Application Nr Approved Date Route Status External Links
ANDA077584 2007-03-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Major Depressive Disorder: Paroxetine Tablets, Usp Are Indicated For The Treatment Of Major Depressive Disorder. The Efficacy Of Paroxetine Tablets, Usp In The Treatment Of A Major Depressive Episode Was Established In 6-Week Controlled Trials Of Outpatients Whose Diagnoses Corresponded Most Closely To The Dsm-Iii Category Of Major Depressive Disorder (see Clinical Pharmacology —clinical Trials). A Major Depressive Episode Implies A Prominent And Relatively Persistent Depressed Or Dysphoric Mood That Usually Interferes With Daily Functioning (nearly Every Day For At Least 2 Weeks); It Should Include At Least 4 Of The Following 8 Symptoms: Change In Appetite, Change In Sleep, Psychomotor Agitation Or Retardation, Loss Of Interest In Usual Activities Or Decrease In Sexual Drive, Increased Fatigue, Feelings Of Guilt Or Worthlessness, Slowed Thinking Or Impaired Concentration, And A Suicide Attempt Or Suicidal Ideation. The Effects Of Paroxetine Tablets, Usp In Hospitalized Depressed Patients Have Not Been Adequately Studied. The Efficacy Of Paroxetine Tablets, Usp In Maintaining A Response In Major Depressive Disorder For Up To 1 Year Was Demonstrated In A Placebo-Controlled Trial (see Clinical Pharmacology —clinical Trials). Nevertheless, The Physician Who Elects To Use Paroxetine Tablets, Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient. Obsessive Compulsive Disorder: Paroxetine Tablets, Usp Are Indicated For The Treatment Of Obsessions And Compulsions In Patients With Obsessive Compulsive Disorder (ocd) As Defined In The Dsm-Iv. The Obsessions Or Compulsions Cause Marked Distress, Are Time-Consuming, Or Significantly Interfere With Social Or Occupational Functioning. The Efficacy Of Paroxetine Tablets, Usp Were Established In Two 12-Week Trials With Obsessive Compulsive Outpatients Whose Diagnoses Corresponded Most Closely To The Dsm-Iiir Category Of Obsessive Compulsive Disorder (see Clinical Pharmacology —clinical Trials). Obsessive Compulsive Disorder Is Characterized By Recurrent And Persistent Ideas, Thoughts, Impulses, Or Images (obsessions) That Are Ego-Dystonic And/or Repetitive, Purposeful, And Intentional Behaviors (compulsions) That Are Recognized By The Person As Excessive Or Unreasonable. Long-Term Maintenance Of Efficacy Was Demonstrated In A 6-Month Relapse Prevention Trial. In This Trial, Patients Assigned To Paroxetine Showed A Lower Relapse Rate Compared To Patients On Placebo (see Clinical Pharmacology — Clinical Trials). Nevertheless, The Physician Who Elects To Use Paroxetine Tablets, Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration). Panic Disorder: Paroxetine Tablets, Usp Are Indicated For The Treatment Of Panic Disorder, With Or Without Agoraphobia, As Defined In Dsm-Iv. Panic Disorder Is Characterized By The Occurrence Of Unexpected Panic Attacks And Associated Concern About Having Additional Attacks, Worry About The Implications Or Consequences Of The Attacks, And/or A Significant Change In Behavior Related To The Attacks. The Efficacy Of Paroxetine Tablets, Usp Were Established In Three 10- To 12-Week Trials In Panic Disorder Patients Whose Diagnoses Corresponded To The Dsm-Iiir Category Of Panic Disorder (see Clinical Pharmacology —clinical Trials). Panic Disorder (dsm-Iv) Is Characterized By Recurrent Unexpected Panic Attacks, I.e., A Discrete Period Of Intense Fear Or Discomfort In Which 4 (or More) Of The Following Symptoms Develop Abruptly And Reach A Peak Within 10 Minutes: (1) Palpitations, Pounding Heart, Or Accelerated Heart Rate; (2) Sweating; (3) Trembling Or Shaking; (4) Sensations Of Shortness Of Breath Or Smothering; (5) Feeling Of Choking; (6) Chest Pain Or Discomfort; (7) Nausea Or Abdominal Distress; (8) Feeling Dizzy, Unsteady, Lightheaded, Or Faint; (9) Derealization (feelings Of Unreality) Or Depersonalization (being Detached From Oneself); (10) Fear Of Losing Control; (11) Fear Of Dying; (12) Paresthesias (numbness Or Tingling Sensations); (13) Chills Or Hot Flushes. Long-Term Maintenance Of Efficacy Was Demonstrated In A 3-Month Relapse Prevention Trial. In This Trial, Patients With Panic Disorder Assigned To Paroxetine Demonstrated A Lower Relapse Rate Compared To Patients On Placebo (see Clinical Pharmacology —clinical Trials). Nevertheless, The Physician Who Prescribes Paroxetine Tablets, Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration). Social Anxiety Disorder: Paroxetine Tablets, Usp Are Indicated For The Treatment Of Social Anxiety Disorder, Also Known As Social Phobia, As Defined In Dsm-Iv (300.23). Social Anxiety Disorder Is Characterized By A Marked And Persistent Fear Of 1 Or More Social Or Performance Situations In Which The Person Is Exposed To Unfamiliar People Or To Possible Scrutiny By Others. Exposure To The Feared Situation Almost Invariably Provokes Anxiety, Which May Approach The Intensity Of A Panic Attack. The Feared Situations Are Avoided Or Endured With Intense Anxiety Or Distress. The Avoidance, Anxious Anticipation, Or Distress In The Feared Situation(s) Interferes Significantly With The Person's Normal Routine, Occupational Or Academic Functioning, Or Social Activities Or Relationships, Or There Is Marked Distress About Having The Phobias. Lesser Degrees Of Performance Anxiety Or Shyness Generally Do Not Require Psychopharmacological Treatment. The Efficacy Of Paroxetine Tablets, Usp Were Established In Three 12-Week Trials In Adult Patients With Social Anxiety Disorder (dsm-Iv). Paroxetine Tablets, Usp Have Not Been Studied In Children Or Adolescents With Social Phobia (see Clinical Pharmacology — Clinical Trials). The Effectiveness Of Paroxetine Tablets, Usp In Long-Term Treatment Of Social Anxiety Disorder, I.e., For More Than 12 Weeks, Has Not Been Systematically Evaluated In Adequate And Well-Controlled Trials. Therefore, The Physician Who Elects To Prescribe Paroxetine Tablets, Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration). Generalized Anxiety Disorder: Paroxetine Tablets, Usp Are Indicated For The Treatment Of Generalized Anxiety Disorder (gad), As Defined In Dsm-Iv. Anxiety Or Tension Associated With The Stress Of Everyday Life Usually Does Not Require Treatment With An Anxiolytic. The Efficacy Of Paroxetine Tablets, Usp In The Treatment Of Gad Was Established In Two 8-Week Placebo-Controlled Trials In Adults With Gad. Paroxetine Tablets, Usp Have Not Been Studied In Children Or Adolescents With Generalized Anxiety Disorder (see Clinical Pharmacology— Clinical Trials). Generalized Anxiety Disorder (dsm-Iv) Is Characterized By Excessive Anxiety And Worry (apprehensive Expectation) That Is Persistent For At Least 6 Months And Which The Person Finds Difficult To Control. It Must Be Associated With At Least 3 Of The Following 6 Symptoms: Restlessness Or Feeling Keyed Up Or On Edge, Being Easily Fatigued, Difficulty Concentrating Or Mind Going Blank, Irritability, Muscle Tension, Sleep Disturbance. The Efficacy Of Paroxetine Tablets, Usp In Maintaining A Response In Patients With Generalized Anxiety Disorder, Who Responded During An 8-Week Acute Treatment Phase While Taking Paroxetine Tablets, Usp And Were Then Observed For Relapse During A Period Of Up To 24 Weeks, Was Demonstrated In A Placebocontrolled Trial (see Clinical Pharmacology —clinical Trials). Nevertheless, The Physician Who Elects To Use Paroxetine Tablets, Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration).

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
2. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
3. 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.
4. Polyethylene Glycol 6000 POLYETHYLENE GLYCOL 6000 Unresolved
5. Povidones POVIDONES Unresolved
6. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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