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




DOSAGE AND ADMINISTRATION


PRECAUTIONS, Drug Interactions
In a single-dose study using 14C-labeled buspirone, 29% to 63% of the dose was excreted in the urine within 24 hours, primarily as metabolites; fecal excretion accounted for 18% to 38% of the dose. The average elimination half-life of unchanged buspirone after single doses of 10 to 40 mg is about 2 to 3 hours.

USE IN SPECIFIC POPULATIONS




PRECAUTIONS

PRECAUTIONS



INDICATIONS & USAGE











BUSPIRONE HYDROCHLORIDE CONTRAINDICATIONS



WARNINGS

The administration of buspirone 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 ReceptorsADVERSE REACTIONS: Postmarketing Experience

INFORMATION FOR PATIENTS









LABORATORY TESTS



DRUG INTERACTIONS

Psychotropic Agents
WARNINGS



Inhibitors and Inducers of Cytochrome P450 3A4 (CYP3A4).




Inhibitors and Inducers of Cytochrome P450 3A4 (CYP3A4)








Other Drugs


Protein Binding

CLINICAL PHARMACOLOGY

DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY




PREGNANCY



LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE


CLINICAL PHARMACOLOGY, Special Populations

Use in Patients With Impaired Hepatic or Renal Function
CLINICAL PHARMACOLOGY

BUSPIRONE HYDROCHLORIDE ADVERSE REACTIONS

PRECAUTIONS

Commonly Observed


Associated With Discontinuation of Treatment


Incidence in Controlled Clinical Trials



Other Events Observed During the Entire Premarketing Evaluation of Buspirone

PRECAUTIONS















Postmarketing Experience


DRUG ABUSE AND DEPENDENCE

Controlled Substance Class


Physical and Psychological Dependence




OVERDOSAGE

Signs and Symptoms
In clinical pharmacology trials, doses as high as 375mg/day were administered to healthy male volunteers. As this dose was approached, the following symptoms were observed: nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. A few cases of overdosage have been reported, with complete recovery as teh usual outcome. No deaths have been reported following overdosage with buspirone alone. Rare cases of intentional overdosage with a fatal outcome were invariably associated with ingestion of multiple drugs and/or alcohol, and a casual relationship of buspirone could not be determined. Toxicology studies of buspirone yielded the following LD50 values: mice, 655 mg/kg; rats, 196 mg/kg; dogs, 586 mg/kg; and monkeys, 356 mg/kg. These dosages are 160 to 550 times the recommended human daily dose.


Recommended Overdose Treatment


DOSAGE & ADMINISTRATION


CLINICAL PHARMACOLOGY
When buspirone is to be given with a potent inhibitor of CYP3A4 the dosage recommendations described in thePRECAUTIONS, Drug Interactionssection should be followed.

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:49349-788(NDC:0591-0718)
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
SILICON DIOXIDE
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
white 13 mm 718 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-788-29 360 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074253 2011-10-13


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