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Esomeprazole Magnesium D/r Recall
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Esomeprazole Magnesium D/r Manufacturers
Esomeprazole Magnesium D/r | Directrx
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 of Esomeprazole Magnesium Delayed-Release CapsulesIndication 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 1 month to < 1 year old‡‡‡ Erosive esophagitis due to acid- mediated GERD weight 3 kg to 5 kg 2.5 mg Once Daily for up to 6 Weeks weight > 5 kg to 7.5 kg 5 mg Once Daily for up to 6 Weeks weight >7.5 kg to 12 kg 10 mg Once Daily for up to 6 Weeks Risk Reduction of NSAID- Associated Gastric Ulcer 20 mg or 40 mg Once Daily for up to 6 months** 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.
+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)].
‡‡‡Doses over 1.33 mg/kg/day have not been studied.
Please refer to amoxicillin and clarithromycin prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients.Special Populations
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 OptionsAdministration 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 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.
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