ESOMEPRAZOLE MAGNESIUM capsule, delayed release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Available from:
A-S Medication Solutions
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are 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 magnesium delayed-release capsules may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older. Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy
Product summary:
Product: 50090-5365 NDC: 50090-5365-0 30 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-5365-1 90 CAPSULE, DELAYED RELEASE in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
50090-5365-0, 50090-5365-1

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MEDICATION GUIDE

Esomeprazole Magnesium (ES-oh-MEP-ra-zole mag-NEE-zee-um) Delayed-Release Capsules, USP

Rx only

Read the Medication Guide that comes with esomeprazole magnesium delayed-release capsules, USP

before you start taking esomeprazole magnesium delayed-release capsules, USP and each time you get a

refill. There may be new information. This information does not take the place of talking with your doctor

about your medical condition or your treatment.

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

capsules, USP?

Esomeprazole magnesium delayed-release capsules, USP may help your acid-related symptoms, but you

could still have serious stomach problems. Talk with your doctor.

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

A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor

(PPI) medicines, including esomeprazole magnesium delayed-release capsules, USP, may develop a

kidney problem called acute interstitial nephritis that can happen at any time during treatment with

esomeprazole magnesium delayed-release capsules, USP. Call your doctor if you have a decrease in

the amount that you urinate or if you have blood in your urine.

Diarrhea. Esomeprazole magnesium delayed-release capsules, USP may increase your risk of

getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your

intestines.

Call your doctor right away if you have watery stool, stomach pain, and fever that does not go

away.

Bone fractures. People who take multiple daily doses of PPI medicines for a long period of time (a

year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take

esomeprazole magnesium delayed-release capsules, USP exactly as prescribed, at the lowest dose

possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of

bone fracture if you take esomeprazole magnesium delayed-release capsules, USP.

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, USP, 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.

Esomeprazole magnesium delayed-release capsules, USP can have other serious side effects. See

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

What are esomeprazole magnesium delayed-release capsules, USP?

Esomeprazole magnesium delayed-release capsules, USP are a prescription medicine called a proton

pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules, USP reduces the amount of

acid in your stomach.

Esomeprazole magnesium delayed-release capsules, USP are used in adults:

for 4 to 8 weeks to treat the symptoms of gastroesophageal reflux disease (GERD). Esomeprazole

magnesium delayed-release capsules, USP may also be prescribed to heal acid-related damage to

the lining of the esophagus (erosive esophagitis), and to help continue this healing.

GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your

mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or

burping.

for up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called

non-steroidal anti-inflammatory drugs (NSAIDs).

to treat patients with a stomach infection (Helicobacter pylori), along with the antibiotics

amoxicillin and clarithromycin.

for 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.

For children and adolescents 1 year to 17 years of age, esomeprazole magnesium delayed-release

capsules, USP may be prescribed for up to 8 weeks for short-term treatment of GERD.

Who should not take esomeprazole magnesium delayed-release capsules, USP?

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

are allergic to esomeprazole magnesium or any of the ingredients in esomeprazole magnesium

delayed-release capsules, USP. See the end of this Medication Guide for a complete list of

ingredients in esomeprazole magnesium delayed-release capsules, USP.

are allergic to any other PPI medicine.

What should I tell my doctor before taking esomeprazole magnesium delayed-release capsules, USP?

Before you take esomeprazole magnesium delayed-release capsules, USP, tell your doctor if you:

have been told that you have low magnesium levels in your blood.

have liver problems.

are pregnant or plan to become pregnant. It is not known if esomeprazole magnesium delayed-

release capsules, USP can harm your unborn baby.

are breastfeeding or planning to breastfeed. Esomeprazole 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, USP.

Tell your doctor about all of the medicines you take, including prescription and non-prescription drugs,

vitamins and herbal supplements. Esomeprazole magnesium delayed-release capsules, USP may affect

how other medicines work, and other medicines may affect how esomeprazole magnesium delayed-

release capsules, USP work.

Especially tell your doctor if you take:

warfarin (Coumadin, Jantoven)

Rifampin (Rimactane, Rifater, Rifamate)

ketoconazole (Nizoral)

cilostazol (Pletal)

voriconazole (Vfend)

diazepam (Valium)

atazanavir (Reyataz)

tacrolimus (Prograf)

nelfinavir (Viracept)

erlotinib (Tarceva)

saquinavir (Fortovase)

methotrexate

products that contain iron

clopidogrel (Plavix)

digoxin (Lanoxin)

mycophenolate mofetil (Cellcept)

St. John's Wort (Hypericum perforatum)

How should I take esomeprazole magnesium delayed-release capsules, USP?

