Adult: The most frequently occurring adverse reactions: were headache, diarrhea, Nausea, flatulence, abdominal pain, constipation, and dry mouth Pediatrics: Aged 12 to 17 years: the most frequently reported adverse reactions: headache, abdominal pain, diarrhea, and nausea. From birth to <1 year of age: abdominal pain, regurgitation, tachypnea, and increased ALT. Combination Treatment with Amoxicillin and Clarithromycin: Diarrhea, taste perversion, and abdominal pain.
Storage
Store at temperature between (15-30) ºC, away from light.
Packaging
Eso-Protocol 40: 20 delayed-release capsules in a carton box with a leaflet.
Overdose
The symptoms described with overdose are transient; manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions. No specific antidote for esomeprazole is known, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive.
Dosage & Administration
The drug should be taken at least one hour before meals. Delayed-Release Capsules:, it can be swallowed whole or can be opened and mixed with applesauce and it shouldn't be hot and should be soft enough to be swallowed without chewing, the mixture shouldn't store for future use. The pellets should not be chewed or crushed. For patients who have a nasogastric tube: the capsules can be opened and the only intact granules should be emptied into a 60 mL catheter tipped syringe and mixed with 50 mL of water. 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 through the nasogastric tube, then nasogastric tube should be flushed with additional water. Recommended Dosage Schedule:
Indication
Dose
Frequency
Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
20 mg
or
40 mg
Once Daily for 4 to 8 Weeks
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.
Maintenance of Healing of Erosive Esophagitis
20 mg
Once Daily
( Controlled studies did not extend beyond six months )
Symptomatic Gastroesophageal Reflux Disease
20 mg
Once Daily for 4 Weeks
If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
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
Risk Reduction of NSAID- Associated Gastric Ulcer
20 mg or 40 mg
Once Daily for up to 6 months
( Controlled studies did not extend beyond six months )
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
40 mg
Twice Daily
The dosage in each condition varies with the individual patient.
Dosage regimens should be adjusted to individual patient needs
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple Therapy
