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

Rx only box

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:

30 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)

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 TabletRx 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

bag label
(click image for full-size original)

Package/Label Display Panel

Busiprone Hydrochloride Tablets, USP

10 mg

10 Tablets

bag label
(click image for full-size original)
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5494(NDC:51079-985)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code M;B1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5494-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the BAG (55154-5494-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075272 03/31/2010 01/31/2030
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5397(NDC:51079-986)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code M;B2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5397-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the BAG (55154-5397-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075272 03/31/2010 01/31/2030
Labeler — Cardinal Health 107, LLC (118546603)

Revised: 12/2022 Cardinal Health 107, LLC

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