Esomeprazole Magenisium

Esomeprazole magnesium is supplied as delayed-release capsules for oral administration. The recommended dosages are outlined in the 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
1 to 11 Year Olds+
20 mg
Once Daily for 4 Weeks
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**
Pathological Hypersecretory ConditionsIncluding 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.
+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)].
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
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 delayed-release capsules 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.