Buspirone Hydrochloride (Page 6 of 7)

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, or 15 mg of buspirone hydrochloride, USP.

The 5 mg tablet is a white, oval, scored tablet 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:

NDC 60429-291-01
bottles of 100 tablets

NDC 60429-291-05
bottles of 500 tablets

The 10 mg tablet is a white, oval, scored tablet 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:

NDC 60429-292-01
bottles of 100 tablets

NDC 60429-292-05
bottles of 500 tablets

The 15 mg tablet is a white, capsule-shaped, flat-faced tablet scored so that it can be either bisected or trisected. It is debossed with M to the left of the score and B3 to the right of the score on one side of the tablet and 5 on each trisect section on the other side. They are available as follows:

NDC 60429-293-60
bottles of 60 tablets

NDC 60429-293-05
bottles of 500 tablets

Storage and Handling

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

PHARMACIST: Patient Instruction Sheet attached to prescribing information. Additional copies are provided separately.

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.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Marketed/ Packaged by:
GSMS, Inc.
Camarillo, CA 93012 USA

Revised: 12/2016
BUSPAS:R15ppt

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 15 mg 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)

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).

Breaking Multi-Scored Tablet

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Marketed/ Packaged by:
GSMS, Inc.
Camarillo, CA 93012 USA
Revised: 12/2016
PL:BUSPAS:R6p

PRINCIPAL DISPLAY PANEL — 5 mg

NDC 60429-291-01

busPIRone
Hydrochloride
Tablets, USP
5 mg

Rx only 100 Tablets

Each tablet contains: Buspirone
hydrochloride, USP 5 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Marketed/ Packaged by:
GSMS, Inc. Camarillo, CA 93012 USA

GSMS.us

RM1140A7

//medlibrary.org/lib/images-rx/buspirone-hydrochloride-62/60429-291-01lb-buspirone-hcl-5-mg-tabs-rev-sep-2011-10-30-2018-300x223.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg

NDC 60429-292-05

busPIRone
Hydrochloride
Tablets, USP
10 mg

Rx only 500 Tablets

Each tablet contains: Buspirone
hydrochloride, USP 10 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Marketed/ Packaged by:
GSMS, Inc. Camarillo, CA 93012 USA

GSMS.us

RM1150A7

//medlibrary.org/lib/images-rx/buspirone-hydrochloride-62/60429-292-05lb-buspirone-hcl-10mg-tabs-rev-dec-2016-10-30-2018-300x231.jpg
(click image for full-size original)

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