Omeprazole and Sodium Bicarbonate

OMEPRAZOLE AND SODIUM BICARBONATE — omeprazole and sodium bicarbonate capsule
Ajanta Pharma Limited

1 INDICATIONS AND USAGE

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 capsules 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 capsules may be considered.
  • maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.

2 DOSAGE AND ADMINISTRATION

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.
  • 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.

2.2 Dosage Regimen

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.

Table 1: Recommended Dosage Regimen of Omeprazole and Sodium Bicarbonate Capsules in Adults by Indication
1 Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy. [see Clinical Studies (14.1)] 2 The efficacy of Omeprazole and Sodium Bicarbonate capsules 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 capsules may be considered.
Indication Dosage of Omeprazole and Sodium Bicarbonate capsules Treatment Duration
Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks 1,2
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 2
Maintenance of Healing of EE due to Acid- Mediated GERD 20 mg once daily Controlled studies do not extend beyond 12 months

2.3 Preparation and Administration

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)].

3 DOSAGE FORMS AND STRENGTHS

Omeprazole and Sodium Bicarbonate is available as:

Capsules

  • 20 mg: Each opaque, hard gelatin, white/light orange capsule, with ‘OM 20’ imprint on body and ‘ap’ logo imprint on cap with black color ink, contains 20 mg omeprazole and 1,100 mg sodium bicarbonate.
  • 40 mg:Each opaque, hard gelatin, white/reddish pink capsule, with ‘OM 40’ imprint on body and ‘ap’ logo imprint on cap with black color ink, contains 40 mg omeprazole and 1,100 mg sodium bicarbonate.

4 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 interstitial 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)].

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with Omeprazole and Sodium Bicarbonate capsules 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.

5.2 Acute Interstitial Nephritis

Acute interstitial nephritis has been observed in patients taking PPIs including Omeprazole and Sodium Bicarbonate capsules. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Omeprazole and Sodium Bicarbonate capsules if acute interstitial nephritis develops. [see Contraindications (4).]

5.3 Sodium Bicarbonate Buffer Content

Each 20 mg and 40 mg Omeprazole and Sodium Bicarbonatecapsule contains 1,100 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 capsules in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance.

5.4 Clostridium difficile- Associated Diarrhea

Published observational studies suggest that PPI therapy like Omeprazole and Sodium Bicarbonate capsules 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.

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