have or have ever had asthma, or liver or kidneydisease.
• 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.
• 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.
• ask your doctor about the safe use of alcoholic beverages while you are taking doxepin. Alcohol can make the side effects from doxepin worse.
• you should know that doxepin may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

Unless your doctor tells you otherwise, continue your normal diet

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.

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

• nausea
• vomiting
• weakness or tiredness
• dizziness
• increase in pupil size
• dry mouth
• mouth sores
• skin more sensitive to sunlight than usual
• flushing
• changes in appetite or weight
• changes in the way things taste
• indigestion
• constipation
• diarrhea
• difficulty urinating
• excessive thirst and urination
• ringing in your ears
• changes in sex drive
• swollen testicles
• increased breast size
• milky discharge from nipples in females
• excessive sweating
• chills
• headache
• hair loss

If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately:

• yellowing of the skin or eyes
• fast heartbeat
• unusual bleeding or bruising
• skin rash, itching, or swelling

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 (https://www.fda.gov/Safety/MedWatch) 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.

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). Store doxepin capsules away from light.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• irregular heart beat
• feeling agitated, confused, or drowsy
• trouble concentrating
• seizures
• muscle stiffness
• vomiting
• increase in pupil size
• hallucination (seeing things or hearing voices that do not exist)
• fever
• cold body temperature
• coma (loss of consciousness for a period of time)

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.

• Sinequan^® Capsules^¶
• Sinequan^® Concentrated Solution^¶