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Omeprazole

(oh me' pray zol)

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IMPORTANT WARNING:   Return to top

[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.

Why is this medication prescribed?   Return to top

Prescription omeprazole is used alone or with other medications to treat ulcers (sores in the lining of the stomach or small intestine), gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus (tube that connects the mouth and stomach), and erosive esophagitis (swelling and wearing away of the lining of the esophagus). Omeprazole delayed-release capsules are also used to treat conditions in which the stomach produces too much acid. Omeprazole delayed-release capsules are also used in combination with other medications to eliminate H. pylori(a bacteria that causes ulcers) and possibly prevent new ulcers from developing in patients who have or have had ulcers of the small intestine. Omeprazole powder for suspension (to be mixed with water) is also used to prevent bleeding from the esophagus, stomach, or the top of the small intestine in people who have life-threatening illnesses. Nonprescription omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 days a week). Omeprazole 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

Omeprazole comes as a delayed-release capsule (Prilosec), a nonprescription delayed-release tablet (Prilosec OTC), a powder for suspension (Zegerid) , and a regular capsule (Zegerid). The powder and regular capsule also contain sodium bicarbonate, a medication that decreases the amount of acid in the stomach and helps omeprazole to work quickly. The delayed-release capsules are usually taken once a day before a meal, but may be taken twice a day when used with other medications to eliminate H. pylori or up to three times a day when used to treat conditions in which the stomach produces too much acid. The capsules are usually taken once a day in the morning on an empty stomach one hour before a meal. The powder is usually taken once a day on an empty stomach one hour before a meal either in the morning or at bedtime. The nonprescription delayed-release tablets are usually taken once a day in the morning before eating. The nonprescription tablets should be taken for 14 days in a row, and additional 14-day treatments may be repeated once every 4 months if needed. To help you remember to take omeprazole, take it at around the same time(s) every day. Follow the directions on your prescription label or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take omeprazole exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor or stated on the package.

Swallow the regular omeprazole capsules with water. Do not swallow the capsules with any other liquid.

Swallow the delayed-release omeprazole capsules, the regular capsules, and the nonprescription delayed-release tablets whole; do not split, open, chew or crush them. Do not crush the nonprescription delayed-release tablets in food and do not open the regular capsules and mix the contents with food.

If you have difficulty swallowing the delayed-release capsules, you may add the contents of a delayed-release capsule to applesauce. Place one tablespoon of soft, cool applesauce in an empty bowl. Open the delayed-release capsule and carefully empty all the pellets inside the capsule onto the applesauce. Mix the pellets with the applesauce and swallow the mixture immediately with a glass of cool water. Do not chew or crush the pellets. Do not store the applesauce/pellet mixture for future use.

If you are taking the powder, you must mix it with water before use. Place 1-2 tablespoons of water into a small cup and add the contents of one powder packet. Mix well and drink the mixture immediately. Refill the cup with water and drink the water to be sure that you swallow all of the medication. Do not mix the medication with any other liquid or with food.

If you are taking the powder or the regular capsules, be sure that you are taking the strength and the number of capsules or powder packets that your doctor prescribed. If you were told to take one 40-mg capsule or powder packet, do not take two 20-mg capsules or powder packets instead. They do not contain the same amount of medication as one 40-mg capsule or packet.Ask your doctor or pharmacist if you have any questions about how many capsules or packets you should take.

Do not take nonprescription omeprazole for immediate relief of heartburn symptoms. It may take 1-4 days for you to feel the full benefit of the medication. Call your doctor if your symptoms get worse or do not improve after 14 days or if your symptoms return sooner than 4 months after you finish your treatment Do not take nonprescription omeprazole for longer than 14 days or more often than once every 4 months without talking to your doctor.

Your doctor may prescribe omeprazole for 10-14 days to eliminate H. pylori or for 4-8 weeks or longer to treat other conditions. Continue to take omeprazole even if you feel well. Do not stop taking prescription omeprazole 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?   Return to top

Before taking omeprazole,

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

What special dietary instructions should I follow?   Return to top

If you will be taking the regular capsules or the powder, your doctor may tell you to limit the amount of milk and other foods and drinks that are high in calcium that you eat and drink during your treatment. Follow these instructions carefully.

If you will be taking any other form of omeprazole, continue your normal diet unless your doctor tells you otherwise.

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?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Omeprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

Omeprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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 light,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:

What other information should I know?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor.

Do not let anyone else take your medication. If you are taking prescription omeprazole, ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names   Return to top

  • Prilosec®
  • Prilosec® OTC
  • Zegerid®

Last Revised - 12/01/2007
Last Reviewed - 08/01/2007


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