Application Nr Approved Date Route Status External Links
ANDA040120 1996-07-11 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage For Control Of Severe Nausea And Vomiting. For The Treatment Of Schizophrenia. Prochlorperazine Is Effective For The Short-Term Treatment Of Generalized Non-Psychotic Anxiety. However, Prochlorperazine 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 (e.g., Benzodiazepines). When Used In The Treatment Of Non-Psychotic Anxiety, Prochlorperazine Should Not Be Administered At Doses Of More Than 20 Mg Per Day Or For Longer Than 12 Weeks, Because The Use Of Prochlorperazine At Higher Doses Or For Longer Intervals May Cause Persistent Tardive Dyskinesia That May Prove Irreversible (see Warnings). The Effectiveness Of Prochlorperazine As Treatment For Non-Psychotic Anxiety Was Established In 4 Week Clinical Studies Of Outpatients With Generalized Anxiety Disorder. This Evidence Does Not Predict That Prochlorperazine Will Be Useful In Patients With Other Non-Psychotic Conditions In Which Anxiety, Or Signs That Mimic Anxiety, Are Found (e.g., Physical Illness, Organic Mental Conditions, Agitated Depression, Character Pathologies, Etc.). Prochlorperazine Has Not Been Shown Effective In The Management Of Behavioral Complications In Patients With Mental Retardation.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
9. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Prochlorperazine Maleate PROCHLORPERAZINE MALEATE ZINC19796018

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