Buspirone Hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- BUSPIRONE HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- USE IN SPECIFIC POPULATIONS
- INDICATIONS & USAGE
- BUSPIRONE HYDROCHLORIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- BUSPIRONE HYDROCHLORIDE ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- REFERENCES
- INFORMATION FOR PATIENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BUSPIRONE HYDROCHLORIDE DESCRIPTION
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
GeneralInterference 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 AgentsWARNINGS
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
PRECAUTIONSCommonly 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 ClassPhysical and Psychological Dependence
OVERDOSAGE
Signs and SymptomsIn 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 HydrochlorideBuspirone Hydrochloride TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
