Omeprazole And Sodium Bicarbonate

Omeprazole And Sodium Bicarbonate

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Questions & Answers

Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

1.1 Duodenal Ulcer

Omeprazole and sodium bicarbonate is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical Studies (14.1)]

1.2 Gastric Ulcer

Omeprazole and sodium bicarbonate is indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer. (See Clinical Studies (14.2)]

1.3 Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD

Omeprazole and sodium bicarbonate is indicated for the treatment of heartburn and other symptoms associated with GERD. [See Clinical Studies (14.3)]

Erosive Esophagitis

Omeprazole and sodium bicarbonate is indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.

The efficacy of omeprazole and sodium bicarbonate used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole and sodium bicarbonate may be considered. [See Clinical Studies (14.3)]

1.4 Maintenance of Healing of Erosive Esophagitis

Omeprazole and sodium bicarbonate capsules is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months . [See Clinical Studies (14.4)]

History

There is currently no drug history available for this drug.

Other Information

Omeprazole and sodium bicarbonate is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its structural formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:

structure

Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.

Omeprazole and sodium bicarbonate is supplied as as immediate-release capsules. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and magnesium stearate. The capsules consist of black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. In addition the ink consists of D&C Yellow #10 aluminum lake, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, FD&C Blue #1 aluminum lake and shellac glaze~45% (20% esterfied) in ethanol.

Omeprazole And Sodium Bicarbonate Manufacturers


  • Par Pharmaceutical Inc.
    Omeprazole And Sodium Bicarbonate Capsule [Par Pharmaceutical Inc.]
  • Oceanside Pharmaceuticals
    Omeprazole And Sodium Bicarbonate (Omepraziole, Sodium Bicarbonate) Capsule Omeprazole And Sodium Bicarbonate (Omeprazole, Sodium Bicarbonate) Capsule [Oceanside Pharmaceuticals]

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