Buspirone

WHY is this medicine prescribed?

Buspirone is used to treat anxiety disorders or in the short-term treatment of symptoms of anxiety. Buspirone is in a class of medications called anxiolytics. It works by changing the amounts of certain natural substances in the brain.

Are there OTHER USES for this medicine?

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Buspirone comes as a tablet to take by mouth. It usually is taken twice daily and must be taken consistently, either always with food or always without food each time. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take buspirone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of buspirone and gradually increase your dose, not more often than once every 2 to 3 days. It may take several weeks before you reach a dose that works for you.

What SPECIAL PRECAUTIONS should I follow?

Before taking buspirone,

• tell your doctor and pharmacist if you are allergic to buspirone, any other medications, or any of the ingredients in buspirone tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticonvulsants such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek); dexamethasone; diazepam (Valium); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin, others); haloperidol (Haldol); ketoconazole; itraconazole (Onmel, Sporanox); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); muscle relaxants; nefazodone (Serzone); pain medications or narcotics; rifampin (Rifadin, Rimactane); ritonavir (Norvir); sedatives; selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); serotonin–norepinephrine reuptake inhibitors (SNRI) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), milnacipran (Savella), and venlafaxine (Effexor); sleeping pills; tranquilizers; trazodone (Desyrel); and verapamil (Calan, Covera, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with buspirone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take buspirone. If you stop taking buspirone, you should wait at least 14 days before you start to take an MAO inhibitor.

• tell your doctor if you have or have ever had kidney or liver disease or a history of alcohol or drug abuse.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking buspirone, call your doctor.

• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.

• remember that alcohol can add to the drowsiness caused by this drug. Do not drink alcohol while taking buspirone.

What SPECIAL DIETARY instructions should I follow?

Avoid drinking large amounts of grapefruit juice while taking buspirone.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Buspirone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• nausea
• diarrhea
• headache
• excitement
• confusion
• fatigue
• nervousness
• difficulty falling asleep or staying asleep
• feelings of anger or hostility
• lightheadedness
• headache
• weakness
• numbness
• increased sweating

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• rash
• hives
• itching
• swelling of the face, eyes, mouth, throat, tongue, or lips
• fast or irregular heartbeat
• blurred vision
• uncontrollable shaking of a part of the body
• agitation, fever, sweating, dizziness, flushing, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, seizures, hallucinations, loss of coordination, nausea, vomiting, or diarrhea

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from light, excess heat, and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• vomiting
• dizziness
• drowsiness
• blurred vision
• upset stomach

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to buspirone.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking buspirone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.