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Clonazepam 1 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. 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 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 ).

Mylan Institutional Inc.


4 years ago ROUND GREEN M C 14 Clonazepam 1 MG Oral Tablet

ROUND GREEN M C 14

4 years ago ROUND GREEN M C 14 Clonazepam 1 MG Oral Tablet

M C 14 ROUND GREEN

HOW SUPPLIED: Clonazepam Tablets, USP are available containing 0.5 mg, 1 mg or 2 mg of clonazepam, USP. The 0.5 mg tablets are yellow, round, scored tablets debossed with M on one side of the tablet and C above the score and 13 below the score on the other side. They are available as follows: NDC 51079-881-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 1 mg tablets are light green, round, scored tablets debossed with M on one side of the tablet and C above the score and 14 below the score on the other side. They are available as follows: NDC 51079-882-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 2 mg tablets are white, round, scored tablets debossed with M on one side of the tablet and C above the score and 15 below the score on the other side. They are available as follows: NDC 51079-883-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Medication Guide with each prescription.


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