Medication info
S.O. Tablets 20 mg (Esomeprazole Magnesium Trihydrate)

S.O. Tablets 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.3mg / 1 tablet
Manufacturer / importer
영일제약(주)
Appearance
Pale pink round film-coated tablets
Packaging
28 tablets (14 tablets/PTP X 2)
Approval status
Active

MFDS item code 201405108 · Approved 2014.10.31 · Insurance code 649404660

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory analgesics, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, maintenance effect for prevention of rebleeding of gastric ulcers.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquids such as water and should not be chewed or crushed. 1. Gastroesophageal Reflux Disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If the esophagitis is not resolved or symptoms persist, take for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily - Symptoms treatment in gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is needed. · Once symptoms are alleviated, subsequent symptoms can be controlled with 20 mg once daily. · In adults, 20 mg can be administered once daily as needed. It is not recommended to administer as needed for continuous symptom control in patients at high risk of developing gastric ulcers and duodenal ulcers due to non-steroidal anti-inflammatory analgesic use. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer 20 mg of this medication along with 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. 3) Short-term therapy for symptoms (pain, discomfort, burning sensation) related to non-steroidal anti-inflammatory analgesic (non-selective, selective COX-2) use - 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is needed. Clinical trials have not been conducted beyond 4 weeks. 4) Patients requiring continuous use of non-steroidal anti-inflammatory analgesics - Treatment of gastric ulcers related to non-steroidal anti-inflammatory analgesic use: 20 mg once daily. Treatment duration is 4-8 weeks. - Prevention of gastric and duodenal ulcers due to non-steroidal anti-inflammatory analgesic use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dosage is 40 mg twice daily. The dose should be adjusted based on individual patients, and treatment should continue as long as there are clinical symptoms. According to clinical data, most patients can be controlled at doses of 80 to 160 mg daily. A dose of more than 80 mg daily should be divided into two doses. 6) Maintenance therapy after intravenous prevention of rebleeding due to gastric or duodenal ulcers 40 mg once daily for 4 weeks after inducing prevention of rebleeding due to gastric or duodenal ulcers via intravenous injection. 2. Adolescents aged 12 years and older 1) Gastroesophageal Reflux Disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If the esophagitis is not resolved or symptoms persist, take for an additional 4 weeks. - Symptoms treatment in gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is needed. · Once symptoms are alleviated, subsequent symptoms can be controlled with 20 mg once daily. · In adults, 20 mg can be administered once daily as needed. It is not recommended to administer as needed for continuous symptom control in patients at high risk of developing gastric ulcers and duodenal ulcers due to non-steroidal anti-inflammatory analgesic use. 3. For children under 12 years: There is no experience with this medication in children under 12. 4. Renal impairment: No dose adjustment is necessary. There is limited experience in patients with severe renal failure, so it should be used with caution. 5. Liver dysfunction: No dose adjustment is necessary for patients with mild to moderate liver impairment. For patients with severe liver impairment, do not exceed the dose of 20 mg of this medication. 6. Elderly: No dose adjustment is necessary.
Children's dosage
Adolescents aged 12 years and older - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: 20 mg once daily -

Ingredients

Manufacturer
영일제약(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory analgesics, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, maintenance effect for prevention of rebleeding of gastric ulcers.

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal pain
  • upper gastrointestinal discomfort
  • upper gastrointestinal burning sensation
  • gastric ulcers
  • duodenal ulcers
  • Zollinger-Ellison syndrome
  • rebleeding from gastric ulcers
View approved original text

