Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)
Heritage Pharmaceuticals Inc. d/b/a Avet 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 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 durat
Buspirone Hydrochloride Tablets USP, 5 mg are available as round, white to off white tablet, scored, debossed “HP ” above and “23 ” below the score on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 23155-023-01 Bottles of 500: NDC 23155-023-05 Bottles of 1000: NDC 23155-023-10 Buspirone Hydrochloride Tablets USP, 10 mg are available as round, white to off white tablet, scored, debossed “HP ” above and “24 ” below the score on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 23155-024-01 Bottles of 500: NDC 23155-024-05 Bottles of 1000: NDC 23155-024-10 Buspirone Hydrochloride Tablets USP, 15 mg are available as capsule shaped, white to off white tablet, Debossed “HP ” on one bisect and “25 ” on bisect segment and Debossed “5 ” on each trisect segment on the other side. They are available as follows: Bottles of 60: NDC 23155-025-06 Bottles of 100: NDC 23155-025-01 Bottles of 180: NDC 23155-025-08 Bottles of 500: NDC 23155-025-05 Buspirone Hydrochloride tablets USP, 30 mg are available as capsule shaped, peach color tablet, Debossed “HP ” on one bisect and “97 ” on other bisect segment and, Debossed “10 ” on each trisect segment on other side. They are available as follows: Bottles of 60: NDC 23155-097-06 Bottles of 100: NDC 23155-097-01 Bottles of 500: NDC 23155-097-05 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 HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC. ---------- BUSPIRONE HYDROCHLORIDE TABLETS, USP RX ONLY DESCRIPTION Buspirone hydrochloride 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 421.96. Chemically, buspirone hydrochloride is N-[4-[4-(2-Pyrimidinyl)-1- piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The empirical formula C H N O •HCl is represented by the following structural formula: 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 and 30 mg 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, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The 30 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake. CLINICAL PHARMACOLOGY The mechanism of action of buspirone is unknown. Buspirone differs from typical 21 31 5 2 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 anxio Læs hele dokumentet