Esomeprazole 40mg Gastro-resistant Tablets

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7. Are Proton Pump Inhibitors Safe?

Esomeprazole and pregnant

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One gastro-resistant tablet contains 40 mg of esomeprazole corresponding to An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed or who have persistent symptoms, esomeprazole and pregnant. The recommended initial dosage is 40 mg esomeprazole twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated.

Based on the clinical data available, the majority of patients can be controlled on doses between 80 to mg esomeprazole daily.

With doses above 80 mg daily, the dose should be divided and given twice daily. Dose adjustment is not required in patients with impaired renal esomeprazole and pregnant. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution see section 5.

Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum dose of 20 mg esomeprazole should not be exceeded see section 5, esomeprazole and pregnant.

For patients who have difficulty in swallowing, the tablets can also be dispersed in half a glass of non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes, esomeprazole and pregnant. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed. For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered through a gastric tube.

It is important that the appropriateness of the selected syringe and tube is carefully tested. For preparation and administration instructions see section 6. Hypersensitivity to the active substance esomeprazole, to substituted benzimidazoles or to any of the excipients listed in section 6.

In the presence of any alarm symptom e. Patients on long-term treatment particularly those treated for more than a year should be kept under regular surveillance.

Patients on on-demand treatment should be instructed to contact their physician if their symptoms change in character. When prescribing esomeprazole for eradication of Helicobacter pylori possible drug interactions for all components in the triple therapy should be considered. Clarithromycin is a potent inhibitor of CYP3A4 and hence contraindications and interactions for clarithromycin should be considered when the triple esomeprazole and pregnant is used in patients concurrently taking other drugs esomeprazole and pregnant via CYP3A4 such as cisapride.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter see section 5. 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 on long-term therapy.

Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors PPIs like esomeprazole for at least three months, esomeprazole and pregnant, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, esomeprazole and pregnant, 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 drugs that may cause hypomagnesaemia e, esomeprazole and pregnant. Esomeprazole and pregnant of this increase may be due to other 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.

Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, esomeprazole and pregnant, 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 Esomeprazole.

Co-administration of esomeprazole with atazanavir is not recommended see section 4. 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 mg with mg of ritonavir; esomeprazole 20mg should not be exceeded, esomeprazole and pregnant.

Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, esomeprazole and pregnant, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole see section 4. The clinical relevance of this interaction is uncertain.

As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged. When prescribing esomeprazole for on-demand can methenamine and doxycycline taken together, the implications for interactions with other pharmaceuticals, esomeprazole and pregnant to fluctuating plasma concentrations of esomeprazole should be considered see section 4.

This medicinal product contains sucrose, esomeprazole and pregnant. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Increased Chromogranin A CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference, esomeprazole treatment should be stopped for at least five days before Esomeprazole and pregnant measurements see section 5.

If CgA and gastrin levels have esomeprazole and pregnant returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment, esomeprazole and pregnant. Omeprazole has been reported to esomeprazole and pregnant 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 CYP 2C For atazanavir and nelfinavir, decreased serum levels have been reported when given esomeprazole and pregnant with omeprazole and concomitant administration is not recommended.

Increasing the atazanavir dose to mg did not compensate for the impact of omeprazole on atazanavir exposure. Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration with esomeprazole and atazanavir is not recommended see section 4, esomeprazole and pregnant. Treatment with omeprazole 20 mg qd had no effect on the exposure of darunavir with concomitant ritonavir and amprenavir with concomitant ritonavir.

Treatment with esomeprazole 20 mg qd had no effect on the exposure of amprenavir with and without concomitant ritonavir. Treatment with omeprazole 40 mg qd 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 esomeprazole and pregnant monitoring of tacrolimus concentrations as well as renal function creatinine clearance should be performed, and dosage of tacrolimus adjusted if needed. 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 intragastric 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. Digoxin toxicity has been rarely reported. However, caution should be exercised when esomeprazole is given at high doses in elderly patients. Therapeutic drug monitoring of digoxin should then be reinforced. Esomeprazole inhibits CYP2C19, the major esomeprazole metabolising enzyme.

Thus, esomeprazole and pregnant, when esomeprazole is combined with drugs metabolised by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin etc.

This should be considered especially when prescribing esomeprazole for on demand therapy. It is recommended to monitor the plasma concentrations of phenytoin when treatment with esomeprazole is introduced or withdrawn.

Omeprazole as esomeprazole and pregnant as esomeprazole act as inhibitors of CYP2C The slightly prolonged QTc interval observed after administration of cisapride alone, was not further prolonged when cisapride was given in combination with esomeprazole see also section 4.

Concomitant administration of 40 mg esomeprazole to warfarin-treated patients in a clinical trial showed that coagulation times were within the accepted range. However, post-marketing, a few isolated cases of elevated INR of clinical significance have been reported during concomitant treatment.

Monitoring is recommended when initiating and ending concomitant esomeprazole treatment during treatment with warfarin or other coumarine derivatives.

As a precaution, concomitant use of clopidogrel should be discouraged. Investigated medicinal products with no clinically relevant interaction.

Esomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin or quinidine. Studies evaluating concomitant administration of esomeprazole and either naproxen or rofecoxib did not identify any clinically relevant pharmacokinetic interactions during short-term studies. Concomitant administration of esomeprazole and a CYP3A4 inhibitor, clarithromycin mg b.

Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4 may result in more than doubling of the esomeprazole exposure. A dose adjustment of esomeprazole is not regularly required in either of these situations. However, esomeprazole and pregnant, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated. Clinical data on exposed pregnancies with esomeprazole are insufficient.

With the racemic mixture, omeprazole, data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor foetotoxic effect, esomeprazole and pregnant. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women, esomeprazole and pregnant.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5, esomeprazole and pregnant. It is not known whether esomeprazole is excreted in human breast milk. Therefore Esomeprazole should not be esomeprazole and pregnant during breast-feeding. Esomeprazole has minor influence on the ability to drive or use machines, esomeprazole and pregnant.

Adverse reactions such as dizziness uncommon and blurred vision rare has been reported see section 4. If affected patients should not drive or use machines, esomeprazole and pregnant. Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have esomeprazole and pregnant 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. The following adverse drug reactions have been identified or suspected in the clinical trials programme for esomeprazole and post-marketing. None was found to be dose-related.

 

Esomeprazole and pregnant

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