FLUPHENAZINE HYDROCHLORIDE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

TYA Pharmaceuticals

INN (International Name):

FLUPHENAZINE HYDROCHLORIDE

Sammensætning:

FLUPHENAZINE HYDROCHLORIDE 5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Fluphenazine HCl is indicated in the management of manifestations of psychotic disorders. Fluphenazine HCl has not been shown effective in the management of behavioral complications in patients with mental retardation. Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. Fluphenazine HCl is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

Produkt oversigt:

NDC:64725-1438-1 in a CONTAINER of 100 TABLET, FILM COATEDS Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container. 03-2011M 7027 Sandoz Inc. Princeton, NJ 08540

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

FLUPHENAZINE HYDROCHLORIDE- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM
COATED
TYA PHARMACEUTICALS
----------
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.FLUPHENAZINEHYDROCHLORIDE
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 and also contain
D & C Red #30 Aluminum Lake and FD & C Red #40 Aluminum Lake; also
contains FD & C Blue #2
Aluminum Lake and FD & C Ye