clonazepam tablet orally disintegrating
INDICATIONS AND USAGE Seizure Disorders Clonazepam orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ).
teva pharmaceuticals usa, inc.
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HOW SUPPLIED Clonazepam Orally Disintegrating Tablets USP are available as: 0.125 mg: white to off-white, round, flat-faced, beveled-edge, unscored tablet. debossed with stylized b over 94 on one side and 1/8 on the other side. Available in cartons of 60 blistered tablets (10 blister cards containing 6 blisters each) (NDC 0555-0094-96). 0.25 mg: white to off-white, round, flat-faced, beveled-edge, unscored tablet. debossed with stylized b over 95 on one side and 1/4 on the other side. Available in cartons of 60 blistered tablets (10 blister cards containing 6 blisters each) (NDC 0555-0095-96). 0.5 mg: white to off-white, round, flat-faced, beveled-edge, unscored tablet. debossed with stylized b over 96 on one side and 1/2 on the other side. Available in cartons of 60 blistered tablets (10 blister cards containing 6 blisters each) (NDC 0555-0096-96). 1 mg: white to off-white, round, flat-faced, beveled-edge, unscored tablet. debossed with stylized b over 97 on one side and 1 on the other side. Available in cartons of 60 blistered tablets (10 blister cards containing 6 blisters each) (NDC 0555-0097-96). 2 mg: white to off-white, round, flat-faced, beveled-edge, unscored tablet. debossed with stylized b over 98 on one side and 2 on the other side. Available in cartons of 60 blistered tablets (10 blister cards containing 6 blisters each) (NDC 0555-0098-96). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. H 1/2021
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