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ZEGERID
(ze' ger id)
(omeprazole / sodium bicarbonate)

Powder for Oral Suspension and Capsules

Read the Patient Information that comes with ZEGERID before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is ZEGERID?

ZEGERID is a medicine called a proton pump inhibitor (PPI). ZEGERID reduces the amount of acid in your stomach.

ZEGERID is used in adults for:

• for 4 weeks to heal ulcers in the first part of the small bowel (duodenal ulcers). Your doctor may prescribe an additional 4 weeks of ZEGERID.
• for up to 8 weeks for healing stomach ulcers
• for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
  GERD is a chronic condition (lasts a long time) that occurs when acid from the stomach backs up into the esophagus (food pipe) causing symptoms, such as heartburn, or damage to the lining of the esophagus. Common symptoms include frequent heartburn that will not go away, a sour or bitter taste in the mouth, and difficulty swallowing.
• for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE)
• to maintain healing of the esophagus. ZEGERID has not been studied for treatment lasting longer than 12 months (1 year)
• to lower the risk of stomach bleeding in critically ill patients (40 mg Oral Suspension Only)

It is not known if ZEGERID is safe and effective in children and adolescents less than 18 years of age.

ZEGERID may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Who should not take ZEGERID?

Do not take ZEGERID if you:

• are allergic to any of the ingredients in ZEGERID. See the end of this leaflet for a complete list of ingredients in ZEGERID.
• are allergic to any other PPI medicine.

What should I tell my doctor before I take ZEGERID?

Before you take ZEGERID, tell your doctor if you:

• have been told that you have low magnesium levels in your blood.
• have any liver problems.
• have heart failure.
• have Bartter's syndrome (a rare kidney disorder).
• have any allergies.
• are pregnant or planning to become pregnant. It is not known if ZEGERID can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or planning to breastfeed. You and your doctor should decide if you will take ZEGERID or breastfeed. You should not do both. Sodium bicarbonate (a part of ZEGERID) should be used with caution in nursing mothers.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. ZEGERID may affect how other medicines work, and other medicines may affect how ZEGERID works. This can cause serious side effects. Know the medicines that you take. Keep a list of them with you and show it to your doctor when you get a new medicine. Be sure to tell your doctor if you are taking:

• diazepam (Valium)®
• warfarin (Coumadin)®
• phenytoin (Dilantin)®
• cyclosporine
• disulfiram (Antabuse)®
• benzodiazepines
• ketoconazole (Nizoral)®
• ampicillin sodium (Unazyn)® or ampicillin trihydrate (Principen)®
• iron salts
• digoxin
• voriconazole (Nizoral)®
• atazanavir (Reyataz)®
• nelfinavir (Viracept)®
• tacrolimus (Prograf)®
• saquinavir (Fortovase)®
• clarithromycin
• clopidogrel (Plavix)
• Methotrexate

How should I take ZEGERID?

• Take ZEGERID exactly as prescribed by your doctor. Do not change your dose or stop taking ZEGERID without talking to your doctor. Take ZEGERID for as long as it is prescribed even if you feel better.
• Take ZEGERID on an empty stomach at least one hour before a meal.
• Empty the contents of a packet of ZEGERID Powder for Oral Suspension into a small cup containing 1-2 tablespoons of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Refill cup with water and drink.
• Swallow ZEGERID Capsules whole with water. DO NOT USE OTHER LIQUIDS. Do not crush or chew the capsule. Do not open the capsule and sprinkle contents into food.
• If you forget to take a dose of ZEGERID, 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 at your regular time. Do not take two doses to make up for a missed dose.
• Do not substitute two 20 mg packets for one 40 mg packet of ZEGERID Powder for Oral Suspension because you will receive twice the amount of sodium bicarbonate. Talk to your doctor if you have questions.
• Do not substitute two 20 mg capsules for one 40 mg capsule of ZEGERID because you will receive twice the amount of sodium bicarbonate. Talk to your doctor if you have questions.
• If you take too much ZEGERID, call your doctor or Poison Control Center right away, or go to the emergency room.
• Your doctor may prescribe antibiotic medicines with ZEGERID to help treat a stomach infection and heal stomach-area (duodenal) ulcers that are caused by bacteria called H. pylori. Make sure you read the patient information that comes with an antibiotic before you start taking it.
• See the “Patient Instructions for Use” at the end of this leaflet for instructions on how to mix and give ZEGERID Powder for Oral Suspension through a nasogastric tube or orogastric tube.

What are the possible side effects of ZEGERID?

ZEGERID may cause serious allergic reactions. See the end of this leaflet for a complete list of ingredients in ZEGERID.

Serious allergic reactions. Tell your doctor if you get any of the following symptoms with ZEGERID.

• rash
• face swelling
• throat tightness
• difficulty breathing

Your doctor may stop ZEGERID if these symptoms happen.

• 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:

• 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 ZEGERID, or during treatment if you will be taking ZEGERID for a long period of time.

The most common side effects with ZEGERID include:

• headache
• abdominal pain
• nausea
• diarrhea
• vomiting
• gas

Using ZEGERID for a long time may cause problems like swelling and weight gain. Tell your doctor if this happens..

If you are on a low-sodium diet or at risk of developing congestive heart failure (CHF), you and your doctor should decide if you will take ZEGERID.

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.

Tell your doctor about any side effects that bother you or that do not go away. These are not all the possible side effects of ZEGERID. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

How should I store ZEGERID?

• Store ZEGERID in a dry place at room temperature, 59 °F to 86 °F (15 °C to 30 °C).

Keep ZEGERID and all medicines out of the reach of children.

General Information about ZEGERID

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use ZEGERID for any condition for which it was not prescribed by your doctor. Do not give ZEGERID to other people, even if they have the same symptoms as you. It may harm them.

This leaflet summarizes the most important information about ZEGERID. If you would like more information, talk to your doctor. You can also ask your doctor or pharmacist for information about ZEGERID that is written for healthcare professionals. For full product information, visit the website at http://www.santarus.com or call the toll-free number 1-888-778-0887.

Patient Instructions for Use

For instructions on taking ZEGERID Capsules and ZEGERID Powder for Oral Suspension by mouth, please see “How Should I Take ZEGERID?”

For giving ZEGERID Powder for Oral Suspension through a nasogastric tube (NG tube) or orogastric tube, as prescribed by your doctor. Follow the instructions below:

• Add 20 mL of water to a catheter tipped syringe and then add the contents of a packet as instructed by your doctor. Use only a catheter tipped syringe to give ZEGERID through a NG tube or orogastric tube.
• Shake the syringe to dissolve the powder.
• Give the medicine through the NG or orogastric tube into the stomach right away.
• Refill the syringe with an equal amount of water.
• Shake and flush any remaining contents from the NG tube or orogastric tube into the stomach.

What are the ingredients in ZEGERID?

Active Ingredients: omeprazole / sodium bicarbonate

Inactive ingredients of ZEGERID Powder for Oral Suspension: xylitol, sucrose, sucralose, xanthan gum, and flavorings.

Inactive ingredients of ZEGERID Capsules: croscarmellose sodium and sodium stearyl fumarate.

Last reviewed on RxList: 5/3/2012
This monograph has been modified to include the generic and brand name in many instances.