TRIFLUOPERAZINE HYDROCHLORIDE- trifluoperazine hydrochloride tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Lake Erie Medical DBA Quality Care Products LLC

INN (Medzinárodný Name):

TRIFLUOPERAZINE HYDROCHLORIDE

Zloženie:

TRIFLUOPERAZINE 1 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

For the management of schizophrenia. Trifluoperazine hydrochloride is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine hydrochloride 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 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 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 hydrochlo

Prehľad produktov:

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 0378-2401-01 bottles of 100 tablets 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 0378-2402-01 bottles of 100 tablets 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 0378-2405-01 bottles of 100 tablets 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 0378-2410-01 bottles of 100 tablets 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. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED SEPTEMBER 2010 TFPZ:R9

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

TRIFLUOPERAZINE HYDROCHLORIDE- TRIFLUOPERAZINE HYDROCHLORIDE TABLET,
FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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:
C H
F N S•2HCL M.W. 4 80.4 3
C H
F N S•2HCL M.W. 4 80.4 3
10-[3-(4-Methyl-1-piperazinyl)propyl]-2-(trifluoromethyl)
phenothiazine dihydrochloride
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,
sodium lauryl sulfate, titanium
dioxi