Prescription Drug Information: Esomeprazole Magnesium

ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release pellets
Glenmark Pharmaceuticals Inc., USA

1 INDICATIONS AND USAGE

1.1 Healing of Erosive Esophagitis (EE)

Adults

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 EE in adults. 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.

Pediatric Patients 12 Years to 17 Years of Age

Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age.

1.2 Maintenance of Healing of EE

Esomeprazole magnesium delayed-release capsules delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months.

1.3 Treatment of Symptomatic GERD

Adults

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.

Pediatric Patients 12 Years to 17 Years of Age

Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age.

1.4 Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (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 adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

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

Triple Therapy

Esomeprazole magnesium delayed-release capsules in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.

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 prescribing information for clarithromycin].

1.6 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, in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Adults by Indication

Table 1 shows the recommended adult dosage of esomeprazole magnesium delayed-release capsules by indication.

The duration of esomeprazole magnesium delayed-release capsules treatment should be based on available safety and efficacy data specific to the defined indication and dosing frequency and individual patient medical needs. Esomeprazole magnesium delayed-release capsules should only be initiated and continued if the benefits outweigh the risks of treatment.

Table 1: Recommended Dosage of Esomeprazole Magnesium Delayed-Release Capsules in Adults by Indication

Adult Indication	Recommended Dosage of Esomeprazole Magnesium delayed-release capsules	Treatment Duration
Healing of EE	20 mg or 40 mg1 once daily	4 to 8 weeks2
Maintenance of Healing of EE	20 mg once daily	Controlled studies do not extend beyond 6 months
Treatment of Symptomatic GERD	20 mg once daily	4 weeks; if symptoms do not resolve completely, consider an additional 4 weeks
Risk Reduction of NSAID-Associated Gastric Ulcer	20 mg or 40 mg1 once daily	Controlled studies do not extend beyond 6 months
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (Triple Therapy)	Esomeprazole magnesium delayed-release capsules 40 mg once daily1	10 days
	Amoxicillin 1000 mg twice daily3	10 days
	Clarithromycin 500 mg twice daily3	10 days
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome	Starting dosage is 40 mg twice daily4 ; individualize the regimen to patient needs. Dosages of up to 240 mg/day have been administered [see Clinical Studies (14.7)].	As long as clinically indicated

^1. A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6)].

^2. Most 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 required to achieve healing [see Clinical Studies (14.1)].

^3. Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients.

^4. A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6)].

2.2 Recommended Dosage in Pediatric Patients by Indication

Table 2 shows the recommended dosage of esomeprazole magnesium delayed-release capsules in pediatric patients by indication.

Table 2: Recommended Dosage of Esomeprazole Magnesium Delayed-Release Capsules in Pediatric Patients by Indication

Indication	Patient Age	Recommended Dosage	Duration
Healing of EE	12 years to 17 years	Esomeprazole magnesium delayed-release capsules: 20 mg or 40 mg once daily	4 to 8 Weeks
Treatment of Symptomatic GERD	12 years to 17 years	Esomeprazole magnesium delayed-release capsules: 20 mg once daily	4 weeks

2.3 Preparation and Administration Instructions

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Take esomeprazole magnesium delayed-release capsules at least one hour before meals [see Clinical Pharmacology (12.3)].

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Antacids may be used concomitantly with esomeprazole magnesium delayed-release capsules.

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Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time.

Esomeprazole Magnesium Delayed-Release Capsules

Administer esomeprazole magnesium delayed-release capsules orally or via a nasogastric tube, as described below.

Oral Administration

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Swallow esomeprazole magnesium delayed-release capsules whole; do not chew or crush the capsules.

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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 has not been evaluated and is not recommended.

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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.

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Open the esomeprazole magnesium delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce.

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Mix the granules with the applesauce.

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Administer the mixture immediately. Do not chew or crush the granules

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Discard any remaining mixture. Do not store the mixture for future use.

Administration via Nasogastric Tube

1.

Open the esomeprazole magnesium delayed-release capsule and empty the granules into a 60 mL catheter-tipped syringe.

2.

Mix the granules with 50 mL of water.

3.

Replace the plunger and shake the catheter-tipped syringe vigorously for 15 seconds.

4.

Hold the catheter-tipped syringe with the tip up and check for any granules remaining in the tip.

5.

Attach the catheter-tipped syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach.

6.

After administering the granules, flush the nasogastric tube with additional water.

7.

Use the mixture immediately after preparation. Do not administer the granules if they have dissolved or disintegrated.