TRIFLUOPERAZINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIFLUOPERAZINE HYDROCHLORIDE (UNII: 6P1Y2SNF5V) (TRIFLUOPERAZINE - UNII:214IZI85K3)

Available from:

Mylan Institutional Inc.

INN (International Name):

TRIFLUOPERAZINE HYDROCHLORIDE

Composition:

TRIFLUOPERAZINE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the management of schizophrenia. Trifluoperazine hydrochloride tablets, USP are effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine hydrochloride tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines). When used in the treatment of non-psychotic anxiety, trifluoperazine hydrochloride tablets should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine hydrochloride tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of trifluoperazine hydrochloride tablets as a treatment for non-psychotic anxiety was established in a 4-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence doe

Product summary:

Trifluoperazine Hydrochloride Tablets, USP are available containing trifluoperazine hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg or 10 mg of trifluoperazine. The 1 mg tablets are white, film-coated, round, unscored tablets debossed with T3 on one side of the tablet and M on the other side. They are available as follows: NDC 51079-572-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 2 mg tablets are white, film-coated, round, unscored tablets debossed with T4 on one side of the tablet and M on the other side. They are available as follows: NDC 51079-573-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). For psychiatric patients who are hospitalized under close supervision. The 5 mg tablets are lavender, film-coated, round, unscored tablets debossed with T5 on one side of the tablet and M on the other side. They are available as follows: NDC 51079-574-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 10 mg tablets are lavender, film-coated, round, unscored tablets debossed with T6 on one side of the tablet and M on the other side. They are available as follows: NDC 51079-575-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Rx only S-12692 4/21

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIFLUOPERAZINE HYDROCHLORIDE- TRIFLUOPERAZINE HYDROCHLORIDE TABLET,
FILM
COATED
MYLAN INSTITUTIONAL INC.
----------
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. TRIFLUOPERAZINE
HYDROCHLORIDE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS (SEE WARNINGS).
DESCRIPTION
Each film-coated tablet, for oral administration, contains
trifluoperazine hydrochloride,
USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg trifluoperazine.
The structural formula is:
10-[3-(4-Methyl-1-piperazinyl)propyl]-2-(trifluoromethyl)
phenothiazine dihydrochloride
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, hypromellose, lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
pregelatinized starch (corn),
sodium lauryl sulfa