In the U.S.—

In Canada—

• Antianxiety agent

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)

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 BUSPIRONE 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—BUSPIRONE 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

• Kidney disease or
• Liver disease—Buspirone may be removed from your body more slowly, which may increase the chance of side effects. Your doctor may need to adjust your dose

Take buspirone only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.

After you begin taking buspirone, 1 to 2 weeks may pass before you begin to feel the effects of BUSPIRONE.

Dosing—

The dose of buspirone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of buspirone. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For oral dosage forms (tablets):
  • Adults: To start, 5 milligrams (mg) two or three times a day, or 7.5 mg two times a day. Your doctor may increase your dose by 5 mg a day every few days if needed. However, the dose usually is not more than 60 mg a day.
  • Children up to 18 years of age: Use and dose must be determined by the doctor.
  • Older adults: To start, 5 milligrams (mg) two or three times a day, or 7.5 mg two times a day. Your doctor may increase your dose by 5 mg a day every few days if needed.

Missed dose—

If you miss a dose of BUSPIRONE, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store BUSPIRONE:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.