buspirone hydrochloride tablet
INDICATIONS AND USAGE Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short‑term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
epic pharma, llc
OVAL WHITE Y 53
Y 53 OVAL WHITE
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HOW SUPPLIED
BUSPIRONE HYDROCHLORIDE Tablets, USP 5 mg are available as white, or almost white, oval tablets debossed with the code Y1 on one side and a score on the other side. They are packaged as follows: Bottles of 100 (packaged in a single bottle) NDC 42806-662-01 Bottles of 500 (packaged in a single bottle) NDC 42806-662-05
BUSPIRONE HYDROCHLORIDE Tablets, USP 10 mg are available as white, or almost white, oval tablets debossed with the code Y7 on one side and a score on the other side. They are packaged as follows: Bottles of 100 (packaged in a single bottle) NDC 42806-663-01 Bottles of 500 (packaged in a single bottle) NDC 42806-663-05
BUSPIRONE HYDROCHLORIDE Tablets, USP 15 mg are available as white, or almost white, bar-shaped tablets debossed with the code Y53 on one side and a score on one side and two scores on the other side. They are packaged as follows: Bottles of 100 (packaged in a single bottle) NDC 42806-664-01 Bottles of 500 (packaged in a single bottle) NDC 42806-664-05
BUSPIRONE HYDROCHLORIDE Tablets, USP 30 mg are available as white, or almost white, bar-shaped tablets debossed with the code Y54 on one side and two scores on the other side. They are packaged as follows: Bottles of 60 (packaged in a single bottle) NDC 42806-665-60 PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
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