Esomeprazole Magnesium (Page 11 of 13)

14.6 H. pylori Eradication in Patients with Duodenal Ulcer Disease

Two multicenter, randomized, double-blind studies were conducted in adult patients using a 10-day treatment regimen of triple therapy (esomeprazole magnesium delayed-release capsules, amoxicillin and clarithromycin). The first study (191) compared esomeprazole magnesium delayed-release capsules 40 mg once daily in combination with amoxicillin 1,000 mg twice daily and clarithromycin 500 mg twice daily to esomeprazole magnesium delayed-release capsules 40 mg once daily plus clarithromycin 500 mg twice daily. The second study (193) compared esomeprazole magnesium delayed-release capsules 40 mg once daily in combination with amoxicillin 1,000 mg twice daily and clarithromycin 500 mg twice daily to esomeprazole magnesium delayed-release capsules 40 mg once daily. H. pylori eradication rates, defined as at least two negative tests and no positive tests from CLOtest® , histology and/or culture, at 4 weeks post-therapy were significantly higher in the esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin group than in the esomeprazole magnesium delayed-release capsules and clarithromycin group or esomeprazole magnesium delayed-release capsules alone group. The results are shown in Table 14:

Table 14: H. pylori Eradication Rates at 4 Weeks after 10 Day Treatment Regimen % of Adult Patients Cured [95% Confidence Interval] (Number of Patients)

1. Patients were included in the analysis if they had H. pylori infection documented at baseline, had at least one endoscopically verified duodenal ulcer ≥ 0.5 cm in diameter at baseline or had a documented history of duodenal ulcer disease within the past 5 years, and were not protocol violators. Patients who dropped out of the study due to an adverse reaction related to the study drug were included in the analysis as not H. pylori eradicated.

2. Patients were included in the analysis if they had documented H. pylori infection at baseline, had at least one documented duodenal ulcer at baseline, or had a documented history of duodenal ulcer disease, and took at least one dose of study medication. All dropouts were included as not H. pylori eradicated.

3. p < 0.05 compared to esomeprazole magnesium delayed-release capsules plus clarithromycin.

4. p < 0.05 compared to esomeprazole magnesium delayed-release capsules alone.

Study Treatment Group Per-Protocol 1 Intent-to-Treat 2
191 Esomeprazole magnesium delayed-release capsules, amoxicillin and clarithromycin 84%3 [78, 89] (n=196) 77%3 [71, 82] (n=233)
Esomeprazole magnesium delayed-release capsules and clarithromycin 55% [48, 62] (n=187) 52% [45, 59] (n=215)
193 Esomeprazole magnesium delayed-release capsules, amoxicillin and clarithromycin 85%4 [74, 93] (n=67) 78%4 [67, 87] (n=74)
Esomeprazole magnesium delayed-release capsules 5% [0, 23] (n=22) 4% [0, 21] (n=24)

The percentage of patients with a healed baseline duodenal ulcer by 4 weeks after the 10-day treatment regimen in the esomeprazole magnesium delayed-release capsules, amoxicillin and clarithromycin group was 75% (n=156) and 57% (n=60) respectively, in the 191 and 193 studies (per-protocol analysis).

14.7 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome in Adults

In a multicenter, open-label dose-escalation study of 21 adult patients (15 males and 6 females, 18 Caucasian and 3 Black, mean age of 56 years) with pathological hypersecretory conditions, such as Zollinger-Ellison Syndrome, esomeprazole magnesium delayed-release capsules significantly inhibited gastric acid secretion. The initial dosage of esomeprazole magnesium delayed-release capsules was 40 mg twice daily in 19 patients and 80 mg twice daily in 2 patients. Total daily doses ranging from 80 mg to 240 mg for 12 months maintained gastric acid output below the target levels of 10 mEq/h in patients without prior gastric acid-reducing surgery and below 5 mEq/hr in patients with prior gastric acid-reducing surgery. At the Month 12 final visit, 18/20 (90%) patients had Basal Acid Output (BAO) under satisfactory control (median BAO = 0.17 mmol/hr). Of the 18 patients evaluated with a starting dose of esomeprazole magnesium delayed-release capsules 40 mg twice daily, 13 (72%) had their BAO controlled with the original dosing regimen at the final visit. See Table 15.

