Drugplain

Omeprazole, Sodium bicarbonate 20 mg/1

Omeprazole, Sodium bicarbonate · CAPSULE · Guardian Drug Company

4 Recalls on RecordCurrently in Shortage
Plain English

Omeprazole, Sodium bicarbonate is a capsule containing omeprazole, sodium bicarbonate at 20 mg/1, taken oral. Manufactured by Guardian Drug Company.

Key Facts

Brand Name
Omeprazole, Sodium bicarbonate
Generic Name
Omeprazole, Sodium bicarbonate
NDC Code (Product)
53041-664
Manufacturer
Guardian Drug Company
Strength
20 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA212587
Drug Class
Proton Pump Inhibitor [EPC]
Marketing Start
05/07/2020

Recall History

4 Recalls on Record
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD70655_8, EXP: 5/29/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD73627_32, EXP: 5/30/2014.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD46300_11, EXP: 5/15/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: AD65457_7, EXP: 5/24/2014.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: W003788, EXP: 6/27/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003870, EXP: 6/27/2014.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/2.6 mg, NDC 63824073116, Pedigree: AD42592_4, EXP: 5/14/2014.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue20,233 reports
nausea20,178 reports
diarrhoea19,974 reports
dyspnoea16,592 reports
drug ineffective15,859 reports
headache14,896 reports
pain13,941 reports
chronic kidney disease13,561 reports
vomiting13,496 reports
dizziness13,324 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 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 a proton pump inhibitor (PPI). Omeprazole and sodium bicarbonate capsules are indicated in adults for: Treatment of active duodenal ulcer ( 1 ) Treatment of act…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Indication Recommended Adult Dosage Omeprazole and sodium bicarbonate capsules Active Duodenal Ulcer 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily for up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks* Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily** * an additional 4 weeks of treatment may be given if no response; if recurrence additional 4 to 8-week courses may be considered. ** studied for 12 months. 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 ea…

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 ), 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 Cipla Ltd. at 1-866-604-3268 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 t…

Frequently Asked Questions

What is Omeprazole, Sodium bicarbonate used for?

Omeprazole, Sodium bicarbonate contains Omeprazole, Sodium bicarbonate. It is a capsule taken oral. Consult your doctor for specific uses.

Is Omeprazole, Sodium bicarbonate a controlled substance?

Omeprazole, Sodium bicarbonate is not classified as a controlled substance by the DEA.

What is the generic name for Omeprazole, Sodium bicarbonate?

The generic name for Omeprazole, Sodium bicarbonate is Omeprazole, Sodium bicarbonate. There are 9 other brand versions of Omeprazole, Sodium bicarbonate.

What is the NDC code for Omeprazole, Sodium bicarbonate 20 mg/1?

The NDC (National Drug Code) for Omeprazole, Sodium bicarbonate 20 mg/1 is 53041-664, listed by Guardian Drug Company.

Product NDC

53041-664

Package NDC

53041-664-77

Other Omeprazole, Brands

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

Data from openFDA · Public domain (CC0 1.0)