▶ Manufacturer: Ilhwa Co., Ltd.
▶ Sold by: Ilhwa Co., Ltd.
▶ Insurance code : 6409031000
▶ Storage : Airtight container, store at room temperature (1~30℃)
Hard capsule with green top and bottom cap containing fine white or grey granules
esomeprazole magnesium granule 87.55mg (20mg as esomeprazole)
This drug must be swallowed with a liquid such as water, and must not be chewed or crushed.
For patients with difficulty swallowing capsules, the contents of the capsule may be mixed into half a cup of non-sparking water. Other beverages may not be used as they may dissolve the enteric coating. After opening the capsule and emptying the contents into water and stirring, drink without chewing. Rinse the cup with half a cup of non-sparkling water and drink again. Granules floating in the water must not be chewed or crushed during administration.
For patients unable to swallow capsules, the contents of the capsule may be mixed into non-sparkling water and administered directly through a gastrointestinal tube. Dissolved or crumbled contents must not be administered. Also, it is important to closely inspect the suitability of the tube and syringe used.
The method of administration using a gastrointestinal tube is as follows.
(1) Open the capsule and place contents in a suitable syringe, and add approx. 50mL water.
(2) Immediately shake the syringe for approx. 15 seconds.
(3) Invert the syringe and check that the tip is not blocked.
(4) With the syringe inverted, connect the syringe to the tube.
(5) Shake the syringe, and turn the tip back down and immediately inject 5 to 10mL into the tube. After injecting, invert the syringe and shake again. (To keep the tip from becoming blocked, be sure to keep the syringe inverted.)
(6) Turn the tip of the syringe back down and immediately inject 5 to 10mL into the tube. Repeat until administration of the drug in the syringe is complete.
(7) If sediment remains inside the syringe, add water and repeat (5).
1. Adults
1) Gastroesophageal reflux disease (GERD)
- Treatment of erosive reflux esophagitis: Administer 40mg once a day for 4 weeks. In the case of patients were esophagitis is not treated or symptoms continue, administer for 4 additional weeks.
- Long-term maintenance therapy to prevent recurrence in esophagitis patients : 20mg once a day
- Therapy for treatment of gastroesophageal reflux disease without esophagitis:
ㆍ20mg once a day. If symptoms are not regulated even after 4 weeks, additional examination is necessary.
ㆍOnce symptoms are alleviated, regulate symptoms thereafter by administering 20g once a day.
ㆍIn adults, 20mg may be administered once a day as needed. In the case of patients with high risk of occurrence for gastric and duodenal ulcers due to administration of NSAIDs, administration as needed to regulate continuing symptoms is not recommended
2) Concomitant therapy with antibiotics to eradicate helicobacter pylori
Administer 20mg of this drug concomitantly with 1g amoxicillin and 500mg clarithromycin twice a day for 7 days.
3) Short-term therapy for treatment of upper gastrointestinal tract symptoms (pain, discomfort, purosis) associated with the administration of NSAIDs (non-COX-2 selective and selective)
- 20mg once a day. Additional examination necessary if symptoms are not regulated after 4 weeks. Clinical trials not carried out past 4 weeks.
4) Patients requiring sustained NSAIDs administration
- Treatment of gastric ulcers associated with administration of NSAIDs: 20mg once a day. Treatment period is 4 to 8 weeks.
- Prevention of gastric ulcers and duodenal ulcers associated with administration of NSAIDs: 20mg once a day.
5) Treatment of Zollinger-Ellison syndrome
Recommended starting does is 40mg administered twice a day. Dose should be adjusted according to patient thereafter, and treatment must be continued while clinical symptoms persist. According to clinical data, 80 to 160mg per day is sufficient for most patients. For doses of 80mg or greater a day, divide between two administrations a day.
6) Maintenance therapy after inducing prevention of recurrent bleeding due to gastric ulcers or duodenal ulcers by intravenous injection: Administer 40mg once a day for 4 weeks after inducing prevention of recurrent bleeding due to gastric ulcers or duodenal ulcers by intravenous injection.
