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:

Sandoz Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

For the management of schizophrenia. Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine HCl is 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 HCl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine HCl at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ). The effectiveness of trifluoperazine HCl as a treatment for non-psychotic anxiety was established in a four-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence does not predict that trifluoperazine HCl 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 HCl has 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 pre-existing liver damage.

उत्पाद समीक्षा:

Trifluoperazine hydrochloride tablets, USP are available as: 1 mg: Round, film-coated, lavender colored tablets, debossed GG 51 on one side and 1 on the reverse side, and supplied as: NDC 0781-8028-01 bottles of 100 2 mg: Round, film-coated, lavender colored tablets, debossed GG 53 on one side and 2 on the reverse side, and supplied as: NDC 0781-8032-01 bottles of 100 5 mg: Round, film-coated, lavender colored tablets, debossed GG 55 on one side and 5 on the reverse side, and supplied as: NDC 0781-8034-01 bottles of 100 This strength tablet for use only in severe neuropsychiatric conditions. 10 mg: Round, film-coated, lavender colored tablets, debossed GG 58 on one side and 10 on the reverse side, and supplied as: NDC 0781-8036-01 bottles of 100 This strength tablet for use only in severe neuropsychiatric conditions. Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

TRIFLUOPERAZINE HYDROCHLORIDE- TRIFLUOPERAZINE HYDROCHLORIDE TABLET,
FILM
COATED
SANDOZ INC.
----------
TRIFLUOPERAZINE HYDROCHLORIDE TABLETS, USP
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. TRIFLUOPERAZINE
HYDROCHLORIDE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS (SEE WARNINGS).
DESCRIPTION
Each tablet for oral administration contains trifluoperazine
hydrochloride equivalent to 1
mg, 2 mg, 5 mg, or 10 mg trifluoperazine. The structural formula is:
10-_H_ -PHENOTHIAZINE, 10-[3-(4-METHYL-1-PIPERAZINYL)PROPYL]-2-
(TRIFLUOROMETHYL)-, DIHYDROCHLORIDE.
Inactive ingredients: D & C Red #30 Aluminum Lake, FD & C Blue #2
Aluminum Lake,
hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose
(monohydrate),
magnesium stearate, polyethylene glycol, povidone, starch (corn), and
titanium dioxide.
INDICATIONS AND USAGE
For the management of schizophrenia.
Trifluoperazine HCl is effective for the shor