Domperidone for Refractory Gastrointestinal Disorders

Exclusion Criteria

• •History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
• •History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
• •Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
• •Presence of a prolactinoma (prolactin-releasing pituitary tumor).
• •Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo- obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
• •Pregnant or breast feeding female.
• •Known allergy to domperidone or any components of the domperidone formulation.
• •Significantly significant electrolyte disorders.
• •Gastrointestinal hemorrhage or obstruction.