Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)
Preferred Pharmaceuticals, Inc.
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 available as white to off-white, round, beveled-edge tablets, debossed “TV” and “53” on one side and scored on the other side, packaged in bottles; Bottle of 30 – 68788-9845-3 Bottle of 60 – 68788-9845-6 Bottle of 90 – 68788-9845-9 Bottle of 100 – 68788-9845-1 BusPIRone Hydrochloride Tablets USP, 10 mg are available as white to off-white, round, beveled-edge tablets, debossed “TEVA” on one side and scored and debossed “54” on the other side; Bottle of 30 – 68788-9844-3 Bottle of 60 – 68788-9844-6 Bottle of 90 – 68788-9844-9 Bottle of 100 – 68788-9844-1 BusPIRone Hydrochloride Tablets USP, 15 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed “TV” and “1003” on bisect segments, and debossed “5” on each trisect segment, and packaged in bottles of; Bottle of 30 – 68788-5665-3 Bottle of 60 – 68788-5665-6 Bottle of 90 – 68788-5665-9 Bottle of 100 – 68788-5665-1 BusPIRone Hydrochloride Tablets USP, 30 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed “TV” and “5200” on bisect segments, and debossed “10” on each trisect segment, and packaged in bottles of 60 (NDC 0093-5200-06) and 500 (NDC 0093-5200-05) tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. 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.
Abbreviated New Drug Application
BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET PREFERRED PHARMACEUTICALS, INC. ---------- BUSPIRONE HYDROCHLORIDE TABLETS USP RX ONLY DESCRIPTION Buspirone hydrochloride tablets USP are 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. Chemically, buspirone hydrochloride is _N_-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride, which can be represented by the following structural formula: C H N O •HCl M.W. 421.96 Each tablet, for oral administration, contains 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 tablets are scored such that they may be bisected or trisected. Thus, a single 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). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 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 USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 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 prominent sedative effect that is associated with more typical anxiolytics. _In vitro_ preclinical studies have shown that buspirone ha Les hele dokumentet