Medication info
Omepran 40 mg (Esomeprazole Magnesium Trihydrate)

Omepran 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›43.38mg / 1 tablet
Manufacturer / importer
원광제약(주)
Appearance
Pink rectangular film-coated tablet
Packaging
Alu-Alu - 28 tablets/box [28 tablets (14 tablets/Alu-Alu * 2)]
Approval status
Active

MFDS item code 202000226 · Approved 2020.01.15 · Insurance code 662600850

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of upper gastrointestinal symptoms associated with nonsteroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This drug should be taken 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. - Long-term maintenance after treatment of esophagitis: 20 mg once daily. - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily. - If necessary, 1
Children's dosage
Adolescents aged 12 years and older - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily. -

Ingredients

Manufacturer
원광제약(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of upper gastrointestinal symptoms associated with nonsteroidal anti-inflammatory drugs.

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

This drug is used for the treatment of gastroesophageal reflux disease, particularly for erosive esophagitis and for long-term maintenance therapy to prevent recurrence of esophagitis. It is also administered in combination with antibiotics for the treatment of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. It briefly alleviates gastrointestinal pain or discomfort associated with the use of nonsteroidal anti-inflammatory drugs and is effective for the treatment and prevention of gastric and duodenal ulcers with long-term use. It is also used for maintenance therapy in the treatment of Zollinger-Ellison syndrome and for the prevention of rebleeding in gastric and duodenal ulcers. Actively used for the treatment and prevention of various gastrointestinal diseases, it improves the patient's symptoms.

Dosage and Administration

Adult dosage

This drug should be taken 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. - Long-term maintenance after treatment of esophagitis: 20 mg once daily. - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily. - If necessary, 1

Children's dosage

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

Precautions

This medicine should not be administered to certain patients. Those allergic to this drug or its components, or with a history of hypersensitivity reactions to benzimidazole derivatives, should not use it. It is also safer not to administer it to individuals taking certain antibiotics or antivirals, nursing women, or patients with a history of myocardial infarction. Various side effects may occur when taking this drug. Gastrointestinal symptoms such as headache, dizziness, abdominal pain, diarrhea, nausea, and vomiting are frequently reported, and rare cases of blood abnormalities, allergic reactions, skin rash, and hepatic dysfunction may occur. Additionally, long-term use may increase the risk of hypomagnesemia or fractures, so caution is advised. It is important to check for abnormalities through regular examinations if this drug is used for a long period. Patients taking it for more than a year should consistently monitor magnesium levels and bone density. This drug may interact with other medications, so consulting a doctor or pharmacist about currently taking medications is essential. Caution is particularly needed when used with anticoagulants, anticonvulsants, certain antibiotics, and antivirals. Pregnant or nursing women should consult a healthcare professional before using this drug, and it is recommended to avoid use if possible. In case of overdose, there is no specific antidote, so it is necessary to receive appropriate treatment based on symptoms. Lastly, this drug should be kept out of the reach of children and not transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, severe allergic reactions, hypomagnesemia (severe), hypocalcemia, hypokalemia, hepatitis, liver failure, jaundice, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, sudden and severe headache, seizures, decreased urine output, severe edema, increased blood pressure.

Mild side effects

Headache, dizziness, drowsiness, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, elevated liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions.

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

Storage

This drug must be stored in a tightly closed container to protect it from air and moisture. It is also safe to keep the drug at room temperature, specifically between 1 degree and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

Pink rectangular film-coated tablet

Package unit

Alu-Alu - 28 tablets/box [28 tablets (14 tablets/Alu-Alu * 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.