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BuSpar is used for:

The short-term relief of anxiety symptoms. It may also be used for other conditions as determined by your doctor.

BuSpar is an antianxiety agent. It is not known exactly how BuSpar works to relieve anxiety. It is believed that it may react with specific chemical receptors in the brain.

Do NOT use BuSpar if:

* you are allergic to any ingredient in BuSpar
* you are taking furazolidone, sodium oxybate (GHB), or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or if you have taken an MAOI within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using BuSpar :

Some medical conditions may interact with BuSpar . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

* if you are pregnant, planning to become pregnant, or are breast-feeding
* if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
* if you have allergies to medicines, foods, or other substances
* if you have a history of alcoholism or substance abuse, or have severe liver or kidney problems

Some MEDICINES MAY INTERACT with BuSpar . Tell your health care provider if you are taking any other medicines, especially any of the following:

* Rifampin because it may decrease BuSpar ’s effectiveness
* Clozapine, diltiazem, HIV protease inhibitors (eg, ritonavir), imidazoles (eg, ketoconazole), macrolides and ketolides (eg, erythromycin, azithromycin), trazodone, or verapamil because they may increase the risk of this medicine’s side effects, such as dizziness, drowsiness, or fatigue
* Clozapine,MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (eg, fluoxetine), orsodium oxybate (GHB) because the risk of their side effects may be increased by BuSpar
* Furazolidone because it can cause serious, sometimes fatal, high blood pressure

This may not be a complete list of all interactions that may occur. Ask your health care provider if BuSpar may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use BuSpar :

Use BuSpar as directed by your doctor. Check the label on the medicine for exact dosing instructions.

* Take BuSpar by mouth. Take it consistently, either always with food or always without food.
* Do not eat grapefruit or drink grapefruit juice while you use BuSpar .
* BuSpar is designed to be taken every day to prevent anxiety symptoms. It does not work if it is only taken as needed or only when anxiety symptoms are present.
* Continue to take BuSpar even if you feel well. Do not miss any doses.
* If you miss a dose of BuSpar , take it as soon as possible. If it is almost time for your next dose skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use BuSpar .
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BUSPIRONE (Systemic)

Some commonly used brand names are:

In the U.S.—
BuSpar
BuSpar DIVIDOSE

In Canada—
BuSpar
Bustab
Category
Antianxiety agent
Description

Buspirone (byoo-SPYE-rone) is used to treat certain anxiety disorders or to relieve the symptoms of anxiety. However, buspirone usually is not used for anxiety or tension caused by the stress of everyday life.

It is not known exactly how buspirone works to relieve the symptoms of anxiety. Buspirone is thought to work by decreasing the amount and actions of a chemical known as serotonin in certain parts of the brain.

Buspirone is available only with your doctor’s prescription, in the following dosage form:
Oral
Tablets (U.S. and Canada)
Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For buspirone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to buspirone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Buspirone has not been studied in pregnant women. However, buspirone has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether buspirone passes into the breast milk of humans.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of buspirone in children up to 18 years of age with use in other age groups.

Older adults—This medicine has been tested in a limited number of older adults and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking buspirone, it is especially important that your health care professional know if you are taking any of the following:
Erythromycin (e.g., ERYC, E.E.S.) or
Itraconazole (e.g., Sporanox)—Higher blood levels of buspirone may occur, increasing the chance of side effects. Your doctor may change the dose of buspirone that you take
Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline at doses more than 10 mg a day [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking buspirone while you are taking monoamine oxidase (MAO) inhibitors may cause high blood pressure

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Information for Patients

To assure safe and effective use of BuSpar, the following information and instructions should be given to patients:
Inform your physician about any medications, prescription or non-prescription, alcohol, or drugs that you are now taking or plan to take during your treatment with BuSpar.
Inform your physician if you are pregnant, or if you are planning to become pregnant, or if you become pregnant while you are taking BuSpar.
Inform your physician if you are breast-feeding an infant.
Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery.
You should take BuSpar (buspirone hydrochloride) consistently, either always with or always without food.
During your treatment with BuSpar, avoid drinking large amounts of grapefruit juice.
Laboratory Tests

There are no specific laboratory tests recommended.
Drug Interactions
Psychotropic Agents

MAO inhibitors: It is recommended that BuSpar not be used concomitantly with MAO inhibitors (see WARNINGS).

Amitriptyline: After addition of buspirone to the amitriptyline dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (Cmax, AUC, and Cmin) of amitriptyline or its metabolite nortriptyline were observed.

Diazepam: After addition of buspirone to the diazepam dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (Cmax, AUC, and Cmin) were observed for diazepam, but increases of about 15% were seen for nordiazepam, and minor adverse clinical effects (dizziness, headache, and nausea) were observed.

Haloperidol: In a study in normal volunteers, concomitant administration of buspirone and haloperidol resulted in increased serum haloperidol concentrations. The clinical significance of this finding is not clear.

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Contraindications

BuSpar is contraindicated in patients hypersensitive to buspirone hydrochloride.
Warnings

The administration of BuSpar 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 BuSpar (buspirone hydrochloride) has been added to a regimen including an MAOI. Therefore, it is recommended that BuSpar not be used concomitantly with an MAOI.

Because BuSpar 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 BuSpar 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 BuSpar (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 BuSpar 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 BuSpar, 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.
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Indications and Usage for BuSpar

BuSpar is indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The efficacy of BuSpar has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and BuSpar relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows:

Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.

The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.

The effectiveness of BuSpar in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with BuSpar for 1 year without ill effect. Therefore, the physician who elects to use BuSpar for extended periods should periodically reassess the usefulness of the drug for the individual patient.

