ESOMEPRAZOLE STRONTIUM 20 mg/1
esomeprazole strontium · CAPSULE, DELAYED RELEASE · R2 Pharma, LLC
ESOMEPRAZOLE STRONTIUM is a capsule, delayed release containing esomeprazole strontium at 20 mg/1, taken oral. Manufactured by R2 Pharma, LLC.
Key Facts
- Brand Name
- ESOMEPRAZOLE STRONTIUM
- Generic Name
- esomeprazole strontium
- NDC Code (Product)
70849-200- Manufacturer
- R2 Pharma, LLC
- Strength
- 20 mg/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA202342
- Marketing Start
- 09/15/2016
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1.INDICATIONS & USAGE SECTION 1.1 Treatment of Gastroesophageal Reflux Disease (GERD) in Adults Healing of Erosive Esophagitis Esomeprazole strontium is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole strontium may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole strontium is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. 1.2 Risk Reduction of NSAID-Associated Gastric Ulcer in Adults Esomeprazole strontium is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk either due to their age (≥60) and/or documented history of gastric ulcers. Controlled …
Dosage & Administration
2.DOSAGE & ADMINISTRATION Esomeprazole strontium is supplied as delayed-release capsules for oral administration. The recommended dosages are outlined in Table 1. Esomeprazole strontium should be taken at least one hour before meals. The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the prescribing information, and individual patient medical needs. Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment. Special Populations Hepatic Insufficiency In patients with mild to moderate liver impairment (Child Pugh Classes A and B), no dosage adjustment is necessary. For patients with severe liver impairment (Child Pugh Class C), a dose of 24.65 mg of esomeprazole strontium (equivalent to 20 mg of esomeprazole) should not be exceeded [ see Clinical Pharmacology (12.3) ]. Administrative Options Directions for use specific to the route and available methods of administration are presented in Table 2. Esomeprazole strontium delayed-release capsules should be swallowed whole. Do not chew or crush capsule…
Contraindications
4.CONTRAINDICATIONS Esomeprazole strontium is contraindicated in patients with known hypersensitivity to proton pump inhibitors. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6)]. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole strontium, refer to the CONTRAINDICATIONS section of their package inserts. Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred) (4)
Drug Interactions
7.DRUG INTERACTIONS 7.1 Interference with Antiretroviral Therapy Concomitant use of atazanavir and nelfinavir with proton pump inhibitors is not recommended. Coadministration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and may result in a loss of therapeutic effect and the development of drug resistance. Coadministration of saquinavir with proton pump inhibitors is expected to increase saquinavir concentrations, which may increase toxicity and require dose reduction. Omeprazole, of which esomeprazole is an enantiomer, has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug. Other possible interaction mechanisms are via CYP2C19. Reduced concentrations of atazanavir and nelfinavir For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole. Following multiple doses of nelfinavir (1250 mg, twice daily) and omeprazole (40 mg daily), AUC was…
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 (5.3)] Bone Fracture [see Warning 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 Warning and Precautions ( 5.8)] 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 practice. The safety of esomeprazole strontium has been established from adequate and well-controlled studies of esomeprazole magnesium [see Clinical Studies (14)]. Below is a display of the adverse reactions of esomeprazole magnesium in these adequate and well-controlled studies. Adults The safety of esomeprazole magnesium was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials…
Frequently Asked Questions
What is ESOMEPRAZOLE STRONTIUM used for?
ESOMEPRAZOLE STRONTIUM contains esomeprazole strontium. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.
Is ESOMEPRAZOLE STRONTIUM a controlled substance?
ESOMEPRAZOLE STRONTIUM is not classified as a controlled substance by the DEA.
What is the generic name for ESOMEPRAZOLE STRONTIUM?
The generic name for ESOMEPRAZOLE STRONTIUM is esomeprazole strontium. There are no other listed brand versions of esomeprazole strontium.
What is the NDC code for ESOMEPRAZOLE STRONTIUM 20 mg/1?
The NDC (National Drug Code) for ESOMEPRAZOLE STRONTIUM 20 mg/1 is 70849-200, listed by R2 Pharma, LLC.
Other ESOMEPRAZOLE STRONTIUM Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)