Buspirone Hydrochloride (Page 6 of 6)
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 (see 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).
HOW SUPPLIED:
Buspirone Hydrochloride Tablets, USP are available containing 5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP.
The 5 mg tablets are white, oval, scored tablets 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:
Overbagged with 10 tablets per bag, NDC 55154-5494-0
The 10 mg tablets are white, oval, scored tablets 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:
Overbagged with 10 tablets per bag, NDC 55154-5397-0
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.
PHARMACIST: Patient Instruction Sheet attached to prescribing information.
REFERENCE
- 1.
- American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental Disorders — III, American Psychiatric Association, May 1980.
The brands listed are trademarks of their respective owners.
Manufacture by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.
Distributed By:
Cardinal Health
Dublin, OH 43017
L34321920222
L48851820222
S-12674
4/21
Buspirone Hydrochloride Tablets, USP Patient Instruction Sheet
HOW TO USE:
Buspirone Hydrochloride
Tablets, USP
15 mg and 30 mg Tablets
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.
If your doctor prescribed the 30 mg tablet:
If your doctor prescribed the 15 mg tablet:
To break a multi-scored 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).
Rx only box30 mg (the entire tablet)20 mg (two-thirds of a tablet)10 mg (one-third of a tablet)15 mg (one-half of a tablet)15 mg (the entire tablet)10 mg (two-thirds of a tablet)5 mg (one-third of a tablet)7.5 mg (one-half of a tablet)Breaking Multi-Scored Tablet
Package/Label Display Panel
Busiprone Hydrochloride Tablets, USP
5 mg
10 Tablets
Package/Label Display Panel
Busiprone Hydrochloride Tablets, USP
10 mg
10 Tablets
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| BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet | ||||||||||||||||||
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| Labeler — Cardinal Health 107, LLC (118546603) |
Revised: 12/2022 Cardinal Health 107, LLC
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