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clonazepam tablet orally disintegrating

INDICATIONS AND USAGE Seizure Disorders: Clonazepam orally disintegrating tablet 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 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 tablet is 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, ie, 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 ).

sun pharmaceutical industries, inc.


1 year ago ROUND WHITE C 1 4 clonazepam tablet orally disintegrating

ROUND WHITE C 1 4

1 year ago ROUND WHITE C 1 4 clonazepam tablet orally disintegrating

C 1 4 ROUND WHITE

HOW SUPPLIED

CLONAZEPAM Orally Disintegrating Tablets USP 0.125 mg are white to off-white colored, round shaped, uncoated, flat-faced, beveled edge tablets debossed with ā€œ1/8ā€ on one side and ā€œCā€ on the other side are available as follows: Bottles of 30 NDC 57664-783-83 Bottles of 60 NDC 57664-783-86 Bottles of 100 NDC 57664-783-88

CLONAZEPAM Orally Disintegrating Tablets USP 0.25 mg are white to off-white colored, round shaped, uncoated, flat-faced, beveled edge tablets debossed with ā€œ1/4ā€ on one side and ā€œCā€ on the other side are available as follows: Bottles of 30 NDC 57664-784-83 Bottles of 60 NDC 57664-784-86 Bottles of 100 NDC 57664-784-88

CLONAZEPAM Orally Disintegrating Tablets USP 0.5 mg are white to off-white colored, round shaped, uncoated, flat-faced, beveled edge tablets debossed with ā€œ1/2ā€ on one side and ā€œCā€ on the other side are available as follows: Bottles of 30 NDC 57664-785-83 Bottles of 60 NDC 57664-785-86 Bottles of 100 NDC 57664-785-88

CLONAZEPAM Orally Disintegrating Tablets USP 1 mg are white to off-white colored, round shaped, uncoated, flat-faced, beveled edge tablets debossed with ā€œ1ā€ on one side and ā€œCā€ on the other side are available as follows: Bottles of 30 NDC 57664-786-83 Bottles of 60 NDC 57664-786-86 Bottles of 100 NDC 57664-786-88

CLONAZEPAM Orally Disintegrating Tablets USP 2 mg are white to off-white colored, round shaped, uncoated, flat-faced, beveled edge tablets debossed with ā€œ2ā€ on one side and ā€œCā€ on the other side are available as follows: Bottles of 30 NDC 57664-787-83 Bottles of 60 NDC 57664-787-86 Bottles of 100 NDC 57664-787-88 Store at 20Ā° to 25Ā°C (68Ā° to 77Ā°F); excursions permitted 15Ā° to 30Ā°C (59Ā° to 86Ā°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Rev. 12/2022


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