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  • Solezol
    / K.S Kim International (SK-PHARMA)

    Active Ingredient
    Esomeprazole 40 mg

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Powder for solution for infusion

    1 X 40 mg


    * Gastric anti secretory:  20-40 mg once daily
    * Reflux esophagitis: 40 mg once daily
    * Reflux disease symptoms: 20 mg once daily
    * Following therapeutic endoscopy: 80 mg should be administered as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/h given over 3 days (72 hours).
    Severe liver impairment:
    GERD: maximum daily dose of 20 mg should not be exceeded.
    Bleeding ulcers: initial bolus dose of 80 mg for infusion, a continuous intravenous infusion dose of 4 mg/h for 71.5 hours may be sufficient.
    Paediatric population
    Children and adolescents aged 1-18 years
    Gastric anti secretory treatment when the oral route is not possible
    Patients who cannot take oral medication may be treated parenterally once daily, as a part of a full treatment period for GERD. Usually the intravenous treatment duration should be short and transfer to oral treatment should be made as soon as possible.
    See prescribing information for full details.


    * Gastroesophageal reflux disease (GERD) in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate.
    * Prevention of re-bleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.
    Children (1-18 years)
    * Gastric anti secretory treatment when the oral route is not possible, such as:  gastroesophageal reflux disease (GERD) in patients with erosive reflux esophagitis and/or severe symptoms of reflux.


    * Hypersensitivity to the active substance esomeprazole or to other substituted benzimidazoles or to any of the excipients of this medicinal product.
    * Should not be used concomitantly with nelfinavir

    Special Precautions

    In the presence of any alarm symptom (e.g., significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with esomeprazole may alleviate symptoms and delay diagnosis.
    Gastrointestinal infections
    Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
    Absorption of vitamin B12
    Esomeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption.
    Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like esomeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicinal products that may cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
    Risk of fracture
    Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
    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 stopping the medicine. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
    Combination with other medicines
    Co-administration of esomeprazole with Atazanavir is not recommended. If the combination of atazanavir with a proton pump inhibitor 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. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.
    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.
    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 trials (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), Administration site reactions.
    See prescribing information for full details.

    Drug interactions

    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 CYP 2C19.
    Together with proton pump inhibitors, 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 dosage 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. As with other medicinal products that decrease intra gastric acidity, the absorption of medicinal products such as ketoconazole, itraconazole and erlotinib can decrease and the absorption of digoxin can increase during treatment with esomeprazole.
    Drugs metabolised by CYP2C19
    Esomeprazole inhibits CYP2C19, the major esomeprazole metabolising enzyme. Thus, when esomeprazole is combined with drugs metabolised by CYP2C19, such as diazepam, citalopram, clomipramine, phenytoin etc., the plasma concentrations of these drugs may be increased and a dose reduction could be needed.
    Medicinal products which inhibit CYP2C19 and/or CYP3A4
    Esomeprazole is metabolised by CYP2C19 and CYP3A4. Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4 may result in more than doubling of the esomeprazole exposure.
    Medicinal products which induce CYP2C19 and/or CYP3A4
    Drugs known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John’s wort) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism.
    Additional interactions: Methotrexate, Tacrolimus, Diazepam, Phenytoin, Voriconazole, Cilostazol, Cisapride, Warfarin, Clopidogrel
    See prescribing information for full details.

    Pregnancy and Lactation

    A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative or foeto/neonatal toxicity of esomeprazole.
    It is not known whether esomeprazole is excreted in human breast 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 an oral dose of 280 mg were gastrointestinal symptoms and weakness. Single oral doses of 80 mg and intravenous doses of 308 mg Esomeprazole over 24 hrs were uneventful. No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilized.

    Anfarm Hellas S.A