2. Youth of 12 years or older
1) Gastroesophageal reflux disease (GERD)
- Treatment of erosive reflux esophagitis: Administer 40mg once a day for 4 weeks. In the case of patients were esophagitis is not treated or symptoms continue, administer for 4 additional weeks.
- Therapy for treatment of gastroesophageal reflux disease without esophagitis:
ㆍ20mg once a day. If symptoms are not regulated even after 4 weeks, additional examination is necessary.
ㆍOnce symptoms are alleviated, regulate symptoms thereafter by administering 20g once a day.
ㆍIn adults, 20mg may be administered once a day as needed. In the case of patients with high risk of occurrence for gastric and duodenal ulcers due to administration of NSAIDs, administration as needed to regulate continuing symptoms is not recommended
3. Children less than 12 years old: No data on administration of this drug in children less than 12 years old.
4. Renal impairment: No need to adjust dose. Administer carefully as there are not many cases of administration to severe renal impairment patients.
5. Liver impairment: No need to adjust dose for mild to moderately severe liver impairment patients. For severe liver impairment patients, dose of 20mg must not be exceeded for this drug.
6. Elderly patients: No need to adjust dose.
1. Gastroesophageal reflux disease (GERD)
- Treatment of erosive reflux esophagitis
- Long-term maintenance therapy to prevent recurrence in esophagitis patients
- Therapy for treatment of gastroesophageal reflux disease without esophagitis
2. Concomitant therapy with antibiotics to eradicate helicobacter pylori
3. Short-term therapy for treatment of upper gastrointestinal tract symptoms (pain, discomfort, purosis) associated with the administration of NSAIDs (non-COX-2 selective and selective)
4) Patients requiring sustained NSAIDs administration
- Treatment of gastric ulcers associated with administration of NSAIDs
- Prevention of gastric ulcers and duodenal ulcers associated with administration of NSAIDs
5) Treatment of Zollinger-Ellison syndrome
6) Maintenance therapy after inducing prevention of recurrent bleeding due to gastric ulcers or duodenal ulcers by intravenous injectionHard capsule with green top and bottom cap containing fine white or grey granules
esomeprazole magnesium granule 87.55mg (20mg as esomeprazole)
This drug must be swallowed with a liquid such as water, and must not be chewed or crushed.
For patients with difficulty swallowing capsules, the contents of the capsule may be mixed into half a cup of non-sparking water. Other beverages may not be used as they may dissolve the enteric coating. After opening the capsule and emptying the contents into water and stirring, drink without chewing. Rinse the cup with half a cup of non-sparkling water and drink again. Granules floating in the water must not be chewed or crushed during administration.
For patients unable to swallow capsules, the contents of the capsule may be mixed into non-sparkling water and administered directly through a gastrointestinal tube. Dissolved or crumbled contents must not be administered. Also, it is important to closely inspect the suitability of the tube and syringe used.
The method of administration using a gastrointestinal tube is as follows.
(1) Open the capsule and place contents in a suitable syringe, and add approx. 50mL water.
(2) Immediately shake the syringe for approx. 15 seconds.
(3) Invert the syringe and check that the tip is not blocked.
(4) With the syringe inverted, connect the syringe to the tube.
(5) Shake the syringe, and turn the tip back down and immediately inject 5 to 10mL into the tube. After injecting, invert the syringe and shake again. (To keep the tip from becoming blocked, be sure to keep the syringe inverted.)
(6) Turn the tip of the syringe back down and immediately inject 5 to 10mL into the tube. Repeat until administration of the drug in the syringe is complete.
(7) If sediment remains inside the syringe, add water and repeat (5).
1. Adults
1) Gastroesophageal reflux disease (GERD)
- Treatment of erosive reflux esophagitis: Administer 40mg once a day for 4 weeks. In the case of patients were esophagitis is not treated or symptoms continue, administer for 4 additional weeks.
