Moban

Before taking molindone,

• tell your doctor and pharmacist if you are allergic to molindone, any other medications, or any of the ingredients in molindone. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; barbiturates such as pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal); medications for anxiety, mental illness, or seizures; narcotic (opiate) medications for pain; phenytoin (Dilantin, Phenytek); sedatives; sleeping pills; tetracycline antibiotics such as demeclocycline, doxycycline (Doryx, Doxteric, Vibramycin, others), minocycline (Dynacin, Minocin, Solodyn), and tetracycline (Achromycin V, in Pylera); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had depression, breast cancer, trouble keeping your balance, or a low number of white blood cells in your blood.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking molindone, call your doctor. Molindone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking molindone.
• you should know that this medication may make you drowsy and may affect your thinking and movements. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcohol while you are taking molindone. Alcohol can make the side effects of molindone worse.
• you should know that molindone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

Dosage Forms & Strengths

tablet

• 5mg
• 10mg
• 25mg
• 50mg

Schizophrenia

Indicated for the management of schizophrenia

Initial: 50-75 mg PO qDay; increase to 100 mg/day in 3-4 days; may titrate up or down based on severity of symptomatology and individual patient response

Maintenance

• Mild: 5-15 mg PO q6-8hr
• Moderate: 10-25 mg PO q6-8hr
• Severe: 225 mg/day PO may be required

Dosage Modifications

• Initiate at lower dose in elderly patients and debilitated patients

Dosing Considerations

• When stopping antipsychotics, gradually taper dose over 6-24 months to avoid withdrawal

Safety and efficacy not established

Use lower initial doses

Black Box Warnings

Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk for death, as shown in short-term controlled trials; deaths in trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature

Not approved for treatment of patients with dementia-related psychosis

Contraindications

Documented hypersensitivity

Severe CNS depression (eg, alcohol, barbiturates, narcotics) or comatose states

Cautions

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs; if signs and symptoms of tardive dyskinesia appear in patients on antipsychotics, consider drug discontinuation; however, some patients may require treatment despite presence of the syndrome

May cause somnolence, postural hypotension, motor instability and sensory instability, which may lead to falls and, consequently, fractures or other injuries; complete fall-risk assessments for patients with diseases, conditions, or medications that could exacerbate these effects, when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy

Neuroleptic malignant syndrome (NMS) reported with antipsychotic drug use; immediately discontinue therapy if it occurs along with nonessential concurrent therapy and administer intensive symptomatic treatment and monitor carefully; if patient requires antipsychotic drug treatment after recovery from NMS, it should be considered carefully and the patient monitored closely since recurrences of NMS have been reported

May cause drowsiness initially; advise patient against activities requiring mental alertness until response to the drug has been established

Convulsive seizures reported with use

Preparation contains calcium sulfate as an excipient; calcium ions may interfere with absorption of preparations containing phenytoin sodium and tetracyclines

Therapy may obscure signs of intestinal obstruction or brain tumor

Antipsychotic drugs elevate prolactin levels; elevation persists during long-term administration; although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, clinical significance of elevated serum prolactin levels is unknown for most patients

Therapy has not been shown effective in the management of behavioral complications in patients with mental retardation

In clinical trial and/or postmarketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia; patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur; patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue therapy and have their WBC count followed until recovery

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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.

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

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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 is not approved for use in psychotic conditions related to dementia. Molindone may increase the risk of death in older adults with dementia-related conditions.

To make sure molindone is safe for you, tell your doctor if you have:

• epilepsy or other seizure disorder;

• a history of low white blood cell (WBC) counts;

• urination problems; or

• a history of breast cancer.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking molindone, do not stop taking it 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.

Moban (molindone hydrochloride) is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenes.

Moban is 3-ethyl-6, 7-dihydro-2-methyl-5-(morpholinomethyl) indol-4 (5H)-one hydrochloride. It is a white to off-white crystalline powder, freely soluble in water and alcohol.

