There may be a slightly increased risk of serious, possibly fatal side effects (such as heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.Who should not take molindone?
Molindone is used to treat certain mental/mood disorders (such as schizophrenia). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can reduce aggression and the desire to hurt yourself/others. It may also help to decrease hallucinations (such as hearing/seeing things that are not there). Molindone is a psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances (such as dopamine) in the brain.
Take this medication by mouth with or without food as directed by your doctor, usually 1 to 4 times daily.
The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects such as drowsiness and shaking (tremor), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's directions carefully.
Molindone tablets contain a small amount of calcium, which can interfere with your body's ability to absorb certain drugs, especially if you take them around the same time. Examples of these drugs include quinolone antibiotics (such as ciprofloxacin, levofloxacin), tetracycline antibiotics (such as doxycycline, minocycline), levodopa, phenytoin, thyroid medications (such as levothyroxine), and drugs for osteoporosis (bisphosphonates such as alendronate). Ask your doctor or pharmacist how long to wait between doses and when you should take your medications.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not stop taking this medication without consulting your doctor. Your condition may become worse when this drug is suddenly stopped. Your doctor may reduce your dose gradually.
Although you may notice some improvement in your symptoms soon after starting this medication, it may take several weeks to months before you get the full benefit of this drug.
Tell your doctor if your condition does not get better or if it gets worse.
See also Warning section.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
This drug may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe a medication to decrease these side effects. Tell your doctor right away if you notice any of the following side effects: stiff muscles, severe muscle spasm/cramping (such as twisting neck, arching back, eyes rolling up), restlessness/constant need to move, shaking (tremor), slow/shuffling walk, drooling/trouble swallowing, mask-like expression of the face.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: depression/suicidal thoughts, fainting, difficulty urinating, signs of infection (such as sore throat that doesn't go away, fever), symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin), severe stomach/abdominal pain.
This medication may cause a condition called tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).
In rare cases, molindone may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
Get medical help right away if you have any very serious side effects, including: seizures.
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (such as a low white blood cell count), a certain eye condition (glaucoma), heart problems (such as slow/fast/irregular heartbeat, low blood pressure), slow movement of the gut/intestines (such as chronic constipation, blockage), liver disease, brain disorder/tumor/injury, drug/alcohol/substance abuse, breast cancer, Parkinson's disease, a certain severe reaction to other antipsychotic-type medications (neuroleptic malignant syndrome-NMS), difficulty urinating (such as due to prostate problems).
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Molindone may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.
Older adults may be more sensitive to the side effects of this drug, especially dizziness, extrapyramidal symptoms (EPS), and tardive dyskinesia (TD) (see also Side Effects section).
During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn, especially during their first month, tell the doctor right away.
Since untreated mental/mood problems (such as schizophrenia) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away the benefits and risks of using this medication during pregnancy.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
See also How to Use section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, inability to wake up (coma).
Do not share this medication with others.
Lab and/or medical tests may be done while you are taking this medication. Keep all medical and lab appointments.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2015. Copyright(c) 2015 First Databank, Inc.
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