Gepirone (je-PYE-rone)

Treats depression.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk. Take it at the same time each day.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have used an MAO inhibitor (including linezolid, methylene blue) within the last 14 days.
• Some medicines can affect how gepirone works. Tell your doctor if you are using any of the following:
  • Glyburide, rifampin, verapamil
  • Diuretic (water pill)
  • Medicine that may cause heart rhythm problems
  • Medicine to treat depression (including SNRIs, SSRIs, TCAs)
  • Steroid medicine
  • Triptan medicine to treat migraine headaches

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or plan to become pregnant. Using this medicine during the last 3 months of pregnancy can harm your unborn baby. Tell your doctor right away if you become pregnant or if you think you may be pregnant while using this medicine.
• Tell your doctor if you are breastfeeding or if you have kidney disease, liver disease, heart disease (including a recent heart attack, heart failure, heart rhythm problems, high blood pressure), underactive thyroid, or a history of electrolyte problems or mental problems (including bipolar disorder, mania, or hypomania).
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may cause the following problems:
  • Heart rhythm problems (including QT prolongation)
  • Serotonin syndrome (may be life-threatening when used with certain other medicines)
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Changes in behavior, thoughts of hurting yourself or others
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat

If you notice these less serious side effects, talk with your doctor:

• Stomach pain or upset
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088