Esomeprazole Strontium Capsule, Delayed Release
Product Images NDC 70849-200

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Esomeprazole Strontium (NDC 70849-200). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by R2 Pharma, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

24.64mg (Eso 20mg 30ct Label Jpeg)

Label for ESOMEPRAZOLE STRONTIUM delayed-release capsules, 24.65 mg strength (equivalent to 20 mg esomeprazole), containing 30 capsules. The label includes storage instructions, pharmacist dispensing notes, manufacturer R2 Pharma, LLC, and NDC 70849-200-30. Note: delayed-release formulation for oral use.*

FDA Label Image

49.3mg (Eso 40mg 30ct Label Jpeg)

Label for ESOMEPRAZOLE STRONTIUM delayed-release capsules, 49.3 mg per capsule (equivalent to 40 mg esomeprazole), 30 capsules per container. The label includes storage instructions, pharmacist dispensing note, barcode, NDC 70849-400-30, and manufacturer information for R2 Pharma, LLC.*

FDA Label Image

Figure2 (Figure2)

A line graph showing maintenance percentages over six months for esomeprazole magnesium 44 mg, 20 mg, and 15 mg, as well as a placebo group. The x-axis represents time in months, and the y-axis shows the percent maintained. The graph compares the effectiveness of different dosages and placebo over time.*

FDA Label Image

Figure3 (Figure3)

A line graph comparing the percent of patients maintaining a condition over a six-month period for four different treatments: Esomeprazole 40 mg, Deomeprazole 40 mg, Pantoprazole 40 mg, and Placebo 10 mg. The x-axis shows months from 0 to 6, and the y-axis shows percent maintained from 0 to 100.*

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Figure4 (Figure4)

A line graph depicting the percentage of patients with symptom relief over a 28-day period for esomeprazole strontium 20 mg and 40 mg compared to placebo. The x-axis represents the day of treatment, and the y-axis shows the percentage of patients responding.*

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Figure5 (Figure5)

A line chart depicting the percent of patients with baseline-free ulcers over a 28-day treatment period. The graph compares two groups: patients treated with Esomeprazole 40 mg and a placebo group, showing trends over time.*

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Formula (Formula)

Chemical structure of esomeprazole strontium showing two esomeprazole molecules complexed with a strontium ion and associated with four water molecules (Sr2+ • 4H2O).*

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Table1 (Table 1)

A data table titled 'Recommended Dosage Schedule of Esomeprazole Strontium Delayed-Release Capsules' showing dosage and frequency information for various indications, including GERD in adults, risk reduction of NSAID-associated gastric ulcer, H. pylori eradication with triple therapy, and pathological hypersecretory conditions. Dosages range from 24.65 mg to 49.3 mg of esomeprazole strontium with frequencies from once daily to twice daily over varying durations.*

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Table10 (Table 10)

Table titled 'Adequate Acid Suppression at Final Visit by Dose Regimen' showing esomeprazole magnesium doses at month 12 visit and corresponding counts of BAO under adequate control among 20 patients. The doses listed are 44.6 mg twice daily, 89.2 mg twice daily, and 89.2 mg three times daily with respective control counts 13/15, 4/4, and 1/1. A note indicates one patient was not evaluated.*

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Table2 (Table 2)

Table presenting administration options for esomeprazole strontium delayed-release capsules. It details oral route options: swallow whole without chewing or crushing, or opening capsule to mix granules with applesauce without chewing. For nasogastric tube administration, granules can be emptied from capsule into a syringe and delivered through the tube.*

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Table6 (Table 6)

Table showing erosive esophagitis healing rates comparing Esomeprazole magnesium (various dosages) and Omeprazole 20 mg across four studies with patient numbers ranging from 572 to 1216. Healing rates at week 4 and week 8 are presented with significance levels, noting some statistically significant differences favoring Esomeprazole magnesium, while others are not significant.*

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Table7 (Table 7)

A table titled 'Sustained Resolution of Heartburn (Erosive Esophagitis Patients)' showing cumulative percent of patients with sustained resolution at Days 14 and 28, across four studies. Treatment groups include Esomeprazole magnesium (22.3 mg and 44.6 mg) and Omeprazole 20 mg, with numbers of patients, percentages for resolution, and significance levels noted. Definitions and statistical notes appear below the table.*

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Table8 (Table 8)

A data table titled 'Table 8: Cumulative Percentage of Patients without Gastric Ulcers at 26 Weeks' showing study groups, number of patients, treatment groups, and the percentage of patients remaining gastric ulcer free. The table includes two studies with esomeprazole magnesium at doses of 22.3 mg and 44.6 mg, and placebo groups, with noted significant differences from placebo (p<0.01).*

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Table9 (Table 9)

A data table titled "H. pylori Eradication Rates at 4 Weeks after 10 Day Treatment Regimen" showing the percentage of patients cured with 95% confidence intervals and patient numbers from two studies (191 and 193). It compares eradication rates for treatment groups using esomeprazole magnesium plus amoxicillin and clarithromycin, esomeprazole magnesium plus clarithromycin, and esomeprazole magnesium alone under per-protocol and intent-to-treat analyses.*

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Table3 (Table3)

A table titled 'Effect on Intragastric pH on Day 5 (N=36)' compares parameters related to intragastric pH between two doses of esomeprazole magnesium: 44.6 mg and 22.3 mg. It presents percentage time gastric pH >4, median 24-hour pH, and coefficient of variation for both parameters, with notes about statistical significance and measurement period.*

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Table4 (Table4)

A data table titled 'Pharmacokinetic Parameters of Esomeprazole Following Single Oral Administration in Healthy Adult Volunteers under Fasting Conditions.' It compares pharmacokinetic parameters such as Cmax, Tmax, AUC0-tlast, and AUC0-∞ of esomeprazole strontium delayed-release capsules 49.3 mg with and without one tablespoon of applesauce. Numeric values include means and standard deviations where applicable.*

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Table5 (Table5)

A data table titled 'Clarithromycin Susceptibility Test Results and Clinical/Bacteriological Outcomes for Triple Therapy' showing clarithromycin pretreatment results categorized by susceptibility (Susceptible, Intermediate, Resistant) and post-treatment outcomes for H. pylori negative (Eradicated) and positive (Not Eradicated) groups. The table includes numerical counts and explanations for susceptibility thresholds and drug dose equivalences.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.