Take esomeprazole magnesium delayed-release capsules, USP exactly as prescribed by your doctor.

Do not change your dose or stop esomeprazole magnesium delayed-release capsules, USP without

talking to your doctor.

Take esomeprazole magnesium delayed-release capsules, USP at least 1 hour before a meal.

Swallow esomeprazole magnesium delayed-release capsules, USP whole. Never chew or crush

esomeprazole magnesium delayed-release capsules, USP.

If you have difficulty swallowing esomeprazole magnesium delayed-release capsules, USP, you

may open the capsule and empty the contents into a tablespoon of applesauce. Do not crush or chew

the granules. Be sure to swallow the applesauce right away. Do not store it for later use.

If you forget to take a dose of esomeprazole magnesium delayed-release capsules, USP, 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 magnesium delayed-release capsules, USP, call your doctor or

local poison control center right away, 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, USP, through a nasogastric tube.

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

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

See "What is the most important information I should know about esomeprazole magnesium

delayed-release capsules, USP?"

Vitamin B-12 deficiency. Esomeprazole magnesium delayed-release capsules, USP reduces the

amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with

your doctor about the possibility of vitamin B-12 deficiency if you have been on esomeprazole

magnesium delayed-release capsules, USP for a long time (more than 3 years).

Low magnesium levels in your body. Low magnesium can happen in some people who take a PPI

medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of

treatment.

You may or may not have symptoms of low magnesium.

Tell your doctor right away if you have any of these symptoms:

seizures

muscle weakness

dizziness

spasms of the hands and feet

abnormal or fast heart beat

cramps or muscle aches

jitteriness

spasm of the voice box

jerking movements or shaking (tremors)

Your doctor may check the level of magnesium in your body before you start taking esomeprazole

magnesium delayed-release capsules, USP or during treatment if you will be taking esomeprazole

magnesium delayed-release capsules, USP for a long period of time.

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.

The most common side effects with esomeprazole magnesium delayed-release capsules, USP may

include:

headache

abdominal pain

diarrhea

constipation

nausea

dry mouth

drowsiness

Other side effects:

Serious allergic reactions. Tell your doctor if you get any of the following symptoms with esomeprazole

magnesium delayed-release capsules, USP:

rash

throat tightness

face swelling

difficulty breathing

Your doctor may stop esomeprazole magnesium delayed-release capsules, USP if these symptoms

happen.

Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the

possible side effects with esomeprazole magnesium delayed-release capsules, USP.

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, USP?

Store esomeprazole magnesium delayed-release capsules, USP at 68 - 77° F (20 - 25° C).

Keep the container of esomeprazole magnesium delayed-release capsules, USP closed tightly.

Keep esomeprazole magnesium delayed-release capsules, USP and all medicines out of the reach of

children.

General information about esomeprazole magnesium delayed-release capsules, USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not

use esomeprazole magnesium delayed-release capsules, USP for a condition for which it was not

prescribed. Do not give esomeprazole magnesium delayed-release capsules, USP to other people, even if

they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about esomeprazole magnesium

delayed-release capsules, USP. If you would like more information, talk with your doctor. You can ask

your pharmacist or doctor for information about esomeprazole magnesium delayed-release capsules, USP

that is written for health professionals.

For more information, call 1-800-818-4555.

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

Active ingredient: esomeprazole magnesium (anhydrous)

Inactive ingredients in esomeprazole magnesium delayed-release capsules (including the capsule shells):

D&C Red #28, FD&C Blue #1, FD&C Red #40, ferric oxide black, gelatin, hydroxypropyl cellulose,

hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides,

polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose),

talc, titanium dioxide, and triethyl citrate.

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, USP?"

Esomeprazole magnesium delayed-release capsules, USP may be given through a nasogastric tube (NG

tube), as prescribed by your doctor. Follow the instructions below:

Esomeprazole magnesium delayed-release capsules, USP:

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, USP 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 in the syringe through the NG tube into the

stomach.

After giving the granules, flush the NG tube with more water.

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

All trademarks are the property of their respective owners.

