Esomeprazole Magenisium

Esomeprazole Magenisium Manufacturers

• Camber Pharmaceuticals, Inc.
  

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  Esomeprazole Magenisium | Camber Pharmaceuticals, Inc.

  

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  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.

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