displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Clonazepam Tablets USP, a benzodiazepine for oral administration, contain 0.5 mg, 1 mg or 2 mg clonazepam. In addition each tablet contains the following inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium benzoate, and sodium starch glycolate. The 0.5 mg tablets also contain D&C yellow #10 aluminum lake. The 1 mg tablets also contain: D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake.Chemically, clonazepam is 5-(o-Chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula:
C15H10ClN3O3 Molecular Weight 315.71
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Seizure Disorders: Clonazepam is 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 may be useful.In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within three months of administration. In some cases, dosage adjustment may re-establish efficacy.Panic Disorder: Clonazepam is 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 clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lllR category of panic disorder (seeCLINICAL 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 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 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (seeDOSAGE AND ADMINISTRATION).
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Clonazepam should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Clonazepam Tablets USP, 0.5 mg, are yellow, round, biconvex scored tablets, debossed with WATSON 746 on one side and scored on the other side supplied in bottles of 100, 500, and 1000.Clonazepam Tablets USP, 1 mg, are aqua colored, round, biconvex scored tablets, debossed with WATSON 747 on one side and scored on the other side supplied in bottles of 100, 500, and 1000.Clonazepam Tablets USP, 2 mg, are white, round, biconvex scored tablets, debossed with WATSON 748 on one side and scored on the other side supplied in bottles of 100, 500, and 1000.Bulk package – Not Intended for Dispensing.Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [see USP controlled room temperature..]Watson Laboratories, Inc.
Corona, CA 92880 USA