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.

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24.64mg (Eso 20mg 30ct Label Jpeg)

Each delayed-release capsule contains 24.65 mg esomeprazole strontium, equivalent to 20 mg esomeprazole. The medication comes in a container with an NDC number of 70849-200-30 and should be kept tightly closed and out of reach of children. It is recommended to store the capsules at temperatures between 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). The medication should be dispensed in a tight container and the pharmacist should refer to the package guide for adult dosage information. The medication is manufactured for R2 Pharma, LLC located in Petal, MS 39465. Lot number and expiration date are not available in the provided text.*

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49.3mg (Eso 40mg 30ct Label Jpeg)

This is a prescription drug with the NDC code of 70849-400-30. It is a delayed-release capsule containing Esomeprazole Strontium. The recommended adult dosage is provided in the package insert. It is manufactured by R2 Pharma LLC in Petal, Mississippi. The container should be kept tightly closed and out of reach of children. It should be stored at controlled room temperature, and dispensing should be done in a tight container. Lot number and expiration date are also listed.*

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Figure2 (Figure2)

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Figure3 (Figure3)

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Figure4 (Figure4)

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Figure5 (Figure5)

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Formula (Formula)

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Table1 (Table 1)

This text provides recommended dosage schedules for Esomeprazole Strontium Delayed-Release Capsules for the treatment of gastroesophageal reflux disease (GERD), maintenance of healing of erosive esophagitis, symptomatic GERD disease, risk reduction of NSAID-associated gastric ulcer, H. pylori eradication, and pathological hypersecretory conditions such as Zollinger-Ellison Syndrome. The dosage schedules vary depending on the indication and patient needs. The majority of patients with erosive esophagitis are healed within 4 to 8 weeks with treatment, but an additional 4 to 8 weeks of treatment may be considered for patients who do not heal. The controlled studies of the drug did not exceed six months. *

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Table10 (Table 10)

This table shows the efficacy of different doses of esomeprazole magnesium in achieving adequate acid suppression at the final visit. The data is based on a sample size of 20 patients, with some patients receiving a dose of 44.6 mg twice daily and others receiving a dose of 89.2 mg twice daily or three times daily. The number of patients whose BAO was under adequate control at the 12-month visit is provided for each dose regimen. One patient was not evaluated.*

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Table2 (Table 2)

This is a description of Administration Options for a medication in Delayed-Release Capsules form. The options include swallowing the capsule whole, mixing the granules with applesauce, or opening the capsule and delivering the granules through a nasogastric tube. The instructions advise against chewing or crushing the capsule or granules.*

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Table6 (Table 6)

This is a table showing the healing rate of erosive esophagitis in different treatment groups over the course of multiple weeks. The study compared the effectiveness of Esomeprazole magnesium and Omeprazole 20mg at various dosages. The percentage of healing rates are shown for each group and statistically significant differences are highlighted. The table also mentions that some results were not found to be significant.*

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Table7 (Table 7)

The text describes a table (Table 7) showing the sustained resolution of heartburn for erosive esophagitis patients. The table shows the cumulative percentages of patients with sustained resolution at Day 14 and Day 28 for each treatment group (Esomeprazole magnesium 223mg, Omeprazole 20mg, Esomeprazole magnesium 44.6mg, and Esomeprazole magnesium 223mg), along with their significance level (p <0.001 or not significant (N.S.)). The sustained resolution is defined as seven consecutive days with no heartburn reported in daily patient diary.*

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Table8 (Table 8)

The text provides a table showing the percentage of patients without gastric ulcers at 26 weeks using different treatments for the study. The study involved two groups of patients, and for each group, three treatments were administered (esomeprazole magnesium 95.4 mg, esomeprazole magnesium 44.6 mg, and placebo). The results indicate that patients administered with esomeprazole magnesium had a significantly lower percentage of gastric ulcers compared to those administered with placebo.*

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Table9 (Table 9)

The text describes the H. pylori eradication rates for different treatment regimens at 4 weeks. It provides the percentage of patients cured along with their confidence intervals for each treatment group. The analysis includes only those patients who had H. pylori infection documented at baseline and had a history of duodenal ulcer disease. Patients who dropped out due to adverse reactions related to study drugs were included as not eradicated. The text indicates which treatment group had a significant difference in eradication rates compared to the other group.*

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Table3 (Table3)

This is a table showing the effect of two different doses of esomeprazole magnesium on intragastric pH on Day 5 of the study. The table provides information such as the percentage of time with gastric pH at 70% and above, pH values for different hours, the median 24-hour pH, and coefficient of variation. The results indicate that the higher dose of esomeprazole magnesium (44.6 mg) had a greater effect on increasing gastric pH compared to the lower dose (22.3 mg). The conclusion is supported by the statistically significant p-value of less than 0.01.*

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Table4 (Table4)

Table 4 shows the pharmacokinetic parameters of Esomeprazole in healthy adults volunteers, who took Esomeprazole strontium delayed-release capsules of 49.3mg in fasting conditions. The mean Conax was 1105.6ng/mL and 1155.6ng/mL, Mean AUCo.tast was 2283.9 and 2389.1 (ng*h/MI) and Mean AUCow was 2310.9 and 2417.8 (ng*h/mL) for the two sets of capsules. Additionally, the capsule contents were administered with one tablespoon of applesauce under otherwise fasting conditions. However, Tmax values were not reported as mean but the median.*

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Table5 (Table5)

This is a table showing the results of a clinical study on the efficacy of triple therapy for Helicobacter pylori eradication. The triple therapy consisted of esomeprazole magnesium, amoxicillin, and clarithromycin, taken twice daily for 10 days. The table includes the results of clarithromycin susceptibility testing before and after treatment, as well as clinical and bacteriological outcomes of the treatment. The table shows the number of patients with H. pylori eradication and those not eradicated, and the number of patients susceptible, intermediate, and resistant to clarithromycin. The study only included patients with available pre- and post-treatment clarithromycin susceptibility test results.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.