Tigan (Oral)

Trimethobenzamide is used to treat nausea and vomiting after surgery. It is also used to treat nausea caused by gastroenteritis.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Trimethobenzamide will increase the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, sleeping medicines, prescription or narcotic pain medicines, barbiturates or seizure medicines, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using trimethobenzamide.

This medicine may cause extrapyramidal symptoms. Check with your doctor right away if you have difficulty speaking, drooling, loss of balance control, muscle trembling, jerking, or stiffness, restlessness, shuffling walk, stiffness of the limbs, twisting movements of the body, or uncontrolled movements, especially of the face, neck, and back.

This medicine may cause some people to feel dizzy, lightheaded, drowsy, or less alert than usual. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you feel dizzy or not alert.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Due to trimethobenzamide's toxicity, it is not recommended for use in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies on how age affects the effects of trimethobenzamide have not been performed in older adults. However, elderly patients are more likely to experience side effects and age-related kidney disease, which may require a dose adjustment for those receiving trimethobenzamide.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust some of the other medicines you take.

• Bromopride
• Potassium Citrate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Brain disease (e.g., encephalopathy, Reye's syndrome) or
• Electrolyte imbalance (high or low levels of minerals in the blood)—Use with caution. May worsen side effects.

• Kidney disease—Use with caution. The effects of this medicine may be increased due to slower removal from the body.

• Liver disease—Use with caution. May worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Abdominal or stomach pain
• change in consciousness
• chills
• clay-colored stools
• confusion about identity, place, and time
• dark urine
• difficulty swallowing
• discouragement
• dizziness
• feeling sad or empty
• fever
• headache
• irritability
• itching
• lack of appetite
• loss of balance control
• loss of consciousness
• loss of interest or pleasure
• mask-like face
• nausea
• pale skin
• rash
• seizures
• severe spasm where the head and heels are bent backward and the body arched forward
• shuffling walk
• slowed movements of the arms and legs
• slurred speech
• sore throat
• swelling of the arms, face, legs, lips, tongue, or throat
• tic-like (jerky) movements of the head, face, mouth, and neck
• trembling and shaking of the fingers and hands
• trouble concentrating
• trouble sleeping
• unpleasant breath odor
• unusual bruising or bleeding
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

Incidence not known

• Blurred vision
• diarrhea
• drowsiness
• muscle cramps

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Tigan

Available Dosage Forms:

• Capsule

Therapeutic Class: Antiemetic

Pharmacologic Class: Anticholinergic

Take this medicine exactly 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 side effects.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules): For nausea and vomiting after surgery and nausea caused by gastroenteritis: Adults—300 milligrams (mg) 3 or 4 times a day. Your doctor may adjust your dose as needed and tolerated. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.