Application Nr Approved Date Route Status External Links
NDA020936 2000-12-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Major Depressive Disorder Paroxetine Hydrochloride Controlled-Release Tablets Are Indicated For The Treatment Of Major Depressive Disorder. The Efficacy Of Paroxetine Hydrochloride Controlled-Release Tablets In The Treatment Of A Major Depressive Episode Was Established In Two 12-Week Controlled Trials Of Outpatients Whose Diagnoses Corresponded To The Dsm-Iv Category Of Major Depressive Disorder (see Clinical Pharmacology: Clinical Trials). A Major Depressive Episode (dsm-Iv) Implies A Prominent And Relatively Persistent (nearly Every Day For At Least 2 Weeks) Depressed Mood Or Loss Of Interest Or Pleasure In Nearly All Activities, Representing A Change From Previous Functioning, And Includes The Presence Of At Least 5 Of The Following 9 Symptoms During The Same 2-Week Period: Depressed Mood, Markedly Diminished Interest Or Pleasure In Usual Activities, Significant Change In Weight And/or Appetite, Insomnia Or Hypersomnia, Psychomotor Agitation Or Retardation, Increased Fatigue, Feelings Of Guilt Or Worthlessness, Slowed Thinking Or Impaired Concentration, A Suicide Attempt, Or Suicidal Ideation. The Antidepressant Action Of Paroxetine In Hospitalized Depressed Patients Has Not Been Adequately Studied. Paroxetine Hydrochloride Controlled-Release Tablets Have Not Been Systematically Evaluated Beyond 12 Weeks In Controlled Clinical Trials; However, The Effectiveness Of Immediate-Release Paroxetine Hydrochloride In Maintaining A Response In Major Depressive Disorder For Up To 1 Year Has Been Demonstrated In A Placebo-Controlled Trial (see Clinical Pharmacology: Clinical Trials). The Physician Who Elects To Use Paroxetine Hydrochloride Controlled-Release Tablets 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 Hydrochloride Controlled-Release Tablets 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 Hydrochloride Controlled-Release Tablets Was Established In Two 10-Week Trials In Panic Disorder Patients Whose Diagnoses Corresponded To The Dsm-Iv 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 With The Immediate-Release Formulation Of Paroxetine Was Demonstrated In A 3-Month Relapse Prevention Trial. In This Trial, Patients With Panic Disorder Assigned To Immediate-Release Paroxetine Demonstrated A Lower Relapse Rate Compared To Patients On Placebo (see Clinical Pharmacology: Clinical Trials). Nevertheless, The Physician Who Prescribes Paroxetine Hydrochloride Controlled-Release Tablets 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 Hydrochloride Controlled-Release Tablets 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 Hydrochloride Controlled-Release Tablets As A Treatment For Social Anxiety Disorder Has Been Established, In Part, On The Basis Of Extrapolation From The Established Effectiveness Of The Immediate-Release Formulation Of Paroxetine. In Addition, The Efficacy Of Paroxetine Hydrochloride Controlled-Release Tablets Was Established In A 12-Week Trial, In Adult Outpatients With Social Anxiety Disorder (dsm-Iv). Paroxetine Hydrochloride Controlled-Release Tablets Have Not Been Studied In Children Or Adolescents With Social Phobia (see Clinical Pharmacology: Clinical Trials). The Effectiveness Of Paroxetine Hydrochloride Controlled-Release Tablets 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 Hydrochloride Controlled-Release Tablets For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration). Premenstrual Dysphoric Disorder Paroxetine Hydrochloride Controlled-Release Tablets Are Indicated For The Treatment Of Pmdd. The Efficacy Of Paroxetine Hydrochloride Controlled-Release Tablets In The Treatment Of Pmdd Has Been Established In 3 Placebo-Controlled Trials (see Clinical Pharmacology: Clinical Trials). The Essential Features Of Pmdd, According To Dsm-Iv, Include Markedly Depressed Mood, Anxiety Or Tension, Affective Lability, And Persistent Anger Or Irritability. Other Features Include Decreased Interest In Usual Activities, Difficulty Concentrating, Lack Of Energy, Change In Appetite Or Sleep, And Feeling Out Of Control. Physical Symptoms Associated With Pmdd Include Breast Tenderness, Headache, Joint And Muscle Pain, Bloating, And Weight Gain. These Symptoms Occur Regularly During The Luteal Phase And Remit Within A Few Days Following The Onset Of Menses; The Disturbance Markedly Interferes With Work Or School Or With Usual Social Activities And Relationships With Others. In Making The Diagnosis, Care Should Be Taken To Rule Out Other Cyclical Mood Disorders That May Be Exacerbated By Treatment With An Antidepressant. The Effectiveness Of Paroxetine Hydrochloride Controlled-Release Tablets In Long-Term Use, That Is, For More Than 3 Menstrual Cycles, Has Not Been Systematically Evaluated In Controlled Trials. Therefore, The Physician Who Elects To Use Paroxetine Hydrochloride Controlled-Release Tablets 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 (12 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. 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.
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Glyceryl Dibehenate GLYCERYL DIBEHENATE Unresolved
5. Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A Unresolved
6. 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.
7. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
11. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
12. Ferric Oxide Red FERRIC OXIDE RED Molecular

Active Ingredients ( 1 Total)

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