LUCEN ® is an esomeprazole-based drug.
THERAPEUTIC GROUP: Antireflux - Antiulcer-Inhibitors of the proton pump
Indications LUCEN ® Esomeprazole
LUCEN ® is useful both as a pharmacological support for the prevention and healing of gastric and duodenal ulcers associated with prolonged therapy with non-steroidal anti-inflammatory drugs, and as a therapeutic approach to the treatment of all those morbid conditions associated with gastric hyperacidity such as gastroesophageal reflux disease, esophagitis erosive, duodenal ulcers, gastric and peptic ulcer, and Zollinger-Ellison syndrome.
In combination with antibiotics, LUCEN ® can also be used in the eradicating treatment of Helicobacter Pylori
LUCEN ® mechanism of action Esomeprazole
Like the other active ingredients belonging to the category of proton pump inhibitors, also esomeprazole, isomer of the more common omeprazole, is able to selectively act on the acid proton pump expressed by the parietal cells of the stomach, reducing the secretion of protons towards the gastric lumen.
The activation of the active principle is observed following protonation, exclusively in the intracellular canaliculi, where the pH reaches low values, while following oral administration, it manages to pass unscathed the acid barrier of the stomach, thanks to the Gastroresistant formulation, thus being absorbed subsequently from the duodenal mucosa.
The maximum plasma peak is observed after about 2 hours with a maximum bioavailability that is around 64% of the total dose taken, given the presence of a slight pre-hepatic metabolism.
All the active ingredient, on the other hand, is completely metabolized in the liver, by cytochrome p450, the CYP2C19 isoform and subsequently excreted mainly through the renal route.
Studies carried out and clinical efficacy
1. ESOMEPRAZOLE AND NSAIDs
Drugs Aging. 2011 Mar 1; 28: 237-48.
Naproxen / Esomeprazole fixed-dose combination: for the treatment of arthritic symptoms and to reduce the risk of gastric ulcers.
Dhillon S.
As is known, one of the therapeutic indications of esomeprazole is represented by the prevention of gastric and duodenal ulcers associated with prolonged therapy with non-steroidal anti-inflammatory drugs. In this study, the concomitant administration at fixed doses of naproxen and esomeprazole, proved particularly useful. in reducing the incidence of gastric and duodenal complications.
2. EXOMEPRAZOLE AND MAINTENANCE THERAPY
Adv Ther. 2011 Feb; 28: 150-9
Safety and tolerability of high-dose intravenous esomeprazole for prevention of peptic ulcer rebleeding.
Kuipers EJ, Sung JJ, Barkun A, Mössner J, Jensen D, Stuart R, Lau JY, Ahlbom H, Lind T, Kilhamn J.
Oral administration of esomeprazole, after endoscopic therapy for the treatment of bleeding ulcer, has been shown to be very well tolerated and effective in preventing possible bleeding and non-healing of the ulcer.
3. EXOMEPRAZOLE AND DYSPEPSIA
Aliment Pharmacol Ther. 2011 Jan; 33: 41-9. doi: 10.1111 / j.1365-2036.2010.04501.x. Epub 2010 Oct 29.
Randomized clinical trial: identification of responders to short-term treatment with esomeprazole for dyspepsia in primary care - a randomized, placebo-controlled study.
Meineche-Schmidt V, Christensen E, Bytzer P.
In some patients, digestive difficulties appear to be caused by an alteration of the normal gastrointestinal microenvironment. In fact, in this study, it was shown that 68% of patients suffering from dyspepsia can derive important benefits, concretized with the reduction of heartburn, abdominal pain, nausea and vomiting, from taking esomeprazole.
Method of use and dosage
LUCEN ® gastro-resistant coated tablets 20 - 40 mg esomeprazole:
the posology used varies according to the therapeutic purposes and the clinical picture of the patient.
In principle, the daily dose of 80 mg is used in the treatment of Zollinger-Ellison syndrome, while in most cases the doses of 40 and 20 mg / day of esomeprazole are sufficient for the treatment of erosive reflux esophagitis, gastroesophageal reflux disease, duodenal and peptic ulcer caused by H. Pylori in association with antibiotics, and in the prevention of gastric ulcers from prolonged treatment with non-steroidal anti-inflammatory drugs.
The correct dosage should in any case be established by the doctor, after a "careful evaluation of the physio-pathological conditions of the patient and of his therapeutic objectives.
LUCEN ® Esomeprazole warnings
The hepatic and renal metabolism of esomeprazole requires close medical supervision when LUCEN ® is taken in patients with impaired hepatic and renal function.
As with other proton pump inhibitors, the administration of esomeprazole should be preceded by an evaluation of the patient's clinical picture, aimed at excluding the malignant origin of the gastro-intestinal diseases, reducing the risk of delaying the diagnosis following the " taking LUCEN ® due to its ability to mask symptoms.
Prolonged use of this medicinal product has been associated with an increase in blood concentrations of gastrin, probably associated with the appearance of gastric and intestinal growths, fortunately not of malignant origin.
The reduction of the acidity of the gastric environment could favor Salmonella and Campylobacter infection, especially for patients who use these drugs continuously.
The onset of episodes of drowsiness, mental confusion and dizziness following the intake of esomeprazole, could make the use of machinery and the driving of vehicles dangerous.
PREGNANCY AND BREASTFEEDING
The safety profile of LUCEN ® when taken during pregnancy is still under debate due to the presence of experimental studies and clinical trials with conflicting results.
For this reason, therefore, the intake of esomeprazole is contraindicated both during pregnancy and in the subsequent lactation period.
Interactions
The interactions described for LUCEN ® are essentially due to:
- Metabolism induced by CYP2C19, a highly polymorphic enzyme, involved in the metabolism of numerous other active ingredients, and inhibited by the metabolites of esomeprazole itself. It is therefore evident how the concomitant administration of esomeprazole and substrates of the aforesaid enzyme, or modulators of the same and esomeprazole can be associated respectively with a variation of the pharmacokinetic properties of the various compounds and of esomeprazole.
- Reduction of intragastric acidity, which can reduce the absorption of drugs such as some antifungals, whose absorption is regulated by gastric pH.
Therefore, to avoid the appearance of unpleasant side effects, it would be useful to avoid the concomitant administration of these drugs or to adjust the relative dosages.
Contraindications LUCEN ® Esomeprazole
LUCEN ® is contraindicated during pregnancy and lactation and in patients with known hypersensitivity to the active substance and its excipients, or to other benzimidazole derivatives, given the possibility of cross-reactivity.
Undesirable Effects - Side Effects
The main side effects described following the administration of LUCEN ® were clinically insignificant, and essentially characterized by abdominal pain, constipation, diarrhea, nausea, vomiting, flatulence, dizziness and insomnia.
More serious and clinically relevant disorders have been observed rarely and especially in particular categories of patients at risk.
In any case, all the aforementioned side effects tend to promptly regress once the therapy is suspended.
Note
LUCEN ® can only be sold under medical prescription
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