Gepirone

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as gepirone 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 gepirone, but in some cases, a doctor may decide that gepirone 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 gepirone or other antidepressants even if you are an adult over 24 years of age. 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; or 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 gepirone, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

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

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with gepirone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

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.

Gepirone is used to treat depression in adults. Gepirone is in a class of medications called serotonin modulators. It works mainly by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Gepirone comes as an extended-release (long-acting) tablet to take by mouth. It is usually taken with food once a day. Take gepirone at around the same time 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 gepirone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor may start you on a low dose of gepirone and gradually increase your dose depending on how well the medication works for you and the side effects you experience.

Gepirone controls depression, but does not cure it. It may take several weeks before you feel the full benefit of gepirone. Continue to take gepirone even if you feel well. Do not stop taking gepirone without talking to your doctor.

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

Before taking gepirone,

• tell your doctor and pharmacist if you are allergic to gepirone, any other medications, or any of the ingredients in gepirone tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• Some medications should not be taken with gepirone. Other medications may cause dosing changes or extra monitoring when taken with gepirone. Make sure you have discussed any medications you are currently taking or plan to take before starting gepirone with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking gepirone, please get the advice of your doctor or pharmacist.
• 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) inhibitors such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate).
• The following nonprescription or herbal products may interact with gepirone: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking gepirone. Do not start this medication while taking gepirone without discussing with your healthcare provider.
• tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or liver problems. Your doctor may tell you not to take gepirone.
• tell your doctor if you have recently had a heart attack and if you have or have ever had a slow or irregular heartbeat, heart failure, or any other heart problems; high blood pressure; a low level of potassium, magnesium, or sodium in your blood; or kidney disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking gepirone, call your doctor. Gepirone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

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.

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

• dizziness
• headache
• sleepiness
• unusual tiredness
• dry mouth
• stomach pain
• heartburn
• increased appetite
• increased weight
• constipation
• sore throat, runny or stuff nose, cough, or fever
• numbness or tingling in the hands, feet, arms, or legs
• rash, itching, or hives

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

• seizures
• fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• seizures

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

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).

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).

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

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.

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:

• vomiting
• decreased consciousness
• irregular heartbeat
• chest pain
• seizures

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to gepirone.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking gepirone.

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.

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