Moban Tablets contain the following inactive ingredients:
Calcium sulfate, lactose, magnesium stearate, microcrystalline cellulose and povidone.
The 5 mg strength also contains alginic acid, colloidal silicon dioxide and FD&C Yellow 6. The 10 mg strength also contains alginic acid, colloidal silicon dioxide, FD&C Blue 2 and FD&C Red 40. The 25 mg strength also contains alginic acid, colloidal silicon dioxide, D&C Yellow 10, FD&C Blue 2, and FD&C Yellow 6. The 50 mg strength also contains FD&C Blue 2 and sodium starch glycolate.

Molindone Hydrochloride is represented by the following structural formula:

The empirical formula is C16H24N2O2• HCl representing a molecular weight of 312.83.

Moban is contraindicated in severe central nervous system depression (alcohol, barbiturates, narcotics, etc.) or comatose states, and in patients with known hypersensitivity to the drug.

CNS Effects

The most frequently occurring effect is initial drowsiness that generally subsides with continued usage of the drug or lowering of the dose.

Noted less frequently were depression, hyperactivity and euphoria.

Neurological

Extrapyramidal symptoms noted below may occur in susceptible individuals and are usually reversible with appropriate management.

Motor restlessness may occur early.

Akinesia, characterized by rigidity, immobility and reduction of voluntary movements and tremor, have been observed. Occurrence is less frequent than akathisia.

Class effect:  Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Antipsychotic drugs are known to cause a syndrome of dyskinetic movements commonly referred to as tardive dyskinesia. The movements may appear during treatment or upon withdrawal of treatment and may be either reversible or irreversible (i.e., persistent) upon cessation of further antipsychotic administration.

The syndrome is known to have a variable latency for development and the duration of the latency cannot be determined reliably. It is thus wise to assume that any antipsychotic agent has the capacity to induce the syndrome and act accordingly until sufficient data has been collected to settle the issue definitively for a specific drug product. In the case of antipsychotics known to produce the irreversible syndrome, the following has been observed.

Tardive dyskinesia has appeared in some patients on long-term therapy and has also appeared after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). There may be involuntary movements of extremities.

There is no known effective treatment of tardive dyskinesia; antiparkinsonism agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked. It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time the syndrome may not develop (See WARNINGS).

Occasionally blurring of vision, tachycardia, nausea, dry mouth and salivation have been reported. Urinary retention and constipation may occur particularly if anticholinergic drugs are used to treat extrapyramidal symptoms. One patient being treated with Moban experienced priapism which required surgical intervention, apparently resulting in residual impairment of erectile function.

Laboratory Tests

There have been rare reports of leucopenia and leucocytosis. If such reactions occur, treatment with Moban may continue if clinical symptoms are absent. Alterations of blood glucose, B.U.N., and red blood cells have not been considered clinically significant.

Metabolic and Endocrine Effects

Alteration of thyroid function has not been significant. Amenorrhea has been reported infrequently. Resumption of menses in previously amenorrheic women has been reported. Initially heavy menses may occur. Galactorrhea and gynecomastia have been reported infrequently. Increase in libido has been noted in some patients. Impotence has not been reported. Although both weight gain and weight loss have been in the direction of normal or ideal weight, excessive weight gain has not occurred with Moban.

Hepatic Effects

There have been rare reports of clinically significant alterations in liver function in association with Moban use.

Cardiovascular

Rare, transient, non-specific T wave changes have been reported on E.K.G. Association with a clinical syndrome has not been established. Rarely has significant hypotension been reported.

Ophthalmological

Lens opacities and pigmentary retinopathy have not been reported where patients have received Moban. In some patients, phenothiazine induced lenticular opacities have resolved following discontinuation of the phenothiazine while continuing therapy with Moban.

Skin

Early, non-specific skin rash, probably of allergic origin, has occasionally been reported. Skin pigmentation has not been seen with Moban usage alone.

Moban has certain pharmacological similarities to other antipsychotic agents. Because adverse reactions are often extensions of the pharmacological activity of a drug, all of the known pharmacological effects associated with other antipsychotic drugs should be kept in mind when Moban is used. Upon abrupt withdrawal after prolonged high dosage an abstinence syndrome has not been noted.

Applies to molindone: oral concentrate, oral tablet

General

The most common side effects include drowsiness; less frequently occurring side effects include depression, hyperactivity, and euphoria.[Ref]

Nervous system

Akathisia/motor restlessness occurred early in treatment.

Drowsiness occurred with initial treatment and usually subsided with continued use or lowering of the dose.

Extrapyramidal symptoms (EPS) may occur in susceptible patients, but is usually reversible with appropriate therapy; EPS symptoms include akathisia.

Parkinson syndrome occurred less frequently than akathisia and includes rigidity, immobility, and reduction of voluntary movements/tremor.[Ref]

Frequency not reported: Drowsiness, hyperactivity, extrapyramidal symptoms, akathisia/motor restlessness, dystonia, tardive dyskinesia, Parkinson syndrome[Ref]

Genitourinary

Urinary retention may occur more frequently during concomitant use with anticholinergic drugs.[Ref]

Frequency not reported: Urinary retention, priapism, amenorrhea, resumption of menses, heavy menses, galactorrhea[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, nausea, salivation, constipation[Ref]

Constipation may occur more frequently during concomitant use with anticholinergic drugs.[Ref]

Cardiovascular

Frequency not reported: Tachycardia, T wave changes, significant hypotension[Ref]

Rare, transient, nonspecific T wave changes have been reported on ECGs; however, there is no established association with this drug.[Ref]

Hematologic

Red blood cell alterations were not clinically significant.[Ref]

Frequency not reported: Leukopenia, leukocytosis, alterations in red blood cells[Ref]

Psychiatric

Frequency not reported: Depression, euphoria, increased libido[Ref]

Metabolic

Blood glucose alterations were not considered clinically significant.[Ref]

Frequency not reported: Blood glucose alteration, weight gain/loss (not excessive)[Ref]

Endocrine

Thyroid function alterations were not clinically significant.[Ref]

Frequency not reported: Alterations in thyroid function, gynecomastia[Ref]

Dermatologic

Nonspecific skin rash (likely of allergic origin) occurred early during treatment.

Skin pigmentation did not occur when this drug is used alone.[Ref]

Frequency not reported: Skin rash, skin pigmentation[Ref]

Hepatic

Frequency not reported: Alterations in liver function[Ref]

Liver function alterations have been clinically significant in some patients.[Ref]

Renal

Frequency not reported: Alterations in blood urea nitrogen (BUN)[Ref]

BUN alterations were not clinically significant.[Ref]

Ocular

Frequency not reported: Blurring of vision[Ref]

Some side effects of Moban may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Summary of Use during Lactation

Because there is no published experience with molindone during breastfeeding, other antipsychotic agents are preferred.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Galactorrhea has been reported with molindone.[1][2] Hyperprolactinemia appears to be the cause of the galactorrhea.[3][4][5] The hyperprolactinemia is caused by the drug's dopamine-blocking action in the tuberoinfundibular pathway.[6] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider

Haloperidol, Risperidone

References

1. Wesp CE Jr, Annitto W, Feinsod R. Galactorrhea associated with molindone. Am J Psychiatry. 1979;136:975. PMID: 572143

2. Kahn JL. More on galactorrhea associated with molindone. Am J Psychiatry. 1979;136:1617-8. Letter. PMID: 574364

3. Turkington RW. Prolactin secretion in patients treated with various drugs: phenothiazines, tricyclic antidepressants, reserpine, and methyldopa. Arch Intern Med. 1972;130:349-54. PMID: 4560178

4. Turkington RW. Serum prolactin levels in patients with gynecomastia. J Clin Endocrinol Metab. 1972;34:62-6. PMID: 5061776

5. Meltzer HY, Fang VS. The effect of neuroleptics on serum prolactin in schizophrenic patients. Arch Gen Psychiatry. 1976;33:279-86. PMID: 1259521

6. Maguire GA. Prolactin elevation with antipsychotic medications: mechanisms of action and clinical consequences. J Clin Psychiatry. 2002;63(suppl 4):56-62. PMID: 11913677

LactMed Record Number

188

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.