Dompenyl tablets

Dompenyl

  • Active Ingredient: Domperidone
  • 10 mg
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What is Dompenyl?

The active ingredient of Dompenyl brand is domperidone.

Used for

Dompenyl is used to treat diseases such as: .

Side Effect

Possible side effects of Dompenyl include: ; ; ; ; ; ; ; .

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Introduction

Dompenyl (Motilium™) is a drug that has, as a side effect, the increasing of milk production, probably by increasing prolactin production by the pituitary gland. Prolactin is the hormone that stimulates the cells in the mother’s breast to produce milk. Dompenyl increases prolactin secretion indirectly, by interfering with the action of dopamine, whose action is to decrease the secretion of prolactin by the pituitary gland. Dompenyl is generally used for disorders of the gastrointestinal tract (gut) and has not been released in Canada for use as a stimulant for milk production. This does not mean that it cannot be prescribed for this reason, but rather that the manufacturer does not back its use for increasing milk production. However, there are several studies that show that it works to increase milk production and that it is safe. It has been used, for several years, in small infants who spit up and lose weight, but was replaced until a few years ago by cisapride (Prepulsid™). (Cisapride has since been taken off the market because it can cause serious cardiac problems.) Dompenyl is not in the same family of medication as cisapride. Another related but older medication, metoclopramide (Maxeran™), is also known to increase milk production, but it has frequent side effects which have made its use for many nursing mothers unacceptable (fatigue, irritability, depression). Dompenyl has many fewer side effects because it does not enter the brain tissue in significant amounts (does not pass the blood-brain barrier).

In June 2004, the Federal Drug Administration (FDA) in the US put out a warning against using Dompenyl because of possible cardiac side effects. This unfortunate step was taken without considering the fact that the cardiac side effects occurred only when the drug was taken intravenously by otherwise very sick patients. In all the years I have used Dompenyl in so many mothers, I have not yet heard of any significant cardiac side effects that could be attributed to Dompenyl. Incidentally, the Federal Drug Administration has no authority outside the US, and even in the US, compounding pharmacies, which are not regulated by the FDA, are continuing to provide patients with Dompenyl.

Dopamine antagonists

Dompenyl is an alternative to metoclopramide with a reduced incidence of extrapyramidal side-effects. It acts locally on gut and is dosed orally, 10–20 mg 3–4 times daily.

Levomepromazine is a class 1 antipsychotic and has useful activity in refractory nausea and vomiting at low doses. Doses range from 3.125 mg up to 25 mg daily and can be given orally or via the subcutaneous route.

Metoclopramide acts centrally and locally, and risk of extrapyramidal side-effects increases in the young and the elderly. Doses of up to 20 mg 6 hourly can be used for severe nausea.

Domper > Dompenyl is a peripheral D 2 receptor antagonist and is used as a prokinetic and antiemetic of low therapeutic efficacy. It is the preferred drug to counteract levodopa-induced vomiting and constipation in patients with Parkinson disease as in recommended doses Dompenyl does not block central dopamine receptors ( Critchley et al., 1985 ). There are isolated reports of Dompenyl-induced akathisia, parkinsonism, depression, and tardive dyskinesias ( Franckx and Noel, 1984; Biasini and Alberti, 1985; Leeser and Bateman, 1985; Steinherz et al., 1986; Bondon-Guitton et al., 2011 ), usually in the context of high doses. Psychosis following Dompenyl withdrawal after chronic use is described ( Roy-Desruisseaux et al., 2011 ). Overdosage can lead to seizures ( Weaving et al., 1984 ).

Missed dose

If you miss a dose of Dompenyl, 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.

Precautions – before starting Dompenyl

  • Do you have problems with your kidneys or liver?
  • Do you have problems with your heart, such as heart failure or an irregular heart rate?
  • Have you had problems with your digestive tract such as a blockage or bleeding?
  • Are you pregnant, planning a pregnancy or breastfeeding?
  • Are you taking any other medicines, including medicines you can buy without a prescription, such as herbal and complementary medicines?

If so, it’s important that you tell your doctor or pharmacist before you start Dompenyl. Sometimes a medicine isn’t suitable for a person with certain conditions, or it can only be used with extra care.

How to take Dompenyl

  • Dompenyl is best taken about 15 to 30 minutes before meals, with a glass of water.
  • If you take Dompenyl after a meal, it will still work, but it may take longer to have an effect.
  • It is not harmful if you miss a dose of Dompenyl . If you miss a dose, take it when you remember. But, if it is nearly time for your next dose, just take the next dose at the right time. Do not take double the dose.

