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, USP. Conversely, at least 14 days should be allowed after stopping buspirone hydrochloride tablets, USP before starting an MAOI antidepressant (see CONTRAINDICATIONS and DRUG INTERACTIONS).

Use of buspirone hydrochloride tablets, USP with (Reversible) MAOIs, Such as Linezolid or Methylene Blue

Do not start buspirone hydrochloride tablets, USP 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, USP 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, USP 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, USP 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, USP 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 5 mg are white to off-white, round, flat-faced, beveled edge bisected tablets debossed “091” above the bisect on one side and “O” logo on the other side. Supplied in bottles of 100’s (NDC 72789-139-01) .
Buspirone Hydrochloride Tablets, USP 10 mg are white to off-white, round, flat-faced, beveled edge bisected tablets debossed “092” above the bisect on one side and “O” logo on the other side. Supplied in bottles of 100’s (NDC 72789-140-01).

Buspirone Hydrochloride Tablets, USP 15 mg are white rectangle, flat faced, beveled edge tablets double-scored and debossed with “0|9|3” on one side and double-scored and debossed “|O|” logo on the other side. Supplied in bottles of 100’s (NDC 72789-141-01).

Buspirone Hydrochloride Tablets, USP 30 mg are white to off-white, capsule shape, flat face, beveled edge tablets, scored and debossed “094 O” on one side and double-scored and debossed “10 10 10” on the other side. Supplied in bottles of 60’s (NDC 72789-142-60), .

Dispense 15 mg and 30 mg with Patient Information Sheet available at: https://www.oxford-rx.com/med-guides

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].

Dispense in a tight, light-resistant container (USP).

REFERENCE

  1. American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental Disorders—III, American Psychiatric Association, May 1980.

Synthroid® is the registered trademark of Abbott Laboratories.

Manufactured by:
Oxford Pharmaceuticals LLC
301 Leaf Lake Parkway
Birmingham, AL 35211 USA

8200017
02/22
R03

Patient Information Sheet
BUSPIRONE HYDROCHLORIDE, USP
Rx Only
Dispense with Patient Information Sheet available at:
https://www.oxford-rx.com/med-guides
HOW TO USE:
Buspirone Hydrochloride Tablets, USP
15 mg and 30 mg Tablets in convenient adjustable dosage tablet form

Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.

This adjustable dosage 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:
30 mg (the entire tablet)30 mg (the entire tablet) 15 mg (the entire tablet)15 mg (the entire tablet)
20 mg (two thirds of a tablet)20 mg (two thirds of a tablet) 10 mg ( two thirds of a tablet)10 mg (two thirds of a tablet)
10 mg (one third of a tablet)10 mg (one third of a tablet) 5 mg (one third of a tablet)5 mg (one third of a tablet)
15 mg entire tablet15 mg (one half of a tablet) 7.5 xxx7.5 mg (one half of a tablet)

To break a adjustable dosage 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).

break in half30 mg (the entire tablet)15 mg (the entire tablet)20 mg (two thirds of a tablet)10 mg ( two thirds of a tablet)10 mg (one third of a tablet)5 mg (one third of a tablet)15 mg entire tablet7.5 xxxbreak in half

Manufactured by: Oxford Pharmaceuticals LLC
301 Leaf Lake Parkway, Birmingham, AL 35211 USA
8200016
02/22
R02

Principal Display Panel


BusPIRone
Hydrochloride
Tablets, USP
5 mg
Rx only

72789139 Label
(click image for full-size original)


BusPIRone
Hydrochloride
Tablets, USP
10 mg
Rx only

image
(click image for full-size original)


BusPIRone
Hydrochloride
Tablets, USP 15 mg

image
(click image for full-size original)


BusPIRone
Hydrochloride
Tablets, USP 30 mg

image
(click image for full-size original)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-139(NDC:69584-091)
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
SILICON DIOXIDE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (off white) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 091;O
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-139-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075388 07/27/2020
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-140(NDC:69584-092)
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
SILICON DIOXIDE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (off white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 092;O
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-140-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075388 07/27/2020
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-141(NDC:69584-093)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (off white) Score 3 pieces
Shape RECTANGLE Size 15mm
Flavor Imprint Code 093;O
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-141-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075388 07/27/2020
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-142(NDC:69584-094)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (off white) Score 3 pieces
Shape CAPSULE Size 18mm
Flavor Imprint Code 094O;101010
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-142-60 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078302 05/01/2020
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-139), repack (72789-140), repack (72789-141), repack (72789-142)

Revised: 12/2023 PD-Rx Pharmaceuticals, Inc.

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