Pronunciation:

moe-LIN-done

Brand Names:

• Moban

Dosage Forms:

• Tablet
• Syrup

Classifications:

Therapeutic

Antipsychotic

Chemical

Dihydroindolone

Uses of This Medicine:

Molindone is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies have not been performed on the relationship of age to the effects of molindone in children below 12 years of age. Safety and efficacy have not been established. .

Older adults

No information is available on the relationship of age to the effects of molindone in geriatric patients. However, elderly patients (especially females) are more likely to have a side effect called tardive dyskinesia (a movement disorder), which may require caution in patients receiving molindone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Droperidol
• Metoclopramide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Hydromorphone
• Lithium
• Milnacipran
• Tramadol
• Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Betel Nut

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breast cancer, prolactin-dependent or
• Difficult urination or
• Enlarged prostate or
• Glaucoma or
• Liver disease or
• Neuroleptic malignant syndrome (NMS), history of or
• Parkinson's disease or
• Seizures, history of Use with caution. May make these conditions worse.

• Nervous system depression, severe (severe drowsiness to loss of consciousness) Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of schizophrenia:
    • Adults and teenagers At first, 50 to 75 milligrams (mg) per day, given in divided doses 3 or 4 times a day. Your doctor may adjust the dose as needed.
    • Children younger than 12 years of age Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits, to allow changes in dose and to check for unwanted effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever or allergies; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Molindone may cause some people to become drowsy or less alert than they are normally, especially during the first few weeks the medicine is being taken. Even if you take this medicine only at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness or lightheadedness may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Molindone may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. If your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infection.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Difficulty with talking or swallowing

inability to move the eyes

lip smacking or puckering

loss of balance control

mask-like face

muscle spasms, especially of the neck and back

puffing of the cheeks

rapid or worm-like movements of the tongue

restlessness or need to keep moving (severe)

shuffling walk

stiffness of the arms and legs

trembling and shaking of the hands

twisting movements of the body

uncontrolled movements of the arms and legs

unusual chewing movements

Less common

Discouragement

false or unusual sense of well-being

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

tiredness

trouble sitting still

trouble with concentrating

trouble with sleeping

Rare

Blurred vision

confusion

dark-colored urine

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

general feeling of tiredness or weakness

headache

hot, dry skin, or lack of sweating

light-colored stools

muscle weakness

skin rash

stomach pain, continuing

sweating

unusual tiredness or weakness

vomiting

yellow eyes or skin

Incidence not known

Absence of or decrease in body movement

decrease in frequency of urination

decrease in urine volume

difficulty in passing urine (dribbling)

fast, pounding, or irregular heartbeat or pulse

increased blinking or spasms of the eyelid

painful urination

slowed movements

sticking out of the tongue

tic-like (jerky) movements of the head, face, mouth, and neck

trouble with breathing, speaking, or swallowing

twisting movements of the neck, trunk, arms, or legs

unusual facial expressions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

decreased sweating

difficult urination

drowsiness

dryness of the mouth

headache

nausea

stuffy nose

Less common

Absent, missed, or irregular menstrual periods

changes in menstrual periods

decreased sexual ability

false sense of well-being

stopping of menstrual bleeding

swelling of the breasts or breast soreness in both females and males

unexpected or excess milk flow from breasts

unusual secretion of milk

Incidence not known

Decreased interest in sexual intercourse

inability to have or keep an erection

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

loss in sexual ability, desire, drive, or performance

painful or prolonged erection of the penis

weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.