FLUPHENAZINE HYDROCHLORIDE- 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:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

FLUPHENAZINE HYDROCHLORIDE

Composition:

FLUPHENAZINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluphenazine hydrochloride is 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 containing either  5 mg or 10 mg of fluphenazine hydrochloride, USP. The 5 mg tablets are green film-coated, triangular shaped tablets debossed with M on one side of the tablet and 74 on the other side. They are available as follows: NDC 0615-1501-39 blistercards of 30 tablets The 10 mg tablets are orange film-coated, triangular shaped tablets debossed with M on one side of the tablet and 97 on the other side. They are available as follows: NDC 0615-3574-39 blistercards of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUPHENAZINE HYDROCHLORIDE- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM
COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
FLUPHENAZINE HYDROCHLORIDE TABLETS, USP
1 MG, 2.5 MG, 5 MG AND 10 MG
RX ONLY
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-piperazine-
ethanol dihydrochloride which may be represented by the following
structural formula:
C
H F N OS•2HCl
M.W. 510.44
Each tablet, for oral administration, contains 1 mg, 2.5 mg, 5 mg, or
10 mg of fluphenazine
hydrochloride, USP per tablet. Inactive ingredients are: hypromellose,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, pregelatinized
starch, sodium lauryl sulfate and
titanium dioxide. The following additional product specific inactive
ingredients are employed:
1 mg – calcium sulfate, hydroxypropyl cellulose and talc
2.5 mg – lecithin, polydextrose, sodium alginate and triacetin
5 mg – hydroxypropyl cellulose
10 mg – lecithin, polydextrose, sodium alginate and triacetin
The following coloring agents are employed:
2.5 mg – D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum
Lake
5 mg – FD&C Blue No. 1 Aluminum Lake, D&C Yellow No. 10 Aluminum
Lake, FD&C Yellow No. 6
Aluminum Lake
10 mg – FD&C Yellow No. 6 Aluminum Lake.
CLINICAL PHARMACOLOGY
Fluphenazine hydrochloride has activity at all levels of the central
nervous system as well as on
multiple organ systems. The mechanism whereby its therapeutic action
is exerted is unknown.
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26
3
3
INDICATIONS AND USAGE
Fluphenazine hydrochloride is 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.
CONTRAINDICATIONS
Phenothiazines are contraindicated in patients with suspected or
established subcortical brain damage, in
patients receiving large doses of hypno