Amoxapine

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as amoxapine 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 amoxapine, but in some cases, a doctor may decide that amoxapine 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 amoxapine 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 when you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking amoxapine, 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 amoxapine. 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: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.

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?

Amoxapine is used to treat depression. Amoxapine is in a class of medications called tricyclic antidepressants (TCAs). It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Amoxapine comes as a tablet to take by mouth. It is usually taken one or more times a day. If you take amoxapine once a day, you should take it at bedtime. Try to take amoxapine 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 amoxapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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

What SPECIAL PRECAUTIONS should I follow?

Before taking amoxapine,

• tell your doctor and pharmacist if you are allergic to amoxapine, doxepin (Sinequan), any other medications, or any of the inactive ingredients in amoxapine tablets. Ask your doctor or pharmacist for a list of the inactive ingredients.

• 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).

• Some medications should not be taken with amoxapine. Other medications may cause dosing changes or extra monitoring when taken with amoxapine. Make sure you have discussed any medications you are currently taking or plan to take before starting amoxapine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking amoxapine, please get the advice of your doctor or pharmacist.

• The following nonprescription or herbal products may interact with amoxapine: allergy medications (diphenhydramine, loratadine, fexofenadine, chlorpheniramine or cetirizine); cimetidine (Tagamet); cold medications; medications for sleep. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking amoxapine. Do not start any of these medications while taking amoxapine without discussing with your healthcare provider.

• tell your doctor if you are being treated with electroshock therapy (procedure in which small electric shocks are administered to the brain to treat certain mental illnesses) and if you have or have ever had a heart attack, glaucoma (an eye disease), an enlarged prostate (a male reproductive organ), difficulty urinating, seizures, an overactive thyroid gland, or liver, kidney, or heart disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking amoxapine, call your doctor immediately.

• 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.

• talk to your doctor about the risks and benefits of taking amoxapine if you are 65 years of age or older. Older adults should not usually take amoxapine because it is not as safe or effective as other medications that can be used to treat the same condition.

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 the 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?

Amoxapine may cause side effects. Tell your doctor if any of the following 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
• excessive sweating

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• muscle stiffness
• confusion
• fast or irregular heartbeat
• slow or difficult speech
• shuffling walk
• uncontrollable shaking or moving of a part of the body
• fever
• rash

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Amoxapine 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).

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 (http://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. http://www.upandaway.org

What should I do in case of OVERDOSE?

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 the following:

• seizures
• coma (loss of consciousness for a period of time)

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.