Manufactured by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

June 2018 FDA-04

Revised: 3/2021

Document Id: d37316e4-ad82-48bd-963f-c7cebbc9ba6a

34391-3

Set id: 6fd71c88-021d-44dd-a6da-80a17461257e

Version: 3

Effective Time: 20210302

A-S Medication Solutions

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ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ESOMEPRAZOLE

MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing

information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES.

ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use

Initial U.S. Approval: 1989 (omeprazole)

RECENT MAJOR CHANGES

INDICATIONS AND USAGE

DOSAGE AND ADMINISTRATION

Gastroesophageal Reflux Disease (GERD) (2)

Adults (2)

20 mg or 40 mg (2)

Once daily for 4 to 8 weeks (2)

12 to 17 years (2)

20 mg or 40 mg (2)

Once daily for up to 8 weeks (2)

1 to 11 years (2)

10 mg or 20 mg (2)

Once daily for up to 8 weeks (2)

Risk Reduction of NSAID-Associated Gastric Ulcer (2)

20 mg or 40 mg (2)

Once daily for up to 6 months (2)

H. pylori Eradication (Triple Therapy): (2)

Esomeprazole magnesium

delayed-release capsules (2)

40 mg (2)

Once daily for 10 days (2)

Amoxicillin (2)

1000 mg (2)

Twice daily for 10 days (2)

Clarithromycin (2)

500 mg (2)

Twice daily for 10 days (2)

Pathological Hypersecretory Conditions (2)

40 mg (2)

Twice daily (2)

See full prescribing information for administration options. (2) (2)

Patients with severe liver impairment-do not exceed dose of 20 mg. (2) (2)

DOSAGE FORMS AND STRENGTHS

CONTRAINDICATIONS

Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have

occurred). (4) (4)

WARNINGS AND PRECAUTIONS

Warnings and Precautions, Fundic Gland Polyps (5.12) 06/2018

Esomeprazole magnesium delayed-release capsules are proton pump inhibitor indicated for the

following:

Treatment of gastroesophageal reflux disease (GERD). (1.1)

Risk reduction of NSAID-associated gastric ulcer. (1.2)

H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3)

Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (1.4)

Indication Dose Frequency

Esomeprazole Magnesium Delayed-Release Capsules: 20 mg and 40 mg. (3)

ADVERSE REACTIONS

Most common adverse reactions (6.1): (6)

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries Inc. at

1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.medwatch. (6)

DRUG INTERACTIONS

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 3/2021

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Treatment of Gastroesophageal Reflux Disease (GERD)

1.2 Risk Reduction of NSAID-Associated Gastric Ulcer

1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Gastric Malignancy: In adults, symptomatic response does not preclude the presence of gastric

malignancy. Consider additional follow-up and diagnostic testing. (5.1)

Acute Interstitial Nephritis: Observed in patients taking PPIs. (5.2)

Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk. (5.3)

Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased

risk for osteoporosis-related fractures of the hip, wrist or spine. (5.4)

Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of

existing disease; discontinue esomeprazole magnesium and refer to specialist for evaluation. (5.5)

Interaction with Clopidogrel: Avoid concomitant use of esomeprazole magnesium. (5.6)

Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead

to malabsorption or a deficiency of cyanocobalamin. (5.7)

Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. (5.8)

Interaction with St. John's Wort or Rifampin: Avoid concomitant use of esomeprazole magnesium. (5.9,

7.3)

Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increased chromogranin A

(CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors, temporarily stop

esomeprazole magnesium at least 14 days before assessing CgA levels. (5.10, 12.2)

Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum

concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose

methotrexate administration, consider temporary withdrawal of esomeprazole magnesium. (5.11,

7.7)

Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest

duration of therapy. (5.12)

Adults (≥ 18 years) (incidence > 1%) are headache, diarrhea, nausea, flatulence, abdominal pain,

constipation, and dry mouth.

Pediatric (1 to 17 years) (incidence > 2%) are headache, diarrhea, abdominal pain, nausea, and

somnolence.

May affect plasma levels of antiretroviral drugs – use with atazanavir and nelfinavir is not

recommended; if saquinavir is used with esomeprazole magnesium, monitor for toxicity and consider

saquinavir dose reduction. (7.1)

May interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts,

erlotinib, digoxin and mycophenolate mofetil). Patients treated with esomeprazole magnesium and

digoxin may need to be monitored for digoxin toxicity. (7.2)

Combined inhibitor of CYP2C19 and 3A4 may raise esomeprazole levels. (7.3)

Clopidogrel: Esomeprazole magnesium decreases exposure to the active metabolite of clopidogrel.

