Adult Dosing

Short-term treatment of active duodenal ulcer

• Recommended dose: 20 mg PO qd x 4 wks

Benign gastric ulcer

• Recommended dose: 40 mg PO qd x 4-8 wks

Gastroesophageal reflux disease (GERD)

Symptomatic GERD with no esophageal erosions

• Recommended dose: 20 mg PO qd x 4 wks

Erosive esophagitis

• Recommended dose: 20 mg PO qd x 4-8 wks

Maintenance of healing of erosive esophagitis

• Recommended dose: 20 mg PO qd

Reduction of risk of upper GI bleeding in critically ill patients

• Suspension (40 mg oral suspension only)
• Recommended dose: 40 mg PO qd followed by 40 mg PO 6-8 hrs later and then 40 mg PO qd x 14 days

GI hypersecretory conditions [Not FDA approved]

• Initial dose: 60 mg PO qd
• Dose exceeding 80 mg should be administered in divided doses
• Max: 120 mg tid

Treatment of heartburn (Zegerid OTC)

• 1 cap PO qd x 14 days
• May repeat a 14-day course every 4 months
• Max: 1 cap/24 hrs

• Dose should be taken on an empty stomach at least one hour before a meal
• Capsules should be swallowed intact with water; do not use other liquids
• Do not cut, chew, or crush the capsule; do not open capsule and sprinkle contents into food

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Short-term treatment of active benign gastric ulcer and active duodenal ulcer
• Treatment of heartburn and symptoms associated with GERD
• Short-term treatment of erosive esophagitis (EE)
• Maintenance of healing of EE
• Reduction of risk of upper GI bleeding in critically ill patients (40 mg suspension only)

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustment

Hepatic Dose Adjustment

• Hepatic Impairment: Consider decreasing dose; specific dose adjustment not defined

See Supplemental Patient Information

• Symptomatic response to therapy does not preclude the presence of gastric malignancy
• Prolonged treatment with omeprazole may result in atrophic gastritis that has been noted occasionally in gastric corpus biopsies
• Consider sodium content of this combination drug when administering therapy to patients on a sodium-restricted diet. Use cautiously in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance. Prolonged administration of bicarbonate with calcium or milk may cause milk-alkali syndrome. Chronic use of sodium bicarbonate may cause systemic alkalosis and increased sodium intake may produce edema and weight increase
• Long-term and multiple daily doses PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated
• Rare cases of symptomatic and asymptomatic hypomagnesemia have been reported in patients treated with PPIs for at least 3 months. However, serious adverse reactions such as tetany, arrhythmias, and seizures have been reported in cases treated for more than a year. If hypomagnesemia occurs, consider magnesium replacement and discontinuation of the PPI
• Avoid co-administration with clopidogrel as it reduces the pharmacological activity of clopidogrel when given concomitantly or when given 12 hrs apart
• Concomitant use with methotrexate may elevate and prolong serum levels of methotexate and/or its metabolite, possibly causing methotrexate toxicities. Consider temporary withdrawal of the PPI in patients receiving high-dose methotrexate administration
• Consider monitoring magnesium levels prior to initiation of therapy and periodically thereafter
• Avoid therapy use if there is trouble or pain swallowing food, vomiting with blood, and bloody or black stools
• Avoid concomitant use of St John’s Wort or rifampin as it may decrease omeprazole concentration
• Drug-induced decrease in gastric acidity may result in increase serum chromogranin A (CgA) levels and may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop omeprazole treatment before assessing CgA levels and consider repeating the test if initial CgA levels are high

Cautions: Use cautiously in

• Hepatic impairment
• Alkalosis
• Bartter syndrome
• Hypocalcemia
• Hypokalemia
• Hypomagnesemia
• Sodium restriction
• CHF
• Prolonged use
• Treatment with high dose
• Elderly patients

Supplemental Patient Information

• Inform patients that chronic use of sodium bicarbonate may cause problems and increased sodium intake may cause swelling and weight gain
• Advise patients to use this drug with caution if they are regularly taking calcium supplements
• Instruct patients to promptly report their physician if they develop any cardiovascular or neurological symptoms including dizziness, palpitations, seizures, and tetany as these may be signs of hypomagnesemia

Pregnancy Category:C

Breastfeeding: Limited information indicates that maternal omeprazole would not be expected to cause any adverse effects in breastfed infants. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 June 2011). As per manufacturer's data, because of the potential for serious adverse reactions in nursing infants from omeprazole, a decision should be made to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother. Use sodium bicarbonate cautiously in nursing mothers.

