DailyMed Label: Molindone Hydrochloride

DailyMed Label: Molindone Hydrochloride

2023

DailyMed Prescription

Molindone Hydrochloride

Molindone Hydrochloride

EPIC PHARMA, LLC

NDC: 42806-336

NDC: 42806-337

NDC: 42806-338

NDC: 42806-336

NDC: 42806-336

NDC: 42806-337

NDC: 42806-337

NDC: 42806-338

NDC: 42806-338

Molindone Hydrochloride is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenes. Molindone Hydrochloride is 3-ethyl-6, 7-dihydro-2-methyl-5-(morpholinomethyl) indol-4(5H)-one hydrochloride. It is a white to off-white or pale-pink crystalline powder, freely soluble in water and alcohol. Molindone Hydrochloride Tablets, USP contain the following 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 Molindone Hydrochloride is represented by the following structural formula: The empirical formula is C 16 H 24 N 2 O 2 •HCl representing a molecular weight of 312.83. structure formula.jpg

Molindone Hydrochloride Tablets, USP are indicated for the management of schizophrenia. The efficacy of Molindone Hydrochloride Tablets, USP in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized, acutely ill, schizophrenic patients as subjects.

Initial and maintenance doses of Molindone Hydrochloride Tablets should be individualized. 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. 1. Mild-5 mg to 15 mg three or four times a day. 2. Moderate-10 mg to 25 mg three or four times a day. Severe-225 mg/day may be required.

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

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. Molindone Hydrochloride 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. Molindone Hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation. 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. Molindone Hydrochloride 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. Molindone Hydrochloride 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 Molindone Hydrochloride 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 Molindone Hydrochloride and have their WBC followed until recovery. Potentiation of drugs administered concurrently with Molindone Hydrochloride has not been reported. Additionally, animal studies have not shown increased toxicity when Molindone Hydrochloride is given concurrently with representative members of three classes of drugs (i.e., barbiturates, chloral hydrate and antiparkinson drugs). Studies in pregnant patients have not been carried out. Reproduction studies have been performed in the following animals: no adverse effect 20 mg/kg/day - 10 days no adverse effect 40 mg/kg/day - 10 days slight increase resorptions 20 mg/kg/day - 10 days slight increase resorptions 40 mg/kg/day - 10 days 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. 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. Molindone Hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data are not available on the content of Molindone Hydrochloride in the milk of nursing mothers. 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.

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

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

Molindone Hydrochloride Tablets USP, 5 mg are light orange to orange, oval-shaped tablets, debossed " Є336 " on one side and plain on the other side. They are supplied as follows: Bottles of 100 NDC 42806-336-01 Molindone Hydrochloride Tablets USP, 10 mg are light blue to blue, oval-shaped tablets, debossed " Є337 " on one side and plain on the other side. They are supplied as follows: Bottles of 100 NDC 42806-337-01 Molindone Hydrochloride Tablets USP, 25 mg are light green to green, oval-shaped tablet, debossed " Є338 " on one side and bisect on the other side. They are supplied as follows: Bottles of 100 NDC 42806-338-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP TIGHTLY CLOSED * Benadryl is a registered trademark of Warner-Lambert. † Symmetrel is a registered trademark of Endo Pharmaceuticals Inc. ‡ Artane is a registered trademark of Lederle Laboratories. § Cogentin is a registered trademark of Merck & Co., Inc. ¶ Akineton is a registered trademark of Knoll Laboratories. Distributed by: Epic Pharma, LLC Laurelton NY, 11413 Rev. 07-2023-00 MF336REV07/23 OE2798

Molindone Hydrochloride 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, Molindone Hydrochloride 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, Molindone Hydrochloride exerts its effect on the ascending reticular activating system. Human metabolic studies show 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 to 36 hours. There are 36 recognized metabolites with less than 2 to 3% unmetabolized Molindone Hydrochloride Tablets being excreted in urine and feces.

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