Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)
Aphena Pharma Solutions - Tennessee, LLC
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 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 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 duration), manifested by symptom
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Buspirone Hydrochloride Tablets, USP are available containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg tablet is a white, oval tablet debossed with M to the left of the score and B1 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1140-01 bottles of 100 tablets NDC 0378-1140-05 bottles of 500 tablets The 7.5 mg tablet is a white to off-white, oval tablet debossed with M to the left of the score and B7 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1145-01 bottles of 100 tablets NDC 0378-1145-05 bottles of 500 tablets The 10 mg tablet is a white, oval tablet debossed with M to the left of the score and B2 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1150-01 bottles of 100 tablets NDC 0378-1150-05 bottles of 500 tablets The 15 mg tablet is a white, capsule-shaped, flat-faced tablet scored so that it can be either bisected or trisected. It is debossed with M to the left of the score and B3 to the right of the score on one side of the tablet and 5 on each trisect section on the other side. They are available as follows: NDC 0378-1165-91 bottles of 60 tablets NDC 0378-1165-80 bottles of 180 tablets NDC 0378-1165-05 bottles of 500 tablets The 30 mg tablet is a white, capsule-shaped tablet debossed with M to the left of the score and B4 to the right of the score on one side of the tablet and 10 on each trisect section on the other side. They are available as follows: NDC 0378-1175-91 bottles of 60 tablets NDC 0378-1175-01 bottles of 100 tablets NDC 0378-1175-80 bottles of 180 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 using a child-resistant closure. PHARMACIST: Patient Instruction Sheet attached to prescribing information. Additional copies are provided separately.
Abbreviated New Drug Application
BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- (Patient Instruction Sheet Attached. Additional copies are provided separately.) 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 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8- azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C H N O •HCl is represented by the following structural formula: Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 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: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, 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 Olvassa el a teljes dokumentumot