Country: United States
Language: English
Source: NLM (National Library of Medicine)
TRIFLUOPERAZINE HYDROCHLORIDE (UNII: 6P1Y2SNF5V) (TRIFLUOPERAZINE - UNII:214IZI85K3)
Mylan Pharmaceuticals Inc.
TRIFLUOPERAZINE HYDROCHLORIDE
TRIFLUOPERAZINE 1 mg
ORAL
PRESCRIPTION DRUG
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.
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. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75069102 Revised: 8/2019 MXA:TFPZ:R1
Abbreviated New Drug Application
TRIFLUOPERAZINE HYDROCHLORIDE- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED MYLAN PHARMACEUTICALS 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: C H F N S•2HCL M.W. 480.43 10-[3-(4-Methyl-1-piperazinyl)propyl]-2-(trifluoromethyl) phenothiazine dihydrochloride 21 24 3 3 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, titanium dioxide, and triacetin. The 5 mg and 10 mg Read the complete document