• CV: Atrial fibrillation (critically ill patients), bradycardia, tachycardia (critically ill patients), hypertension (critically ill patients), CHF exacerbation, hypotension
• CNS: Headache, seizures, tetany
• GI: Hepatic impairment, nausea, vomiting, flatulence, diarrhea, atrophic gastritis (long-term use), pancreatitis, Clostridium difficile associated diarrhea, abdominal pain
• GU: Interstitial nephritis
• HEMA: Blood dyscrasias, thrombocytopenia (critically ill patients)
• METABOLIC: Alkalosis, hypomagnesemia (long-term use), hypophosphatemia
• DERM: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
• RESP: URTI, nosocomial pneumonia (critically ill patients)
• MUSC: Fractures
• MISC: Hyperpyrexia, oral candidiasis (critically ill patients)

Omeprazole

• Proton pump inhibitor (PPI); decreases gastric acid secretion and increases gastric mucus and bicarbonate production, creating protective coating on gastric mucosa and easing discomfort from excess gastric acid
• Absolute bioavailability (compared with IV administration): 30-40% at doses of 20-40 mg
• Extensively metabolized in the liver
• Excreted in urine (77%) and the remainder is eliminated in feces
• Half-life: 0.5-1 hr (increased in hepatic impairment)

Sodium bicarbonate

• Alkalinizing agent; increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis; also increases the excretion of free bicarbonate ions in the urine, causing alkalinization of urine
• Metabolism: Unknown
• Renally excreted
• Half-life: Unknown

US Trade Name(s)

• Zegerid
• Zegerid OTC

US Availability

omeprazole/sodium bicarbonate (generic)

• CAPS:
• 20 mg/1.1 g
• 40 mg/1.1 g

Zegerid (omeprazole/sodium bicarbonate)

• SUSP:
• [20 mg/1.68 g]/packet
• [40 mg/1.68 g]/packet

• CAPS:
• 20 mg/1.1 g
• 40 mg/1.1 g

Zegerid OTC

• CAPS: 20 mg/1.1 g
• SUSP: [20 mg/1.68 g]/packet]

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Gastrointestinal

Proton Pump Inhibitor Combination

Pricing data from www.DrugStore.com in U.S.A.

• Zegerid 20-1680 MG PACK [Packet] (SANTARUS)
  30 mg = $282.14
  90 mg = $815.06
• Zegerid 40-1100 MG CAPS [Bottle] (SANTARUS)
  30 mg = $298.94
  90 mg = $850.89
• Zegerid 40-1680 MG PACK [Packet] (SANTARUS)
  30 mg = $296.69
  90 mg = $844.25
• Omeprazole-Sodium Bicarbonate CAPS [Bottle] (PRASCO LABORATORIES)
  30 = $185.99
  90 = $525.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Zegerid Reformulated Aug 2006 (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule

Ingredient(s): Omeprazole mixture with Sodium Bicarbonate

Imprint: 20

Color(s): White

Shape: Capsule

Size (mm): 23.00

Score: 1

Inactive Ingredient(s): croscarmellose sodium / sodium stearyl fumarate

Drug Label Author:
Santarus, Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Zegerid Reformulated Aug 2006 (omeprazole 40 MG / sodium bicarbonate 1100 MG) Oral Capsule

Ingredient(s): Omeprazole mixture with Sodium Bicarbonate

Imprint: 40

Color(s): Blue, White

Shape: Capsule

Size (mm): 23.00

Score: 1

Inactive Ingredient(s): croscarmellose sodium / sodium stearyl fumarate

Drug Label Author:
Santarus, Inc.

DEA Schedule:
Non-Scheduled