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Drug Notebook

Generic Name: esomeprazole

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Nexium, Nexium I.V.
A proton pump inhibitor - It prevents the production of acid in the stomach
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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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esomeprazole
(es oh ME pray zol)
What is this medicine?What is the price of this medication and similar alternatives?What side effects may I notice from receiving this medicine?How should I use this medicine?What if I miss a dose?What may interact with this medicine?Who should NOT use this medication?What should I watch for while using this medicine?What should I tell my health care provider before I take this medicine?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 this medicine?
ESOMEPRAZOLE (es oh ME pray zol) prevents the production of acid in the stomach. It is used to treat gastroesophageal reflux disease (GERD), ulcers, certain bacteria in the stomach, and inflammation of the esophagus. It can also be used to prevent ulcers in patients taking medicines called NSAIDs.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

NexIUM 20MG Delayed-release Capsules ASTRAZENECA LP30/$181.29 or 90/$494.53
NexIUM 40MG Delayed-release Capsules ASTRAZENECA LP30/$162.99 or 90/$471.97

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • chest pain or tightness
  • dark urine
  • unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • diarrhea or constipation
  • dry mouth
  • headache
  • nausea/vomiting
  • stomach pain or gas

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
Take this medicine by mouth. Swallow the capsules whole with a drink of water. Follow the directions on the prescription label. Do not crush, break or chew. The capsules can be opened and the contents sprinkled on applesauce. Do not crush the contents into the food. This medicine works best if taken on an empty stomach at least one hour before a meal. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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What may interact with this medicine?

  • ampicillin
  • digoxin
  • iron salts
  • itraconazole, ketoconazole, voriconazole, or other prescription medicines for fungus or yeast infections
  • warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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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). Hypersensitivity reactions (e.g., angioedema, anaphylactic shock) have been reported with use of esomeprazole.

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What should I watch for while using this medicine?
It can take several days before your stomach pains get better. Check with your doctor or health care professional if your condition does not start to get better, or if it gets worse.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • liver disease
  • an unusual or allergic reaction to esomeprazole, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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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.

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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.

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Where can I get more information?
More Information

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