Indication for ZEGERID
ZEGERID® (omeprazole/sodium bicarbonate) is a prescription medicine called a proton pump inhibitor (PPI). ZEGERID reduces the amount of acid in your stomach.
ZEGERID is used in adults for:
- short term to heal ulcers in the first part of the small bowel (duodenal ulcers).
- short term healing of stomach ulcers.
- treatment of heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
- healing of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE).
- maintenance of healing of the esophagus. It is not known if ZEGERID is safe and effective if used longer than 12 months (1 year).
- reduction of the risk of stomach bleeding in critically ill people.
Important Safety Information about ZEGERID
Do not take ZEGERID® (omeprazole/sodium bicarbonate) if you are allergic to omeprazole or any of the other ingredients in ZEGERID, or are allergic to any other proton pump inhibitor (PPI) medicine.
Before you take ZEGERID, tell your doctor if you have been told that you have low magnesium, calcium, or potassium levels in your blood, liver problems, heart failure, or have Bartter’s syndrome (a rare kidney disorder).
Tell your doctor about all the medicines you take, including prescription and non-prescription drugs, anti-cancer drugs, 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. Be sure to tell your doctor if you are taking:
- Mycophenolate mofetil (Cellcept)
- diazepam (Valium®)
- warfarin (Coumadin® Jantoven)
- phenytoin (Dilantin®)
- cyclosporine (Gengraf, Neoral, Sandimmune)
- disulfiram (Antabuse®)
- a benzodiazepine medicine
- ketoconazole (Nizoral®)
- an antibiotic that contains ampicillin
- products that contain irondigoxin (Lanoxin®)
- voriconazole (Vfend®)
- atazanavir (Reyataz®)
- nelfinavir (Viracept®)
- tacrolimus (Prograf®)
- saquinavir (Fortovase®)
- clarithromycin (Biaxin®, Biaxin XL)
- clopidogrel (Plavix®)
- St. John's Wort (Hypericum perforatum)
- rifampin (Rifater, Rifamate, Rimactane, Rifadin)
Do not substitute two 20 mg capsules for one 40 mg capsule of ZEGERID because you will receive twice the amount of sodium bicarbonate. 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.
Taking ZEGERID for a long period of time may increase the risk of inflammation to your stomach lining (atrophic gastritis). You may or may not have symptoms. Tell your doctor if you have stomach pain, nausea, vomiting, or weight loss.
ZEGERID may cause vitamin B-12 deficiency. ZEGERID reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on ZEGERID for a long time (more than 3 years).
Your doctor may stop ZEGERID if you have 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.
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.
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.
It is not known if ZEGERID is safe and effective in children and adolescents less than 18 years of age.
If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking ZEGERID. It is unknown if ZEGERID can harm your unborn baby.
The most common side effects with ZEGERID include headache, abdominal pain, nausea, diarrhea, vomiting, and gas. However, tell your doctor right away if you develop the following symptoms: seizures, dizziness, abnormal or fast heartbeat, jitteriness, jerking movements or shaking (tremors), muscle weakness, spasms of the hands and feet, cramps or muscle aches, spasm of the voice box.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Please see complete Medication Guide and Prescribing Information for ZEGERID.
ZEGERID is a registered trademark of Santarus, Inc, a wholly owned subsidiary of
Salix Pharmaceuticals, Inc.
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.