Esomeprazole

Esomeprazole is a prescription medication used to treat gastroesophageal reflux disease, or GERD. It is also used to heal acid-related damage to the lining of the esophagus, and to prevent ulcers caused by NSAIDs and H. Pylori bacteria. Esomeprazole belongs to a group of drugs called proton pump inhibitors. These work by decreasing the amount of acid produced in the stomach.

This medication is available as delayed capsules and as packets for preparation of delayed-release oral suspensions. The oral forms are usually taken once a day, at least one hour before a meal.

Esomeprazole is also available in an injectable for to be given directly into a vein (IV) by a healthcare provider, usually once daily.

Common side effects include headache, diarrhea, and nausea.

Esomeprazole is a prescription medication used to treat the symptoms of gastroesophageal reflux disease (GERD). Esomeprazole may also be prescribed to heal acid-related damage to the lining of the esophagus (erosive esophagitis), and to help continue this healing. Esomeprazole is also used to prevent ulcers caused by NSAIDs and H. Pylori bacteria, and for Zollinger-Ellison syndrome.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Esomeprazole may be found in some form under the following brand names:

• Nexium

Esomeprazole can cause serious side effects. See the "Esomprazole Precautions" section.

Common side effects of esomeprazole include:

• headache
• diarrhea
• nausea
• gas
• abdominal pain
• constipation
• dry mouth
• drowsiness

People who are taking multiple daily doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist or spine.

Using esomeprazole for a long period of time may increase the risk of inflammation to your stomach lining. You may or may not have symptoms. Tell your doctor if you have stomach pain, nausea, vomiting, or weight loss.

Tell your doctor about any side effects that bother you or that do not go away. These are not all the possible side effects with esomeprazole. Talk with your doctor or pharmacist if you have any questions about side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all of the medicines you take including prescription and non-prescription drugs, vitamins and herbal supplements. Esomeprazole may affect how other medicines work, and other medicines may affect how esomeprazole works. Especially tell your doctor if you take:

• warfarin (Coumadin, Jantoven)
• ketoconazole (Nizoral)
• voriconazole (Vfend)
• atazanavir (Reyataz)
• nelfinavir (Viracept)
• saquinavir (Fortovase)
• products that contain iron
• digoxin (Lanoxin, Lanoxicaps)
• St.John’s Wort (Hypericum perforatum)
• Rifampin (Rimactane, Rifater, Rifamate)
• cilostazol (Pletal)
• diazepam (Valium)
• tacrolimus (Prograf)
• Erlotinib (Tarceva)
• Methotrexate
• clopidogrel (Plavix)

This is not a complete list of esomeprazole drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Nexium including the following:

• Diarrhea. Esomeprazole may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
• Bone fractures. People who take multiple daily doses of Proton Pump Inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take esomeprazole exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take esomeprazole.
• Esomeprazole can cause serious allergic reactions. Tell your doctor if you get any of the following symptoms:
• Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you have any of these symptoms:

• rash
• face swelling
• throat tightness
• difficulty breathing
• seizures
• dizziness
• abnormal or fast heart beat
• jitteriness
• jerking movements or shaking (tremors)
• muscle weakness
• spasms of the hands and feet
• cramps or muscle aches
• spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking esomeprazole or during treatment if you will be taking esomeprazole for a long period of time.

Do not take esomeprazole if you:

• are allergic to esomeprazole or to any of its ingredients
• are allergic to any other Proton Pump Inhibitor (PPI) medicine

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of esomeprazole there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor about all your medical conditions, including if you:

• have been told that you have low magnesium levels in your blood
• have liver problems
• are pregnant or breastfeeding

Tell your doctor about all of the medicines you take including prescription and non-prescription drugs, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Esomeprazole falls into category B. There are no well-done studies that have been done in humans with esomeprazole. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if esomeprazole crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using esomeprazole.

Esomeprazole delayed-release capsules:

• Take esomeprazole exactly as prescribed by your doctor.
• Do not change your dose or stop esomeprazole without talking to your doctor.
• Take esomeprazole at least 1 hour before a meal.
• Swallow esomeprazole capsules whole. Never chew or crush esomeprazole.
• If you have difficulty swallowing esomeprazole capsules, you may open the capsule and empty the contents into a tablespoon of applesauce. Be sure to swallow the applesauce right away. Do not store it for later use.
• If you forget to take a dose of esomeprazole, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take a double dose to make up for a missed dose.
• If you take too much esomeprazole, tell your doctor right away.

Esomeprazole for delayed-release oral suspension:

• Esomeprazole for delayed-release oral suspension comes in foil packets containing 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg strengths.
• You should use an oral syringe to measure the amount of water needed to mix your dose. Ask your pharmacist for an oral syringe.
• If your prescribed dose is 2.5 mg or 5 mg, add 5 mL of water to a container, then add the contents of a foil packet containing the dose prescribed by your doctor.
• If your prescribed dose is 10 mg, 20 mg, or 40 mg, add 15 mL of water to a container, then add the contents of a foil packet containing the dose prescribed by your doctor.
• If you or your child are instructed to use more than one foil packet for the prescribed dose, follow the mixing instructions provided by your pharmacist or doctor.
• Stir.
• Leave 2 to 3 minutes to thicken.
• Stir and take dose within 30 minutes. If not used within 30 minutes, throw away this dose and mix a new dose.
• If any medicine remains after drinking, add more water, stir, and take dose right away.
• For young children, you can give the dose with an oral syringe. Rinse the oral syringe with water after each use.

Esomeprazole delayed-release capsules and esomeprazole for delayed-release oral suspension may be given through a nasogastric (NG) tube or gastric tube, as prescribed by your doctor. Follow the instructions below:

Esomeprazole Delayed-Release Capsules through NG tube:

• Open the capsule and empty the granules into a 60 mL catheter tipped syringe. Mix with 50 mL of water. Use only a catheter tipped syringe to give esomeprazole through a NG tube.
• Replace the plunger and shake the syringe well for 15 seconds. Hold the syringe with the tip up and check for granules in the tip.
• Give the medicine right away.
• Do not give the granules if they have dissolved or have broken into pieces.
• Attach the syringe to the NG tube. Give the medicine in the syringe through the NG tube into the stomach.
• After giving the granules, flush the NG tube with more water.

Esomeprazole for Delayed-Release Oral Suspension through NG tube:

• Esomeprazole for delayed-release oral suspension comes in foil packets containing 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg strengths.
• Use only a catheter tipped syringe to give esomeprazole through a NG tube or gastric tube
• If your prescribed dose is 2.5 mg or 5 mg, add 5 mL of water to a catheter tipped syringe, then add the contents of a foil packet containing the dose prescribed by your doctor.
• If your prescribed dose is 10 mg, 20 mg, or 40 mg, add 15 mL of water to a catheter tipped syringe, then add the contents of a foil packet containing the dose prescribed by your doctor.
• Shake the syringe right away and then leave it for 2 to 3 minutes to thicken.
• Shake the syringe and give the medicine through the NG or gastric tube (French size 6 or larger) into the stomach within 30 minutes.
• Refill the syringe with the same amount of water (either 5 mL or 15 mL of water depending on your dose).
• Shake the syringe and flush any remaining medicine from the NG tube or gastric tube into the stomach.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age
• your body weight

The recommended adult dose of esomeprazole for GERD is 20 ot 40 mg daily of oral or injectable forms.

If you take too much esomeprazole, call your local Poison Control Center or seek emergency medical attention right away.

If esomeprazole is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store esomeprazole capsules and packets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the container of esomeprazole closed tightly.
• Keep esomeprazole and all medicines out of the reach of children.