(7.3)

May increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction. (7.3)

Tacrolimus: Esomeprazole magnesium may increase serum levels of tacrolimus. (7.5)

Methotrexate: Esomeprazole magnesium may increase serum levels of methotrexate. (7.7)

1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

5.2 Acute Interstitial Nephritis

5.3 Clostridium difficile-Associated Diarrhea

5.4 Bone Fracture

5.5 Cutaneous and Systemic Lupus Erythematosus

5.6 Interaction with Clopidogrel

5.7 Cyanocobalamin (Vitamin B-12) Deficiency

5.8 Hypomagnesemia

5.9 Interaction with St. John's Wort or Rifampin

5.10 Interactions with Diagnostic Investigations for Neuroendocrine Tumors

5.11 Interaction with Methotrexate

5.12 Fundic Gland Polyps

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Interference with Antiretroviral Therapy

7.2 Drugs for Which Gastric pH Can Affect Bioavailability

7.3 Effects on Hepatic Metabolism/Cytochrome P-450 Pathways

7.4 Interactions with Investigations of Neuroendocrine Tumors

7.5 Tacrolimus

7.6 Combination Therapy with Clarithromycin

7.7 Methotrexate

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Healing of Erosive Esophagitis

14.2 Symptomatic Gastroesophageal Reflux Disease (GERD)

14.3 Pediatric Gastroesophageal Reflux Disease (GERD)

14.4 Risk Reduction of NSAID-Associated Gastric Ulcer

14.5 Helicobacter pylori (H. pylori) Eradication in Patients with Duodenal Ulcer Disease

14.6 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Treatment of Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis

Esomeprazole magnesium delayed-release capsules are 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 magnesium

delayed-release capsules may be considered.

Maintenance of Healing of Erosive Esophagitis

Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom

resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6

months.

Symptomatic Gastroesophageal Reflux Disease

Esomeprazole magnesium delayed-release capsules are indicated for short-term

treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in

adults and children 1 year or older.

1.2 Risk Reduction of NSAID-Associated Gastric Ulcer

Esomeprazole magnesium delayed-release capsules are 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 due to their

age (> 60) and/or documented history of gastric ulcers. Controlled studies do not

extend beyond 6 months.

1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy (esomeprazole magnesium plus amoxicillin and clarithromycin):

Esomeprazole magnesium delayed-release capsules, in combination with amoxicillin and

clarithromycin, are indicated for the treatment of patients with H. pylori infection and

duodenal ulcer disease (active or history of within the past 5 years) to eradicate H.

pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer

recurrence [see Dosage and Administration (2) and Clinical Studies (14)].

In patients who fail therapy, susceptibility testing should be done. If resistance to

clarithromycin is demonstrated or susceptibility testing is not possible, alternative

antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the

Sections or subsections omitted from the full prescribing information are not listed.

prescribing information for clarithromycin].

1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison

Syndrome

Esomeprazole magnesium delayed-release capsules are indicated for the long-term

treatment of pathological hypersecretory conditions, including Zollinger-Ellison

Syndrome.

2 DOSAGE AND ADMINISTRATION

Esomeprazole magnesium is supplied as delayed-release capsules for oral

administration. The recommended dosages are outlined in Table 1. Esomeprazole

magnesium delayed-release capsules 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.

Table 1: Recommended Dosage Schedule for Esomeprazole Magnesium

Delayed-Release Capsules

Indication

Gastroesophageal Reflux Disease (GERD)

Dose

Frequency

Healing of Erosive Esophagitis

20 mg or

40 mg

Once Daily for 4 to 8

Weeks

Maintenance of Healing of

Erosive Esophagitis

Symptomatic Gastroesophageal

20 mg

Once Daily

Reflux Disease

20 mg

Once Daily for 4

Weeks

Pediatric GERD

12 to 17 Year Olds

Healing of Erosive Esophagitis

20 mg or

40 mg

Once Daily for 4 to 8

Weeks

Symptomatic GERD

20 mg

Once Daily for 4

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Weeks

1 to 11 Year Olds

4

Short-term Treatment of

Symptomatic GERD

10 mg

Once Daily for up to

8 Weeks

Healing of Erosive Esophagitis

weight < 20 kg

10 mg

Once Daily for 8

Weeks

weight > 20 kg

10 mg or

20 mg

Once Daily for 8

Weeks

Risk Reduction of NSAID-

Associated Gastric Ulcer

20 mg or

40 mg

Once Daily for up to

6 months

Triple Therapy:

