Medication info
Sotec 40 mg (Esomeprazole Magnesium Trihydrate)

Sotec 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Pink round film-coated tablet
Packaging
For domestic use - 28 tablets/box [(14 tablets/PTP*2)], for export - 28 tablets/box [(14 tablets/PTP*2)]
Approval status
Active

MFDS item code 201905342 · Approved 2019.07.29 · Insurance code 057600110

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of benign peptic ulcers associated with Helicobacter pylori, alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, and prevention of rebleeding from gastric ulcers.
Who uses it
Adults · Children
Adult dosage
This medicine should be swallowed with liquid such as water and should not be chewed or crushed. 1) Treatment of gastroesophageal reflux disease - Erosive esophagitis: 40 mg once daily for 4 weeks. If not cured, continue for an additional 4 weeks. - Maintenance therapy for prevention of recurrence: 20 mg once daily. - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily.
Children's dosage
Adolescents over 12 years: - Treatment of gastroesophageal reflux disease - Erosive esophagitis: 40 mg once daily for 4 weeks. If not cured, continue for an additional 4 weeks. - Gastroesophageal reflux disease without esophagitis symptoms.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of benign peptic ulcers associated with Helicobacter pylori, alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, and prevention of rebleeding from gastric ulcers.

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • benign duodenal ulcers associated with Helicobacter pylori
  • peptic ulcers
  • upper gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcers
  • duodenal ulcers
  • Zollinger-Ellison syndrome
View approved original text

This medicine is used for the treatment and symptom relief of esophagitis caused by gastroesophageal reflux disease, as well as for the treatment and prevention of recurrence of duodenal and peptic ulcers caused by Helicobacter pylori infection. It is also effective in treating gastrointestinal symptoms due to non-steroidal anti-inflammatory drug administration, as well as gastric and duodenal ulcers. It is utilized as maintenance therapy to prevent rebleeding of gastric or duodenal ulcers after intravenous injection. It is widely used for various gastrointestinal-related diseases, aiding in symptom improvement and health recovery for patients.

Dosage and Administration

Adult dosage

This medicine should be swallowed with liquid such as water and should not be chewed or crushed. 1) Treatment of gastroesophageal reflux disease - Erosive esophagitis: 40 mg once daily for 4 weeks. If not cured, continue for an additional 4 weeks. - Maintenance therapy for prevention of recurrence: 20 mg once daily. - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily.

Children's dosage

Adolescents over 12 years: - Treatment of gastroesophageal reflux disease - Erosive esophagitis: 40 mg once daily for 4 weeks. If not cured, continue for an additional 4 weeks. - Gastroesophageal reflux disease without esophagitis symptoms.

Precautions

This medicine is used to treat gastrointestinal diseases by suppressing gastric acid secretion. Some patients may experience side effects such as allergic reactions or skin rashes, headaches, dizziness, and gastrointestinal disturbances after taking this medicine. You should not take this medicine if you are allergic to this medicine, its ingredients, or certain antibiotics. Additionally, it is advisable for individuals with heart disease or nursing women to avoid using this medicine. Long-term users should have regular examinations to ensure no unusual symptoms occur. This medicine may interact with other drugs, so you must inform your doctor or pharmacist if you are taking any other medications. The safety of this medicine during pregnancy has not been sufficiently confirmed, so caution is advised. In case of overdose, there is no specific antidote, so treatment should be based on symptoms, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Rash, angioedema, anaphylactic reaction, shock, angioedema, rash → severe allergic reactions
  • Severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain → severe skin reactions
  • Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) → severe skin reactions
  • Difficulty breathing, asthma

Mild side effects

  • Leukopenia
  • thrombocytopenia
  • agranulocytosis
  • pancytopenia
  • fever
  • peripheral edema
  • hyponatremia
  • hypomagnesemia
  • hypocalcemia
  • hypokalemia
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  • insomnia
  • anxiety
  • confusion
  • depression
  • aggression
  • hallucination
  • headache
  • dizziness
  • paresthesia
  • drowsiness
  • dysgeusia
  • blurred vision
  • bronchospasm
  • pancreatitis
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal distension
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • microscopic findings

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

Storage

This medicine may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is best to maintain the storage temperature between 1 to 30 degrees Celsius. Proper storage preserves the drug's efficacy and safety for an extended period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

For domestic use - 28 tablets/box [(14 tablets/PTP*2)], for export - 28 tablets/box [(14 tablets/PTP*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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.