Generic Name: esomeprazole

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A proton pump inhibitor - treats NSAID-Induced Gastric Ulcer, Pathological Hypersecretory Conditions... more

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esomeprazole

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(ee so MEP ra zol)

Most Important What is...? Before Taking How to Take Missed Dose Avoid Taking Side Effects Interactions Overdose More Info

What is the most important information I should know about esomeprazole?

Do not use this medication if you are allergic to esomeprazole or to any other benzimidazole medication such as albendazole (Albenza), or mebendazole (Vermox). Before taking this medication, tell your doctor if you have ever had liver disease or any type of heart disease. You may need a dose adjustment or special tests during treatment.

Some conditions are treated with a combination of esomeprazole and antibiotics. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before your treatment is completed. Do not crush, break, or open a delayed-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

What is esomeprazole?

Esomeprazole decreases the amount of acid produced in the stomach.

Esomeprazole is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. Esomeprazole is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid),

Esomeprazole may also be given to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori), or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Esomeprazole may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking esomeprazole?

Do not use this medication if you are allergic to esomeprazole or to any other benzimidazole medication such as albendazole (Albenza), or mebendazole (Vermox). Before taking this medication, tell your doctor if you have ever had liver disease or any type of heart disease. You may need a dose adjustment or special tests during treatment.

Some conditions are treated with a combination of esomeprazole and antibiotics. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether esomeprazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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FDA Alerts

Special Alerts:

[UPDATE 12/11/2007] FDA informed healthcare professionals of the issuance of the Agency’s follow-up communication regarding its review of safety data for the drugs omeprazole (Prilosec) and esomeprazole (Nexium) that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products. See the “Update of Safety Review” for information regarding the two studies that were reviewed. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Omeprazole and http://www.fda.gov/cder/drug/early_comm/omeprazole_esomepazole_update.htm.

[Posted August 09, 2007] FDA issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, omeprazole (Prilosec) and esomeprazole (Nexium). The new safety data was from two small long-term clinical studies in patients with severe gastroesophageal reflux disease (GERD). In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their GERD.

The results from the study of omeprazole and analyses from an ongoing study of esomeprazole raised concerns that long-term use of omeprazole or esomeprazole may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. After reviewing these and other data submitted by the company, FDA’s preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.

Both drugs are used for the treatment of GERD, esophageal erosions and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Omeprazole is also sold over the counter for frequent heartburn. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Omeprazole and http://www.fda.gov/cder/drug/early_comm/omeprazole_esomeprazole.htm.

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