Application Nr Approved Date Route Status External Links
ANDA040209 1997-07-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage 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.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE ZINC19418959