Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
TRIFLUOPERAZINE HYDROCHLORIDE (UNII: 6P1Y2SNF5V) (TRIFLUOPERAZINE - UNII:214IZI85K3)
Sandoz Inc
TRIFLUOPERAZINE HYDROCHLORIDE
TRIFLUOPERAZINE HYDROCHLORIDE 1 mg
ORAL
PRESCRIPTION DRUG
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 w
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 0781-1030-01 bottles of 100 NDC 0781-1030-05 bottles of 500 NDC 0781-1030-10 bottles of 1000 NDC 0781-1030-13 unit dose packages 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 0781-1032-01 bottles of 100 NDC 0781-1032-05 bottles of 500 NDC 0781-1032-10 bottles of 1000 NDC 0781-1032-13 unit dose packages 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 0781-1034-01 bottles of 100 NDC 0781-1034-05 bottles of 500 NDC 0781-1034-10 bottles of 1000 NDC 0781-1034-13 unit dose packages 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 0781-1036-01 bottles of 100 NDC 0781-1036-05 bottles of 500 NDC 0781-1036-10 bottles of 1000 NDC 0781-1036-13 unit dose packages 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.
Abbreviated New Drug Application
TRIFLUOPERAZINE HYDROCHLORIDE- TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED SANDOZ INC ---------- TRIFLUOPERAZINE HYDROCHLORIDE TABLETS, USP 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. 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 read_full_document