NANSEN ® Omeprazole

NANSEN ® is a medicine based on Omeprazole

THERAPEUTIC GROUP: Antireflux - Antiulcer - Inhibitors of the acid pump

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications NANSEN ® Omeprazole

NANSEN ® is indicated in the prevention of pathological manifestations of the gastro-intestinal tract associated with the continuous and prolonged use 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, the gastric environment passes undamaged thanks to the gastro-resistant capsule formulation, to be absorbed fairly quickly in the first part 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 performed at the level of the gastric canaliculi, where thanks to an acidic environment, the active principle is transformed into the biologically effective metabolite, which interacting with a residue of cysteine expressed by the acid protonic pump of the parietal cells of the stomach, irreversibly inhibits it the secretory activity of H + (responsible for the acidification of gastric contents).

Despite a low half-life, made such by a marked hepatic metabolism and subsequent renal excretion, the blockade of the receptor allows a prolonged therapeutic action, which can persist even for 24 hours, time necessary for the parietal cell to provide for the synthesis of new functioning proteins.

Studies carried out and clinical efficacy

1. EFFECTIVENESS OF THE OMEPRAZOLE

BMC Gastroenterol. 2011 Feb 28; 11 (1): 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 showed how the administration of omeprazole, according to therapeutic protocol, for a period between 4 and 8 weeks in about 10, 000 patients suffering from gastroesophageal reflux, can guarantee a significant regression of symptoms in about 80% of patients treated, with a marked improvement in the quality of life.

2. OMEPRAZOLO IN PEDIATRIC AGE

Curr Clin Pharmacol. 2011 Jan 11.

Proton Pump Inhibitors in Pediatrics: Evaluation of Efficacy in GERD Therapy.

Romano C, Chiaro A, Comito D, Loddo I, Ferrau V.

Gastro-oesophageal reflux is one of the most frequent clinical manifestations in pediatric age. Despite the proton pump inhibitors, among which omeprazole, to date represent the drugs of first choice 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 the therapy.

3. OMEPRAZOLO AND CUTANEOUS REACTIONS

Int J Clin Pharmacol Ther. 2001 May; 39 (5): 219-23.

Erythrodermia induced by omeprazole.

Borrás-Blasco J, Navarro-Ruiz A, Navarro-Blasco F, Tovar-Beltran J, González-Delgado M.

Despite the excellent tolerability of omeprazole, different case-reports present in the literature highlight the presence of possible dermatological reactions in some cases even serious. In general, the most affected range of patients appears to consist of elderly and patients with reduced kidney function, for which therefore the administration of omeprazole should be carried out under strict medical supervision.

Method of use and dosage

NANSEN ® gastro-resistant hard 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 the therapeutic objective.

However, studies show that the daily dose of omeprazole 20 mg can guarantee a significant improvement in symptoms in about 2 to 4 weeks, in most patients treated.

Combination therapy with antibiotics should be considered in the treatment and eradication of H. Pylori infection.

Warnings NANSEN ® Omeprazole

The intake of omeprazole should be carried out with particular care, and under strict medical supervision in patients suffering from reduced liver and kidney function, in order to avoid significant 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 gastro-intestinal tract, could significantly delay the time of diagnosis, rendering the subsequent therapy ineffective. In light of these data, it would therefore be necessary to investigate the possible malign origin of the patient's symptoms, in order to avoid an unpleasant progression of the disease.

The appearance of side effects such as headache, drowsiness and dizziness could make the use of machinery or driving vehicles dangerous.

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 the period of pregnancy.

Furthermore, pharmacokinetic studies have not completely clarified the possible secretion of the active ingredient in breast milk, therefore it is advisable to stop breast-feeding while taking NANSEN ®

Interactions

The omeprazole contained in NANSEN ® is metabolized to the hepatic level by particular cytochrome p450 oxidase isoforms, also responsible for the metabolism of other active ingredients such as warfarin, vitamin K antagonists, phenytoin, diazepam and tacrolimus.

Therefore it would be opportune to avoid the concomitant administration or it would be useful to foresee an adjustment of the dosage, taking into account the pharmacokinetic variations.

The reduction of intragastric acidity induced by omeprazole may 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 ingredient or to one of its excipients and during the period of pregnancy and lactation.

Furthermore, the presence of possible cross-resistance extends the contraindications even 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 proved to be fairly safe for patients' health, clinical trials and post-marketing monitoring, a series of clinically minor but frequent side effects emerged such as: headache, abdominal pain, nausea and vomiting, diarrhea, constipation, dizziness and drowsiness.

The most clinically significant cases were more rare, for which side effects, even serious, affecting the hematopoietic, hepatic, renal and cutaneous system were described, promptly returned following the suspension of therapy.