Application Nr Approved Date Route Status External Links
ANDA074979 1997-08-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Seizure Disorders Clonazepam Tablets, Usp Are Useful Alone Or As An Adjunct In The Treatment Of The Lennox-Gastaut Syndrome (petit Mal Variant), Akinetic And Myoclonic Seizures. In Patients With Absence Seizures (petit Mal) Who Have Failed To Respond To Succinimides, Clonazepam Tablets, Usp May Be Useful. In Some Studies, Up To 30% Of Patients Have Shown A Loss Of Anticonvulsant Activity, Often Within 3 Months Of Administration. In Some Cases, Dosage Adjustment May Reestablish Efficacy. Panic Disorder Clonazepam Tablets, Usp Are Indicated For The Treatment Of Panic Disorder, With Or Without Agoraphobia, As Defined In Dsm-V. 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 Clonazepam Tablets, Usp Was Established In Two 6- To 9-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-V) Is Characterized By Recurrent Unexpected Panic Attacks, I.e., A Discrete Period Of Intense Fear Or Discomfort In Which Four (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. The Effectiveness Of Clonazepam Tablets, Usp In Long-Term Use, That Is, For More Than 9 Weeks, Has Not Been Systematically Studied In Controlled Clinical Trials. The Physician Who Elects To Use Clonazepam Tablets, Usp For Extended Periods Should Periodically Reevaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration ).

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Anhydrous Lactose ANHYDROUS LACTOSE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clonazepam CLONAZEPAM ZINC3813003