Esomeprazole

Magnesium Delayed-

Release capsules

40 mg

Once Daily for 10 Days

Amoxicillin

1000 mg

Twice Daily for 10 Days

Clarithromycin

500 mg

Twice Daily for 10 Days

Pathological

Hypersecretory

Conditions Including

Zollinger-Ellison

Syndrome

40 mg

Twice Daily

[See Clinical Studies (14.1)] The majority of patients are healed within 4 to 8

weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks

of treatment may be considered.

Controlled studies did not extend beyond six months.

If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of

treatment may be considered.

Please refer to amoxicillin and clarithromycin prescribing information for

Contraindications, Warnings, and dosing in elderly and renally-impaired patients.

Specific 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 20 mg of esomeprazole magnesium delayed-release capsules should

not be exceeded [see Clinical Pharmacology (12.3)].

Directions for use specific to the route and available methods of administration for each

of these dosage forms are presented in Table 2.

Table 2: Administration Options

Oral

Esomeprazole magnesium delayed-release capsules should be swallowed whole.

Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of

applesauce can be added to an empty bowl and the esomeprazole magnesium delayed-

release capsule can be opened, and the granules inside the capsule carefully emptied

onto the applesauce. The granules should be mixed with the applesauce and then

swallowed immediately: do not store for future use. The applesauce used should not be

hot and should be soft enough to be swallowed without chewing. The granules should

not be chewed or crushed. If the granules/applesauce mixture is not used in its entirety,

the remaining mixture should be discarded immediately.

treatment may be considered.

Doses over 1 mg/kg/day have not been studied.

The dosage of esomeprazole magnesium delayed-release capsules in patients with

pathological hypersecretory conditions varies with the individual patient. Dosage

regimens should be adjusted to individual patient needs.

Doses up to 240 mg daily have been administered [see Drug Interactions (7)].

Administration Options

(See text following table for additional instructions.)

Dosage

Form

Route

Options

Delayed-

Release

Capsules

Capsule can be swallowed whole.

-or-

Capsule can be opened and mixed with

applesauce.

Delayed-

Release

Capsules

Nasogastric

Tube

Capsule can be opened and the intact granules

emptied into a syringe and delivered through

the nasogastric tube.

For patients who have a nasogastric tube in place, esomeprazole magnesium delayed-

release capsules can be opened and the intact granules emptied into a 60 mL catheter

tipped syringe and mixed with 50 mL of water. It is important to only use a catheter

tipped syringe when administering esomeprazole magnesium through a nasogastric

tube. Replace the plunger and shake the syringe vigorously for 15 seconds. Hold the

syringe with the tip up and check for granules remaining in the tip. Attach the syringe to

a nasogastric tube and deliver the contents of the syringe through the nasogastric tube

into the stomach. After administering the granules, the nasogastric tube should be

flushed with additional water. Do not administer the granules if they have dissolved or

disintegrated.

The mixture must be used immediately after preparation.

3 DOSAGE FORMS AND STRENGTHS

Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg – Size 4 capsule with

pink opaque cap imprinted with 'RB66' and pink opaque body imprinted with '20 mg' in

black ink containing off-white to brownish colored beads.

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40 mg - Size 3 capsule with

pink opaque cap imprinted with 'RB67' and pink opaque body imprinted with '40 mg' in

black ink containing off-white to brownish colored beads.

4 CONTRAINDICATIONS

Esomeprazole magnesium is contraindicated in patients with known hypersensitivity to

substituted benzimidazoles or to any component of the formulation. Hypersensitivity

reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm,

acute interstitial nephritis, and urticaria [see Adverse Reactions (6)].

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with esomeprazole magnesium does not

preclude the presence of gastric malignancy. Consider additional follow-up and

diagnostic testing in adult patients who have a suboptimal response or an early

symptomatic relapse after completing treatment with a PPI. In older patients, also

consider an endoscopy.

5.2 Acute Interstitial Nephritis

For information about contraindications of antibacterial agents (clarithromycin and

amoxicillin) indicated in combination with esomeprazole magnesium, refer to the

CONTRAINDICATIONS section of their package inserts.

