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LUCKY-13's Photo LUCKY-13 Posts: 11,837
9/7/09 9:52 P

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Take this information to your GI doctor if you feel that Domperidone is a medication you want to try for your gastroparesis. I will also add the link to our Links tab.

How To Obtain Domperidone

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 (800) INFO-FDA or (301) 796-3400.

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LUCKY-13's Photo LUCKY-13 Posts: 11,837
8/28/09 7:39 P

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Hi Tami!
Good to hear from you!
It was on Reglan for 3-4 years and didn't have any sides, but when I got a new GI doc, he immediately got me off of it since it wasn't working, and told me about the horrible irreversible side effects that some people get. I've been on several other things since that and nothing helps.

I haven't been on the Domperidone for long and my GI doc has me started on a the lowest dose possible and said he'd increase it very slowly to try to avoid any side effects. I did take two of them about 4 hours apart and had tenderness in both breasts, so I guess taking it slow is going to be best for me.

I haven't been able to digest anything "new" - the dose must be too low to do anything for me so far. My emptying study sounds a lot like yours. My ability to digest food had deteriorated since my diagnosis ten years ago. How is your diet now? Are you on an all-liquid diet?

Hope all is well with you.

Hugs,
Lucky

Life's an adventure ... take it one step at a time and don't underestimate yourself! You're capable of more than you think you are! How do I know this? You're still here aren't you? That means you haven't given up!


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NEALSNEWS's Photo NEALSNEWS Posts: 74
8/28/09 5:46 P

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My gastroenterologist told me that he couldn't in good conscience prescribe Reglan (that was before everything came out on it) and the only other drug that would do the same thing without the same horrible, non-reversible side effects was Domperidone. He actually gave me the prescription and told me how to get Domperidone from Canada.
He did an emptying study before and after I began taking it. The results were "little to no emptying" before I took it and "little to no emptying" after I took it so I stopped taking it.
I had no known side effects and took it for several months.

Tami


"..and the blood of Jesus Christ his Son cleanseth us from all sin. I John 1:7b


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LUCKY-13's Photo LUCKY-13 Posts: 11,837
8/23/09 10:23 P

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This is an easier to read version from MedicineNet.com:

Domperidone, Oral side effects:

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.

POSSIBLE 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. Domperidone 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.

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.

Edited by: LUCKY-13 at: 8/28/2009 (19:39)
Life's an adventure ... take it one step at a time and don't underestimate yourself! You're capable of more than you think you are! How do I know this? You're still here aren't you? That means you haven't given up!


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LUCKY-13's Photo LUCKY-13 Posts: 11,837
8/23/09 10:15 P

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The website, Drugs.higsinc.com, states Potential Side Effects from using domperidone include:

* Diarrhea,
* Gynaecomastia (an abnormal enlargement of one or both breasts in men),
* Extrapyramidal effects (Medicinet.com defines this as "physical symptoms including tremor, slurred speech, akathisia (this can be anxiety, inability to sit still, uncontrollable movements like those associated with Reglan, and even indescribable terror and doom),
* Dystonia (From the National Institute of Neurological Disorders and Stroke) "neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures",
* Anxiety,
* Distress,
* Paranoia, and
* Bradyphrenia (slowed thought process),
* Breast pain,
* Urticaria (hives),
* Hyperprolactinaemia (An overproduction of prolactin by the pituitary gland, this condition affects ovulation and breast milk production and can occur in both men and women),
* Stomach cramps,
* Decreased sex drive.

Life's an adventure ... take it one step at a time and don't underestimate yourself! You're capable of more than you think you are! How do I know this? You're still here aren't you? That means you haven't given up!


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LUCKY-13's Photo LUCKY-13 Posts: 11,837
8/23/09 10:15 P

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From the June 10, 2004 FDA Alert:

"FDA warned healthcare professionals and breastfeeding women not to use an unapproved drug, domperidone, to increase milk production (lactation). The agency is concerned with the potential public health risks associated with domperidone. FDA took these actions because it has become aware that some women are purchasing this drug from compounding pharmacies and from foreign sources. Although domperidone is approved in several countries outside the U.S. to treat certain gastric disorders, it is not approved in any country, including the U.S., for enhancing breast milk production in lactating women and is also not approved in the U.S. for any indication."



Life's an adventure ... take it one step at a time and don't underestimate yourself! You're capable of more than you think you are! How do I know this? You're still here aren't you? That means you haven't given up!


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LUCKY-13's Photo LUCKY-13 Posts: 11,837
8/23/09 9:43 P

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According to Wikipedia, which I used to find some simplified info, domperidone is also sold by more than one pharmaceutical company:

"Many brand names and combinations of the drug exist. The combination of domperidone and pantoprazole(1) is marketed as Dompan by Medley Pharmaceuticals (not a US company). Domperidone is sold as Motinorm by GlaxoSmithKline. In India for Paediatric purpose Domperidone is available as Domperi Suspension(Domperidone 1 mg/ml, 30 ml Suspension;Ipca Laboratories Ltd, Mumbai)[1]and Domstal(Torrent Pharmaceuticals Ltd.)"

(1) Pantoprazole is also known as Protonix and at least a dozen other names. Protonix is a PPI (proton pump inhibitor) drug used for short-term treatment of erosion and ulceration of the esophagus caused by GERD (gastroesophageal reflux disease). As a side note on PPIs, I found this on the same site: "A study published in the August 12, 2008 issue of the Canadian Medical Association Journal found that those who use proton pump inhibitors for five or more years have a 1.6-fold increased risk of fracturing a hip, while those who use the drugs for 7 or more years have a 4.5 fold increased risk of fracturing a hip."

Many countries allow domperidone to be prescribed for certain gastric disorders, such as GP, but the US doesn't.

Life's an adventure ... take it one step at a time and don't underestimate yourself! You're capable of more than you think you are! How do I know this? You're still here aren't you? That means you haven't given up!


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LUCKY-13's Photo LUCKY-13 Posts: 11,837
8/16/09 7:44 P

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* What do we know about this medication that the FDA refuses to make legal?
* Did you know that there are quite a few clinical studies going on in the US?
* What are the side effects of taking domperidone?
* And is it even better than the other meds commonly used for GP?
* Is it safer?
* Did you know that you CAN get this medication in the US, and do you know how?

Let's ask questions and get answers on this often-talked about medication. I bet there's more information on the web and from our GI docs that will answer our questions.

Life's an adventure ... take it one step at a time and don't underestimate yourself! You're capable of more than you think you are! How do I know this? You're still here aren't you? That means you haven't given up!


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