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?
This medication 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 aggressive behavior 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, usually 1 to 4 times daily or as directed by your doctor.
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. Some conditions may become worse when the drug is suddenly stopped. Your doctor may need to 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 improve or if it worsens.
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 another medication to decrease these side effects. Therefore, tell your doctor immediately 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.
This medication may cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any involuntary/repetitive muscle movements such as lip smacking/puckering, tongue thrusting, chewing, or finger/toe movements.
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 immediately.
For males, in the very unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention, or permanent problems could occur.
Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (such as fever, persistent sore throat), signs of liver problems (such as persistent nausea/vomiting, unusual tiredness, yellowing eyes/skin), seizures, severe stomach/abdominal pain.
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, change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.
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. Avoid 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 decrease your ability to sweat, making you more likely to get heat stroke. Avoid activities that may cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). Drink plenty of fluids and dress lightly. If you become overheated, promptly seek cooler shelter and stop exercising. Seek immediate medical attention if you develop fever, 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 Side Effects).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
See also How To Use section.
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Some products that may interact with this drug include: anticholinergic/antispasmodic drugs (such as atropine, dicyclomine, scopolamine), drugs that increase the amount of dopamine in your body (such as bromocriptine, cabergoline, levodopa, pergolide, ropinirole), drugs for high blood pressure (such as guanethidine, alpha blockers like prazosin).
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, and narcotic pain relievers (such as codeine).
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.
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
If overdose is suspected, contact a poison control center or emergency room immediately. 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.
Laboratory and/or medical tests (such as white blood cell count, eye exams) may be performed periodically to check for side effects. Consult your doctor for more details.
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 and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. 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 for more details about how to safely discard your product.
Information last revised July 2013. Copyright(c) 2013 First Databank, Inc.
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