Drugplain

Omeprazole DR 40 mg/1

Omeprazole · CAPSULE, DELAYED RELEASE · Advanced Rx Pharmacy of Tennessee, LLC

No Recall HistoryCurrently in Shortage
Plain English

Omeprazole Dr is a prescription medication that reduces stomach acid by blocking proton pumps in the stomach lining, used to treat conditions like acid reflux, GERD, and ulcers. This delayed-release capsule allows the medication to pass through the stomach and dissolve in the small intestine where it works most effectively.

Key Facts

Brand Name
Omeprazole DR
Generic Name
Omeprazole
NDC Code (Product)
80425-0109
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Strength
40 mg/1
Dosage Form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing Status
HUMAN PRESCRIPTION DRUG
Application #
ANDA078490
Drug Class
Cytochrome P450 2C19 Inhibitors [MoA]; Proton Pump Inhibitor [EPC]
Marketing Start
10/25/2019

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1. Indications and Usage Section 1 INDICATIONS AND USAGE 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. 1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults. Dual Therapy Omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility…

Dosage & Administration

2. Dosage and Administration Section 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Adult Dosage Regimen by Indication Table 1 shows the recommended dosage of omeprazole in adult patients by indication. Table 1: Recommended Dosage Regimen of Omeprazole in Adults by Indication Indication Dosage of Omeprazole Treatment Duration Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks1 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Omeprazole 20 mg Amoxicillin 1000 mg Clarithromycin 500 mg Take all three drugs twice daily 10 days In patients with an ulcer present at the time of initiation of therapy, continue omeprazole 20 mg once daily for an additional 18 days for ulcer healing and symptom relief. Dual Therapy Omeprazole 40 mg once daily Clarithromycin 500 mg three times daily 14 days In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief. 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…

Contraindications

4. Contraindications Omeprazole delay-release capsules are contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazol. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)]. Proton pump inhibitors (PPIs), including omeprazole, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)]. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the CONTRAINDICATIONS section of their package inserts.

Drug Interactions

7. Drug Interactions Tables 3 and 4 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 3: 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-containin…

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 (5.3)] • Bone Fracture [see Warnings and Precautions (5.4)] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.5)] • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.7)] • Hypomagnesemia [see Warnings and Precautions (5.8)] • Fundic Gland Polyps [see Warnings and Precautions (5.12)] 6.1 Clinical Trials Experience with Omeprazole Monotherapy 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 practice. The safety data described below reflects exposure to omeprazole delayed-release capsules in 3096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, r…

Frequently Asked Questions

What is Omeprazole DR used for?

Omeprazole Dr is a prescription medication that reduces stomach acid by blocking proton pumps in the stomach lining, used to treat conditions like acid reflux, GERD, and ulcers. This delayed-release capsule allows the medication to pass through the stomach and dissolve in the small intestine where it works most effectively.

Is Omeprazole DR a controlled substance?

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

What is the generic name for Omeprazole DR?

The generic name for Omeprazole DR is Omeprazole. There are 12 other brand versions of Omeprazole.

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

The NDC (National Drug Code) for Omeprazole DR 40 mg/1 is 80425-0109, listed by Advanced Rx Pharmacy of Tennessee, LLC.

Product NDC

80425-0109

Package NDC

80425-0109-1

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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