Table 15: Adequate Acid Suppression at Final Visit by Dose Regimen in Adult Patients with Pathological Hypersecretory Conditions
*
One patient was not evaluated.
Esomeprazole magnesium delayed-release capsules dose at the Month 12 visit BAO under adequate control at the Month 12 visit (N=20)*
40 mg twice daily 13/15
80 mg twice daily 4/4
80 mg three times daily 1/1

16 HOW SUPPLIED/STORAGE AND HANDLING

Esomeprazole magnesium delayed-release capsules, USP 20 mg are size ‘4’ hard gelatin white opaque colored capsule, imprinted with ‘186’ on cap and ’20 mg’ on body and filled with white to slightly yellow colored pellets. They are supplied as follows:

Bottles of 30 Capsules with child-resistant closure, NDC 70377-055-11

Bottles of 90 Capsules with child-resistant closure, NDC 70377-055-12

Bottles of 1,000 Capsules, NDC 70377-055-13

Esomeprazole magnesium delayed-release capsules, USP 40 mg are size ‘3’ hard gelatin white opaque colored capsule, imprinted with ‘187’ on cap and ’40 mg’ on body and filled with white to slightly yellow colored pellets. They are supplied as follows:

Bottles of 30 Capsules with child-resistant closure, NDC 70377-056-11

Bottles of 90 Capsules with child-resistant closure, NDC 70377-056-12

Bottles of 1,000 Capsules, NDC 70377-056-13

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules product package is subdivided.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Acute Tubulointerstitial Nephritis

Advise the patient or caregiver to call the patient’s healthcare provider immediately if they experience signs and/or symptoms associated with suspected acute TIN [see Warnings and Precautions (5.2)].

Clostridium difficile -Associated Diarrhea

Advise the patient or caregiver to immediately call the patient’s healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.3)].

Bone Fracture

Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patient’s healthcare provider [see Warnings and Precautions (5.4)].

Cutaneous and Systemic Lupus Erythematosus

Advise the patient or caregiver to immediately call the patient’s healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions (5.5)].

Cyanocobalamin (Vitamin B-12) Deficiency

Advise the patient or caregiver to report any clinical symptoms that may be associated with cyanocobalamin deficiency to the patient’s healthcare provider if they have been receiving esomeprazole for longer than 3 years [see Warnings and Precautions (5.7)].

Hypomagnesemia

Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia to the patient’s healthcare provider, if they have been receiving esomeprazole for at least 3 months [see Warnings and Precautions (5.8)].

Drug Interactions

Advise the patient or caregiver to report to their healthcare provider if starting treatment with rilpivirine-containing products, clopidogrel, St. John’s Wort or rifampin; or, if they take high-dose methotrexate [see Contraindications (4), Warnings and Precautions (5.6, 5.9, 5.11)].

Administration

  • Take esomeprazole magnesium delayed-release capsules at least one hour before meals.
  • Antacids may be used concomitantly with esomeprazole.
  • Swallow esomeprazole magnesium delayed-release capsules whole; do not chew or crush the capsules.
  • For patients who have difficulty swallowing capsules, esomeprazole magnesium delayed-release capsules can be opened, and the contents sprinkled on applesauce. Use with other foods is not recommended.
  1. Add one tablespoon of applesauce to an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
  2. Open the esomeprazole magnesium delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce.
  3. Mix the granules with the applesauce.
  4. Administer the mixture immediately. Do not chew or crush the granules
  5. Discard any remaining mixture. Do not store the mixture for future use.
  • Esomeprazole magnesium delayed-release capsules can also be administered via a nasogastric tube, as described in the Instructions for Use.

Manufactured by:

Graviti Pharmaceuticals Pvt. Ltd.

Telangana-502307, INDIA.

Manufactured for:

Biocon Pharma Inc.,

Iselin, NJ 08830-3009, USA.

All Brand names mentioned are registered trademarks of their respective owners and are not of Graviti Pharmaceuticals Private Limited.

Revised: October 2021

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