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After single or multiple doses in adults, no significant differences in buspirone pharmacokinetics (AUC and Cmax) were observed between elderly and younger subjects or between men and women.
Hepatic Impairment

After multiple-dose administration of buspirone to patients with hepatic impairment, steady-state AUC of buspirone increased 13-fold compared with healthy subjects (see PRECAUTIONS).
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After multiple-dose administration of buspirone to renally impaired (Clcr = 10–70 mL/min/1.73 m2) patients, steady-state AUC of buspirone increased 4-fold compared with healthy (Clcr?80 mL/min/1.73 m2) subjects (see PRECAUTIONS).
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The effects of race on the pharmacokinetics of buspirone have not been studied.

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The mechanism of action of buspirone is unknown. Buspirone differs from typical benzodiazepine anxiolytics in that it does not exert anticonvulsant or muscle relaxant effects. It also lacks the prominent sedative effect that is associated with more typical anxiolytics. In vitro preclinical studies have shown that buspirone has a high affinity for serotonin (5-HT1A) receptors. Buspirone has no significant affinity for benzodiazepine receptors and does not affect GABA binding in vitro or in vivo when tested in preclinical models.

Buspirone has moderate affinity for brain D2-dopamine receptors. Some studies do suggest that buspirone may have indirect effects on other neurotransmitter systems.

BuSpar is rapidly absorbed in man and undergoes extensive first-pass metabolism. In a radiolabeled study, unchanged buspirone in the plasma accounted for only about 1% of the radioactivity in the plasma. Following oral administration, plasma concentrations of unchanged buspirone are very low and variable between subjects. Peak plasma levels of 1 ng/mL to 6 ng/mL have been observed 40 to 90 minutes after single oral doses of 20 mg. The single-dose bioavailability of unchanged buspirone when taken as a tablet is on the average about 90% of an equivalent dose of solution, but there is large variability.

The effects of food upon the bioavailability of BuSpar have been studied in eight subjects. They were given a 20 mg dose with and without food; the area under the plasma concentration-time curve (AUC) and peak plasma concentration (Cmax) of unchanged buspirone increased by 84% and 116%, respectively, but the total amount of buspirone immunoreactive material did not change. This suggests that food may decrease the extent of presystemic clearance of buspirone (see DOSAGE AND ADMINISTRATION).

A multiple-dose study conducted in 15 subjects suggests that buspirone has nonlinear pharmacokinetics. Thus, dose increases and repeated dosing may lead to somewhat higher blood levels of unchanged buspirone than would be predicted from results of single-dose studies.

An in vitro protein binding study indicated that approximately 86% of buspirone is bound to plasma proteins. It was also observed that aspirin increased the plasma levels of free buspirone by 23%, while flurazepam decreased the plasma levels of free buspirone by 20%. However, it is not known whether these drugs cause similar effects on plasma levels of free buspirone in vivo, or whether such changes, if they do occur, cause clinically significant differences in treatment outcome. An in vitro study indicated that buspirone did not displace highly protein-bound drugs such as phenytoin, warfarin, and propranolol from plasma protein, and that buspirone may displace digoxin.

Buspirone is metabolized primarily by oxidation, which in vitro has been shown to be mediated by cytochrome P450 3A4 (CYP3A4). (See PRECAUTIONS: Drug Interactions.) Several hydroxylated derivatives and a pharmacologically active metabolite, 1-pyrimidinylpiperazine (1-PP), are produced. In animal models predictive of anxiolytic potential, 1-PP has about one quarter of the activity of buspirone, but is present in up to 20-fold greater amounts. However, this is probably not important in humans: blood samples from humans chronically exposed to BuSpar (buspirone hydrochloride) do not exhibit high levels of 1-PP; mean values are approximately 3 ng/mL and the highest human blood level recorded among 108 chronically dosed patients was 17 ng/mL, less than 1/200th of 1-PP levels found in animals given large doses of buspirone without signs of toxicity.

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 mg to 40 mg is about 2 to 3 hours.

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BuSpar

Generic Name: buspirone hydrochloride
Dosage Form: tablets

(Patient Instruction Sheet Included)
BuSpar Description

BuSpar® (buspirone hydrochloride tablets, USP) is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs.

Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2• HCl is represented by the following structural formula:

BuSpar is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in the DIVIDOSE® tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). BuSpar Tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The 30 mg tablet also contains iron oxide.

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Special warnings about BuSpar

The effects of BuSpar on the central nervous system (brain and spinal cord) are unpredictable. Therefore, you should not drive or operate dangerous machinery or participate in any hazardous activity that requires full mental alertness while you are taking BuSpar.
Possible food and drug interactions when taking BuSpar

Although BuSpar does not intensify the effects of alcohol, it is best to avoid alcohol while taking BuSpar.

If BuSpar is taken with certain other drugs, the effects of either can be increased, decreased, or altered. It is especially important to check with your doctor before combining BuSpar with the following:

The blood-thinning drug warfarin sodium
Haloperidol
MAO inhibitors
Trazodone
Special information if you are pregnant or breastfeeding

The effects of BuSpar during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. It is not known whether BuSpar appears in breast milk. If BuSpar is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment is finished.

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What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking BuSpar.
Side effects may include:
Dizziness, dry mouth, fatigue, headache, light-headedness, nausea, nervousness, unusual excitement
Why should BuSpar not be prescribed?

If you are sensitive to or have ever had an allergic reaction to BuSpar or similar mood-altering drugs, you should not take BuSpar. Make sure your doctor is aware of any drug reactions you have experienced.

Anxiety or tension related to everyday stress usually does not require treatment with BuSpar. Discuss your symptoms thoroughly with your doctor.

The use of BuSpar is not recommended if you have severe kidney or liver damage.

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