Esomeprazole Magnesium: Package Insert and Label Information (Page 6 of 7)

14.4 Pediatric GERD

12 Years to 17 Years of Age

In a multicenter, randomized, double-blind, parallel-group study, 149 adolescent patients (12 to 17 years of age; 89 female; 124 Caucasian, 15 Black, 10 Other) with clinically diagnosed GERD were treated with either esomeprazole magnesium delayed-release capsules 20 mg or 40 mg once daily for up to 8 weeks to evaluate safety and tolerability. Patients were not endoscopically characterized as to the presence or absence of EE.

14.5 Risk Reduction of NSAID-Associated Gastric Ulcer

Two multicenter, double-blind, placebo-controlled studies were conducted in adult patients at risk of developing gastric and/or duodenal ulcers associated with continuous use of non-selective and COX-2 selective NSAIDs. A total of 1,429 patients were randomized across the 2 studies. Patients ranged in age from 19 to 89 (median age 66 years) with 71% female, 29% male, 83% Caucasian, 5% Black, 4% Asian, and 8% Others. At baseline, the patients in these studies were endoscopically confirmed not to have ulcers but were determined to be at risk for ulcer occurrence due to their age (at least 60 years) and/or history of a documented gastric or duodenal ulcer within the past 5 years. Patients receiving NSAIDs and treated with esomeprazole magnesium delayed-release capsules 20 mg or 40 mg once daily experienced significant reduction in gastric ulcer occurrences relative to placebo treatment at 26 weeks. See Table 13. No additional benefit was seen with esomeprazole magnesium delayed-release capsules 40 mg over esomeprazole magnesium delayed-release capsules 20 mg. Esomeprazole magnesium delayed-release capsules 40 mg once daily is not recommended regimen for the risk reduction of NSAID-associated gastric ulcer in adults. These studies did not demonstrate significant reduction in the development of NSAID-associated duodenal ulcer due to the low incidence.

Table 13: Cumulative Percentage of Patients at Least 60 Years of Age Taking NSAIDS Without Gastric Ulcers at 26 Weeks in Two Randomized Placebo-Controlled Studies

1 %= Life Table Estimate. Significant difference from placebo (p<0.01).

Study No. of Patients Treatment Group % of Patients Remaining Gastric Ulcer Free1
1 191 Esomeprazole magnesium delayed-release capsules 20 mg 95.4
194 Esomeprazole magnesium delayed-release capsules 40 mg 96.7
184 Placebo 88.2
2 267 Esomeprazole magnesium delayed-release capsules 20 mg 94.7
271 Esomeprazole magnesium delayed-release capsules 40 mg 95.3
257 Placebo 83.3

14.6 H. pylori Eradication in Adult 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-Protocol1 Intent-to-Treat2
191 Esomeprazole magnesium delayed-release capsules, amoxicillin and clarithromycin 84%3 77%3
[78, 89] [71, 82]
(n=196) (n=233)
Esomeprazole magnesium delayed-release capsules and clarithromycin 55% 52%
[48, 62] [45, 59]
(n=187) (n=215)
193 Esomeprazole magnesium delayed-release capsules, amoxicillin and clarithromycin 85%4 78%4
[74, 93] [67, 87]
(n=67) (n=74)
Esomeprazole magnesium delayed-release capsules 5% 4%
[0, 23] [0, 21]
(n=22) (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

1 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)1
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 69844-031-01

Bottles of 90 Capsules with child-resistant closure, NDC 69844-031-02

Bottles of 1,000 Capsules, NDC 69844-031-03

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 69844-032-01

Bottles of 90 Capsules with child-resistant closure, NDC 69844-032-02

Bottles of 1,000 Capsules, NDC 69844-032-03

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)].

Severe Cutaneous Adverse Reactions

Advise the patient or caregiver to discontinue esomeprazole magnesium delayed-release capsules and immediately call the patient’s healthcare provider for at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity signs or symptoms associated with Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5)].

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 (5.6)].

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 (5.8)].

Hypomagnesemia and Mineral Metabolism

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 (5.9)].

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 (5.7, 5.10, 5.12)].

