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Buspirone Hydrochloride (Buspirone Hcl)

Trade Name : Buspirone HCl

Impax Generics

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 Hcl) which is also known as Buspirone HCl and Manufactured by Impax Generics. It is available in strength of 5 mg/1 per ml. Read more

Buspirone Hydrochloride (Buspirone Hcl) 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 anu00a0antianxiety 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 empirical formula CHNO u2022 HCl is represented by the following structural formula:
  • Each tablet for oral administration containing 5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 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 tablet is provided in a special tablet design. This tablet is scored so it 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). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, 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 is rapidly absorbed in man and undergoes 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 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 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.
  • Age and Gender Effects
  • After single or multiple doses in adults, no significant differences in buspirone pharmacokinetics (AUC and C were observed between elderly and younger subjects or between men and women.
  • Hepatic Impairment
  • After multiple-dose administration of buspirone to patients with hepatic impairment, steady-state AUC of buspirone increased 13-fold compared with healthy subjects (see ).
  • Renal Impairment
  • After multiple-dose administration of buspirone to renally impaired (Cl = 10-70 mL/min/1.73 m) patients, steady-state AUC of buspirone increased 4-fold compared with healthy (Cl u226580 mL/min/1.73 m) subjects (see u00a0).
  • Race Effects
  • The effects of race on the pharmacokinetics of buspirone have not been studied.
  • 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 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 Associationu2019s Diagnostic and Statistical Manual, lll 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 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 for 1 year without ill effect. Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient.
  • Buspirone tablets are contraindicated in patients hypersensitive to buspirone hydrochloride.
  • The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.
  • Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see WARNINGS, DOSAGE AND ADMINISTRATION AND DRUG INTERACTIONS)
  • The administration of buspirone to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard
  • Serotonin Syndrome
  • The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists.
  • Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for emergence of serotonin syndrome. u00a0
  • The concomitant use of buspirone with MAOIs intended to treat depression is contraindicated. Buspirone should also not be started in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. There have been no reports involving the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with a reversible MAOI such as linezolid or intravenous methylene blue in a patient taking buspirone. Buspirone should be discontinued before initiating treatment with the reversible MAOI [see CONTRAINDICATIONS, DOSAGE AND ADMINISTRATION AND DRUG INTERACTIONS].
  • If concomitant use of buspirone with a 5-hydroxytryptmine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
  • The concomitant use of buspirone with serotonin precursors (such as tryptophan) is not recommended.
  • Treatment with buspirone and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
  • Because buspirone has no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.
  • No data
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  • 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 ). 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 :u00a0 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. Conversely, at least 14 days should be allowed after stopping buspirone before starting an MAOI antidepressant CONTRAINDICATIONS and DRUG INTERACTIONS).
  • Use of Buspirone with (Reversible) MAOIs, Such as Linezolid or Methylene Blue
  • Do not start buspirone 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 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 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 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 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).
  • Buspirone HCl Tablets USP are supplied as follows:
  • 5 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 657, in bottles of 100 (NDC 0115-1690-01), 500 (NDC 0115-1690-02), and 1000 (NDC 0115-1690-03).
  • 10 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 658, in bottles of 100 (NDC 0115-1691-01), 500 (NDC 0115-1691-02), and 1000 (NDC 0115-1691-03).
  • 15 mg tablets: White to off-white, oval shaped, scored tablets, debossed with the Watson logo and 718, and scoring on both sides so it can be either bisected or trisected, in bottles of 60 (NDC 0115-1692-13), 180 (NDC 0115-1692-19), 500 (NDC 0115-1692-02).
  • Store at 20u00b0 - 25u00b0C (68u00b0- 77u00b0F). [See USP controlled room temperature]. Protect from temperatures greater than 30u00b0C (86u00b0F).
  • Dispense in a tight, light-resistant container as defined in USP/NF.
  • 1. American Psychiatric Association. Ed.: Diagnostic and Statistical Manual of Mental Disorders - lll, American Psychiatric Association, May 1980.
  • Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OHu00a045237 USA
  • Distributed by:Impax GenericsHayward, CA 94544
  • 7003300Revised: January 2017
  • LA-1849-02
  • BusPIRone HCl Tablets, USPn- Patient Instruction Sheetn- Rx only
  • HOW TO USE: n- Arrayn- BusPIRone HCl Tablets, USP
  • Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.
  • The 15 mg 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 the tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown in the photo. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).
  • Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USA
  • Distributed by:Impax GenericsHayward, CA 94544
  • 70033000
  • Revised: January 2017LA-1849-02
  • NDC n- 1690
  • BusPIRoneHydrochlorideTablets, USP
  • 5 mg
  • Rx only100 tablets
  • Impax Generics
  • NDCn- 1691
  • BusPIRoneHydrochlorideTablets, USP
  • 10 mg
  • Rx only100 Tablets
  • Impax Genericsu00a0
  • NDC n- 1692
  • BusPIRoneHydrochlorideTablets, USP
  • 15 mg
  • 60 TabletsRx only
  • Impax Generics

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