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 drug which is prescribed for the relief of symptoms of fullness, bloating, nausea and other stomach discomfort after eating. It is also effective in relieving heartburn and trapped wind, as well as vomiting and nausea caused by migraines, stress, food poisoning, viruses and drugs taken for the treatment of Parkinson’s disease. Feelings of bloating and fullness after eating are often caused because of the digestive system slowing and not moving food effectively. The active ingredient, domperidone, works by increasing the contractions in the stomach and bowels, thus aiding digestion and relieving feelings of discomfort. Domperidone is a dopamine antagonist, and primarily blocks dopamine receptors found in the digestive system. This in turn causes the muscles at the stomach entrance to tighten, and the exit muscles to relax. These actions speed up the process whereby food is passed through the stomach and into the intestines. The action is basically inducing the natural rhythm of the digestive system.
Motilium Side Effects:
As with any drug, there may be side effects from taking Motilium including headache, constipation, diarrhea, decrease in appetite, abdominal cramps, dry mouth, dizziness, heartburn, insomnia and some hormonal changes such as breast enlargement or tenderness and irregular menstrual periods. More serious side effects may include change in urination, severe dizziness and difficulty balancing, muscle cramps, changes in heartbeat and allergic reactions which may include itching, swelling of the mouth, throat and lips and difficulty breathing. If you experience any side effects you must seek medical attention immediately for safety.
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.
If you are allergic to any of the ingredients of Motilium, you should avoid taking it and inform your doctor. You must consult your doctor if you have any pre-existing medical conditions including pituitary gland diseases (brain tumor), stomach or duodenal ulcer, kidney or liver disease or disorders, blocked gut (from conditions such a fecal impaction), perforated gut, any other bowel conditions, hernia or regular stomach cramps that occur for more than 14 days. You must consult your doctor if you are taking any other medications as they may interact with Motilium, including antifungal medication, antibiotics, MAO inhibitors, HIV/AIDs medication, antidepressants or any other medication for bowel and digestive disorders. It is important that you inform your doctor if you are pregnant, planning to conceive or breastfeeding as Motilium may cause harm to unborn and new born babies, and can pass to babies through breast milk.
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