ACID CONTROL THAT HOLDS STRONG
  ZEGERID(R) omeprazole/sodium bicarbonate
  ACID CONTROL THAT HOLDS STRONG
  Long-lasting acid control that covers patients for 24 hours

  *Powder for oral suspension.

  ZEGERID 40 mg maintained gastric pH >4 for a median 18.6 hours1
 
The correlation of pharmacodynamic data to clinical effect has not been established.

Available for $10 with ZEGERID Instant Savings Card for most patients with commercial insurance

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INDICATION
ZEGERID is a proton pump inhibitor indicated for:
Short-term treatment of active duodenal ulcer.
Short-term treatment of active benign gastric ulcer.
Treatment of gastroesophageal reflux disease (GERD).
Maintenance of healing of erosive esophagitis.
Reduction of risk of upper GI bleeding in critically ill patients.
DOSAGE AND ADMINISTRATION
Short-Term Treatment of Active Duodenal Ulcer: 20 mg once daily for 4 weeks (some patients may require an additional 4 weeks of therapy).
Gastric Ulcer: 40 mg once daily for 4-8 weeks.
Gastroesophageal Reflux Disease (GERD)
—Symptomatic GERD (with no esophageal erosions): 20 mg once daily for up to 4 weeks.
—Erosive Esophagitis: 20 mg once daily for 4-8 weeks.
Maintenance of Healing of Erosive Esophagitis: 20 mg once daily.
Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients: (40 mg oral suspension only) 40 mg initially followed by 40 mg 6-8 hours later and 40 mg daily thereafter for 14 days.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ZEGERID is contraindicated in patients with known hypersensitivity to any components of the formulation.
WARNINGS AND PRECAUTIONS
Concomitant Gastric Malignancy: Symptomatic response to therapy with ZEGERID does not preclude the presence of gastric malignancy.
Atrophic Gastritis: Has been observed in gastric corpus biopsies from patients treated long-term with omeprazole.
Buffer Content: Contains sodium bicarbonate.
PPI therapy may be associated with increased risk of Clostridium difficile–associated diarrhea.
Avoid concomitant use of ZEGERID with clopidogrel.
Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.
Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
Avoid concomitant use of ZEGERID with St. John’s Wort or rifampin due to the potential reduction in omeprazole concentrations.
Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors.
ADVERSE REACTIONS
Most common adverse reactions (incidence >2%) are headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.
DRUG INTERACTIONS
ZEGERID may interfere with absorption of some drugs due to inhibition of gastric acid secretion.
ZEGERID can prolong the elimination of some drugs metabolized by cytochrome P450.
Concomitant treatment of PPIs and warfarin may warrant monitoring for increases in INR/ prothrombin time.
Voriconazole: May increase plasma levels of omeprazole.
Saquinavir: ZEGERID increases plasma levels of saquinavir.
Atazanavir and nelfinavir: ZEGERID may reduce plasma levels of atazanavir and nelfinavir.
Clopidogrel: ZEGERID decreases exposure to the active metabolite of clopidogrel.
Tacrolimus: ZEGERID may increase serum levels of tacrolimus.
Methotrexate: ZEGERID may increase serum levels of methotrexate.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based upon animal data, may cause fetal harm.
Pediatric Use: Safety and effectiveness of ZEGERID in pediatric patients less than 18 years of age have not been established.
Hepatic Impairment: Consider dose reduction, particularly for maintenance of healing of erosive esophagitis.

The Important Safety Information does not include all the information needed to use ZEGERID safely and effectively. See Full Prescribing Information for additional information.

Study Design
 
 
 
Results from a pharmacokinetic/pharmacodynamic study of the antisecretory effect of repeated once-daily dosing of ZEGERID Powder for Oral Suspension 40 mg and 20 mg in 52 healthy subjects.1

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Santarus, Inc(R) ZEGERID is a registered trademark of Santarus, Inc.

© 2013 Santarus, Inc. 1-ZEG13305 August 2013 Reference: 1. ZEGERID Prescribing Information.
Santarus, Inc. November 2012.