Moban (Molindone Hydrochloride Tablets)
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Moban (Molindone Hydrochloride Tablets)

MOBAN®
(molindone hydrochloride) Tablets, USP

WARNING

Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. MOBAN (molindone hydrochloride tablets) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

DRUG DESCRIPTION

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

MOBAN (molindone hydrochloride tablets) 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 (molindone hydrochloride tablets) 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:

MOBAN® (Molindone Hydrochloride)  Structural Formula Illustration

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

What are the possible side effects of molindone (Moban)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking molindone and call your doctor at once if you have a serious side effect such as:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremor (uncontrolled shaking);
  • trouble swallowing;
  • seizure (convulsions);
  • easy bruising or bleeding,...

Read All Potential Side Effects and See Pictures of Moban »

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

MOBAN (molindone hydrochloride tablets) is indicated for the management of schizophrenia. The efficacy of MOBAN (molindone hydrochloride tablets) in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized, acutely ill, schizophrenic patients as subjects.

DOSAGE AND ADMINISTRATION

Initial and maintenance doses of MOBAN (molindone hydrochloride tablets) should be individualized.

Initial Dosage Schedule

The usual starting dosage is 50-75 mg/day.

  • Increase to 100 mg/day in 3 or 4 days.
  • Based on severity of symptomatology, dosage may be titrated up or down depending on individual patient response.
  • An increase to 225 mg/day may be required in patients with severe symptomatology.

Elderly and debilitated patients should be started on lower dosage.

Maintenance Dosage Schedule

  1. Mild-5 mg-15 mg three or four times a day.
  2. Moderate-10 mg-25 mg three or four times a day.
  3. Severe-225 mg/day may be required.

HOW SUPPLIED

MOBAN (molindone hydrochloride) tablets are supplied in bottles of 100 tablets as follows:

5 mg Orange, round, biconvex tablet, one face debossed with “Moban (molindone hydrochloride tablets) 5”, and the other face plain. NDC 63481-072-70

10 mg Lavender, round, biconvex tablet, one face debossed with “Moban (molindone hydrochloride tablets) 10”, and the other face plain. NDC 63481-073-70

25 mg Green, round, biconvex tablet, one face debossed with “Moban (molindone hydrochloride tablets) 25”, and the other face plain with partial bisect. NDC 63481-074-70

50 mg Blue, round, biconvex tablet, one face with partial bisect and debossed with “Moban (molindone hydrochloride tablets) 50”, and the other face plain. NDC 63481-076-70

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP TIGHTLY CLOSED

Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317. December, 2010

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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

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

Akathisia

Motor restlessness may occur early.

Parkinson Syndrome

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

Dystonia

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.

Tardive Dyskinesia

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).

Autonomic Nervous System

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 (molindone hydrochloride tablets) 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 (molindone hydrochloride tablets) 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 (molindone hydrochloride tablets) .

Hepatic Effects

There have been rare reports of clinically significant alterations in liver function in association with MOBAN (molindone hydrochloride tablets) 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 (molindone hydrochloride tablets) . In some patients, phenothiazine induced lenticular opacities have resolved following discontinuation of the phenothiazine while continuing therapy with MOBAN (molindone hydrochloride tablets) .

Skin

Early, non-specific skin rash, probably of allergic origin, has occasionally been reported. Skin pigmentation has not been seen with MOBAN (molindone hydrochloride tablets) usage alone.

MOBAN (molindone hydrochloride tablets) 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 (molindone hydrochloride tablets) is used. Upon abrupt withdrawal after prolonged high dosage an abstinence syndrome has not been noted.

Read the Moban (molindone hydrochloride tablets) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Potentiation of drugs administered concurrently with MOBAN (molindone hydrochloride tablets) has not been reported. Additionally, animal studies have not shown increased toxicity when MOBAN (molindone hydrochloride tablets) is given concurrently with representative members of three classes of drugs (i.e., barbiturates, chloral hydrate and antiparkinson drugs).

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. MOBAN (molindone hydrochloride tablets) is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).

Tardive Dyskinesia

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, antipsychotics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.

(For further information about the description of tardive dyskinesia and its clinical detection, please refer to the section on Adverse Reactions.)

Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include, 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

PRECAUTIONS

General

Some patients receiving MOBAN (molindone hydrochloride) may note drowsiness initially and they should be advised against activities requiring mental alertness until their response to the drug has been established.

