FLUPHENAZINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, Inc.

INN (International Name):

FLUPHENAZINE HYDROCHLORIDE

Composition:

FLUPHENAZINE HYDROCHLORIDE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Fluphenazine Hydrochloride Tablets, USP are available as follows: 1 mg tablets are white, round, film-coated tablets debossed “LCI” on one side and “1788” on the other side. They are supplied in bottles of 100 (NDC 0527-1788-01) and 500 (NDC 0527-1788-05). 2.5 mg tablets are blue, round, film-coated tablets debossed “LCI” on one side and “1789” on the other side. They are supplied in bottles of 100 (NDC 0527-1789-01) and 500 (NDC 0527-1789-05). 5 mg tablets are dark pink, round, film-coated tablets debossed “LCI” on one side and “1790” on the other side. They are supplied in bottles of 100 (NDC 0527-1790-01) and 500 (NDC 0527-1790-05). 10 mg tablets are orange, round, film-coated tablets debossed “LCI” on one side and “1791” on the other side. They are supplied in bottles of 100 (NDC 0527-1791-01) and 500 (NDC 0527-1791-05). 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. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB70359D   Rev. 12/19

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUPHENAZINE HYDROCHLORIDE- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM
COATED
LANNETT COMPANY, INC.
----------
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
corn starch, D&C Red No. 27 (2.5
mg and 5 mg tablet), D&C Red No. 30 (5 mg tablet), D&C Yellow No. 10
(5 mg tablet), dibasic calcium
phosphate dihydrate, FD