Tigan is an antiemetic indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. (1)

Limitation of Use:

• Tigan is not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (CNS) effects and the risk of exacerbation of the underlying disease in pediatric patients with Reye's syndrome or other hepatic impairment. (1, 8.4)

• The recommended adult dosage is 300 mg orally three or four times daily. (2.1)
• Geriatric patients and/or patients with renal impairment (creatinine clearance 70 mL/min/1.73m2 or less): Reduce the daily dosage by increasing the dosing interval; monitor renal function. (2.2, 8.5, 8.6)
• Select the lowest effective daily dosage and adjust as needed based upon therapeutic response and tolerability. (2.1, 2.2)

Capsule: 300 mg of trimethobenzamide hydrochloride. (3)

Known hypersensitivity to trimethobenzamide. (4)

• Acute Dystonic Reactions and Other Extrapyramidal Symptoms (EPS): Depending on the severity of symptoms, reduce the dosage or discontinue the drug. Treat acute dystonic reactions with anticholinergics. Avoid Tigan in patients receiving other drugs that are likely to cause EPS. (5.1, 7.2)
• Masking of Other Serious Disorders: EPS and other CNS symptoms in patients treated with Tigan may be confused with CNS signs of undiagnosed primary disease (e.g., encephalopathy, metabolic imbalance, Reye's Syndrome). If CNS symptoms occur, evaluate the risks and benefits of continuing Tigan. (5.2, 7.2)
• Other CNS Reactions: Coma, depression of mood, disorientation, and seizures have been reported. The recent use of other drugs that cause CNS depression or EPS symptoms may also increase the risk; consider reducing the dosage or discontinuing the drug. (5.3, 7.1, 7.2)
• Hepatotoxicity: Avoid use in patients whose signs and symptoms suggest the presence of hepatic impairment. Discontinue Tigan in patients who develop impaired liver function while on treatment. (5.4, 8.7)
• Effects on the Ability to Drive or Operate Machinery: Mental and/or physical abilities may be impaired. Concomitant use of other drugs that cause CNS depression or EPS symptoms may increase this effect; either Tigan or the other interacting drug should be chosen, depending on the importance of the drug to the patient. (5.5, 7.1, 7.2)

Adverse reactions include hypersensitivity reactions and Parkinson-like symptoms; blood dyscrasias, blurring of vision, coma, convulsions, depression of mood, diarrhea, disorientation, dizziness, drowsiness, headache, jaundice, muscle cramps, and opisthotonos. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Alcohol: May cause drowsiness; avoid concomitant use. (7.1)
• Other Drugs that Cause CNS Depression or EPS: Either Tigan or the other interacting drug should be chosen, depending on the importance of the drug to the patient. If CNS-acting drugs cannot be avoided, monitor patients for CNS adverse reactions. (7.2)