Omeprazole/Bicarbonate 40 mg/1

Omeprazole and Sodium Bicarbonate · CAPSULE, GELATIN COATED · Proficient Rx LP

No Recall HistoryCurrently in Shortage

Plain English

Omeprazole/Bicarbonate is a capsule, gelatin coated containing omeprazole and sodium bicarbonate at 40 mg/1, taken oral. Manufactured by Proficient Rx LP.

Key Facts

Brand Name: Omeprazole/Bicarbonate
Generic Name: Omeprazole and Sodium Bicarbonate
NDC Code (Product): 71205-985
Manufacturer: Proficient Rx LP
Strength: 40 mg/1
Dosage Form: CAPSULE, GELATIN COATED
Route: ORAL
Marketing Status
Application #: ANDA207476
Drug Class: Proton Pump Inhibitor [EPC]
Marketing Start: 07/27/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

chronic kidney disease108 reports

drug ineffective66 reports

acute kidney injury50 reports

renal failure44 reports

incorrect product administration duration39 reports

nausea31 reports

headache26 reports

inappropriate schedule of product administration26 reports

death22 reports

product dose omission issue22 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Omeprazole and sodium bicarbonate is a proton pump inhibitor (PPI) indicated for: • Short-term treatment of active duodenal ulcer ( 1.1 ) • Short-term treatment of active benign gastric ulcer ( 1.2 ) • Treatment of gastroesophageal reflux disease (GERD) ( 1.3 ) • Maintenance of healing of erosive esophagitis ( 1.4 ) The safety and effectiveness of omeprazole and sodium bicarbonate capsules in pediatric patients (<18 years of age) have not been established. ( 8.4 ) 1.1 Duodenal Ulcer Omeprazole and sodium bicarbonate is 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 is indicated for short-term treatment (4-8 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 is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. [See Clinical Studies (14.3) .] Erosive Esophagitis Omeprazole and sodium bicarbo…

Dosage & Administration

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 (1,100 mg), two capsules of 20 mg are not equivalent 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 Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy. [See Clinical Studies (14.1) .] , For additional information, [See Indications and Usage (1) ] Benign Gastric Ulcer 40 mg Once daily fo…

Contraindications

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, acute interstitial nephritis, and urticaria. [See Adverse Reactions (6) .] • Known hypersensitivity to any components of the formulation ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • May interfere with drugs for which gastric pH can affect bioavailability (e.g., ketoconazole, ampicillin esters, iron salts, erlotinib, digoxin, and mycophenolate mofetil). ( 7.1 ) • Drugs metabolized by cytochrome P450 (e.g., diazepam, warfarin, phenytoin, cyclosporine, disulfiram, benzodiazepines): Omeprazole and sodium bicarbonate can prolong their elimination. Monitor to determine the need for possible dose adjustments when taken with omeprazole and sodium bicarbonate. ( 7.2 ) • Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. ( 7.2 ) • Voriconazole: May increase plasma levels of omeprazole. ( 7.2 ) • Saquinavir: Omeprazole and sodium bicarbonate increases plasma levels of saquinavir. ( 7.3 ) • Omeprazole and sodium bicarbonate may reduce plasma levels of atazanavir and nelfinavir. ( 7.3 ) • Clopidogrel: Omeprazole and sodium bicarbonate decreases exposure to the active metabolite of clopidogrel. ( 7.5 ) • Tacrolimus: Omeprazole and sodium bicarbonate may increase serum levels of tacrolimus. ( 7.6 ) 7.1 Drugs for Which Gastric pH Can Affect Bioavailability Due to its…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Acute Interstitial 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) ] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6) ] • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.8) ] • Hypomagnesemia [see Warnings and Precautions (5.9) ] • Fundic Gland Polyps [see Warnings and Precautions (5.13) ] Most common adverse reactions (incidence ≥ 2%) are: headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the U.S. clinical trial p…

Frequently Asked Questions

What is Omeprazole/Bicarbonate used for?

Omeprazole/Bicarbonate contains Omeprazole and Sodium Bicarbonate. It is a capsule, gelatin coated taken oral. Consult your doctor for specific uses.

Is Omeprazole/Bicarbonate a controlled substance?

Omeprazole/Bicarbonate is not classified as a controlled substance by the DEA.

What is the generic name for Omeprazole/Bicarbonate?

The generic name for Omeprazole/Bicarbonate is Omeprazole and Sodium Bicarbonate. There are 11 other brand versions of Omeprazole and Sodium Bicarbonate.

What is the NDC code for Omeprazole/Bicarbonate 40 mg/1?

The NDC (National Drug Code) for Omeprazole/Bicarbonate 40 mg/1 is 71205-985, listed by Proficient Rx LP.

Product NDC

71205-985

Package NDC

71205-985-30

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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