What is Motilium?: The legal use of the drug and its side effects

2024-09-04 15:38:38

Motilium (domperidone) is a drug Esteve’s laboratory used to treat gastrointestinal symptoms such as nausea, vomiting, a feeling of fullness and stomach discomfort. This article can serve as a guide to indications, recommended dosages, contraindications and side effects of using Motilium.

What is Motilium?

Well, it is a drug that acts as a dopamine antagonist with antiemetic properties (to try to avoid nausea). Its main component, domperidone, helps to increase intestinal motility, accelerate bowel movements and eliminate symptoms such as nausea and vomiting. Motilium is available in different forms: tablets, oral suspension and suppositories.

What are your therapeutic indications? Well and Adults, Motilium is indicated for the relief of:

• Nausea and vomiting.
• Sensation of epigastric fullness.
• Depression inside.
• Regurgitation of stomach contents.

In children, Motilium is mainly used to treat nausea and vomiting.

Dosage and administration

The dosage of Motilium varies depending on the age, weight of the patient and the selected drug form:

For adults and adolescents (over 12 years and ≥35 kg):

• Medicines: 1-2 10 mg tablets, three or four times a day, with a maximum dose of 80 mg per day.
• mouth suspension: 10-20 ml (1 mg / ml) three or four times a day, with a maximum of 80 ml per day.
• Suppositories: 1 suppository of 60 mg, twice a day.

For children:

• Tablets and oral suspension: 0.25-0.5 mg/kg of body weight, three or four times a day, without exceeding 80 mg per day.
• Suppositories1 suppository of 30 mg, twice a day, for children who weigh more than 15 kg.

Your risks

Motilium is contraindicated in the following cases:

The location of the touch internal motility can be dangerous, such as gastrointestinal bleeding, mechanical obstruction or perforation.

Attention known to domperidone or any of its excipients.

Patients as well prolactinoma (prolactin-secreting pituitary tumor).

We had warning What do health authorities do about this treatment? Special care must be taken in the following patients and conditions: +

1. Patients with food intolerances: Contains tablets lactoseand oral suspension contains sorbitol, which may not be suitable for people with certain hereditary allergies.
2. Use during lactationAlthough the amount of domperidone excreted in breast milk is small, its use in nursing mothers is not recommended.
3. Interactions with other drugs: Combination of Motilium with strong CYP3A4 inhibitors such as Ketoconazole and erythromycindue to the increased risk of prolongation of the QTc interval (recommend the duration of ventricular electrical systole; it is a way of viewing the heart of work).

Adverse reactions

Motilium can cause side effects ranging from mild to severe. The most common effects include:

• Internal disturbances: diarrhea, constipation.
• Nervous system disorders: Drowsiness, headache, extrapyramidal effect.
• Cardiac disorders: QTc prolongation, ventricular arrhythmias.

In rare cases, it has been reported severe allergic reactionsendocrine disorders such as hyperprolactinemia, and neuroendocrine side effects such as gynecomastia and galactorrhea.

My thoughts after researching this drug

So far I have given you a glimpse of knowledge leafletbut having said that, one of the things that has caught my attention the most in more than 23 years that I have been researching as a journalist everything that is around drugs, is the ease with which we have to complicate our lives with depending on such treatments.

To give an example, the Motilium drug. It is indicated for Relief of nausea and vomiting in adults and children 12 years or older and weighing 35 kg or more. Of course, with these indications one definitely thinks it is an innocent product. What drug treatment can be harmful if it works to relieve nausea or vomiting? But the product’s technical documentation calls for caution from its first lines:

Motilium should be used internally the lowest dose for the shortest period of time necessary to control nausea and vomiting (…) Normally, the maximum duration of treatment should not exceed one week.

Spanish Agency for Medicines and Health Products.

This “innocent” drug has domperidone as an active ingredient, which has many contraindications and important warnings and precautions for use. Especially noteworthy are the cardiovascular effects. In fact, the Pharmaceutical industry states that treatment with domperidone should be discontinued if associated signs or symptoms occur heart arrhythmiaand patients should contact their doctor.

Those who use this drug should be advised to report any cardiac symptoms as soon as possible because there are few that are described as dangerous. These effects can occur through breastfeeding Domperidone is excreted in human milk and children receive less than 0.1% of the weight-adjusted maternal dose.

Appearance of adverse effects, especially cardiacafter exposure through breast milk. A decision should be made whether to stop breastfeeding or to stop/avoid using domperidone after considering the benefit of breastfeeding for the baby and the benefit of treatment for the mother. As I said above, how easy it is for us to complicate our lives with drugs.

What is this all about? Well, it’s a long story. Them The medical journal of the independent French Process asked many years ago to the European Medicines Agency (EMA) that the domperidone was withdrawn from the market. He did so after conducting a study in which he explained this The drug causes between 25 and 120 premature deaths in 2012, only in France.

Already at that time there was word that the drug offered a high risk of significant ventricular arrhythmias. In 2010, two the lessons case-control, one Canadian and one Dutch showed that patients who suffered sudden death or had significant ventricular arrhythmias possibly more than those who did not take the drug.

Well, know how we know that the active ingredient is extracted from the milk, this The drug is also used to increase lactation in mothers during childbirth, anger that can cost the life of the child.

It happens that in the USAagency prescription drugs, as they call drugs there, the FDA, not approved at the time of domperidone. In 2004, the FDA warned doctors and expectant mothers Breastfeeding Do not use domperidone to increase milk production because of the risk of adverse reactions.

The agency cited reports from cardiac arrhythmias, cardiac arrest and sudden death in patients receiving intravenous domperidone. And with the passage of time, the maintenance brochures and technical books have been updated, but the danger is there. That’s why I ask myself: What is the need there to risk for some vomiting or nausea?

By using it to have more milk: Don’t we read the documents I mentioned, in which we have explained the harm that each drug can do? I also understand that if it is necessary for a woman to take more milk for her child There are natural ways to do it.

Safe use and medical supervision

It is important that the use of Motilium is monitored by a doctor who knows the drug well, especially in patients with kidney or liver failure, and those using other drugs that may interact. The doctor will determine the need to adjust the dosage or frequency of administration based on the severity of the patient’s condition and possible interactions.