TRIFLUOPERAZINE HYDROCHLORIDE tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

REMEDYREPACK INC.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 does not predict that trifluoperazine hydrochloride tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (i.e., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Trifluoperazine hydrochloride tablets have not been shown effective in the management of behavioral complications in patients with mental retardation. A known hypersensitivity to phenothiazines, comatose or greatly depressed states due to central nervous system depressants and, in cases of existing blood dyscrasias, bone marrow depression and preexisting liver damage.

उत्पाद समीक्षा:

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: 70518-2106-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

TRIFLUOPERAZINE HYDROCHLORIDE- TRIFLUOPERAZINE HYDROCHLORIDE TABLET,
FILM
COATED
REMEDYREPACK 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 sulfate, tit