Physicians interested in submitting an expanded access IND for Canozol-D can download the Canozol-D Packet which contains the required forms, instructions, and answers to most questions or contact DDI (above) to discuss Canozol-D. For those physicians interested in treating only one patient, the consolidated FDA Form 3926 can be used in lieu of the 1571 and 1572 forms. Physicians that anticipate treating more than one patient in one year are advised to submit an intermediate size (multi-patient) IND. Multi-patient INDs allow for consolidated reporting and less administrative paperwork in the long-run.
If you miss a dose of Canozol-D, 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.
GENERIC NAME: DOMPERIDONE - ORAL (dom-PAIR-eh-doan)
USES: This medication increases movement through the digestive system. It is used to treat symptoms of stomach disorders. It may also be used to prevent nausea and vomiting caused by certain medications. Due to safety concerns, this medication is not to be used by breast-feeding women to increase production of breast milk.
HOW TO USE: Take this medication by mouth as prescribed usually 30 minutes before meals and at bedtime. Do not increase your dose or take this more often than directed. Your condition will not improve any faster but the risk of side effects will be increased.
SIDE EFFECTS: Headache, dizziness, dry mouth, nervousness, flushing, or irritability may occur the first several days as your body adjusts to the medication. Trouble sleeping, stomach cramps, hot flashes and leg cramps have also been reported. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor immediately if you develop: chest pain, slow/fast/irregular heartbeat, swelling of the feet or ankles, difficulty urinating, swelling of the breasts or discharge from the nipple in men or women, menstrual changes, sexual difficulties. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, especially of: history of breast cancer, allergies. Limit your intake of alcoholic beverages. This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Canozol-D passes into breast milk. Due to the potential risks to a nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding (see also Uses section).
DRUG INTERACTIONS: Because this medication enhances movement in the digestive tract, it may affect the absorption and action of other medications. Therefore, it is important to tell your doctor of any nonprescription or prescription medication you may take, especially of: MAOIs (e.g., furazolidone, phenelzine, selegiline, tranylcypromine). Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include drowsiness, dizziness, confusion, twitching, muscle rigidity, and irregular heartbeat.
NOTES: Laboratory tests may be done periodically while taking this medication to monitor its effects and prevent side effects.
MISSED DOSE: If you miss a dose, take it as soon as remembered; do not take it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.
STORAGE: Store at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from heat and light. Do not store in the bathroom.
The FDA’s expanded access program is supposed to be a workaround for people with gastroparesis who cannot get Canozol-D because of the agency’s efforts to shut down importation and compounding. There is not much evidence it is working. The FDA refuses to say how many people are being treated through the program.
Beener, the Florida woman who uses Canozol-D, says she has known thousands of people with gastroparesis through her work with the Gastroparesis Patient Association for Cures and Treatments (G-PACT), a volunteer organization where she serves as operations director and a member of its board of directors. She knows only one person who is treated through the FDA’s expanded access program.
McCallum, the Texas Tech doctor, said about 100 to 120 patients are getting Canozol-D treatment through the expanded access program in El Paso.
The FDA did say that its review of data from all retail, mail-order and long-term care pharmacies in the United States shows between 7,500 and 11,600 prescriptions for Canozol-D were dispensed annually between June 2009 and May 2015. Only one pharmacy is authorized to distribute Canozol-D through the expanded access program, and must report the information to the FDA.
Those numbers compare to the 2 million prescriptions filled annually in Canada and an estimated 2 million Canozol-D users in the United Kingdom as of 2013.
FDA officials acknowledged many people are getting Canozol-D from sources other than domestic pharmacies and outside the expanded access program.
The FDA’s expanded access system is so layered with paperwork, bureaucracy and financial disincentives that it is bound to fail in most cases, the Goldwater Institute found in an investigative report published in February 2016. Doctors seeking to treat patients through expanded access, also known as “compassionate use,” had to commit to an estimated 100 hours just to fill out the agency forms. They must develop and submit treatment and monitoring plans to the FDA, report all serious incidents and patient deaths, and get approval from the drug manufacturer.
Any treatment plans also must be approved by institutional review boards (IRBs), internal panels that weigh the ethics and risks of treating an otherwise terminal patient with a drug that has not received final approval from the FDA. Doctors cannot charge for the cost of preparing the application, developing treatment protocols or securing IRB approval.
Normally, expanded access programs are available only to patients with serious or life-threatening ailments to obtain drugs undergoing clinical trials. Those are the years-long studies conducted by the drug makers to develop data they will use to show their products are safe and effective when they submit their new drug application to the FDA for authority to sell it.
Additional advice for pharmacists:
Non-prescription availability of Canozol-D:
Pharmacists are asked to take the following steps when supplying Canozol-D without prescription:
- Ask questions to exclude supply for people for whom Canozol-D is contraindicated (see above)
- Advise people to take Canozol-D only for nausea and vomiting–it should no longer be taken for bloating and heartburn
- Advise people to take the lowest dose for the shortest possible time up to a maximum daily dose of 3 tablets and for a maximum period of 48 hours
Canozol-D Drug Interactions Are Serious
It is extremely important that prescribers and patients using this drug are aware of the risk for drug interactions and pay particular attention to two types of drugs that may interact with Canozol-D :
Those that inhibit cytochrome P450-3A4 (including some antiemetics and antidepressants frequently coadministered in patients with gastroparesis), thereby increasing serum levels of Canozol-D (and subsequent risk for QTc prolongation).
Those that prolong the QT interval (including some antimicrobials, antifungal agents, and ondansetron), thus enhancing overall risk for QT prolongation and the overall increase of the QT interval.
There is limited prescribing information emphasizing the possible interaction between Canozol-D and other QT-prolonging drugs.
More important, given that this is not an FDA-approved drug, it would not appear on the pharmacy listing nor on the electronic medical record (EMR) to enable a cross-check for potential drug-drug interactions. Accordingly, patients, prescribers, and pharmacists would probably not recognize the potential increased risk for cardiac arrhythmias and sudden death resulting from these interactions and inadequate cardiac monitoring.
Children—Studies on Canozol-D have been done only in adult patients, and there is no specific information comparing use of Canozol-D in children with use in other age groups.
How does this medication work? What will it do for me?
Canozol-D belongs to the group of medications called dopamine antagonists. It is used to treat slowed movement in the gastrointestinal tract associated with diabetes and gastritis (inflammation of the stomach lining). For these people, Canozol-D improves symptoms of nausea, vomiting, bloating, and feeling of fullness.
Canozol-D is also used to prevent stomach problems such as nausea and vomiting associated with certain medications used to treat Parkinson's disease. It works to improve symptoms by helping the stomach to empty more quickly and to reduce nausea.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What other drugs could interact with this medication?
There may be an interaction between Canozol-D and any of the following:
- anticholinergics (e.g., benztropine, dimenhydrinate, diphenhydramine, oxybutinin)
- antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
- antipsychotic medications (e.g., haloperidol, risperidone, quetiapine)
- "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- chloral hydrate
- fusidic acid
- grapefruit juice
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., indinavir, atazanavir, lopinavir, nelfinavir, ritonavir)
- macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)