FLUPHENAZINE HYDROCHLORIDE tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Proficient Rx LP

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride 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 hydrochloride is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

Vörulýsing:

Fluphenazine Hydrochloride Tablets, USP are available as follows: 1 mg tablets are white to off-white, film-coated, round tablets debossed “T” on one side and “136” on the other side. They are supplied in bottles of 30 (NDC 71205-837-30), 60 (NDC 71205-837-60), 90 (NDC 71205-837-90), 100 (NDC 71205-837-00), 120 (NDC 71205-837-72), 180 (NDC 71205-837-78), 240 (NDC 71205-837-64), 500 (NDC 71205-837-55), and 1000 (NDC 71205-837-11). 2.5 mg tablets are blue, film-coated, round tablets debossed “T” on one side and “137” on the other side. They are supplied in bottles of 30 (NDC 71205-838-30), 60 (NDC 71205-838-60), 90 (NDC 71205-838-90), 100 (NDC 71205-838-00), 120 (NDC 71205-838-72), 180 (NDC 71205-838-78), 240 (NDC 71205-838-64), 500 (NDC 71205-838-55), and 1000 (NDC 71205-838-11). 5 mg tablets are pink to purple, film-coated, round tablets debossed “T” on one side and “138” on the other side. They are supplied in bottles of 30 (NDC 71205-839-30), 60 (NDC 71205-839-60), 90 (NDC 71205-839-90), 100 (NDC 71205-839-00), 120 (NDC 71205-839-72), 180 (NDC 71205-839-78), 240 (NDC 71205-839-64), 500 (NDC 71205-839-55), and 1000 (NDC 71205-839-11). 10 mg tablets are orange, film-coated, round tablets debossed “T” on one side and “139” on the other side. They are supplied in bottles of 30 (NDC 71205-840-30), 60 (NDC 71205-840-60), 90 (NDC 71205-840-90), 100 (NDC 71205-840-00), 120 (NDC 71205-840-72), 180 (NDC 71205-840-78), 240 (NDC 71205-840-64), 500 (NDC 71205-840-55), and 1000 (NDC 71205-840-11). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from light. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Manufactured for: TWi Pharmaceuticals USA, Inc. Paramus, NJ 07652 Manufactured by: TWi Pharmaceuticals, Inc. Taoyuan City, 320023, Taiwan Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Rev. 06/2022

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

FLUPHENAZINE HYDROCHLORIDE- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM
COATED
PROFICIENT RX LP
----------
FLUPHENAZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
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. The chemical designation is
4-[3-[2-(Trifluoromethyl)
phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride.
The structural formula is represented below:
Fluphenazine Hydrochloride Tablets, USP, for oral administration,
contain 1 mg, 2.5 mg,
5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet
also
contains FD&C Blue No. 1 Aluminum Lake (2.5 mg and 5 mg tablet), FD&C
Blue No. 2
Aluminum Lake (2.5 mg tablet), FD&C Red No. 3 Aluminum Lake (5 mg
tablet), FD&C
Yellow No.