国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
MOLINDONE HYDROCHLORIDE (UNII: 1DWS68PNE6) (MOLINDONE - UNII:RT3Y3QMF8N)
EPIC PHARMA, LLC
ORAL
PRESCRIPTION DRUG
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. 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.
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
Abbreviated New Drug Application
MOLINDONE HYDROCHLORIDE- MOLINDONE HYDROCHLORIDE TABLET EPIC PHARMA, LLC ---------- MOLINDONE HYDROCHLORIDE TABLETS 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. MOLINDONE HYDROCHLORIDE TABLETS, USP ARE NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (SEE WARNINGS). DESCRIPTION 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 # 完全なドキュメントを読む