FDA Alert: How to Obtain Domperidone: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm073070.htm
On June 7, 2004, the Food and Drug Administration (FDA) warned compounding pharmacies and firms that supply domperidone for use in compounding that it is illegal to compound domperidone and issued an import alert advising FDA field personnel that they may detain shipments of finished drug products and bulk ingredients containing domperidone. These actions were the result of the Agency's concern about the potential public health risks associated with the use of domperidone by lactating women. Although FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women, there are some patients with severe gastrointestinal disorders, such as severe gastroparesis or severe GI motility disorders that are refractory to standard therapy, who may benefit from the drug and in whom the drug’s benefits outweigh its risks.
FDA encourages physicians who would like to prescribe domperidone for their patients with severe gastrointestinal disorders that are refractory to standard therapy to open an Investigational New Drug Application (IND). An IND is a request for FDA authorization to administer an investigational drug to humans. Such authorization would allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S.
For questions relating to domperidone INDs contact the Division of Drug Information, toll free at (888) INFO-FDA or (301) 796-3400.
Eligibility for Domperidone
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
• Male or female
• Age 18 or older
• Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
• Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
• Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:
o increased prolactin levels
o extrapyramidal side effects
o breast changes
o cardiac arrhythmias including QT prolongation
o there is a potential for increased risk of adverse events with the drugs listed in the addendum
• 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.
Motilium (Generic name: Domperidone) is a prescription medicine that increases the movements or contractions of the stomach and bowel. Motilium is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson's disease. Domperidone is a dopamine antagonist works by blocking the action of a chemical messenger in the brain which causes the feeling of nausea and vomiting, as well as increasing the movement or contractions of the stomach and intestines, allowing food to move more easily through the stomach. Your doctor may prescribe Motilium for other medical purposes that not listed here. Take Motilium exactly as it was prescribed for you.
Motilium Side Effects:
The most common Motilium side effects are abdominal cramps, constipation, diarrhea, dry mouth, dizziness, headache, heartburn, insomnia, itchy rash, nausea, and hormonal effects (e.g., breast enlargement, tenderness, production of milk and irregular menstruation). If you are experiencing any severe side effects such as abnormal urination, irregular heartbeat, loss of balance, muscle cramps, and serious allergic reaction (e.g., swelling of face, hands, mouth, legs or feet), please inform your doctor immediately.
You should follow the instructions of the doctor who prescribed Motilium to you. Directions and dosage information can also be found on the pack or leaflet inside the pack. Motilium comes in tablet form. You should swallow Motilium whole with a glass of water. Motilium can be taken with or without food. It is safe to take up to 4 tablets in a 24 hour period, and it is advised to take one of these at night before bed. Motilium should be stored at room temperature away from direct sunlight and heat.
You should follow the instructions of the doctor who prescribed Motilium to you. Directions and dosage information can also be found on the pack or leaflet inside the pack. Motilium comes in tablet form. You should swallow Motilium whole with a glass of water. Motilium can be taken with or without food. Motilium should be stored at room temperature away from direct sunlight and heat.
The generic alternative is not manufactured by the company that makes the brand product.
Domperidone may be associated with a small increased risk of serious ventricular arrhythmias or sudden cardiac death. A higher risk was observed in patients:
• older than 60 years of age;
• using daily doses greater than 30 mg;
• having predisposing factors for QT prolongation including concomitant use of QT-prolonging drugs or CYP 3A4 inhibitors.
• Domperidone is now contraindicated in patients:
• with prolongation of cardiac conduction intervals, particularly QT;
• with significant electrolyte disturbances;
• with cardiac disease (such as congestive heart failure);
• with moderate or severe liver impairment;
• receiving QT-prolonging drugs and potent CYP3A4 inhibitors.
Domperidone should be used at the lowest effective dose to a maximum recommended daily dose of 30 mg and for the shortest possible duration.
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