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:

Amneal Pharmaceuticals NY LLC

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 tablets are contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

Product summary:

Fluphenazine Hydrochloride Tablets, USP are available containing either 1 mg, 2.5 mg, 5 mg or 10 mg of fluphenazine hydrochloride, USP. Fluphenazine Hydrochloride Tablets USP, 1 mg are supplied as white to off-white colored, round shaped, film-coated tablets debossed with "D5" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure:                NDC 69238-1678-1   Fluphenazine Hydrochloride Tablets USP, 2.5 mg are supplied as yellow colored, round shaped, film-coated tablets debossed with "E4" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure:                NDC 69238-1679-1   Fluphenazine Hydrochloride Tablets USP, 5 mg are supplied as green colored, round shaped, film-coated tablets debossed with "E1" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure:                NDC 69238-1680-1 Fluphenazine Hydrochloride Tablets USP, 10 mg are supplied as orange to light orange colored, round shaped, film-coated tablets debossed with "E2" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure:                NDC 69238-1681-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.   Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 11-2020-02

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUPHENAZINE HYDROCHLORIDE- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM
COATED
AMNEAL PHARMACEUTICALS NY LLC
----------
FLUPHENAZINE HYDROCHLORIDE TABLETS, USP
(1 MG, 2.5 MG, 5 MG AND 10 MG)
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. Chemically it is
4-[3-[2-(Trifluoromethyl) phenothiazin-10-
yl]propyl]-1-piperazineethanol dihydrochloride which may be
represented by the
following structural formula:
Molecular Formula: C
H
F N OS.2HCl
Molecular Weight: 510.44 g/mol.
Fluphenazine hydrochloride, USP is a white or nearly white,
crystalline powder. It is
soluble in water, and practically insoluble in acetone, methylene
chloride and in
chloroform.
Each tablet, for oral administration, con