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buspirone hydrochloride 30 mg

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.

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4 weeks ago RECTANGLE PINK B 3 0 buspirone hydrochloride 30 mg

RECTANGLE PINK B 3 0

4 weeks ago RECTANGLE PINK B 3 0 buspirone hydrochloride 30 mg

B 3 0 RECTANGLE PINK

HOW SUPPLIED

BUSPIRONE HYDROCHLORIDE Tablets USP, 5 mg are white, ovoid rectangular shaped, beveled edged, uncoated tablets debossed “B” and “5” separated by score line on one side and plain on other side and are available in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 59651-389-30 Bottles of 60 NDC 59651-389-60 Bottles of 100 NDC 59651-389-01 Bottles of 500 NDC 59651-389-05 Unit dose package of 100 (10 x 10) NDC 59651-389-78

BUSPIRONE HYDROCHLORIDE Tablets USP, 7.5 mg are white, ovoid rectangular shaped, beveled edged, uncoated tablets debossed “B” and “75” separated by score line on one side and plain on other side and are available in bottles of 100 and 500. Bottles of 100 NDC 59651-390-01 Bottles of 500 NDC 59651-390-05

BUSPIRONE HYDROCHLORIDE Tablets USP, 10 mg are white, ovoid rectangular shaped, beveled edged, uncoated tablets debossed “B” and “10” separated by score line on one side and plain on other side and are available in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 59651-391-30 Bottles of 60 NDC 59651-391-60 Bottles of 100 NDC 59651-391-01 Bottles of 500 NDC 59651-391-05 Unit dose package of 100 (10 x 10) NDC 59651-391-78

BUSPIRONE HYDROCHLORIDE Tablets USP, 15 mg are white, flat rectangular shaped, beveled edged, uncoated tablets debossed “B”, “1” and “5” on trisected segments of one side and score line on other side are available in bottles of 30, 60, 100, 180, 500 and unit dose package of 100 (10 x 10). The 15 mg tablet is in a multi-scored tablet design and scored so it can be either bisected or trisected. Bottles of 30 NDC 59651-392-30 Bottles of 60 NDC 59651-392-60 Bottles of 100 NDC 59651-392-01 Bottles of 180 NDC 59651-392-18 Bottles of 500 NDC 59651-392-05 Unit dose package of 100 (10 x 10) NDC 59651-392-78

BUSPIRONE HYDROCHLORIDE Tablets, USP 30 mg are light pink coloured, flat, rectangular shaped, beveled edged, uncoated tablets debossed “B”, “3” and “0” on trisected segments of one side and score line on other side and are available in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). The 30 mg tablet is in a multi-scored tablet design and scored so it can be either bisected or trisected. Bottles of 30 NDC 59651-393-30 Bottles of 60 NDC 59651-393-60 Bottles of 100 NDC 59651-393-01 Bottles of 500 NDC 59651-393-05 Unit dose package of 100 (10 x 10) NDC 59651-393-78 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F). Dispense in a tight, light-resistant container (USP).


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