Post-publication note, December 2019

Following further European review, Dompenyl is no longer licensed for use in children younger than 12 years or those weighing less than 35 kg because of a lack of evidence for benefit. Findings from a placebo-controlled study in children with acute gastroenteritis that did not show Dompenyl to be more effective than placebo at relieving nausea and vomiting. See Drug Safety Update, December 2019.

Article date: May 2014

Dompenyl is a dopamine antagonist with antiemetic properties.

A European review assessed the benefits and risks of Dompenyl following continued reports of cardiac side effects. The review confirmed a small increased risk of serious cardiac side effects. A higher risk was observed particularly in people older than 60 years, people taking daily oral Dompenyl doses of more than 30 mg, and those taking QT-prolonging medicines or CYP3A4 inhibitors at the same time as Dompenyl. For indications other than nausea and vomiting, the benefits were not considered to outweigh the cardiac risk. Based on the results of this review, the treatment advice for Dompenyl has been updated.

The overall safety profile of Dompenyl, and in particular its cardiac risk and potential interactions with other medications, should be taken into account if there is a clinical need to use it at doses or durations greater than those authorised (eg, to control side effects of Parkinson’s disease treatment in some patients).

Dompenyl use in children is under further investigation. Dompenyl licence-holders are required to conduct studies to provide further data to support Dompenyl efficacy in children.

Dompenyl as an Alternative for Gastroparesis

Clinicians know well that the pharmacologic options for the treatment of gastroparesis are extremely limited, particularly in the United States. Currently, metoclopramide is the only prokinetic approved by the US Food and Drug Administration (FDA) for this indication. The potential for side effects with metoclopramide is well recognized and may occur in up to 40% of patients.

The recent American College of Gastroenterology (ACG) guideline on gastroparesis states: "For patients unable to use metoclopramide, Dompenyl can be prescribed with investigational new drug clearance from the Food and Drug Administration (FDA) and has been shown to be as effective as metoclopramide in reducing symptoms without the propensity for causing central nervous system side effects. "

Dompenyl is a peripherally selective D2 dopamine receptor antagonist used as an antiemetic, gastroprokinetic agent, and galactagogue and is widely available in most countries in the world. Dompenyl has been extensively used over the past 30-plus years for gastroparesis, although there are only a few well-controlled, double-blind studies of patients with gastroparesis directly comparing the efficacy of Dompenyl with other prokinetic agents, such as metoclopramide and cisapride, which is no longer available. In the United States, Dompenyl is not FDA-approved due to the concerns for public health risks. However, it may be available at select compounding pharmacies with a doctor's prescription using the Expanded Access to Investigational Drugs program. Otherwise, most patients obtain it through foreign pharmacies, particularly Canadian pharmacies.

Serious risks associated with Dompenyl include cardiac arrhythmias, cardiac arrest, and sudden death. Dompenyl may prolong the QT interval and cause life-threatening arrhythmias; torsades de pointes has been described with its use. These risks are related to the serum level of Dompenyl, and higher levels are associated with greater risks for these events. The ACG guideline on gastroparesis recommends that "Given the propensity of Dompenyl to prolong corrected QT interval on electrocardiogram and to rarely cause cardiac arrhythmias, a baseline electrocardiogram is recommended and treatment with this agent should be withheld if the corrected QT is > 470 ms in male and over 450 ms in female patients. Follow-up electrocardiogram on Dompenyl is also advised. "

Workaround

The FDA’s expanded access program is supposed to be a workaround for people with gastroparesis who cannot get Dompenyl 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 Dompenyl, 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 Dompenyl 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 Dompenyl were dispensed annually between June 2009 and May 2015. Only one pharmacy is authorized to distribute Dompenyl 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 Dompenyl users in the United Kingdom as of 2013.

FDA officials acknowledged many people are getting Dompenyl 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.

Pharmacokinetics

Dompenyl is absorbed from the GI tract but has an oral bioavailability of only 20% in the dog. This is presumably due to a high first-pass effect. The drug is highly protein bound (93%). Peak levels occur about 2 h after dosing. Metabolites are excreted in urine and feces.

Other DA Antagonists

Metoclopram >Dompenyl are potent D-2 DA antagonists which, like the antipsychotics, stimulate PRL secretion . Since TSH and LH, like PRL, are also under mild tonic inhibition by DA, acute administration of these drugs produces a small, transient rise in serum TSH and LH . Chronic endocrine effects are similar to those of the antipsychotics . Acutely, metoclopramide, but not sulpiride, Dompenyl, or haloperidol, stimulates vasopressin secretion .

Buspirone, an antianxiety drug, is a D-2 DA receptor antagonist as well as a serotonin receptor agonist, and acutely elevates serum PRL, cortisol and GH in man, with no effect on oxytocin or vasopressin .

Dompenyl is a peripheral D2 receptor antagonist and is used as a prokinetic and antiemetic of low therapeutic efficacy.


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