MOLINDONE HYDROCHLORIDE tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

MOLINDONE HYDROCHLORIDE (UNII: 1DWS68PNE6) (MOLINDONE - UNII:RT3Y3QMF8N)

Доступно од:

EPIC PHARMA, LLC

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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.

Резиме производа:

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

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

MOLINDONE HYDROCHLORIDE- MOLINDONE HYDROCHLORIDE TABLET
EPIC PHARMA, LLC
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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 #