Moban

Name: Moban

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

  • unusual, slowed, or uncontrollable movements of any part of the body
  • loss of consciousness

Adverse Effects

Frequency Not Defined

Drowsiness

Depression

Hyperactivity

Euphoria

Extrapyramidal symptoms

Akathisia

Parkinson syndrome

Dystonia

Tardive dyskineisa

Tachycardia

Nausea

Dry mouth

Salivation

Urinary retention

Constipation

Priapism

Amenorrhea

Gynecomastia

Galactorrhea

Libido increased

Leukopenia

Alteration in liver function tests

T-wave changes (transient, rare)

Lens opacities and pigmentary retinopathy

Rash

Pharmacology

Mechanism of Action

Dihydroindolone derivative, which is not structurally related to phenothiazines, butyrophenones, or thioxanthenes; blocks postsynaptic dopaminergic receptors in the nucleus accumbens, striatum, and ventral tegmental area; has negligible affinity for the alpha-1 adrenergic receptor and the histamine H1 receptor in the frontal cortex; lacks affinity for the muscarinic acetylcholine receptor in the caudate nucleus and intermediate affinity for the alpha-2 adrenergic receptor in the frontal cortex

Absorption

Rapidly absorbed

Peak serum time: 1.5 hr

Duration: 24-36 hr

Distribution

Protein bound: 76%

Metabolism

Hepatic

Elimination

Half-life: 1.5 hr

Excretion: Urine and feces (2-3% unmetabolized)

Moban Drug Class

Moban is part of the drug class:

  • Indole derivatives

What happens if I miss a dose?

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.

Moban (molindone) side effects

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

High doses or long-term use of molindone can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take molindone, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

Stop using molindone and call your doctor at once if you have:

  • tremor (uncontrolled shaking);

  • trouble breathing or swallowing;

  • a seizure (convulsions);

  • restless muscle movements in your face or neck;

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or

  • low white blood cell counts--sudden weakness or ill feeling, fever, chills, sore throat, red or swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough.

Common side effects may include:

  • drowsiness;

  • fast heart rate, feeling restless or nevous, being unable to sit still;

  • blurred vision;

  • dry mouth;

  • little or no urination;

  • nausea, constipation;

  • breast swelling or discharge;

  • impotence, sexual problems; or

  • changes in your menstrual periods.

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.

What other drugs will affect Moban (molindone)?

Taking molindone with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • phenytoin; or

  • an antibiotic such as demeclocycline, doxycycline, minocycline, or tetracycline.

This list is not complete. Other drugs may interact with molindone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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. Caution should be exercised where increased activity may be harmful.

Moban 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 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 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 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 and have their WBC followed until recovery.

Drug Interactions

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

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.

Nursing Mothers

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

Pediatric Use

Use of Moban 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 some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Shakiness, trouble moving around, or stiffness.
  • Seizures.
  • Nipple discharge.
  • For women, no period.
  • Enlarged breasts.
  • Change in sex ability.
  • Erection that lasts more than 4 hours.
  • Not able to sit still.
  • Mood changes.
  • Restlessness.
  • Trouble swallowing.
  • A fast heartbeat.
  • Trouble passing urine.
  • Some people who take this drug may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if this drug is stopped. Sometimes, signs may lessen or go away over time after this drug is stopped. The risk of tardive dyskinesia may be greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer you take this drug or with higher doses. Muscle problems may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
  • A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
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