Molindone

What is Molindone?

• Molindone (Moban) is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenes used for the management of schizophrenia.

Molindone

What are the uses of this medicine?

• Molindone (Moban) is used for the management of schizophrenia.

Limitations of use:

• Molindone Hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.

How does this medicine work?

• Molindone (moe lin' done) is a dihydroindolone antipsychotic medication that is not structurally related to the phenothiazines and which appears to act by blocking dopamine type 2 (D2) receptors.
• Molindone has other central and peripheral effects including anticholinergic and alpha adrenergic blockade.
• Molindone Hydrochloride 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, Molindone Hydrochloride antagonizes the depression caused by the tranquilizing agent tetrabenazine.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• severe central nervous system depression (alcohol, barbiturates, narcotics, etc.) or comatose states.
• known hypersensitivity to the drug.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other 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)
• tranquilizers

Is this medicine FDA approved?

• Molindone was approved for use in the therapy of psychotic disorders in the United States in 1974.
• Since then, however, molindone has been replaced in large part by the atypical antipsychotics, which have fewer extrapyramidal side effects.

How should this medicine be used?

Recommended dosage: Initial Dosage:

• The usual starting dosage is 50 to 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: Mild cases:

• 5 mg to 15 mg three or four times a day.

Moderate cases:

• 10 mg to 25 mg three or four times a day.

Severe cases:

• 225 mg/day may be required.

Administration:

• Molindone comes as a tablet to take by mouth.
• It is usually taken three or four times a day.
• Try to take molindone at around the same times every day.
• Your doctor will probably start you on a low dose of molindone and gradually increase your dose after 3 to 4 days.
• Later, your doctor may increase or decrease your dose, depending on your response to the medication and the side effects you experience.
• Be sure to tell your doctor how you are feeling during your treatment with molindone.
• Molindone may help to control your condition but will not cure it.
• Continue to take molindone even if you feel well.
• Do not stop taking molindone without talking to your doctor.
• It may take several weeks or longer for you to feel the full benefit of molindone.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Molindone Hydrochloride Tablets

This medicine is available in fallowing brand namesː

• Moban

What side effects can this medication cause?

The most common side effects of this medicine include:

• drowsiness, dizziness, headache, blurred vision, dry mouth, and tremor.

Additional side effects may include:

• Extrapyramidal Symptoms
• Akathisia
• Parkinson Syndrome
• Dystonia
• Tardive Dyskinesia
• blurring of vision, tachycardia, nausea, dry mouth and salivation
• leucopenia and leucocytosis
• Alteration of thyroid function
• Amenorrhea
• Galactorrhea and gynecomastia
• hypotension
• Lens opacities
• pigmentary retinopathy
• skin rash
• Skin pigmentation

What special precautions should I follow?

• 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. Molindone Hydrochloride Tablets are not approved for the treatment of patients with dementia-related psychosis.
• 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 a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.
• Molindone Hydrochloride may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs.
• 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.
• Some patients receiving 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 Molindone Hydrochloride. Caution should be exercised where increased activity may be harmful.
• Molindone Hydrochloride 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.
• Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration.
• Increased activity has been noted in patients receiving Molindone Hydrochloride. Caution should be exercised where increased activity may be harmful.
• Data are not available on the content of Molindone Hydrochloride in the milk of nursing mothers.
• Ask your doctor about the safe use of alcohol while you are taking molindone. Alcohol can make the side effects of molindone worse.
• Molindone therapy is commonly associated with minor serum aminotransferase elevations but has rarely been linked to cases of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Extrapyramidal symptoms

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Symptomatic, supportive therapy should be the rule.
• Gastric lavage is indicated for the reduction of absorption of Molindone Hydrochloride which is freely soluble in water.
• Since the adsorption of Molindone Hydrochloride 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 Molindone Hydrochloride in animals, this blocking effect has not been determined in humans.
• A significant increase in the rate of removal of unmetabolized Molindone Hydrochloride from the body by forced diuresis, peritoneal or renal dialysis would not be expected.
• Extrapyramidal symptoms have responded to the use of Diphenhydramine (Benadryl®)*, Amantadine HCl (Symmetrel®)† and the synthetic anticholinergic antiparkinson agents, (i.e., Artane®‡, Cogentin®§, Akineton®¶).

Can this medicine be used in pregnancy?

• Molindone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Can this medicine be used in children?

• Use of Molindone Hydrochloride in pediatric patients below the age of twelve years is not recommended because safe and effective conditions for its usage have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Molindone Hydrochloride Tablets

Inactive ingredients:

• alginic acid, calcium sulfate, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.
• Colors: 5 mg contains FD&C Yellow #6 Aluminum Lake
• 10 mg contains FD&C Blue #2 Aluminum Lake
• 25 mg contains FD&C Blue #2 Aluminum Lake, FD&C Yellow #6, Aluminum Lake and D&C Yellow #10 Aluminum Lake

Who manufactures and distributes this medicine?

Distributed by:

• Epic Pharma, LLC
• Laurelton NY

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Molindone
• FDA Molindone

Molindone Resources
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