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    / K.S Kim International (SK-PHARMA)

    Active Ingredient
    Esomeprazole 20 mg

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Gastro-resistant hard capsules

    7 x20 mg

    not in the basket chart

    Gastro-resistant hard capsules

    14 x 20 mg

    not in the basket chart


    The recommended dose is 20 mg esomeprazole (one capsule) per day.
    It might be necessary to take the capsules for 2-3 consecutive days to achieve improvement of symptoms. The duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued.
    Paediatric population
    There is no relevant use of this medical product in the paediatric population below 18 years of age.
    See prescribing information for full details.


    Short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.


    * Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients.
    * Esomeprazole must not be used concomitantly with nelfinavir

    Special Precautions

    * Unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena.
    * History of gastric ulcer or gastric ulcer is suspected or present.
    * Malignancy should be excluded as treatment with esomeprazole may alleviate symptoms and delay diagnosis
    * Continuous indigestion or heartburn for 4 or more weeks.
    * Jaundice or severe liver disease.
    * Should not take this medical product as a long term preventive medicinal product.
    * Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile.
    Combination with other medicinal products
    * Co-administration of esomeprazole with atazanavir is not recommended. If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir. Esomeprazole 20 mg should not be exceeded.
    * Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole. The clinical relevance of this interaction is uncertain. The use of esomeprazole with clopidogrel should be discouraged
    * Patients should not take another PPI or H2 antagonist concomitantly.
    Interference with laboratory tests
    Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Esomeprazole treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
    Subacute cutaneous lupus erythematosus (SCLE)
    Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stop Esomeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
    See prescribing information for full details.

    Side Effects

    Summary of the safety profile
    Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical studies (and also from post-marketing use). In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations. No dose-related adverse reactions have been identified.
    Common: headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/ vomiting, fundic gland polyps (benign).
    See prescribing information for full details.

    Drug interactions

    Protease inhibitors
    Omeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms behind these reported interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the protease inhibitors. Other possible interaction mechanisms are via inhibition of CYP2C19.
    For atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended.
    For saquinavir (with concomitant ritonavir), increased serum levels (80-100%) have been reported during concomitant omeprazole treatment (40 mg once a day). Treatment with omeprazole 20 mg once a day had no effect on the exposure of darunavir (with concomitant ritonavir) and amprenavir (with concomitant ritonavir).
    Treatment with esomeprazole 20 mg once a day had no effect on the exposure of amprenavir (with and without concomitant ritonavir). Treatment with omeprazole 40 mg once a day had no effect on the exposure of lopinavir (with concomitant ritonavir).
    When given together with PPIs, methotrexate levels have been reported to increase in some patients. In high-dose methotrexate administration a temporary withdrawal of esomeprazole may need to be considered.
    Concomitant administration of esomeprazole has been reported to increase the serum levels of tacrolimus. A reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be performed, and the dose of tacrolimus adjusted if needed.
    Medicinal products with pH dependent absorption
    Gastric acid suppression during treatment with esomeprazole and other PPIs might decrease or increase the absorption of medicinal products with a gastric pH dependent absorption. The absorption of medicinal products taken orally such as ketoconazole, itraconazole and erlotinib can decrease during treatment with esomeprazole and the absorption of digoxin can increase during treatment with esomeprazole.
    Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (up to 30% in two out of ten subjects). Digoxin toxicity has been rarely reported. However, caution should be exercised when esomeprazole is given at high doses in elderly patients. Therapeutic monitoring of digoxin should then be reinforced.
    Medicinal products metabolised by CYP2C19
    Esomeprazole inhibits CYP2C19, the major esomeprazole metabolising enzyme. Thus, when esomeprazole is combined with medicinal products metabolised by CYP2C19, such as warfarin, phenytoin, citalopram, imipramine, clomipramine, diazepam, etc., the plasma concentrations of these medicinal products may be increased and a dose reduction could be needed. In case of clopidogrel, a prodrug which is transformed into its active metabolite via CYP2C19, the plasma concentrations of the active metabolite may be decreased.
    Additional interactions: Diazepam, Phenytoin, Voriconazole, Cilostazol, Cisapride, Warfarin, Clopidogrel
    Medicinal products which inhibit CYP2C19 and/or CYP3A4
    Esomeprazole is metabolised by CYP2C19 and CYP3A4. Concomitant administration of esomeprazole and a CYP3A4 inhibitor, clarithromycin (500 mg twice a day (b.i.d.)), resulted in a doubling of the exposure (AUC) to esomeprazole. Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4 may result in more than doubling of the esomeprazole exposure. The CYP2C19 and CYP3A4 inhibitor voriconazole increased omeprazole AUCt by 280%. A dose adjustment of esomeprazole is not regularly required in either of these situations. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.
    Medicinal products which induce CYP2C19 and/or CYP3A4
    Medicinal products known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John’s wort (Hypericum perforatum)) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism.
    See prescribing information for full details.

    Pregnancy and Lactation

    Pregnancy: A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative or foeto/neonatal toxicity of esomeprazole.
    : It is unknown whether esomeprazole/metabolites are excreted in human milk. There is insufficient information on the effects of esomeprazole in newborns/infants. Esomeprazole should not be used during breast-feeding.


    There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280 mg esomeprazole were gastrointestinal symptoms and weakness. Single doses of 80 mg esomeprazole were uneventful. No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialysable. Treatment should be symptomatic and general supportive measures should be utilised.

    Towa pharmaceutical europe, S.L