Omeprazole and Sodium Bicarbonate 20 mg/1

Omeprazole and Sodium Bicarbonate · POWDER, FOR SUSPENSION · Dr. Reddy's Laboratories Inc.,

1 Recall on RecordCurrently in Shortage

Plain English

Omeprazole and Sodium Bicarbonate is a powder, for suspension containing omeprazole and sodium bicarbonate at 20 mg/1, taken oral. Manufactured by Dr. Reddy's Laboratories Inc.,.

Key Facts

Brand Name: Omeprazole and Sodium Bicarbonate
Generic Name: Omeprazole and Sodium Bicarbonate
NDC Code (Product): 43598-010
Manufacturer: Dr. Reddy's Laboratories Inc.,
Strength: 20 mg/1
Dosage Form: POWDER, FOR SUSPENSION
Route: ORAL
Marketing Status
Application #: ANDA217784
Drug Class: Proton Pump Inhibitor [EPC]
Marketing Start: 07/15/2024

Recall History

1 Recall on Record

Class II02/02/2024

Bausch Health Companies, Inc.

Subpotent Drug: Out of specification for assay

CompletedVoluntary: Firm initiated

Side Effects Reported to FDA

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

chronic kidney disease118 reports

drug ineffective66 reports

acute kidney injury53 reports

renal failure53 reports

incorrect product administration duration39 reports

nausea33 reports

headache27 reports

inappropriate schedule of product administration27 reports

death22 reports

dyspnoea22 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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. 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 for oral suspension is indicated in adults for the : reduction of risk of upper GI bleeding in criticall…

Dosage & Administration

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 daily** ( 2 ) 40 mg Omeprazole and Sodium Bicarbonate for oral suspension ( 2 ) Reduction of Risk of Upper GI Bleeding in Critically Ill Patients ( 2 ) 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 14 days ( 2 ) *an additional 4 weeks of treatment may be given if no response; if recurrence, additional 4 to 8-week courses may be considered. ( 2 ) **studied for 12 months. ( 2 ) 2.1 Important Administration Instructions Omeprazole and Sodium Bicarbonate is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazo…

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)] . Proton pump inhibitors (PPIs), including Omeprazole and Sodium Bicarbonate, are contraindicated in patients receiving rilpivirine containing products [see Drug Interactions (7) ] . Known hypersensitivity to any components of the formulation ( 4 ) Patients receiving rilpivirine-containing products ( 4 , 7 )

Drug 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. The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology (12.3) ] . Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see Clinical Pharmacology (12.3) ] . There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole. Intervention: Rilpivirine-containing p…

Adverse Reactions

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 (5.9) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10) ] Fundic Gland Polyps [see Warnings and Precautions (5.14) ] Most common adverse reactions (≥2%) are: headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 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 ref…

Frequently Asked Questions

What is Omeprazole and Sodium Bicarbonate used for?

Omeprazole and Sodium Bicarbonate contains Omeprazole and Sodium Bicarbonate. It is a powder, for suspension taken oral. Consult your doctor for specific uses.

Is Omeprazole and Sodium Bicarbonate a controlled substance?

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

What is the generic name for Omeprazole and Sodium Bicarbonate?

The generic name for Omeprazole and Sodium Bicarbonate is Omeprazole and Sodium Bicarbonate. There are 4 other brand versions of Omeprazole and Sodium Bicarbonate.

What is the NDC code for Omeprazole and Sodium Bicarbonate 20 mg/1?

The NDC (National Drug Code) for Omeprazole and Sodium Bicarbonate 20 mg/1 is 43598-010, listed by Dr. Reddy's Laboratories Inc.,.

Product NDC

43598-010

Package NDC

43598-010-01

Other Omeprazole and Sodium Bicarbonate Dosages

Other Omeprazole Brands

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

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