Molindone

Molindone is a medicine used to treat schizophrenia.

Molindone may also be used for other reasons that are not listed in this medication guide.

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.

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.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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 go away. 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 right away 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 faint; 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 nervous, 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.

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/dayMaintenance 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/dayComments:-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/dayMaintenance 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/dayComments:-Patients with severe symptomology may require 225 mg/day.-Debilitated patients should begin on the lower dosage.Use: Management of schizophrenia

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

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

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.

Taking molindone with other medications that can make you sleepy or slow your breathing can lead to serious side effects or even death. Talk to your doctor before using opioid medications, sleeping pills, muscle relaxers, or medicines for anxiety or seizures.

Inform your doctor about all the other medicines you are taking, especially:

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

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