- Long-term maintenance therapy to prevent recurrence in esophagitis patients : 20mg once a day
- Therapy for treatment of gastroesophageal reflux disease without esophagitis:
ㆍ20mg once a day. If symptoms are not regulated even after 4 weeks, additional examination is necessary.
ㆍOnce symptoms are alleviated, regulate symptoms thereafter by administering 20g once a day.
ㆍIn adults, 20mg may be administered once a day as needed. In the case of patients with high risk of occurrence for gastric and duodenal ulcers due to administration of NSAIDs, administration as needed to regulate continuing symptoms is not recommended
2) Concomitant therapy with antibiotics to eradicate helicobacter pylori
Administer 20mg of this drug concomitantly with 1g amoxicillin and 500mg clarithromycin twice a day for 7 days.
3) Short-term therapy for treatment of upper gastrointestinal tract symptoms (pain, discomfort, purosis) associated with the administration of NSAIDs (non-COX-2 selective and selective)
- 20mg once a day. Additional examination necessary if symptoms are not regulated after 4 weeks. Clinical trials not carried out past 4 weeks.
4) Patients requiring sustained NSAIDs administration
- Treatment of gastric ulcers associated with administration of NSAIDs: 20mg once a day. Treatment period is 4 to 8 weeks.
- Prevention of gastric ulcers and duodenal ulcers associated with administration of NSAIDs: 20mg once a day.
5) Treatment of Zollinger-Ellison syndrome
Recommended starting does is 40mg administered twice a day. Dose should be adjusted according to patient thereafter, and treatment must be continued while clinical symptoms persist. According to clinical data, 80 to 160mg per day is sufficient for most patients. For doses of 80mg or greater a day, divide between two administrations a day.
6) Maintenance therapy after inducing prevention of recurrent bleeding due to gastric ulcers or duodenal ulcers by intravenous injection: Administer 40mg once a day for 4 weeks after inducing prevention of recurrent bleeding due to gastric ulcers or duodenal ulcers by intravenous injection.
2. Youth of 12 years or older
1) Gastroesophageal reflux disease (GERD)
- Treatment of erosive reflux esophagitis: Administer 40mg once a day for 4 weeks. In the case of patients were esophagitis is not treated or symptoms continue, administer for 4 additional weeks.
- Therapy for treatment of gastroesophageal reflux disease without esophagitis:
ㆍ20mg once a day. If symptoms are not regulated even after 4 weeks, additional examination is necessary.
ㆍOnce symptoms are alleviated, regulate symptoms thereafter by administering 20g once a day.
ㆍIn adults, 20mg may be administered once a day as needed. In the case of patients with high risk of occurrence for gastric and duodenal ulcers due to administration of NSAIDs, administration as needed to regulate continuing symptoms is not recommended
3. Children less than 12 years old: No data on administration of this drug in children less than 12 years old.
4. Renal impairment: No need to adjust dose. Administer carefully as there are not many cases of administration to severe renal impairment patients.
5. Liver impairment: No need to adjust dose for mild to moderately severe liver impairment patients. For severe liver impairment patients, dose of 20mg must not be exceeded for this drug.
6. Elderly patients: No need to adjust dose.
1. Gastroesophageal reflux disease (GERD)
- Treatment of erosive reflux esophagitis
- Long-term maintenance therapy to prevent recurrence in esophagitis patients
- Therapy for treatment of gastroesophageal reflux disease without esophagitis
2. Concomitant therapy with antibiotics to eradicate helicobacter pylori
3. Short-term therapy for treatment of upper gastrointestinal tract symptoms (pain, discomfort, purosis) associated with the administration of NSAIDs (non-COX-2 selective and selective)
4) Patients requiring sustained NSAIDs administration
- Treatment of gastric ulcers associated with administration of NSAIDs
- Prevention of gastric ulcers and duodenal ulcers associated with administration of NSAIDs
5) Treatment of Zollinger-Ellison syndrome
6) Maintenance therapy after inducing prevention of recurrent bleeding due to gastric ulcers or duodenal ulcers by intravenous injection
