Principal Display Panel

BusPIRone
** Hydrochloride**
** Tablets, USP**

15 mg

PHARMACIST: DISPENSE WITH PATIENT
INFORMATION SHEET

Rx only

Print Patient Information Sheet at:
https://www.oxford-rx.com/med-guides

DESCRIPTION

Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs.

Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 50 2• HCl is represented by the following structural formula:

Buspirone hydrochloride, USP is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5-mg and 10-mg tablets are scored so they can be bisected. Thus, the 5-mg tablet can also provide a 2.5-mg dose, and the 10-mg tablet can provide a 5-mg dose. The 15-mg and 30-mg tablets are provided in the adjustable dosage tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15-mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30-mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride, USP tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A).

HOW SUPPLIED:

Buspirone Hydrochloride Tablets, USP 15 mgare 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 60’s (NDC 72789-332-60).

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.

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).