Drug Catalog - Product Detail
Buspirone HCl Tab 30 MG 500 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 29300-0247-05 | UNICHEM PHARMACEUTICALS | 500 | 30MG | TABLET |
PACKAGE FILES
Generic Name
BUSPIRONE HYDROCHLORIDE
Substance Name
BUSPIRONE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA210907
Description
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 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 21 H 31 N 5 O 2 •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 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. Image
How Supplied
HOW SUPPLIED Buspirone Hydrochloride Tablets, USP, are supplied as follows: Buspirone Hydrochloride Tablets, USP 5 mg: White to off white, round flat faced beveled edge tablet, debossed with "244" on one side and "U" on either side of the break line. Bottle of 30: NDC 76420-807-30 (repackaged from NDC 29300-244-XX) Bottle of 60: NDC 76420-807-60 (repackaged from NDC 29300-244-XX) Bottle of 90: NDC 76420-807-90 (repackaged from NDC 29300-244-XX) Bottle of 100: NDC 76420-807-01 (relabeled from NDC 29300-244-01) Bottle of 500: NDC 76420-807-05 (relabeled from NDC 29300-244-05) Buspirone Hydrochloride Tablets, USP 10 mg: White to off white, round flat faced beveled edge tablet, debossed with "245" on one side and "U" on either side of the break line. Bottle of 30: NDC 76420-808-30 (repackaged from NDC 29300-245-XX) Bottle of 60: NDC 76420-808-60 (repackaged from NDC 29300-245-XX) Bottle of 90: NDC 76420-808-90 (repackaged from NDC 29300-245-XX) Bottle of 100: NDC 76420-808-01 (relabeled from NDC 29300-245-01) Bottle of 500: NDC 76420-808-05 (relabeled from NDC 29300-245-05) Buspirone Hydrochloride Tablets, USP 15 mg: White to off white, rectangular flat faced beveled edge tablet that can either be bisected or trisected, debossed with "U" and "246" on one side of the trisect segments and plain on other side of the trisect segment. Bottle of 30: NDC 76420-809-30 (repackaged from NDC 29300-246-XX) Bottle of 60: NDC 76420-809-60 (relabeled from NDC 29300-246-16) Bottle of 90: NDC 76420-809-90 (repackaged from NDC 29300-246-XX) Bottle of 100: NDC 76420-809-01 (relabeled from NDC 29300-246-01) Bottle of 180: NDC 76420-809-18 (relabeled from NDC 29300-246-18) Bottle of 500: NDC 76420-809-05 (relabeled from NDC 29300-246-05) Bottle of 30: NDC 76420-724-30 (repackaged from NDC 29300-477-XX) Bottle of 60: NDC 76420-724-60 (relabeled from NDC 29300-477-16) Bottle of 90: NDC 76420-724-90 (repackaged from NDC 29300-477-XX) Bottle of 100: NDC 76420-724-01 (relabeled from NDC 29300-477-01) Bottle of 180: NDC 76420-724-18 (relabeled from NDC 29300-477-18) Bottle of 500: NDC 76420-724-05 (relabeled from NDC 29300-477-05) Buspirone Hydrochloride Tablets, USP 30 mg: White to off white, rectangular flat faced beveled edge tablet that can either be bisected or trisected, debossed with "U" and "247" on one side of the trisect segments and plain on other side of the trisect segment. Bottle of 30: NDC 76420-811-30 (repackaged from NDC 29300-247-XX) Bottle of 60: NDC 76420-811-60 (relabeled from NDC 29300-247-16) Bottle of 90: NDC 76420-811-90 (repackaged from NDC 29300-247-XX) Bottle of 100: NDC 76420-811-01 (relabeled from NDC 29300-247-01) Bottle of 500: NDC 76420-811-05 (relabeled from NDC 29300-247-05) Bottle of 30: NDC 76420-725-30 (repackaged from NDC 29300-478-XX) Bottle of 60: NDC 76420-725-60 (relabeled from NDC 29300-478-16) Bottle of 90: NDC 76420-725-90 (repackaged from NDC 29300-478-XX) Bottle of 100: NDC 76420-725-01 (relabeled from NDC 29300-478-01) Bottle of 500: NDC 76420-725-05 (relabeled from NDC 29300-478-05) Store at 20 0 to 25 0 C (68 0 to 77 0 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 drugs out of reach of children. Additional patient information leaflets can be obtained by calling Unichem at 1-866-562-4616.
Indications & Usage
INDICATIONS AND USAGE Buspirone hydrochloride tablets, USP 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, USP 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, USP 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: Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 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, USP 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, USP for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets, USP for extended periods should periodically reassess the usefulness of the drug for the individual patient.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 mg to 30 mg per day were commonly employed. The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY ). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food. When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS, Drug Interactions section should be followed. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with buspirone hydrochloride tablets. Conversely, at least 14 days should be allowed after stopping buspirone hydrochloride tablets before starting an MAOI antidepressant CONTRAINDICATIONS and DRUG INTERACTIONS ). Use of buspirone hydrochloride tablets with (Reversible) MAOIs, Such as Linezolid or Methylene Blue Do not start buspirone hydrochloride tablets in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered (see CONTRAINDICATIONS and DRUG INTERACTIONS ). In some cases, a patient already receiving therapy with buspirone hydrochloride tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, buspirone hydrochloride tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with buspirone hydrochloride tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS ). The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg per kg with buspirone hydrochloride tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see CONTRAINDICATIONS , WARNINGS and DRUG INTERACTIONS ).