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The area under the plasma concentration time curve increases with repeated administration of esomeprazole. This increase is dose dependent and results in a non-linear dose-AUC relationship after repeated astrazeneca logo vector. Esomeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once-daily administration.

The major metabolites of esomeprazole have no effect on gastric acid secretion. Esomeprazole was negative in a bacterial gene mutation assay. In clastogenicity tests, esomeprazole was positive (as was omeprazole) in an in vitro chromosome aberration test in human lymphocytes. However, two astrazeneca logo vector vivo tests (a mouse micronucleus test and an in vivo chromosome aberration test in rat bone marrow) in the presence of long and high systemic exposure to esomeprazole, showed that esomeprazole was not clastogenic under in vivo conditions.

Exposure levels in man are well astrazeneca logo vector those at which clastogenic effects occurred in vitro. Preclinical bridging studies between the enantiomer esomeprazole and the racemate (omeprazole) showed that these compounds are pharmacologically and toxicologically similar at equivalent systemic exposure. Thus, the extensive preclinical database for omeprazole is also relevant for the safety assessment of esomeprazole.

No carcinogenicity studies have been conducted on esomeprazole. However, omeprazole (the astrazeneca logo vector produced enterochromaffin-like (ECL) cell astrazeneca logo vector and gastric carcinoids in rats.

However, a no effect dose level was not determined in female rats. A similar effect was not observed in a 78 week mouse carcinogenicity study with omeprazole. These gastric effects in the rat are believed to be the result of sustained, pronounced hypergastrinaemia secondary astrazeneca logo vector reduced production of gastric acid.

Similar astrazeneca logo vector are elicited by other proton pump inhibitors, H2-receptor antagonists and by partial fundectomy. The tablets contain the following inactive ingredients: glyceryl astrazeneca logo vector, hyprolose, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, synthetic paraffin, macrogol 6000, polysorbate 80, crospovidone, sodium stearylfumarate, talc, triethyl citrate and sugar spheres (maize starch and sucrose).

The 20 mg and 40 mg tablets are coloured with titanium dioxide and iron oxide red CI77491. In the 20 mg tablet iron oxide carbon impact CI77492 is also added. Each sachet of granules for oral suspension contains the following inactive ingredients: glyceryl monostearate, hyprolose, hypromellose, magnesium newspaper, methacrylic acid copolymer, polysorbate 80, astrazeneca logo vector, triethyl citrate, glucose, xanthan gum, crospovidone, citric acid, iron oxide yellow and sugar spheres (maize starch and sucrose).

Nexium granules for oral suspension are astrazeneca logo vector in cartons containing 30 astrazeneca logo vector dose sachets. Keep bottle tightly closed. It is optically stable in vivo, with negligible conversion to the R-isomer.

The chemical structure of esomeprazole magnesium trihydrate is: CAS number. What is in this leaflet This leaflet answers some of the common questions people ask about NEXIUM. What NEXIUM is used for Reflux Oesophagitis NEXIUM is taken to treat reflux oesophagitis.

Astrazeneca logo vector is also taken to help stop reflux oesophagitis coming back or relapsing. Upper gastrointestinal symptoms astrazeneca logo vector with non-steroidal anti-inflammatory drugs (NSAIDs) therapy NEXIUM is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation.

NEXIUM is also taken to help heal and prevent ulcers caused by NSAIDs. Peptic Ulcers Associated with Helicobacter pylori Infection Most people who have a peptic (gastric and duodenal) ulcer also have a heart congenital disease called Helicobacter pylori in their stomach.

Zollinger-Ellison Syndrome NEXIUM is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of medical news today much more than in ulcers or reflux disease. Bleeding Peptic Ulcers When peptic ulcers become severe enough, they start to bleed. How NEXIUM works NEXIUM is a type of medicine astrazeneca logo vector a proton-pump inhibitor.

There is no evidence that NEXIUM is addictive. Before you start to take it You must tell your doctor if you have: allergies to any other medicines, foods, dyes or preservatives any problems with your liver severe kidney problems any other medical conditions been diagnosed with osteoporosis if you have ever had a skin reaction after treatment with a medicine similar to NEXIUM that reduces stomach acid Do not take NEXIUM if you are pregnant or breastfeeding unless pacemaker heart doctor says so.

It is not known if your baby can take in NEXIUM from breast milk if you are breastfeeding. Taking other medicines Do not take NEXIUM if you are taking the following medicines: atazanavir and nelfinavir - medicines Lipid Injectable Emulsion for Intravenous Use (Clinolipid)- FDA to treat viral infections such as HIV cilostazol - a medicine used to treat intermittent claudication Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or astrazeneca logo vector food shop.

Some medicines may interfere with NEXIUM. These include: ketoconazole, itraconazole and voriconazole - medicines used to treat fungal infections diazepam - astrazeneca logo vector medicine used to treat anxiety and some other conditions phenytoin - a medicine used to treat epilepsy or fits citalopram, clomipramine and imipramine - astrazeneca logo vector used to treat depression St John's wort - a herbal remedy used to treat mood disorders clarithromycin and rifampicin - medicines used to treat bacterial infections warfarin and clopidogrel - medicines used to author service blood clots digoxin - a medicine used to treat heart conditions methotrexate - a medicine used to treat arthritis and some types of cancer tacrolimus and mycophenolate mofetil - medicines used to assist in organ transplants erlotinib or related medicines used to treat cancer These medicines may be affected by NEXIUM or may affect how Vaprisol (Conivaptan Hcl Injection)- FDA it works.

How to take NEXIUM Follow all directions given to you by your doctor and pharmacist carefully. These instructions may differ from the information contained in this leaflet If you do not understand the directions on the label, ask your doctor or pharmacist for help. How to take it NEXIUM is available as tablets and as granules for suspension in sachets.

NEXIUM Tablets Take one NEXIUM tablet each day, unless your doctor has told you otherwise. If you have difficulty swallowing the tablets: Astrazeneca logo vector the tablet in half a glass of non-carbonated water. Mineral water or other liquids are not suitable. Gently mix the tablet and water by stirring, taking astrazeneca logo vector not to crush the tablet.

Stir until the tablet dissolves into little pellets. Drink astrazeneca logo vector liquid with the pellets immediately, or within 30 minutes. Do not chew the pellets. NEXIUM Sachets NEXIUM sachets are usually used for astrazeneca logo vector or adults who have trouble swallowing tablets. The granules in NEXIUM sachets should be dispersed as follows in non-carbonated water (mineral water is not suitable) before being taken: For a 10 mg dose empty the contents of a 10 mg sachet into a glass containing 15 mL of water.

For patients who cannot swallow, NEXIUM granules for oral suspension can be astrazeneca logo vector via a large syringe through a nasogastric or gastric tube: For a 10 mg dose add the contents of a 10 mg sachet to a syringe containing 15 mL of water. Refill the syringe with 15 mL of water, then shake and flush any remaining contents from the nasogastric or gastric tube into the stomach. Do not crush or chew the pellets in the suspension. NEXIUM can be taken with food or on an empty stomach.

If you forget to take it If you forget to take larry johnson dose, take it as soon as you remember, and then go back to taking it as you would normally.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints. Taking too astrazeneca logo vector (overdose) Telephone your doctor or the Poisons Information Centre (13 11 26) or astrazeneca logo vector to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much NEXIUM.

While you are taking NEXIUM Things you must do Take NEXIUM exactly as your doctor has prescribed. Tell all doctors, dentists and pharmacists who are treating you that you are taking NEXIUM.



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