Overview
Omeprazole and Sodium Bicarbonate capsules are 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]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion.
Mechanism of Action
12.1 Mechanism of Action Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acidpump inhibitor, in that it blocks the final step of acid production. This effect is dose related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. 12.
Indications
- Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.
Common Doses
- 20 mg
- 40 mg
- 100 mg
- 304 mg
Dosage
2.1 Important Administration Instructions Omeprazole and Sodium Bicarbonate is available as a capsule in 20 mg and 40 mg strengths of omeprazole for adult use. All recommended doses throughout the labeling are based upon omeprazole. The sodium content of Omeprazole and Sodium Bicarbonate capsules should be taken into consideration when prescribing this product [see Warnings and Precautions (5.3)]: Omeprazole and Sodium Bicarbonate capsule: each 20 mg and 40 mg capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg.
Contraindications
- Omeprazole and Sodium Bicarbonate capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)]. Proton pump inhibitors (PPIs), including Omeprazole and Sodium Bicarbonate capsules, are contraindicated in patients receiving rilpivirine containing products[see Drug Interactions (7)].
Side Effects
- The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)] Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.4)] Bone Fracture [see Warnings and Precautions (5.5)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6)] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.7)] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.9)] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.
Interactions
- Tables 6 and 7 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 6: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable.