Molindone is an antipsychotic medicine that is used to treat schizophrenia.

Molindone may also be used for purposes not listed in this medication guide.

You should not use molindone if you have decreased alertness caused by taking certain medications or drinking alcohol.

Molindone is not approved for use in older adults with dementia-related psychosis.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may not start feeling better right away when you start taking molindone. For best results, keep using the medication as directed.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Schizophrenia:

Initial Dosing Schedule:
-Recommended dose: 50 to 75 mg orally per day, increasing the dose to 100 mg/day in 3 to 4 days
-Maximum dose: 225 mg/day

Maintenance Dosing Schedule:
-Mild symptomology: 5 to 15 mg orally 3 to 4 times a day
-Moderate symptomology: 10 to 25 mg orally 3 to 4 times a day
-Severe symptomology: Up to 225 mg/day

Comments:
-Patients with severe symptomology may require 225 mg/day.
-Elderly and/or debilitates patients should begin on the lower dosage.

Use: Management of schizophrenia

Usual Pediatric Dose for Schizophrenia:

12 to 18 years:
Initial Dosage Schedule:
-Recommended dose: 50 to 75 mg orally per day, increasing the dose to 100 mg/day in 3 to 4 days
-Maximum dose: 225 mg/day

Maintenance Dosing Schedule:
-Mild symptomology: 5 to 15 mg orally 3 to 4 times a day
-Moderate symptomology: 10 to 25 mg orally 3 to 4 times a day
-Severe symptomology: Up to 225 mg/day

Comments:
-Patients with severe symptomology may require 225 mg/day.
-Debilitated patients should begin on the lower dosage.

Use: Management of schizophrenia

You should not use molindone if you are allergic to it, or:

• if you have decreased alertness caused by taking certain medications or drinking alcohol.

Molindone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• epilepsy or other seizure disorder;

• low white blood cell (WBC) counts;

• urination problems; or

• breast cancer.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking molindone without your doctor's advice.

It is not known whether molindone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

It may not be safe to breastfeed while using molindone. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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 (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

Unless your doctor tells you otherwise, continue your normal diet.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how molindone will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of molindone can cause a serious movement disorder that may not be reversible. The longer you use molindone, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Molindone may cause serious side effects. Call your doctor at once if you have:

• any new or unusual muscle movements you cannot control;

• tremor (uncontrolled shaking);

• trouble breathing or swallowing;

• a seizure (convulsions);

• (in women) irregular menstrual periods, breast or vaginal changes, nipple discharge;

• (in men) breast swelling, impotence;

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or

• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing.

Common side effects of molindone may include:

• drowsiness;

• fast heart rate, feeling restless or nevous, being unable to sit still;

• blurred vision;

• dry mouth;

• little or no urination;

• nausea, constipation;

• breast swelling or discharge;

• impotence, sexual problems; or

• changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking molindone with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• phenytoin; or

• an antibiotic such as demeclocycline, doxycycline, minocycline, or tetracycline.

This list is not complete. Other drugs may affect molindone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.