Overview
11 DESCRIPTION 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.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 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 acid-pump 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
- 1 INDICATIONS AND USAGE Omeprazole and Sodium Bicarbonate for oral suspension and 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 DOSAGE AND ADMINISTRATION Indication ( 2 ) Recommended Adult Dosage ( 2 ) Omeprazole and Sodium Bicarbonate for oral suspension or Omeprazole and Sodium Bicarbonate capsules ( 2 ) Active Duodenal Ulcer ( 2 ) 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks ( 2 ) Active Benign Gastric Ulcer ( 2 ) 40 mg once daily for 4 to 8 weeks ( 2 ) Treatment of Symptomatic GERD ( 2 ) 20 mg once daily for up to 4 weeks ( 2 ) Treatment of EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks* ( 2 ) Maintenance of Healing of EE due to Acid-Mediated GERD ( 2 ) 20 mg once...
Contraindications
- 4 CONTRAINDICATIONS Omeprazole and Sodium Bicarbonate is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2) Error! Hyperlink reference not valid. Adverse Reactions (6.2)] .
Side Effects
- 6 ADVERSE REACTIONS 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.
Interactions
- 7 DRUG 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.