Increased activity has been noted in patients receiving MOBAN (molindone hydrochloride tablets) . Caution should be exercised where increased activity may be harmful.

MOBAN (molindone hydrochloride tablets) does not lower the seizure threshold in experimental animals to the degree noted with more sedating antipsychotic drugs. However, in humans convulsive seizures have been reported in a few instances.

The physician should be aware that this tablet preparation contains calcium sulfate as an excipient and that calcium ions may interfere with the absorption of preparations containing phenytoin sodium and tetracyclines.

MOBAN (molindone hydrochloride tablets) has an antiemetic effect in animals. A similar effect may occur in humans and may obscure signs of intestinal obstruction or brain tumor.

Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro , a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of antipsychotic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.

MOBAN (molindone hydrochloride tablets) has not been shown effective in the management of behavioral complications in patients with mental retardation

Leukopenia, Neutropenia and Agranulocytosis

Class Effect: 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 count (WBC) and history of drug induced leukopenia/neutropenia. Patients with a history of a clinically significant low WBC or drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of MOBAN (molindone hydrochloride tablets) should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

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 MOBAN (molindone hydrochloride tablets) and have their WBC followed until recovery.

Pregnancy

Studies in pregnant patients have not been carried out. Reproduction studies have been performed in the following animals:

Pregnant Rats oral dose—  
  no adverse effect 20 mg/kg/day - 10 days
  no adverse effect 40 mg/kg/day - 10 days
Pregnant Mice oral dose—  
  slight increase resorptions 20 mg/kg/day - 10 days
  slight increase resorptions 40 mg/kg/day - 10 days
Pregnant Rabbits oral dose—  
  no adverse effect 5 mg/kg/day - 12 days
  no adverse effect 10 mg/kg/day - 12 days
  no adverse effect 20 mg/kg/day - 12 days

Animal reproductive studies have not demonstrated a teratogenic potential. The anticipated benefits must be weighed against the unknown risks to the fetus if used in pregnant patients.

Non-teratogenic Effects

Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Moban (molindone hydrochloride tablets) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Data are not available on the content of MOBAN (molindone hydrochloride tablets) (molindone hydrochloride) in the milk of nursing mothers.

Pediatric Use

Use of MOBAN (molindone hydrochloride tablets) in pediatric patients below the age of twelve years is not recommended because safe and effective conditions for its usage have not been established.

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Symptomatic, supportive therapy should be the rule.

Gastric lavage is indicated for the reduction of absorption of MOBAN (molindone hydrochloride tablets) which is freely soluble in water.

Since the adsorption of MOBAN (molindone hydrochloride tablets) by activated charcoal has not been determined, the use of this antidote must be considered of theoretical value.

Emesis in a comatose patient is contraindicated. Additionally, while the emetic effect of apomorphine is blocked by MOBAN (molindone hydrochloride tablets) in animals, this blocking effect has not been determined in humans.

A significant increase in the rate of removal of unmetabolized MOBAN (molindone hydrochloride tablets) from the body by forced diuresis, peritoneal or renal dialysis would not be expected. (Only 2% of a single ingested dose of MOBAN (molindone hydrochloride tablets) is excreted unmetabolized in the urine). However, poor response of the patient may justify use of these procedures.

While the use of laxatives or enemas might be based on general principles, the amount of unmetabolized MOBAN (molindone hydrochloride tablets) in feces is less than 1%. Extrapyramidal symptoms have responded to the use of Diphenhydramine (Benadryl®), Amantadine HCl (Symmetrel®) and the synthetic anticholinergic antiparkinson agents, (i.e., Artane®, Cogentin®, Akineton®).

CONTRAINDICATIONS

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

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

MOBAN (molindone hydrochloride tablets) has a pharmacological profile in laboratory animals which predominantly resembles that of other antipsychotic agents causing reduction of spontaneous locomotion and aggressiveness, suppression of a conditioned response and antagonism of the bizarre stereotyped behavior and hyperactivity induced by amphetamines. In addition, MOBAN (molindone hydrochloride tablets) antagonizes the depression caused by the tranquilizing agent tetrabenazine.

