FLUPHENAZINE HYDROCHLORIDE tablet film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

FLUPHENAZINE HYDROCHLORIDE (UNII: ZOU145W1XL) (FLUPHENAZINE - UNII:S79426A41Z)

متاح من:

Avera McKennan Hospital

INN (الاسم الدولي):

FLUPHENAZINE HYDROCHLORIDE

تركيب:

FLUPHENAZINE HYDROCHLORIDE 5 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FLUPHENAZINE HYDROCHLORIDE- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM
COATED
AVERA MCKENNAN HOSPITAL
----------
FLUPHENAZINE HYDROCHLORIDE TABLETS, USP
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.
FLUPHENAZINE
HYDROCHLORIDE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
(SEE WARNINGS).
DESCRIPTION
Fluphenazine hydrochloride is a trifluoromethyl phenothiazine
derivative intended for the management
of schizophrenia.
Each tablet for oral administration contains 1 mg, 2.5 mg, 5 mg or 10
mg fluphenazine hydrochloride
USP. Inactive ingredients include D & C Yellow #10 Aluminum Lake,
lactose (monohydrate),
hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium
stearate, microcrystalline
cellulose, polyethylene glycol, starch (corn), titanium dioxide, and
Polysorbate 80. The 1 MG and 10
MG also contain D & C Red #30 Aluminum Lake and FD & C Red #40
Aluminum Lake; 2.5 MG also
contains FD & C Blue #2 Alum