OMEPRAZOLE/BICARBONATE- omeprazole and sodium bicarbonate capsule, gelatin coated
Westminster Pharmaceuticals, LLC
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.
- The efficacy of omeprazole and sodium bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of omeprazole and sodium bicarbonate may be considered.
- maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.
- 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.
- Due to the sodium bicarbonate content of omeprazole and sodium bicarbonate capsules:
- Two 20 mg omeprazole and sodium bicarbonate capsules are not interchangeable with one 40 mg omeprazole and sodium bicarbonate capsule.
The recommended dosage regimen by indication in adults of omeprazole and sodium bicarbonate capsules is summarized in Table 1. All recommended dosages are based upon omeprazole content.
|Indication||Dosage of Omeprazole and Sodium Bicarbonate Capsules||Treatment Duration|
|Treatment of Active Duodenal Ulcer||20 mg once daily||4 weeks *, †|
|Treatment of Active Benign Gastric Ulcer||40 mg once daily||4 to 8 weeks|
|Treatment of Symptomatic GERD||20 mg once daily||Up to 4 weeks|
|Treatment of EE due to Acid-Mediated GERD||20 mg once daily||4 to 8 weeks †|
|Maintenance of Healing of EE due to Acid-Mediated GERD||20 mg once daily||Controlled studies do not extend beyond 12 months.|
Omeprazole and Sodium Bicarbonate Capsules
- Swallow capsules intact with water. Do not open the capsule and do not administer with liquids other than water.
- Take on an empty stomach at least one hour before a meal [see Clinical Pharmacology (12.3)].
Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: White to off white powder filled in size “00” hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted “SG” on cap and “363” on body with black ink.
Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: White to off white powder filled in size “00” hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted “SG” on cap and “364” on body with black ink.
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), Adverse Reactions (6.2)]. Proton pump inhibitors (PPIs), including omeprazole and sodium bicarbonate, are contraindicated in patients receiving rilpivirine containing products [see Drug Interactions (7)].
In adults, symptomatic response to therapy with omeprazole and sodium bicarbonate does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a proton pump inhibitor (PPI). In older patients, also consider an endoscopy.
Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea and anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue omeprazole and sodium bicarbonate and evaluate patients with suspected acute TIN [see Contraindications (4)].
Each 20 mg and 40 mg omeprazole and sodium bicarbonate capsule contains 1100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg.
Chronic 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 gain.
The sodium content of omeprazole and sodium bicarbonate products should be taken into consideration when administering to patients on a sodium-restricted diet or those at risk for developing congestive heart failure.
Avoid omeprazole and sodium bicarbonate in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance.
Published observational studies suggest that PPI therapy like omeprazole and sodium bicarbonate may be associated with an increased risk of Clostridium difficile- associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)].
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.