NANSEN ® is a drug based on Omeprazole
THERAPEUTIC GROUP: Antireflux - Antiulcer - Acid pump inhibitors
Indications NANSEN ® Omeprazole
NANSEN ® is indicated in the prevention of pathological manifestations of the gastrointestinal tract associated with the continuous and prolonged intake of non-steroidal anti-inflammatory drugs and in the treatment of all those conditions associated with gastric hyperacidity such as duodenal ulcers, gastric ulcers, esophagitis, peptic ulcer by H. Pylori, functional dyspepsia and Zollinger-Ellison syndrome.
Mechanism of action NANSEN ® Omeprazole
The omeprazole contained in NANSEN ® represents the active principle responsible for the therapeutic action of this drug.
Taken orally, it passes unscathed the gastric environment thanks to the formulation in gastro-resistant capsules, to be absorbed quickly enough in the first tract of the small intestine.
Despite its low bioavailability, estimated at around 35% of the total dose taken, omeprazole guarantees an intense therapeutic action, managing to reduce the acid content of the stomach by about 80% after just one day of therapy.
Its action is carried out at the level of the gastric canaliculi, where thanks to an acidic environment, the active ingredient is transformed into the biologically effective metabolite, which interacting with a residue of cysteine expressed by the acid proton pump of the parietal cells of the stomach, irreversibly inhibits it. the secreting activity of H + (responsible for the acidification of the gastric contents).
Despite a low half-life, made such by a marked hepatic metabolism and subsequent renal excretion, the blocking of the receptor allows a prolonged therapeutic action, which can persist even for 24 hours, the time necessary for the parietal cell to provide for the synthesis of new functioning proteins.
Studies carried out and clinical efficacy
1. EFFECTIVENESS OF OMEPRAZOLE
BMC Gastroenterol. 2011 Feb 28; 11: 15.
Effects of omeprazole on symptoms and quality of life in Japanese patients with reflux esophagitis: Final results of OMAREE, a large-scale clinical experience investigation.Yoshida S, Nii M, Date M.
Recent study that demonstrated how the administration of omeprazole, according to the therapeutic protocol, for a period between 4 and 8 weeks in about 10,000 patients with gastroesophageal reflux, can guarantee a significant regression of symptoms in about 80% of the patients treated, with a marked improvement in the quality of life.
2. OMEPRAZOLE IN PEDIATRIC AGE
Curr Clin Pharmacol. 2011 Jan 11.
Romano C, Chiaro A, Comito D, Loddo I, Ferrau V.
Gastro-oesophageal reflux is one of the most frequent clinical manifestations in pediatric age. Although proton pump inhibitors, including omeprazole, represent today the first choice drugs and well tolerated in the treatment of this pathology, there are still no international guidelines capable of guiding the pediatrician in the correct therapeutic procedure, minimizing the possible side effects of therapy.
3. OMEPRAZOLE AND SKIN REACTIONS
Int J Clin Pharmacol Ther. 2001 May; 39: 219-23.
Borrás-Blasco J, Navarro-Ruiz A, Navarro-Blasco F, Tovar-Beltran J, González-Delgado M.
Despite the excellent tolerability of omeprazole, different case reports in the literature highlight the presence of possible dermatological reactions, in some cases even severe. In general, the group of patients most affected seems to be the elderly and patients with reduced renal function, for whom the administration of omeprazole should therefore be carried out under close medical supervision.
Method of use and dosage
NANSEN ® hard gastro-resistant capsules of 10 - 20 mg of omeprazole:
the effective therapeutic dose should be established by your doctor after a "careful evaluation of the physio-pathological conditions and of the" therapeutic goal.
However, studies show that the daily dose of 20 mg of omeprazole can guarantee a significant improvement in symptoms in about 2 - 4 weeks, in the majority of treated patients.
Combination therapy with antibiotics should be considered in the treatment and eradication of H. Pylori infection.
NANSEN ® Omeprazole warnings
The intake of omeprazole should be carried out with particular care, and under strict medical supervision in patients with impaired hepatic and renal function, in order to avoid important changes in the pharmacokinetic properties of the active ingredient.
Furthermore, the ability of this medicine to mask some important signs and symptoms of serious pathologies of the gastrointestinal tract, could significantly delay the moment of diagnosis, making subsequent therapy ineffective. In the light of these data, it would therefore be necessary to investigate the possible malignant origin of the patient's symptoms, in order to avoid an unpleasant progression of the disease.
The onset of side effects such as headache, sleepiness and dizziness could make it dangerous to use machines or drive vehicles.
PREGNANCY AND BREASTFEEDING
At the moment, the absence of studies useful to clarify the safety profile of omeprazole when taken during pregnancy, on the health of the fetus, does not allow the drug NANSEN ® to be used during pregnancy.
Furthermore, pharmacokinetic studies have not fully clarified the possible secretion of the active ingredient in breast milk, therefore it is advisable to stop breastfeeding while taking NANSEN ®.
Interactions
The omeprazole contained in NANSEN ® is metabolised in the liver by particular isoforms of cytochrome p450 oxidase, which are also responsible for the metabolism of other active ingredients such as warfarin, vitamin K antagonists, phenytoin, diazepam and tacrolimus.
Consequently, concomitant administration should be avoided or dosage adjustment should be provided, taking into account pharmacokinetic variations.
The reduction of intragastric acidity induced by omeprazole could also reduce the absorption of drugs and active ingredients that require particularly acidic pH.
Contraindications NANSEN ® Omeprazole
NANSEN ® is contraindicated in case of hypersensitivity to the active substance or to one of its excipients and during pregnancy and lactation.
Furthermore, the presence of possible cross-resactivity extends the contraindications to all those patients who are hypersensitive to active ingredients belonging to the same pharmaceutical category as omeprazole.
Undesirable Effects - Side Effects
Although omeprazole therapy was found to be quite safe for patients' health, clinical trials and post-marketing monitoring revealed a number of clinically insignificant but frequent side effects such as: headache, abdominal pain, nausea and vomiting. , diarrhea, constipation, dizziness and sleepiness.
Clinically more significant cases were rarer, for which serious side effects were described, affecting the haematopoietic, hepatic, renal and cutaneous system, promptly returned following the suspension of therapy.
Note
NANSEN ® a drug that can only be sold under medical prescription.
The information on NANSEN ® Omeprazole published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
