Omeprazole and sodium bicarbonate

What is Omeprazole and sodium bicarbonate?

• Omeprazole and sodium bicarbonate (Zegerid) is a proton pump inhibitor used for the treatment of duodenal ulcer, benign gastric ulcer, gastroesophageal reflux disease (GERD), erosive esophagitis and reduction of risk of upper GI bleeding.

What are the uses of this medicine?

• Omeprazole and sodium bicarbonate (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.

How does this medicine work?

• Omeprazole (oh mep' ra zole), like other PPIs, inhibits gastric acid production by binding to and inactivating the H+/K+-ATPase of gastric parietal cells, causing inhibition of the proton pump that transports H+ into the gastric lumen, the common final step in gastric acid production.
• Omeprazole is a prodrug and is converted to the active form (sulfenic acid) in the acidic secretory canaliculi of parietal cells.
• Because the inhibition is irreversible, acid secretion is suppressed for 24 to 48 hours, until new proton pump molecules have been synthesized and transported to the cell membrane.
• Zegerid Capsules and Powder for Oral Suspension are immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity to any components of the formulation

What drug interactions can this medicine cause?

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:

• 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

Is this medicine FDA approved?

• Initial U.S. Approval: 2004

How should this medicine be used?

Recommended dosage: 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:

• (40mg oral suspension only) 40 mg initially followed by 40 mg 6-8 hours later and 40 mg daily thereafter for 14 days.

Administration:

• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths

This medicine is available in fallowing brand namesː

• Zegerid

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• abdominal pain
• nausea
• diarrhea
• vomiting
• gas
• Using Zegerid for a long time may cause problems like swelling and weight gain.
• 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.

Zegerid may cause serious side effects include:

• Serious allergic reactions
• Low magnesium levels in your body

What special precautions should I follow?

• Symptomatic response to therapy with Zegerid does not preclude the presence of gastric malignancy.
• Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.
• Contains sodium bicarbonate. Because Zegerid products contain sodium bicarbonate, they should be used with caution in patients with Bartter's syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance. Long-term administration of bicarbonate with calcium or milk can cause milk-alkali syndrome. Chronic use of sodium bicarbonate may lead to systemic alkalosis and increased sodium intake can produce edema and weight increase.
• 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.
• Clopidogrel is a prodrug. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that interfere with CYP2C19 activity. Avoid concomitant use of clopidogrel and omeprazole.
• Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Omeprazole overdose:

• may cause confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth.

sodium bicarbonate overdose:

• may cause hypocalcemia, hypokalemia, hypernatremia, and seizures.

Management of overdosage:

• No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
• As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose, a certified Regional Poison Control Center should be contacted.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies on the use of omeprazole in pregnant women.
• It is not known if Zegerid can harm your unborn baby.
• Talk to your doctor if you are pregnant or plan to become pregnant.

Can this medicine be used in children?

• Safety and effectiveness of Zegerid have not been established in pediatric patients less than 18 years of age.

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

• Zegerid® is a registered trademark of Santarus, Inc.
• Zegerid® Capsules are manufactured for Santarus, Inc., San Diego, CA by Norwich Pharmaceuticals, Inc., North Norwich, NY 13814.
• Zegerid® Powder for Oral Suspension is manufactured for Santarus, Inc. by Patheon Inc., Whitby, Ontario L1N 5Z5, Canada.

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Omeprazole and sodium bicarbonate
• FDA Omeprazole and sodium bicarbonate

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