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Buspar is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs.

Buspar is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, Buspar is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2•HCl.

Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 30 mg of Buspar, 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 a multi-scored 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: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate.

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* If you have any questions about Buspar , please talk with your doctor, pharmacist, or other health care provider.
* Buspar is to be used only by the patient for whom it is prescribed. Do not share it with other people.
* If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Buspar . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include decreased pupil size; extreme dizziness or drowsiness; nausea; vomiting.

Proper storage of Buspar:
Store Buspar at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Avoid storing at temperatures above 86 degrees F (30 degrees C). Keep Buspar out of the reach of children and away from pets.

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All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; dizziness; drowsiness; excitability; headache; lightheadedness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal muscle movements; chest pain; fainting; fever; irregular heartbeat; loss of coordination; memory problems; new or worsening mental, mood, or personality changes (eg, anger, hostility, confusion, depression); seizures; suicidal thoughts or actions; unusual restlessness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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* Buspar may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Buspar with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
* Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Buspar . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
* Buspar should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
* BUSPAR PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Buspar while you are pregnant. It is not known if Buspar is found in breast milk. Do not breast-feed while taking Buspar.

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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.
* Avoid large amounts of grapefruit or grapefruit juice while you are taking Buspar . Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking 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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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 liver or kidney problems
* if you have a history of suicidal thoughts or actions

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

* Furazolidone or MAOIs (eg, phenelzine) because serious side effects, including severe high blood pressure, may occur
* Azole antifungals (eg, ketoconazole), diltiazem, HIV protease inhibitors (eg, ritonavir), macrolides and ketolides (eg, erythromycin, azithromycin), nefazodone, or verapamil because they may increase the risk of Buspar ’s side effects
* Carbamazepine, dexamethasone, phenobarbital, phenytoin, or rifampin because they may decrease Buspar ’s effectiveness
* Sodium oxybate (GHB) because the risk of its side effects may be increased by Buspar

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.

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* you are allergic to any ingredient in BuSpar
* you have severe liver or kidney problems
* 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.

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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.

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Any medication taken in excess can have serious consequences. If you suspect an overdose of Buspar, seek medical attention immediately.

* The symptoms of Buspar overdose may include:
Dizziness, drowsiness, nausea or vomiting, severe stomach upset, unusually small pupils

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