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Generic Name: esomeprazole

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

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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esomeprazole

(ee so MEP ra zol)

What is esomeprazole?What is the price of this medication and similar alternatives?What are the possible side effects of esomeprazole?How should I take esomeprazole?What is the most important information I should know about esomeprazole?What happens if I miss a dose?What other drugs will affect esomeprazole?Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?Who should NOT use this medication?What happens if I overdose?What should I discuss with my healthcare provider before taking esomeprazole?Can I stop taking the medication if I feel better?I am on so many medications; do I have to take them all?Where can I get more information?

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).

What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Nexium 20MG CPDR	ASTRAZENECA LP	30/$164.31 or 90/$448.22
Nexium 40MG CPDR	ASTRAZENECA LP	30/$149.99 or 90/$429.97

What are the possible side effects of esomeprazole?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

headache;
diarrhea;
nausea, stomach pain, gas, constipation; or
dry mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

How should I take esomeprazole?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. This medicine is usually given for 4 to 8 weeks only. Your doctor may recommend a second course of treatment if you need additional healing time. Take each dose with a full glass (8 ounces) of water. Esomeprazole should be taken at least one hour before a meal. 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 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.

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What other drugs will affect esomeprazole?
Before taking esomeprazole, tell your doctor if you are using any of the following drugs: atazanavir (Reyataz); digoxin (Lanoxin, Lanoxicaps); diazepam (Valium); ketoconazole (Nizoral); iron (Feosol, Mol-Iron, Fergon, Femiron, others); or a blood thinner such as warfarin (Coumadin). This list is not complete and there may be other drugs that can interact with esomeprazole. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Esomeprazole has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity or fetal harm at therapeutic doses. However, doses of 5.5 to 56 times the human dose on a body surface area basis have produced dose-related embryolethality and fetal resorption. There are no controlled data in human pregnancy. Esomeprazole is only recommended for use during pregnancy when benefit outweighs risk.

There are no data on the excretion of esomeprazole into human milk. However, the potential for tumorigenicity with omeprazole administration has been illustrated in rat carcinogenicity studies. Because esomeprazole is the S-isomer of omeprazole which is excreted into human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Who should NOT use this medication?

Known hypersensitivity to esomeprazole, any ingredient in the formulation, or other substituted benzimidazoles (e.g., lansoprazole, omeprazole, pantoprazole, rabeprazole).

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include confusion, headache, drowsiness, blurred vision, fast heartbeat, nausea, dry mouth, sweating, flushing, shortness of breath, tremor, loss of coordination, or seizure (convulsions).

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.

Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

Where can I get more information?
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