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:

Mylan Pharmaceuticals 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 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. The 1 mg tablets are white film-coated, triangular shaped tablets debossed with M on one side of the tablet and 4 on the other side. They are available as follows: NDC 0378-6004-01 bottles of 100 tablets NDC 0378-6004-05 bottles of 500 tablets The 2.5 mg tablets are yellow film-coated, triangular shaped tablets debossed with M on one side of the tablet and 9 on the other side. They are available as follows: NDC 0378-6009-01 bottles of 100 tablets NDC 0378-6009-05 bottles of 500 tablets 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 0378-6074-01 bottles of 100 tablets NDC 0378-6074-05 bottles of 500 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 0378-6097-01 bottles of 100 tablets NDC 0378-6097-05 bottles of 500 tablets 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. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 11/2016 FPHZ:R12

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUPHENAZINE HYDROCHLORIDE- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM
COATED
MYLAN PHARMACEUTICALS INC.
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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:
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 emp