Esomeprazole (Nexium) (es oh me' pray zol) IMPORTANT WARNING:   [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. Why is this medication prescribed?   Esomeprazole is used to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus (food pipe between the mouth and stomach). Esomeprazole is used to treat the symptoms of GERD, allow the esophagus to heal, and prevent further damage to the esophagus. Esomeprazole is also used to decrease the chance of getting an ulcer in people who are taking nonsteroidal anti-inflammatory medications (NSAIDs). It is also used with other medications to treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori). Esomeprazole is also used for long-term treatment conditions (such as Zollinger-Ellison Syndrome) in which the stomach makes too much acid. Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach. How should this medicine be used?   Return to top Esomeprazole comes as a delayed-release (long-acting) capsule to take by mouth and as granules to mix with water to take by mouth or give through a feeding tube. Esomeprazole is usually taken once a day at least 1 hour before a meal. To help you remember to take esomeprazole, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take esomeprazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow the capsules whole; do not split, chew, or crush them. If you cannot swallow the capsule, put 1 tablespoon of cool, soft applesauce in an empty bowl. Open one esomeprazole capsule and carefully sprinkle the pellets onto the applesauce. Mix the pellets with the applesauce, and swallow the entire tablespoonful of the applesauce and pellet mixture immediately. Do not chew the pellets in the applesauce. Do not save the pellets and applesauce for later use. To mix the granules, follow these steps: Place 1 tablespoon (15 mL) of water into a cup. Open the esomeprazole packet and empty the granules into the cup containing the water. Stir the granules into the water and leave the mixture alone for 2 to 3 minutes so that it will thicken. Stir the mixture again, and drink all the mixture within 30 minutes. If any material remains in the cup after drinking, add some more water and stir. Drink all of the mixture immediately. Your doctor will tell you how long you will need to take esomeprazole. If you are taking esomeprazole for GERD, you may take it for 4-8 weeks or longer.If you are taking esomeprazole to treat an ulcer, you may take it with other medications for 10 days.If you are taking esomeprazole to decrease the risk of getting an ulcer while taking NSAIDs, you may take it for up to 6 months. Your doctor will tell you how long it will take to feel the full benefit of esomeprazole. Call your doctor if your symptoms worsen or do not improve during this time. Continue to take esomeprazole even if you feel well. Do not stop taking esomeprazole without talking to your doctor. Other uses for this medicine   Return to top This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. What special precautions should I follow?   Before taking esomeprazole, tell your doctor and pharmacist if you are allergic to esomeprazole, lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), rabeprazole (AcipHex), or any other medications. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention atazanavir (Reyataz); anticoagulants ('blood thinners') such as warfarin (Coumadin); voriconazole (Vfend). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. If you are taking digoxin (Lanoxin, Lanoxicaps), iron supplements, vitamins that contain iron, or ketoconazole (Nizoral), you should take these medications at least 2 hours before taking esomeprazole. tell your doctor if you have or have ever had liver disease. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking esomeprazole, call your doctor. You may take antacids with esomeprazole. If you feel you need an antacid, ask your doctor to recommend one and to tell you when and how to take it. What special dietary instructions should I follow?   Return to top Talk to your doctor about your diet. Some foods and drinks can make your symptoms worse. Your doctor can tell you which foods and drinks you should avoid or eat/drink only in small quantities. What should I do if I forget a dose?   Return to top Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. What side effects can this medication cause?  Esomeprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: headache diarrhea nausea gas stomach pain constipation dry mouth Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately: blisters or peeling skin hives rash itching difficulty breathing or swallowing swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs hoarseness Some people who took a medication similar to esomeprazole for a long time developed atrophic gastritis, a condition in which the stomach muscles weaken and shrink. It is not known if taking esomeprazole increases your risk of developing this condition. Talk to your doctor about the risks of taking esomeprazole. Esomeprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088]. What storage conditions are needed for this medicine?   Return to top Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. In case of emergency/overdose   Return to top In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. Symptoms of overdose may include: confusion drowsiness blurred vision fast heartbeat nausea sweating flushing headache dry mouth What other information should I know?   Return to top Keep all appointments with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.