Molindone

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as molindone have an increased chance of death during treatment.

Molindone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking molindone. For more information visit the FDA website: https://www.fda.gov/Drugs

Molindone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Molindone is in a class of medications called conventional (typical) antipsychotics. It works by decreasing abnormal excitement in the brain.

Molindone comes as a tablet to take by mouth. It is usually taken three or four times a day. Try to take molindone at around the same times 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 molindone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of molindone and gradually increase your dose after 3 to 4 days. Later, your doctor may increase or decrease your dose, depending on your response to the medication and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with molindone.

Molindone may help to control your condition but will not cure it. Continue to take molindone even if you feel well. Do not stop taking molindone without talking to your doctor. It may take several weeks or longer for you to feel the full benefit of molindone.

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

Before taking molindone,

• tell your doctor and pharmacist if you are allergic to molindone, any other medications, or any of the ingredients in molindone. Ask your pharmacist for a list of the ingredients.
• 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 molindone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had depression, breast cancer, trouble keeping your balance, or a low number of white blood cells in your blood.
• 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 breastfeeding. If you become pregnant while taking molindone, call your doctor. Molindone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking molindone.
• you should know that this medication may make you drowsy and may affect your thinking and movements. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcohol while you are taking molindone. Alcohol can make the side effects of molindone worse.
• you should know that molindone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

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.

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

• dizziness, feeling unsteady, or having trouble keeping your balance
• dry mouth
• blurred vision
• increased saliva
• nausea
• constipation
• difficulty urinating
• blank facial expression
• shuffling walk
• unusual, slowed, or uncontrollable movements of any part of the body
• restlessness
• excitement or increased activity
• depression
• inappropriate happiness
• breast enlargement
• breast milk production
• menstrual period changes (missed periods or heavy bleeding)
• changes in sex drive

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment,:

• fever
• muscle stiffness
• falling
• confusion
• fast or irregular heartbeat
• rash
• sweating
• neck cramps
• tongue that sticks out of the mouth
• tightness in the throat
• difficulty breathing or swallowing
• fine, worm-like tongue movements
• uncontrollable, rhythmic face, mouth, or jaw movements
• seizures
• changes in vision

Molindone may cause other side effects. Tell your doctor if you have any unusual problems while you are 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 light, 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 (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 the following:

• unusual, slowed, or uncontrollable movements of any part of the body
• loss of consciousness

Keep all appointments with your doctor. Your doctor may order certain lab tests to check your body's response to molindone.

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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