Prescription Drug Information: Omeprazole and Sodium Bicarbonate

OMEPRAZOLE AND SODIUM BICARBONATE — omeprazole and sodium bicarbonate capsule
Aurolife Pharma, LLC

1 INDICATIONS AND USAGE

1.1 Duodenal Ulcer

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

Erosive Esophagitis

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

2 DOSAGE AND ADMINISTRATION

Omeprazole and sodium bicarbonate is available as a capsule in 20 mg and 40 mg strengths of omeprazole for adult use. Directions for use for each indication are summarized in Table 1.

All recommended doses throughout the labeling are based upon omeprazole.

Since both the 20 mg and 40 mg capsules contain the same amount of sodium bicarbonate (1100 mg), two capsules of 20 mg are notequivalent to one capsule of omeprazole and sodium bicarbonate 40 mg; therefore, two 20 mg capsules of omeprazole and sodium bicarbonate should not be substituted for one capsule of omeprazole and sodium bicarbonate 40 mg.

Omeprazole and sodium bicarbonate capsules should be taken on an empty stomach at least one hour before a meal.

Table 1: Recommended Doses of Omeprazole and Sodium Bicarbonate by Indication for Adults 18 Years and Older

Indication Recommended Dose Frequency
Short-Term Treatment of Active Duodenal Ulcer 20 mg Once daily for 4 weeks*,+
Benign Gastric Ulcer 40 mg Once daily for 4 to 8 weeks **,+
Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD (with no esophageal erosions) 20 mg Once daily for up to 4 weeks+
Erosive Esophagitis 20 mg Once daily for 4 to 8 weeks+
Maintenance of Healing of Erosive Esophagitis 20 mg Once daily**

* Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy. [See Clinical Studies (14.1)]

** Controlled studies do not extend beyond 12 months. [See Clinical Studies (14)]

+ For additional information, [See Indications and Usage (1)]

Special Populations

Hepatic Insufficiency

Consider dose reduction, particularly for maintenance of healing of erosive esophagitis. [See Clinical Pharmacology (12.3)]

Administration of Capsules

Omeprazole and sodium bicarbonate capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD.

3 DOSAGE FORMS AND STRENGTHS


Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg: each hard gelatin capsule has a light blue opaque cap and white opaque body, imprinted in black ink with ‘U’ on the cap, ‘88’ on the body and contains 20 mg omeprazole, USP and 1100 mg sodium bicarbonate, USP.

Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: each hard gelatin capsule has a dark blue opaque cap and white opaque body, imprinted in black ink with ‘U’ on the cap, ‘89’ on the body and contains 40 mg omeprazole, USP and 1100 mg sodium bicarbonate, USP.

4 CONTRAINDICATIONS


Omeprazole and sodium bicarbonate is contraindicated in patients with known hypersensitivity to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria. [See Adverse Reactions (6)]

5 WARNINGS AND PRECAUTIONS

5.1 Concomitant Gastric Malignancy


Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.

5.2 Atrophic gastritis


Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.

5.3 Acute Interstitial Nephritis

Acute interstitial nephritis has been observed in patients taking PPIs including omeprazole and sodium bicarbonate. 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 if acute interstitial nephritis develops. [See Contraindications (4)].

5.4 Cyanocobalamin (vitamin B-12) Deficiency

Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.

5.5 Buffer Content

Each omeprazole and sodium bicarbonate capsule contains 1100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg.

The sodium content of omeprazole and sodium bicarbonate capsules should be taken into consideration when administering to patients on a sodium restricted diet.

Because omeprazole and sodium bicarbonate capsules contain sodium bicarbonate, they should be used with caution in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance. Long-term 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 increase.

5.6 Clostridium difficile Associated Diarrhea

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.

5.7 Interaction with Clopidogrel

Avoid concomitant use of omeprazole and sodium bicarbonate with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that interfere with CYP2C19 activity. Concomitant use of clopidogrel with 80 mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using omeprazole and sodium bicarbonate, consider alternative anti-platelet therapy. [See Drug Interactions (7.5) and Pharmacokinetics (12.3)]

5.8 Bone Fracture


Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis- related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long- term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines. [See Dosage and Administration (2) and Adverse Reactions (6.2)]

5.9 Hypomagnesemia


Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.[See Adverse Reactions (6.2)]

5.10 Concomitant Use of Omeprazole and Sodium Bicarbonate with St John’s

Drugs which induce CYP2C19 OR CYP34A (such as St John’s Wort or rifampin) can substantially decrease omeprazole concentrations [See Drug Interactions (7.2)].Avoid concomitant use of omeprazole and sodium bicarbonate with St John’s Wort or rifampin.

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