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

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.

You may open the delayed-release capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Esomeprazole can be given through a nasogastric (NG) feeding tube. Open the capsule and sprinkle the medicine into a 60-milliliter syringe. Mix in 50 milliliters of water. Place the plunger into the syringe and shake the mixture well. Make sure there are no medicine granules stuck in the tip of the syringe. Attach the syringe to the NG tube and push the plunger down to empty the syringe into the tube. Then flush the tube with more water to wash the contents down.

It is important to use esomeprazole regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before your treatment is completed. Store esomeprazole at room temperature away from moisture and heat.

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 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 avoid while taking esomeprazole?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using esomeprazole.

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.

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.

Where can I get more information?

Your pharmacist can provide more information about esomeprazole.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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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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