Buspirone

Buspirone
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Overview

Buspirone is {{{aOrAn}}} Antianxiety that is FDA approved for the {{{indicationType}}} of anxiety disorders or the short-term relief of the symptoms of anxiety. Common adverse reactions include Nausea, Dizziness, Headache, Somnolence, Feeling nervous.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Anxiety Disorders

• Dosing information

• Recommended initial dose: 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed.
• The bioavailability of buspirone is increased when given with food as compared to the fasted state . Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.
• When buspirone is to be given with a potent inhibitor of CYP3A4 the dosage recommendations described in the PRECAUTIONS, Drug Interactions section should be followed.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Buspirone in adult patients.

Non–Guideline-Supported Use

Depression

• Dosing information

• 5 mg administered 3 times daily for 4 weeks

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Buspirone FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Buspirone in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Buspirone in pediatric patients.

Contraindications

Buspirone Hydrochloride Tablets, USP are contraindicated in patients hypersensitive to buspirone hydrochloride.

Warnings

The administration of buspirone to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride has been added to a regimen including an MAOI. Therefore, it is recommended that buspirone not be used concomitantly with an MAOI. Because buspirone has no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.

===PRECAUTIONS General Interference With Cognitive and Motor Performance Studies indicate that buspirone is less sedating than other anxiolytics and that it does not produce significant functional impairment. However, its CNS effects in any individual patient may not be predictable. Therefore, patients should be cautioned about operating an automobile or using complex machinery until they are reasonably certain that buspirone treatment does not affect them adversely. While formal studies of the interaction of buspirone hydrochloride with alcohol indicate that buspirone does not increase alcohol-induced impairment in motor and mental performance, it is prudent to avoid concomitant use of alcohol and buspirone. Potential for Withdrawal Reactions in Sedative/Hypnotic/Anxiolytic Drug-Dependent Patients Because buspirone does not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic drugs, it will not block the withdrawal syndrome often seen with cessation of therapy with these drugs. Therefore, before starting therapy with buspirone, it is advisable to withdraw patients gradually, especially patients who have been using a CNS-depressant drug chronically, from their prior treatment. Rebound or withdrawal symptoms may occur over varying time periods, depending in part on the type of drug, and its effective half-life of elimination. The syndrome of withdrawal from sedative/hypnotic/anxiolytic drugs can appear as any combination of irritability, anxiety, agitation, insomnia, tremor, abdominal cramps, muscle cramps, vomiting, sweating, flu-like symptoms without fever, and occasionally, even as seizures. Possible Concerns Related to Buspirone’s Binding to Dopamine Receptors Because buspirone can bind to central dopamine receptors, a question has been raised about its potential to cause acute and chronic changes in dopamine-mediated neurological function (e.g., dystonia, pseudo-parkinsonism, akathisia, and tardive dyskinesia). Clinical experience in controlled trials has failed to identify any significant neuroleptic-like activity; however, a syndrome of restlessness, appearing shortly after initiation of treatment, has been reported in some small fraction of buspirone-treated patients. The syndrome may be explained in several ways. For example, buspirone may increase central noradrenergic activity; alternatively, the effect may be attributable to dopaminergic effects (i.e., represent akathisia). See ADVERSE REACTIONS, Postmarketing Experience.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Buspirone Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Buspirone Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Buspirone Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Buspirone in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Buspirone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Buspirone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Buspirone in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Buspirone in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Buspirone in geriatric settings.

Gender

There is no FDA guidance on the use of Buspirone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Buspirone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Buspirone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Buspirone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Buspirone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Buspirone in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Buspirone Administration in the drug label.

Monitoring

There is limited information regarding Buspirone Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Buspirone and IV administrations.

Overdosage

There is limited information regarding Buspirone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Buspirone Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Buspirone Mechanism of Action in the drug label.

Structure

There is limited information regarding Buspirone Structure in the drug label.

Pharmacodynamics

There is limited information regarding Buspirone Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Buspirone Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Buspirone Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Buspirone Clinical Studies in the drug label.

How Supplied

There is limited information regarding Buspirone How Supplied in the drug label.

Storage

There is limited information regarding Buspirone Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Buspirone Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Buspirone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Buspirone Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Buspirone Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.