This medication is used for long-term maintenance therapy for the treatment of gastroesophageal reflux disease and erosive esophagitis, as well as for alleviation of symptoms in gastroesophageal reflux disease without esophagitis. It is effective when used in combination with antibiotics for the treatment and prevention of recurrence of Helicobacter pylori positive duodenal ulcers and peptic ulcers. It is also used for the treatment of upper gastrointestinal symptoms related to the use of non-steroidal anti-inflammatory analgesics (both non-selective and selective COX-2), and for the treatment and prevention of gastric and duodenal ulcers. Additionally, it is utilized for maintenance therapy to prevent rebleeding due to gastric or duodenal ulcers and for the treatment of Zollinger-Ellison syndrome. In general, it is a medication that helps improve gastrointestinal health and treat related diseases.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquids such as water and should not be chewed or crushed. 1. Gastroesophageal Reflux Disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If the esophagitis is not resolved or symptoms persist, take for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily - Symptoms treatment in gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is needed. · Once symptoms are alleviated, subsequent symptoms can be controlled with 20 mg once daily. · In adults, 20 mg can be administered once daily as needed. It is not recommended to administer as needed for continuous symptom control in patients at high risk of developing gastric ulcers and duodenal ulcers due to non-steroidal anti-inflammatory analgesic use. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer 20 mg of this medication along with 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. 3) Short-term therapy for symptoms (pain, discomfort, burning sensation) related to non-steroidal anti-inflammatory analgesic (non-selective, selective COX-2) use - 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is needed. Clinical trials have not been conducted beyond 4 weeks. 4) Patients requiring continuous use of non-steroidal anti-inflammatory analgesics - Treatment of gastric ulcers related to non-steroidal anti-inflammatory analgesic use: 20 mg once daily. Treatment duration is 4-8 weeks. - Prevention of gastric and duodenal ulcers due to non-steroidal anti-inflammatory analgesic use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dosage is 40 mg twice daily. The dose should be adjusted based on individual patients, and treatment should continue as long as there are clinical symptoms. According to clinical data, most patients can be controlled at doses of 80 to 160 mg daily. A dose of more than 80 mg daily should be divided into two doses. 6) Maintenance therapy after intravenous prevention of rebleeding due to gastric or duodenal ulcers 40 mg once daily for 4 weeks after inducing prevention of rebleeding due to gastric or duodenal ulcers via intravenous injection. 2. Adolescents aged 12 years and older 1) Gastroesophageal Reflux Disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If the esophagitis is not resolved or symptoms persist, take for an additional 4 weeks. - Symptoms treatment in gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is needed. · Once symptoms are alleviated, subsequent symptoms can be controlled with 20 mg once daily. · In adults, 20 mg can be administered once daily as needed. It is not recommended to administer as needed for continuous symptom control in patients at high risk of developing gastric ulcers and duodenal ulcers due to non-steroidal anti-inflammatory analgesic use. 3. For children under 12 years: There is no experience with this medication in children under 12. 4. Renal impairment: No dose adjustment is necessary. There is limited experience in patients with severe renal failure, so it should be used with caution. 5. Liver dysfunction: No dose adjustment is necessary for patients with mild to moderate liver impairment. For patients with severe liver impairment, do not exceed the dose of 20 mg of this medication. 6. Elderly: No dose adjustment is necessary.

Children's dosage

Adolescents aged 12 years and older - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: 20 mg once daily -

Precautions

This medication should not be used in certain patients. For example, those with allergies to this drug or its components, or those who have experienced hypersensitivity reactions should not take it. Additionally, patients allergic to certain antibiotics, those with specific heart conditions, and nursing women should refrain from taking this medication. This medication contains the pigment Yellow No. 4, so those with allergies or hypersensitivity to this component should use it with caution. When taking this medication, various adverse reactions may occur and caution is needed. For instance, issues related to blood, allergic reactions, neurological symptoms, gastrointestinal problems, skin rashes, etc., have been reported. Especially if symptoms like muscle pain or weakness appear, consult a physician immediately. This medication requires regular check-ups during long-term use, and any changes in symptoms should be discussed with a physician. This medication can interact with other drugs, so if you are taking any other medications, you must inform your doctor or pharmacist. Caution is especially needed when taken alongside certain antibiotics or antiviral medications, and medications that affect blood coagulation. Pregnant women should use this medication cautiously, and it is better for nursing women not to take it. In case of overdose, there is no specific antidote, so it is important to receive symptomatic treatment. This medication must be kept out of reach of children, and transferring it to another container can negatively affect its quality, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction/shock, severe symptoms due to hypomagnesemia, mental confusion, jaundice, hepatitis, hepatic failure, encephalopathy, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), elevation of myoglobin and rhabdomyolysis, myocardial infarction, ventricular arrhythmias (ventricular tachycardia,

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, elevated liver enzymes, hepatitis, dermatitis, itching, rash, hair loss, photosensitivity, fracture, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, fatigue, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, allergic reactions,

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pale pink round film-coated tablets

Package unit

28 tablets (14 tablets/PTP X 2)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.