ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release
Lake Erie Medical DBA Quality Care Products LLC
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.
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.
Triple Therapy (esomeprazole magnesium plus amoxicillin and clarithromycin): Esomeprazole magnesium delayed-release capsules, USP 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 prescribing information for clarithromycin ].
Esomeprazole magnesium delayed-release capsules, USP are 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.
*[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 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)].
|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***|
|12 to 17 Year Olds Healing of Erosive EsophagitisSymptomatic GERD||20 mg or 40 mg20 mg||Once Daily for 4 to 8 WeeksOnce 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 . pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence|
|Esomeprazole Magnesium||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|
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 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.
|Administration Options ( See text following table for additional instructions .)|
|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 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.
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