Buspirone Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Buspirone Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BUSPIRONE HYDROCHLORIDE DESCRIPTION



Buspirone Hydrochloride




CLINICAL PHARMACOLOGY










USE IN SPECIFIC POPULATIONS

Age and Gender Effects


Hepatic Impairment


Renal Impairment


Race Effects


INDICATIONS & USAGE











BUSPIRONE HYDROCHLORIDE CONTRAINDICATIONS



WARNINGS

The administration of buspirone hydrochloride tablets to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard


PRECAUTIONS

General

Interference With Cognitive and Motor Performance



Potential for Withdrawal Reactions in Sedative/Hypnotic/Anxiolytic Drug-Dependent Patients



Possible Concerns Related to Buspirone's Binding to Dopamine Receptors


INFORMATION FOR PATIENTS









LABORATORY TESTS



DRUG INTERACTIONS

Psychotropic Agents

MAO inhibitors


Amitriptyline


Diazepam


Haloperidol


Nefazodone


Trazodone


Triazolam/flurazepam


Other psychotropics


Inhibitors and Inducers of Cytochrome P450 3A4 (CYP3A4)


Diltiazem and verapamil


Erythromycin


Grapefruit juice


Itraconazole
In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with itraconazole (200 mg/day for 4 days) increased plasma buspirone concentrations (13 fold increase in Cmax and 19 fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.

Nefazodone
In a study of steady-state pharmacokinetics in healthy volunteers, coadministration of buspirone (2.5 or 5 mg b.i.d.) with nefazodone (250 mg b.i.d.) resulted in marked increases in plasma buspirone concentrations (increases up to 20 fold in Cmax and up to 50 fold in AUC) and statistically significant decreases (about 50%) in plasma concentrations of the buspirone metabolite 1-PP. With 5 mg b.i.d. doses of buspirone, slight increases in AUC were observed for nefazodone (23%) and its metabolites hydroxynefazodone (HO-NEF) (17%) and meta-chlorophenylpiperazine (9%). Slight increases in Cmax were observed for nefazodone (8%) and its metabolite HO-NEF (11%). Subjects receiving buspirone 5 mg b.i.d. and nefazodone 250 mg b.i.d. experienced lightheadedness, asthenia, dizziness, and somnolence, adverse events also observed with either drug alone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.

Rifampin


Other inhibitors and inducers of CYP3A4
Substances that inhibit CYP3A4, such as ketoconazole or ritonavir, may inhibit buspirone metabolism and increase plasma concentrations of buspirone while substances that induce CYP3A4, such as dexamethasone or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine), may increase the rate of buspirone metabolism. If a patient has been titrated to a stable dosage on buspirone, a dose adjustment of buspirone may be necessary to avoid adverse events attributable to buspirone or diminished anxiolytic activity. Consequently, when administered with a potent inhibitor of CYP3A4, a low dose of buspirone used cautiously is recommended. When used in combination with a potent inducer of CYP3A4 the dosage of buspirone may need adjusting to maintain anxiolytic effect.

Other Drugs

Cimetidine
Coadministration of buspirone with cimetidine was found to increase Cmax (40%) and Tmax (2 fold), but had minimal effects on the AUC of buspirone.

Protein Binding
In vitro, buspirone does not displace tightly bound drugs like phenytoin, propranolol, and warfarin from serum proteins. However, there has been one report of prolonged prothrombin time when buspirone was added to the regimen of a patient treated with warfarin. The patient was also chronically receiving phenytoin, phenobarbital, digoxin, and levothyroxine sodium. In vitro, buspirone may displace less firmly bound drugs like digoxin. The clinical significance of this property is unknown.
Therapeutic levels of aspirin, desipramine, diazepam, flurazepam, ibuprofen, propranolol, thioridazine, and tolbutamide had only a limited effect on the extent of binding of buspirone to plasma proteins (see CLINICAL PHARMACOLOGY).

DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY




PREGNANCY

Teratogenic Effects

Pregnancy Category B


LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE




Use in Patients With Impaired Hepatic or Renal Function


BUSPIRONE HYDROCHLORIDE ADVERSE REACTIONS



Commonly Observed


Associated With Discontinuation of Treatment


Incidence in Controlled Clinical Trials


1
1
2

1

2


Other Events Observed During the Entire Premarketing Evaluation of Buspirone Hydrochloride Tablets



Cardiovascular

Central Nervous System

EENT

Endocrine

Gastrointestinal

Genitourinary

Musculoskeletal

Respiratory

Sexual Function

Skin

Clinical Laboratory

Miscellaneous


Postmarketing Experience


DRUG ABUSE AND DEPENDENCE

Controlled Substance Class


Physical and Psychological Dependence




OVERDOSAGE

Signs and Symptoms


Recommended Overdose Treatment


DOSAGE & ADMINISTRATION





HOW SUPPLIED






STORAGE AND HANDLING





REFERENCES



INFORMATION FOR PATIENTS










PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Buspirone Hydrochloride

Buspirone Hydrochloride

Buspirone Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-728(NDC:0093-1003)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE BUSPIRONE 15 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
SILICON DIOXIDE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
white 15 mm TV;1003;5;5;5 RECTANGLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-728-28 300 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075022 2011-08-23


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