Trimethobenzamide

IMPORTANT WARNING:

In April 2007, the Food and Drug Administration (FDA) announced that suppositories containing trimethobenzamide may no longer be marketed in the United States. The FDA made this decision because trimethobenzamide suppositories have not been shown to work to treat nausea and vomiting. If you are currently using trimethobenzamide suppositories, you should call your doctor or other healthcare professional to talk about switching to another treatment.

WHY is this medicine prescribed?

Trimethobenzamide is used to treat nausea and vomiting that may occur after surgery. It is also used to control nausea caused by gastroenteritis ('stomach flu'; a virus that may cause nausea, vomiting, and diarrhea). Trimethobenzamide is in a class of medications called antihistamines. Trimethobenzamide may work by decreasing activity in the area of the brain that causes nausea and vomiting.

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?

Trimethobenzamide comes as a capsule to take by mouth. Trimethobenzamide usually is taken three or four times a day. Take trimethobenzamide at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take trimethobenzamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking trimethobenzamide,

• tell your doctor and pharmacist if you are allergic to trimethobenzamide or any other medications.

• 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: antidepressants; antihistamines; barbiturates such as phenobarbital (Luminal); belladonna alkaloids (Donnatal); medications for anxiety, mental illness, pain and seizures; other medications for nausea and vomiting; sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.

• tell your doctor if you have Reye's Syndrome (a condition affecting the brain and liver that can happen after a viral illness), encephalitis (inflammation of the brain), or a high fever, or if you have or have ever had liver disease. If you will be giving trimethobenzamide to a child, also tell the child's doctor if the child has any of the following symptoms before he or she receives the medication: vomiting, listlessness, drowsiness, confusion, aggression, seizures, yellowing of the skin or eyes, weakness, or flu-like symptoms. Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated.

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

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

• ask your doctor about the safe use of alcoholic beverages while you are taking trimethobenzamide. Alcohol can make the side effects from trimethobenzamide worse.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

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?

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

• drowsiness
• dizziness
• headache
• depression
• diarrhea

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

• rash
• backward arching of the head, neck, and back
• muscle cramps
• uncontrollable shaking of a part of the body
• slow, jerking movements
• shuffling walk
• slow speech
• confusion
• blurred vision
• yellowing of the skin or eyes
• seizures
• coma (loss of consciousness for a period of time)

Trimethobenzamide may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

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 and away from 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 OTHER INFORMATION should I know?

Keep all appointments with your doctor.

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.