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Clonazepam 0.5 MG Oral Tablet

INDICATIONS AND USAGE Seizure Disorders: Clonazepam 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 tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS : Loss of Effect ). Panic Disorder: Clonazepam 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 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 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 tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ).

Accord Healthcare Inc.


8 years ago ROUND ORANGE 1 2 Clonazepam 0.5 MG Oral Tablet

ROUND ORANGE 1 2

8 years ago ROUND ORANGE 1 2 Clonazepam 0.5 MG Oral Tablet

1 2 ROUND ORANGE

HOW SUPPLIED

CLONAZEPAM tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows: Bottles of 100 NDC 16729-136-00 Bottles of 500 NDC 16729-136-16

CLONAZEPAM tablets USP 1 mg are blue, round, flat faced, beveled edge, debossed with “C 1” on one side and plain on the other. They are supplied as follows: Bottles of 100 NDC 16729-137-00 Bottles of 500 NDC 16729-137-16

CLONAZEPAM tablets USP 2 mg are white to off white, round, flat faced, beveled edge tablets debossed with “C 2” on one side and plain on the other. They are supplied as follows: Bottles of 100 NDC 16729-138-00 Bottles of 500 NDC 16729-138-16 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Manufactured For: Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA. Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad -380 054, India. 10 0533 5 6025625 Issued October 2023


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