Country: United States
Language: English
Source: NLM (National Library of Medicine)
Buspirone Hydrochloride (UNII: 207LT9J9OC) (Buspirone - UNII:TK65WKS8HL)
Dr. Reddy's Laboratories Limited
Buspirone Hydrochloride
Buspirone Hydrochloride 5 mg
ORAL
PRESCRIPTION DRUG
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, III1 as follows: Generalized, persistent anxiety (of at least 1 month continual du
Buspirone hydrochloride tablets, USP 5 mg are white to off-white, ovoid-rectangular shaped, biconvex, uncoated scored tablet embossed “RïDY” on one side and “472” on the other side and are supplied in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-472-30 Bottles of 60 NDC 55111-472-60 Bottles of 100 NDC 55111-472-01 Bottles of 500 NDC 55111-472-05 Unit dose package of 100 (10 x 10) NDC 55111-472-78 Buspirone hydrochloride tablets, USP 10 mg are white to off-white, ovoid-rectangular shaped, biconvex, uncoated scored tablet embossed “RïDY” on one side and “473” on the other side and are supplied in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-473-30 Bottles of 60 NDC 55111-473-60 Bottles of 100 NDC 55111-473-01 Bottles of 500 NDC 55111-473-05 Unit dose package of 100 (10 x 10) NDC 55111-473-78 Buspirone hydrochloride tablets, USP 15 mg are white to off-white, flat-rectangular shaped, beveled edged, uncoated scored tablet embossed “RïDY” on one side and “4ï7ï4” on the other side and are supplied in bottles of 30, 60, 100, 180, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-474-30 Bottles of 60 NDC 55111-474-60 Bottles of 100 NDC 55111-474-01 Bottles of 180 NDC 55111-474-18 Bottles of 500 NDC 55111-474-05 Unit dose package of 100 (10 x 10) NDC 55111-474-78 Buspirone hydrochloride tablets, USP 30 mg are light pink to pink coloured, flat, rectangular shaped, beveled edged, uncoated scored tablet embossed “RïDY” on one side and “4ï7ï5” on the other side and are supplied in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-475-30 Bottles of 60 NDC 55111-475-60 Bottles of 100 NDC 55111-475-01 Bottles of 500 NDC 55111-475-05 Unit dose package of 100 (10 x 10) NDC 55111-475-78 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F). Dispense in a tight, light-resistant container (USP).
Abbreviated New Drug Application
BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET DR. REDDY'S LABORATORIES LIMITED ---------- BUSPIRONE HYDROCHLORIDE (PATIENT INSTRUCTION SHEET INCLUDED) DESCRIPTION Buspirone hydrochloride, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8- azaspiro[4.5]decane-7,9- dione monohydrochloride. The empirical formula C H N O · HCl is represented by the following structural formula: Buspirone hydrochloride is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The 30 mg tablet also contains ferric oxide. CLINICAL PHARMACOLOGY The mechanism of action of buspirone is unknown. Buspirone differs from typical benzodiazepine anxiolytics in that it does not exert anticonvulsant or muscle relaxant effects. It also lacks the prominen Read the complete document