BUSPIRONE HYDROCHLORIDE (Page 5 of 5)
Postmarketing Experience
Postmarketing experience has shown an adverse experience profile similar to that given above. Voluntary reports since introduction have included rare occurrences of allergic reactions (including urticaria), angioedema, cogwheel rigidity, dizziness (rarely reported as vertigo), dystonic reactions (including dystonia), ataxias, extrapyramidal symptoms, dyskinesias (acute and tardive), ecchymosis, emotional lability, serotonin syndrome, transient difficulty with recall, urinary retention, visual changes (including tunnel vision), parkinsonism, akathisia, restless leg syndrome, and restlessness. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to buspirone hydrochloride treatment has not been determined.
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
Buspirone hydrochloride is not a controlled substance.
Physical and Psychological Dependence
In human and animal studies, buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. Human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. None of the subjects were able to distinguish between buspirone hydrochloride and placebo. By contrast, subjects showed a statistically significant preference for methaqualone and diazepam. Studies in monkeys, mice, and rats have indicated that buspirone lacks potential for abuse.
Following chronic administration in the rat, abrupt withdrawal of buspirone did not result in the loss of body weight commonly observed with substances that cause physical dependency.
Although there is no direct evidence that buspirone hydrochloride causes physical dependence or drug-seeking behavior, it is difficult to predict from experiments the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of buspirone hydrochloride misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).
OVERDOSAGE
Signs and Symptoms
In clinical pharmacology trials, doses as high as 375 mg/day were administered to healthy male volunteers. As this dose was approached, the following symptoms were observed: nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. A few cases of overdosage have been reported, with complete recovery as the usual outcome. No deaths have been reported following overdosage with buspirone hydrochloride alone. Rare cases of intentional overdosage with a fatal outcome were invariably associated with ingestion of multiple drugs and/or alcohol, and a causal relationship to buspirone could not be determined. Toxicology studies of buspirone yielded the following LD50 values: mice, 655 mg/kg; rats, 196 mg/kg; dogs, 586 mg/kg; and monkeys, 356 mg/kg. These dosages are 160 to 550 times the recommended human daily dose.
Recommended Overdose Treatment
General symptomatic and supportive measures should be used along with immediate gastric lavage. Respiration, pulse, and blood pressure should be monitored as in all cases of drug overdosage. No specific antidote is known to buspirone, and dialyzability of buspirone has not been determined.
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. Conversely, at least 14 days should be allowed after stopping buspirone hydrochloride before starting an MAOI antidepressant (see CONTRAINDICATIONS and DRUG INTERACTIONS).
Use of buspirone hydrochloride with (Reversible) MAOIs, Such as Linezolid or Methylene Blue
Do not start buspirone hydrochloride 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 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 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 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 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).
HOW SUPPLIED
Buspirone Hydrochloride Tablets USP, 10 mg are white, ovoid rectangular shaped, beveled edged, uncoated tablets debossed “B” and “10”’
separated by score line on one side and plain on other side.
NDC: 71335-2081-1: 30 Tablets in a BOTTLE
NDC: 71335-2081-2: 60 Tablets in a BOTTLE
NDC: 71335-2081-3: 90 Tablets in a BOTTLE
NDC: 71335-2081-4: 45 Tablets in a BOTTLE
NDC: 71335-2081-5: 180 Tablets in a BOTTLE
NDC: 71335-2081-6: 120 Tablets in a BOTTLE
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F). Dispense in a
tight, light-resistant container (USP).
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
REFERENCE
1. American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental Disorders—III, American Psychiatric Association, May 1980.
The brands listed are the trademarks of their respective owners and are not trademarks of the Aurobindo Pharma Limited.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Revised: 12/2019
Buspirone Hydrochloride Tablets, USP
Patient Instruction Sheet
Rx only
HOW TO USE:
Buspirone Hydrochloride Tablets, USP
15 mg and 30 mg
in convenient multi-scored tablet form
Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.
This multi-scored tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India Revised: 12/2019
Buspirone Hcl 10mg Tablet
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| Labeler — Bryant Ranch Prepack (171714327) |
| Registrant — Bryant Ranch Prepack (171714327) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bryant Ranch Prepack | 171714327 | REPACK (71335-2081), RELABEL (71335-2081) | |
Revised: 11/2023 Bryant Ranch Prepack
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