Buspirone Hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- BUSPIRONE HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- 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
- REFERENCES
- SPL PATIENT PACKAGE INSERT
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BUSPIRONE HYDROCHLORIDE DESCRIPTION
CLINICAL PHARMACOLOGY
Special Populations
Age and Gender Effects
Hepatic Impairment
Renal Impairment
Race Effects
INDICATIONS & USAGE
BUSPIRONE HYDROCHLORIDE CONTRAINDICATIONS
WARNINGS
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 Receptors
INFORMATION FOR PATIENTS
LABORATORY TESTS
DRUG INTERACTIONS
Psychotropic AgentsMAO 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
Nefazodone
Rifampin
Other inhibitors and inducers of CYP3A4
Other Drugs
Cimetidine
Protein Binding
DRUG & OR LABORATORY TEST INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
Teratogenic EffectsPregnancy 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
Postmarketing Experience
DRUG ABUSE AND DEPENDENCE
Controlled Substance ClassPhysical and Psychological Dependence
OVERDOSAGE
Signs and SymptomsRecommended Overdose Treatment
DOSAGE & ADMINISTRATION
HOW SUPPLIED
REFERENCES
SPL PATIENT PACKAGE INSERT
PATIENT INFORMATION
INACTIVE INGREDIENT
SILICON DIOXIDEANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Buspirone HydrochlorideBuspirone Hydrochloride TABLET
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