In human clinical studies an antipsychotic effect is achieved in the absence of muscle relaxing or incoordinating effects. Based on EEG studies, MOBAN (molindone hydrochloride tablets) exerts its effect on the ascending reticular activating system.

Human metabolic studies show MOBAN (molindone hydrochloride tablets) to be rapidly absorbed and metabolized when given orally. Unmetabolized drug reached a peak blood level at 1.5 hours. Pharmacological effect from a single oral dose persists for 24-36 hours. There are 36 recognized metabolites with less than 23% unmetabolized MOBAN (molindone hydrochloride tablets) being excreted in urine and feces.

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

MOBAN®
(molindone hydrochloride) Tablets, USP

WARNING

Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. MOBAN (molindone hydrochloride tablets) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

DRUG DESCRIPTION

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

MOBAN (molindone hydrochloride tablets) 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 (molindone hydrochloride tablets) 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:

MOBAN® (Molindone Hydrochloride)  Structural Formula Illustration

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

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

MOBAN®
(molindone hydrochloride) Tablets, USP

WARNING

Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. MOBAN (molindone hydrochloride tablets) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

DRUG DESCRIPTION

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

MOBAN (molindone hydrochloride tablets) 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 (molindone hydrochloride tablets) 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:

MOBAN® (Molindone Hydrochloride)  Structural Formula Illustration

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

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

MOBAN®
(molindone hydrochloride) Tablets, USP

WARNING

Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. MOBAN (molindone hydrochloride tablets) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

DRUG DESCRIPTION

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

MOBAN (molindone hydrochloride tablets) 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 (molindone hydrochloride tablets) 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:

MOBAN® (Molindone Hydrochloride)  Structural Formula Illustration

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

Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.

Moban Patient Information Including Side Effects

Brand Names: Moban

Generic Name: molindone (Pronunciation: MOE lin done)

What is molindone (Moban)?

Molindone is an antipsychotic medication. It affects the actions of chemicals in your brain.

Molindone is used to treat schizophrenia.

Molindone may also be used for purposes not listed in this medication guide.

What are the possible side effects of molindone (Moban)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking molindone and call your doctor at once if you have a serious side effect such as:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremor (uncontrolled shaking);
  • trouble swallowing;
  • seizure (convulsions);
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • severe constipation; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dizziness or drowsiness;
  • depressed mood;
  • feeling restless or agitated;
  • blurred vision;
  • dry mouth;
  • breast swelling or discharge;
  • changes in your menstrual periods;
  • nausea, constipation; or
  • changes in weight.

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.

Read the Moban (molindone hydrochloride tablets) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about molindone (Moban)?

Molindone is not for use in psychotic conditions related to dementia. Molindone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to molindone, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

Call your doctor at once if you have restless muscle movements in your eyes, tongue, jaw, or neck.

Molindone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid drinking alcohol. You should not take molindone if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Molindone can decrease perspiration and you may be more prone to heat stroke.

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Moban Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking molindone (Moban)?

Molindone is not for use in psychotic conditions related to dementia. Molindone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to molindone, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

To make sure you can safely take molindone, tell your doctor if you have any of these other conditions:

  • 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. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take molindone (Moban)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take molindone with a full glass of water.

You may not start feeling better right away when you start taking molindone. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve during treatment.

Store at room temperature away from moisture, heat, and light.

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Moban Patient Information including If I Miss a Dose

What happens if I miss a dose (Moban)?

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.

What happens if I overdose (Moban)?

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

Overdose symptoms may include drowsiness, dizziness, muscle stiffness or twitching, increased salivation, trouble swallowing, fainting, or seizure (convulsions).

What should I avoid while taking molindone (Moban)?

Molindone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid drinking alcohol. You should not take molindone if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Molindone can decrease perspiration and you may be more prone to heat stroke.

What other drugs will affect molindone (Moban)?

Before using molindone, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). You should not take molindone if you have drowsiness caused by other medications.

Tell your doctor about all other medications you use, especially:

  • phenytoin (Dilantin);
  • chloral hydrate (Somnote);
  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or
  • medicine to treat Parkinson's disease, such as carbidopa or levodopa (Larodopa, Lodosyn, Atamet, Sinemet), pramipexole (Mirapex), rasagiline (Azilect), ropinirole (Requip), or selegiline (Eldepryl, Emsam).

This list is not complete and other drugs may interact with molindone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about molindone.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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