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Esomeprazole Magnesium Powder for Oral suspension

It prevents the production of acid in the stomach

Generic Name: esomeprazole

Brand Names: Nexium

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: [Web] and [Web].

[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: [Web] and [Web].

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.

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
  • low levels of magnesium in the blood
  • an unusual or allergic reaction to esomeprazole, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. To prepare the suspension, empty the contents of the packet into a container with 1 tablespoon (15 ml) of water. Stir the mixture, and let it stand for 2 to 3 minutes to thicken. Once thickened, stir the mixture and drink it. You must drink the prepared suspension within 30 minutes of preparation. Take this medicine at least 1 hour before meals. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 month for selected conditions, precautions do apply.

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.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • atazanavir
  • nelfinavir

This medicine may also interact with the following medications:

  • ampicillin
  • digoxin
  • diuretics
  • iron salts
  • itraconazole
  • ketoconazole
  • warfarin

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.

You may need blood work done while you are taking this medicine.

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
  • bone, muscle or joint pain
  • breathing problems
  • chest pain or chest tightness
  • dark yellow or brown urine
  • fast, irregular heartbeat
  • feeling faint or lightheaded
  • fever or sore throat
  • muscle spasms
  • tremors
  • unusual bleeding or bruising
  • unusually weak or tired
  • upset stomach
  • yellowing of the eyes or skin

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

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

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.

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.


Last Updated: June 24, 2013
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