buspirone hydrochloride 5 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 have 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.
zydus pharmaceuticals (usa) inc.
OVAL WHITE ZE 36
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HOW SUPPLIED
BUSPIRONE HYDROCHLORIDE Tablets USP, 5 mg are white to off-white, capsule-shaped, flat- faced, beveled-edge tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '36' and other side is plain and are supplied as follows: NDC 68382-180-01 in bottle of 100 tablets NDC 68382-180-05 in bottle of 500 tablets NDC 68382-180-10 in bottle of 1000 tablets NDC 68382-180-30 in blister pack of 100 unit-dose tablets
BUSPIRONE HYDROCHLORIDE Tablets USP, 7.5 mg are white to off-white coloured, capsule-shaped, flat-faced, beveled-edged, uncoated tablets, debossed with '6' and "23" on either side of functional score line on one side and plain on other side and are supplied as follows: NDC 68382-623-01 in bottle of 100 tablets with child-resistant closure NDC 68382-623-05 in bottle of 500 tablets with child-resistant closure NDC 68382-623-30 in unit-dose blister cartons of 10 tablets (1 x 10 unit-dose)
BUSPIRONE HYDROCHLORIDE Tablets USP, 10 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '37' and other side is plain and are supplied as follows: NDC 68382-181-01 in bottle of 100 tablets NDC 68382-181-05 in bottle of 500 tablets NDC 68382-181-10 in bottle of 1000 tablets NDC 68382-181-30 in blister pack of 100 unit-dose tablets
BUSPIRONE HYDROCHLORIDE Tablets USP, 15 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets, bisected on one side and trisected on other side. The trisected side of tablet is debossed with '5' on each trisect segment. The bisected side is debossed with 'ZE', on one bisect and '38' on other bisect segment and are supplied as follows: NDC 68382-182-14 in bottle of 60 tablets NDC 68382-182-01 in bottle of 100 tablets NDC 68382-182-28 in bottle of 180 tablets NDC 68382-182-05 in bottle of 500 tablets NDC 68382-182-10 in bottle of 1000 tablets NDC 68382-182-30 in blister pack of 100 unit-dose tablets
BUSPIRONE HYDROCHLORIDE Tablets USP, 30 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets, bisected on one side and trisected on other side. The trisected side of tablet is debossed with '10' on each trisect segment. The bisected side is debossed with 'ZE', on one bisect and '39' on other bisect segment and are supplied as follows: NDC 68382-183-14 in bottle of 60 tablets NDC 68382-183-05 in bottle of 500 tablets NDC 68382-183-10 in bottle of 1000 tablets NDC 68382-183-30 in blister pack of 100 unit-dose tablets Storage: Store at 20°C to 25° C (68°F to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. REFERENCE American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental Disorders—III, American Psychiatric Association, May 1980. Desyrel ® is the registered trademark of Bristol Myers Squibb Company. Synthroid ® is the registered trademark of Abbott Laboratories
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