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:

Graviti Pharmaceuticals Inc.,

Wilmington, Delaware-19801, USA.

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

Revised: March 2022

MEDICATION GUIDE

Esomeprazole Magnesium Delayed-Release Capsules, USP

(es”oh mep’ra zole mag nee’zee um)

What is the most important information I should know about esomeprazole magnesium delayed-release capsules?

Esomeprazole magnesium delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Esomeprazole magnesium delayed-release capsules can cause serious side effects, including:

  • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including esomeprazole magnesium delayed-release capsules, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with esomeprazole magnesium delayed-release capsules. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
  • Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool or stomach pain that does not go away. You may or may not have a fever.
  • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.
  • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including esomeprazole magnesium delayed-release capsules, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

Talk to your doctor about risk of these serious side effects.

Esomeprazole magnesium delayed-release capsules can have other serious side effects. See “What are the possible side effects of esomeprazole magnesium delayed-release capsules?”

What are esomeprazole magnesium delayed-release capsules?

A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.

Esomeprazole magnesium delayed-release capsules are used in adults for:

  • 4 to 8 weeks for the healing and symptom relief of acid-related damage to the esophagus (erosive esophagitis or EE). Your doctor may prescribe another 4 to 8 weeks of esomeprazole magnesium delayed-release capsules in patients whose EE does not heal.
  • maintaining healing of EE.
  • 4 to 8 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
  • up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
  • treating patients with a stomach infection (Helicobacter pylori) and a stomach ulcer, along with the antibiotics amoxicillin and clarithromycin.
  • the long-term treatment of conditions where your stomach makes too much acid, including Zollinger-Ellison Syndrome. Zollinger-Ellison Syndrome is a rare condition in which the stomach produces a more than normal amount of acid.

Esomeprazole is used in children and adolescents 12 to 17 years of age for:

  • 4 to 8 weeks to heal EE.
  • 4 weeks to treat heartburn and other symptoms that happen with GERD.

Esomeprazole is used in children 1 to 11 years of age for:

  • 8 weeks to heal EE.
  • up to 8 weeks to treat heartburn and other symptoms that happen with GERD.

It is not known if esomeprazole is safe and effective in children to reduce the risk of stomach ulcers in children who take medicines called NSAIDs, to treat Helicobacter pylori stomach infection to lower the risk of a stomach ulcer returning, and to treat conditions where your stomach makes too much acid.

Do not take esomeprazole magnesium delayed-release capsules if you are:

  • allergic to esomeprazole magnesium, any other PPI medicine, or any of the ingredients in esomeprazole magnesium delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in esomeprazole magnesium delayed-release capsules.
  • Tell your doctor right away or get emergency medical help if you get any of the following symptoms of an allergic reaction with esomeprazole magnesium delayed-release capsules:
  • rash
  • throat tightness
  • face swelling
  • difficulty breathing
  • taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

Before taking esomeprazole magnesium delayed-release capsules, tell your doctor about all of your medical conditions, including if you:

  • have low magnesium levels, low calcium levels and low potassium levels in your blood.
  • have liver problems.
  • are pregnant or plan to become pregnant. It is not known if esomeprazole magnesium delayed-release capsules can harm your unborn baby.
  • are breastfeeding or planning to breastfeed. Esomeprazole magnesium may pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take esomeprazole magnesium delayed-release capsules.

Tell your doctor about all of the medicines you take , including prescription and over-the-counter medicines, vitamins and herbal supplements.

Especially tell your doctor if you take: clopidogrel (Plavix), methotrexate (Otrxup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), rilpivirine (EDURANT), St. John’s Wort (Hypericum perforatum), or rifampin (Rimactane, Rifater, Rifamate).

How should I take esomeprazole magnesium delayed-release capsules?

