ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium dihydrate capsule, delayed release
DIRECT RX

INDICATIONS & USAGE SECTION

1.1 Treatment of Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis

Esomeprazole Magnesium Delayed-Release Capsules USP 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 USP may be considered.

Maintenance of Healing of Erosive Esophagitis

Esomeprazole Magnesium Delayed-Release Capsules USP 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 USP 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 USP 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 Delayed-Release Capsules USP plus amoxicillin and clarithromycin): Esomeprazole Magnesium Delayed-Release Capsules USP, in combination with amoxicillin and clarithromycin, is 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 prescribing information for clarithromycin].

1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Esomeprazole Magnesium Delayed-Release Capsules USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

DOSAGE & ADMINISTRATION SECTION

Esomeprazole Magnesium Delayed-Release Capsules are 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 of Esomeprazole Magnesium Delayed-Release Capsules

Indication

Dose

Frequency

Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis

20 mg or 40 mg

Once Daily for 4 to 8 weeks*

Maintenance of Healing of Erosive Esophagitis

20 mg

Once Daily**

Symptomatic Gastroesophageal

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 Weeks

1 to 11 Year Olds+

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**

H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

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

40mg†

‡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.

+ 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)].

Please refer to amoxicillin and clarithromycin prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients.

Special 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

Administration Options

(See text following table for additional instructions.)

Dosage Form

Route

Options

Delayed-Release Capsules

Oral

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.

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.

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.

DOSAGE FORMS & STRENGTHS SECTION

Esomeprazole magnesium delayed-release capsules, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “logo“ and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.

Esomeprazole magnesium delayed-release capsules, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “logo“ and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.

CONTRAINDICATIONS SECTION

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)].

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.