Buspirone Hydrochloride (Buspirone Hydrochloride)

Trade Name : Buspirone Hydrochloride

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 5 mg/1

BUSPIRONE HYDROCHLORIDE

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Buspirone Hydrochloride (Buspirone Hydrochloride) which is also known as Buspirone Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 5 mg/1 per ml. Read more

Buspirone Hydrochloride (Buspirone Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 -[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride, which can be represented by the following structural formula:
  • CHNOu2022HCl 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.
  • 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. preclinical studies have shown that buspirone has a high affinity for serotonin (5-HT) receptors. Buspirone has no significant affinity for benzodiazepine receptors and does not affect GABA binding or when tested in preclinical models.
  • Buspirone has moderate affinity for brain D-dopamine receptors. Some studies do suggest that buspirone may have indirect effects on other neurotransmitter systems.
  • Buspirone hydrochloride tablets are rapidly absorbed in man and undergo extensive first-pass metabolism. In a radiolabeled study, unchanged buspirone in the plasma accounted for only about 1% of the radioactivity in the plasma. Following oral administration, plasma concentrations of unchanged buspirone are very low and variable between subjects. Peak plasma levels of 1 ng/mL to 6 ng/mL have been observed 40 to 90 minutes after single oral doses of 20 mg. The single-dose bioavailability of unchanged buspirone when taken as a tablet is on the average about 90% of an equivalent dose of solution, but there is large variability.
  • The effects of food upon the bioavailability of buspirone hydrochloride tablets have been studied in eight subjects. They were given a 20 mg dose with and without food; the area under the plasma concentration-time curve (AUC) and peak plasma concentration (C) of unchanged buspirone increased by 84% and 116%, respectively, but the total amount of buspirone immunoreactive material did not change. This suggests that food may decrease the extent of presystemic clearance of buspirone (see ).
  • A multiple-dose study conducted in 15 subjects suggests that buspirone has nonlinear pharmacokinetics. Thus, dose increases and repeated dosing may lead to somewhat higher blood levels of unchanged buspirone than would be predicted from results of single-dose studies.
  • An protein binding study indicated that approximately 86% of buspirone is bound to plasma proteins. It was also observed that aspirin increased the plasma levels of free buspirone by 23%, while flurazepam decreased the plasma levels of free buspirone by 20%. However, it is not known whether these drugs cause similar effects on plasma levels of free buspirone , or whether such changes, if they do occur, cause clinically significant differences in treatment outcome. An study indicated that buspirone did not displace highly protein-bound drugs such as phenytoin, warfarin, and propranolol from plasma protein, and that buspirone may displace digoxin.
  • Buspirone is metabolized primarily by oxidation, which has been shown to be mediated by cytochrome P450 3A4 (CYP3A4) (see ). Several hydroxylated derivatives and a pharmacologically active metabolite, 1-pyrimidinylpiperazine (1-PP), are produced. In animal models predictive of anxiolytic potential, 1-PP has about one quarter of the activity of buspirone, but is present in up to 20 fold greater amounts. However, this is probably not important in humans: blood samples from humans chronically exposed to buspirone hydrochloride tablets do not exhibit high levels of 1-PP; mean values are approximately 3 ng/mL and the highest human blood level recorded among 108 chronically dosed patients was 17 ng/mL, less than 1/200th of 1-PP levels found in animals given large doses of buspirone without signs of toxicity.
  • In a single-dose study using C-labeled buspirone, 29% to 63% of the dose was excreted in the urine within 24 hours, primarily as metabolites; fecal excretion accounted for 18% to 38% of the dose. The average elimination half-life of unchanged buspirone after single doses of 10 to 40 mg is about 2 to 3 hours.
  • 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 Associationu2019s Diagnostic and Statistical Manual, III as follows:
  • Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
  • 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 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 for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
  • Buspirone hydrochloride tablets are contraindicated in patients hypersensitive to buspirone hydrochloride.
  • The administration of buspirone hydrochloride tablets to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard.
  • Because buspirone hydrochloride tablets has no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.
  • No data
  • (See also .)
  • No data
  • No data
  • 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 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 ). 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 section should be followed.
  • BusPIRone Hydrochloride Tablets USP, 5 mg are available as white to off-white, round, beveled-edge tablets, debossed u201cTVu201d and u201c53u201d on one side and scored on the other side, packaged in bottles of 100 and 500 tablets.
  • BusPIRone Hydrochloride Tablets USP, 10 mg are available as white to off-white, round, beveled-edge tablets, debossed u201cTEVAu201d on one side and scored and debossed u201c54u201d on the other side, packaged in bottles of 100 and 500 tablets.
  • BusPIRone Hydrochloride Tablets USP, 15 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed u201cTVu201d and u201c1003u201d on bisect segments, and debossed u201c5u201d on each trisect segment, and packaged in bottles of 100 and 500 tablets.
  • BusPIRone Hydrochloride tablets USP, 30 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed u201cTVu201d and u201c5200u201d on bisect segments, and debossed u201c10u201d on each trisect segment, and packaged in bottles of 60 and 500 tablets.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [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.
  • Manufactured In Croatia By:
  • PLIVA HRVATSKA d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. Y 2/2016
  • BUSPIRONE HYDROCHLORIDE TABLETS USP
  • Rx only
  • HOW TO USE:
  • BUSPIRONE HYDROCHLORIDE TABLETS, 15 mg
  • Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.
  • This tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages:
  • If your doctor prescribed the 15 mg tablet:
  • To break a tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown below. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).
  • Manufactured In Croatia By:
  • PLIVA HRVATSKA d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. G 2/2016
  • PATIENT INFORMATION
  • BUSPIRONE HYDROCHLORIDE TABLETS USP
  • Rx only
  • HOW TO USE:
  • BUSPIRONE HYDROCHLORIDE TABLETS, 30 mg
  • Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.
  • This tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages:
  • If your doctor prescribed the 30 mg tablet:
  • To break a tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown below. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).
  • Manufactured In Croatia By:
  • PLIVA HRVATSKA d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. G 2/2016
  • No data
  • No data
  • No data
  • No data

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