Acute interstitial nephritis has been observed in patients taking PPIs including

esomeprazole magnesium. Acute interstitial nephritis may occur at any point during

PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction.

Discontinue esomeprazole magnesium if acute interstitial nephritis develops [see

5.3 Clostridium difficile-Associated Diarrhea

Published observational studies suggest that PPI therapy like esomeprazole magnesium

may be associated with an increased risk of Clostridium difficile-associated diarrhea,

especially in hospitalized patients. This diagnosis should be considered for diarrhea that

does not improve [see Adverse Reactions (6.2)].

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to

the condition being treated.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all

antibacterial agents. For more information specific to antibacterial agents (clarithromycin

and amoxicillin) indicated for use in combination with esomeprazole magnesium, refer to

Warnings and Precautions section of the corresponding prescribing information.

5.4 Bone Fracture

Several published observational studies suggest that proton pump inhibitor (PPI) therapy

may be associated with an increased risk for osteoporosis-related fractures of the hip,

wrist, or spine. The risk of fracture was increased in patients who received high-dose,

defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients

should use the lowest dose and shortest duration of PPI therapy appropriate to the

condition being treated. Patients at risk for osteoporosis-related fractures should be

managed according to established treatment guidelines [see Dosage and Administration

(2) and Adverse Reactions (6.2)].

5.5 Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have

been reported in patients taking PPIs, including esomeprazole. These events have

occurred as both new onset and an exacerbation of existing autoimmune disease. The

majority of PPI-induced lupus erythematosus cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE

(SCLE) and occurred within weeks to years after continuous drug therapy in patients

ranging from infants to the elderly. Generally, histological findings were observed

without organ involvement.

Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients

receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of

SLE typically occurred within days to years after initiating treatment primarily in patients

ranging from young adults to the elderly. The majority of patients presented with rash;

however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms

consistent with CLE or SLE are noted in patients receiving esomeprazole magnesium,

discontinue the drug and refer the patient to the appropriate specialist for evaluation.

Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological

testing (e.g., ANA) may be positive and elevated serological test results may take longer

to resolve than clinical manifestations.

5.6 Interaction with Clopidogrel

Contraindications (4)].

Avoid concomitant use of esomeprazole magnesium with clopidogrel. Clopidogrel is a

prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active

metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use

with concomitant medications, such as esomeprazole, that inhibit CYP2C19 activity.

Concomitant use of clopidogrel with 40 mg esomeprazole reduces the pharmacological

activity of clopidogrel. When using esomeprazole magnesium consider alternative anti-

platelet therapy [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)].

5.7 Cyanocobalamin (Vitamin B-12) Deficiency

Daily treatment with any acid-suppressing medications over a long period of time (e.g.,

longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12)

caused by hypo-or achlorhydria. Rare reports of cyanocobalamin deficiency occurring

with acid-suppressing therapy have been reported in the literature. This diagnosis should

be considered if clinical symptoms consistent with cyanocobalamin deficiency are

observed.

5.8 Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients

treated with PPIs for at least three months, in most cases after a year of therapy.

Serious adverse events include tetany, arrhythmias, and seizures. In most patients,

treatment of hypomagnesemia required magnesium replacement and discontinuation of

the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications

such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care

professionals may consider monitoring magnesium levels prior to initiation of PPI

treatment and periodically [see Adverse Reactions (6.2)].

5.9 Interaction with St. John's Wort or Rifampin

Drugs which induce CYP2C19 or CYP3A4 (such as St. John's Wort or rifampin) can

substantially decrease esomeprazole concentrations [see Drug Interactions (7.3)]. Avoid

concomitant use of esomeprazole magnesium with St. John's Wort or rifampin.

5.10 Interactions with Diagnostic Investigations for Neuroendocrine Tumors

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in

gastric acidity. The increased CgA level may cause false positive results in diagnostic

investigations for neuroendocrine tumors. Healthcare providers should temporarily stop

esomeprazole treatment at least 14 days before assessing CgA levels and consider

repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for

monitoring), the same commercial laboratory should be used for testing, as reference

ranges between tests may vary [see Clinical Pharmacology (12.2)].

5.11 Interaction with Methotrexate

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high

dose; see methotrexate prescribing information) may elevate and prolong serum levels

of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In

high-dose methotrexate administration a temporary withdrawal of the PPI may be

considered in some patients [see Drug Interactions (7.7)].

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