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Buspirone Hydrochloride buspirone hydrochloride 10 MG Oral 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 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 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: Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 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 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 for 1 year without ill effect. Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient.

Strides Shasun Limited


3 years ago RECTANGLE WHITE 10 Buspirone Hydrochloride  buspirone hydrochloride 10 MG Oral Tablet

RECTANGLE WHITE 10

HOW SUPPLIED

BUSPIRONE HYDROCHLORIDE Tablets, USP are available as: 100 tablets in a HDPE bottle NDC: 64380-741-06 5 mg 500 tablets in a HDPE bottle NDC: 64380-741-07 white to off white ovoid- rectangular uncoated functionally scored tablet with score line on one side and engraved '5' on the other side. 1000 tablets in a HDPE bottle NDC: 64380-741-08 7.5 mg 100 tablets in a HDPE bottle NDC: 64380-787-06 white to off white colour, oval, biconvex tablets, debossed with 7.5 on one side and score line on other side. 500 tablets in a HDPE bottle NDC: 64380-787-07 100 tablets in a HDPE bottle NDC: 64380-742-06 10 mg 500 tablets in a HDPE bottle NDC: 64380-742-07 white to off white ovoid- rectangular uncoated functionally scored tablet with score line on one side and engraved '10' on the other side. 1000 tablets in a HDPE bottle NDC: 64380-742-08 60 tablets in a HDPE bottle NDC: 64380-743-03 15 mg 100 tablets in a HDPE bottle NDC: 64380-743-06 white to off white rectangular uncoated functionally scored tablet with bisected score lines on one side and trisected score line with engraved '5' on each trisection of other side. The 15 mg tablet is in xx tablet design and functionally scored so that it can be either bisected or trisected. 180 tablets in a HDPE bottle NDC: 64380-743-18 30 mg 60 tablets in a HDPE bottle NDC: 64380-744-03 white to off white rectangular uncoated functionally scored tablet with bisected score lines on one side and trisected score line with engraved '10' on each trisection of other side. Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [See USP controlled room temperature]. Dispense in a tight, light-resistant container (USP).


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