  • Take esomeprazole magnesium delayed-release capsules exactly as prescribed by your doctor.
  • Do not change your dose or stop esomeprazole magnesium delayed-release capsules without talking to your doctor.
  • Take esomeprazole magnesium delayed-release capsules at least 1 hour before a meal.
  • Antacids may be taken with esomeprazole magnesium delayed-release capsules.
  • Swallow esomeprazole magnesium delayed-release capsules whole. Never chew or crush esomeprazole magnesium delayed-release capsules.
  • If you have difficulty swallowing esomeprazole capsules, you may open the capsule and empty the granules into 1 tablespoon of applesauce. The applesauce used should not be hot and should be soft enough to swallow without chewing. Do not mix the esomeprazole granules with any other food.
  • Do not crush or chew the granules. Be sure to swallow the applesauce right away. Throw away any remaining mixture. Do not store it for later use.
  • If you forget to take a dose of esomeprazole, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take a double dose to make up for a missed dose.
  • If you take too much esomeprazole, call your doctor or local poison control center right away at 1-800-222-1222, or go to the nearest hospital emergency room.
  • See the Instructions for Use at the end of this Medication Guide for instructions how to mix and give esomeprazole magnesium delayed-release capsules through a nasogastric tube.

What are the possible side effects of esomeprazole magnesium delayed-release capsules?

Esomeprazole can cause serious side effects, including:

  • SeeWhat is the most important information I should know about esomeprazole?”
  • Low vitamin B-12 levels in your body can happen in people who have taken esomeprazole for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
  • Low magnesium levels in your body can happen in people who have taken esomeprazole for at least 3 months. Tell your doctor right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
  • Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.
  • Severe skin reactions. Esomeprazole magnesium delayed-release capsules can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
  • Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).
  • You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.

Stop taking esomeprazole magnesium delayed-release capsules and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

The most common side effects with esomeprazole magnesium delayed-release capsules include:

  • headache
  • stomach (abdominal) pain
  • diarrhea
  • constipation
  • nausea
  • dry mouth
  • gas

These are not all the possible side effects with esomeprazole magnesium delayed-release capsules.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store esomeprazole magnesium delayed-release capsules?

  • 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 the container of esomeprazole magnesium delayed-release capsules tightly closed.

Keep esomeprazole magnesium delayed-release capsules and all medicines out of the reach of children.

General information about the safe and effective use of esomeprazole magnesium delayed-release capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use esomeprazole magnesium delayed-release capsules for a condition for which it was not prescribed. Do not give esomeprazole magnesium delayed-release capsules to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about esomeprazole magnesium delayed-release capsules that is written for health professionals.

What are the ingredients in esomeprazole magnesium delayed-release capsules?

Active ingredient: esomeprazole magnesium trihydrate

Inactive ingredients in esomeprazole magnesium delayed-release capsules (including the capsule shells): hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono-and di-glycerides, polysorbate 80, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink also contains ferric oxide black, shellac, strong ammonium solution, potassium hydroxide and propylene glycol.

Manufactured by:

Graviti Pharmaceuticals Pvt. Ltd.

Telangana-502307, INDIA.

Manufactured for:

Graviti Pharmaceuticals Inc.,

Wilmington, Delaware-19801, USA.

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

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: March 2022

Instructions for Use

For instructions on taking Delayed-Release Capsules, see the section of this leaflet called “How should I take Esomeprazole magnesium delayed-release capsules?”

Esomeprazole magnesium delayed-release capsules may be given through a nasogastric tube (NG tube) or gastric tube, as prescribed by your doctor. Follow the instructions below:

  • Open the capsule and empty the granules into a 60 mL catheter tipped syringe. Mix with 50 mL of water. Use only a catheter tipped syringe to give esomeprazole magnesium delayed-release capsules through a NG tube.
  • Replace the plunger and shake the syringe well for 15 seconds. Hold the syringe with the tip up and check for granules in the tip.
  • Give the medicine right away.
  • Do not give the granules if they have dissolved or have broken into pieces.
  • Attach the syringe to the NG tube. Give the medicine right away in the syringe through the NG tube into the stomach.
  • After giving the granules, flush the NG tube with more water.

This Instructions for use has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Graviti Pharmaceuticals Pvt. Ltd.

Telangana-502307, INDIA.

Manufactured for:

Graviti Pharmaceuticals Inc.,

Wilmington, Delaware-19801, USA.

Revised: 03/2022

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