Medication info
Esopra Tablet 20 mg (Esomeprazole Magnesium Dihydrate)

Esopra Tablet 20 mg (Esomeprazole Magnesium Dihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›21.69mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu X 2)
Approval status
Active

MFDS item code 201508308 · Approved 2015.12.17 · Insurance code 628900520

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, prevention and maintenance therapy for rebleeding from gastric and duodenal 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 not resolved or symptoms persist, an additional 4 weeks of treatment - Long-term maintenance therapy for preventing recurrence: 20 mg once daily - Treatment of symptoms without esophagitis: 20 mg once daily (if symptoms remain uncontrolled after 4 weeks, further consultation is needed). In adults, it may be taken as needed, up to 20 mg once daily. For patients at high risk for the development of gastric and duodenal ulcers due to non-steroidal anti-inflammatory drug administration, it is not recommended to take it continuously for symptom control. 2) Combination therapy with antibiotics for the eradication of Helicobacter pylori Administer 20 mg of this medication in combination with 1 g of amoxicillin and 500 mg of clarithromycin twice daily for 7 days. 3) Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, burning sensation) associated with the use of non-steroidal anti-inflammatory drugs (COX-2 non-selective, selective) - 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) For patients requiring continuous non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers related to non-steroidal anti-inflammatory drugs: 20 mg once daily for 4-8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drugs: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent dosing should be adjusted based on the patient's condition, and treatment should be continued as long as clinical symptoms are present. According to clinical data, most patients can be controlled on doses ranging from 80 to 160 mg per day. Doses exceeding 80 mg per day should be divided into two doses. 6) Maintenance therapy after preventing rebleeding from gastric or duodenal ulcers through intravenous administration After inducing the prevention of rebleeding through intravenous administration, administer 40 mg once daily for 4 weeks. 2. Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, an additional 4 weeks of treatment is necessary. - Treatment of symptoms of 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, ongoing symptoms should be managed with 20 mg once daily. In adults, it may be taken as needed, up to 20 mg once daily. For patients at high risk for developing gastric and duodenal ulcers due to the use of non-steroidal anti-inflammatory drugs, it is not recommended to take it continuously for symptom control. 3. Children under 12 years of age There is no experience administering this medication to children under 12 years of age. 4. Renal impairment No dosage adjustment is necessary. There is little experience administering to patients with severe renal failure, so it should be administered cautiously. 5. Hepatic impairment No dosage adjustment is necessary for patients with mild to moderate liver dysfunction. In patients with severe liver dysfunction, doses greater than 20 mg of this medication should not be employed. 6. Elderly patients No dosage adjustment is necessary.
Children's dosage
Adolescents aged 12 years and older - Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - If symptoms persist or are not resolved, an additional 4 weeks of treatment is necessary. -

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

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

  • Gastroesophageal reflux disease
  • erosive gastroesophagitis
  • esophagitis
  • symptoms of gastroesophageal reflux disease without esophagitis
  • Helicobacter pylori positive duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal pain
  • upper gastrointestinal discomfort
  • burning sensation in the upper gastrointestinal tract
  • gastric ulcers and duodenal ulcers related to non-steroidal anti-inflammatory drug administration
  • Zollinger-Ellison syndrome
  • rebleeding due to gastric ulcers and duodenal ulcers.
View approved original text

This medication is effective in treating gastroesophageal reflux disease and erosive gastroesophagitis, and is also used for long-term maintenance therapy to prevent recurrence in esophagitis patients. Additionally, it helps eliminate Helicobacter pylori in combination with antibiotics for the treatment of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. This medication is utilized in the treatment and prevention of upper gastrointestinal symptoms or gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs. It is also used for the treatment of Zollinger-Ellison syndrome and for maintenance therapy after intravenous administration to prevent rebleeding from gastric and duodenal ulcers, improving patients' symptoms. This is a medication that is effective for the treatment of various gastrointestinal diseases and related symptoms.

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 not resolved or symptoms persist, an additional 4 weeks of treatment - Long-term maintenance therapy for preventing recurrence: 20 mg once daily - Treatment of symptoms without esophagitis: 20 mg once daily (if symptoms remain uncontrolled after 4 weeks, further consultation is needed). In adults, it may be taken as needed, up to 20 mg once daily. For patients at high risk for the development of gastric and duodenal ulcers due to non-steroidal anti-inflammatory drug administration, it is not recommended to take it continuously for symptom control. 2) Combination therapy with antibiotics for the eradication of Helicobacter pylori Administer 20 mg of this medication in combination with 1 g of amoxicillin and 500 mg of clarithromycin twice daily for 7 days. 3) Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, burning sensation) associated with the use of non-steroidal anti-inflammatory drugs (COX-2 non-selective, selective) - 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) For patients requiring continuous non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers related to non-steroidal anti-inflammatory drugs: 20 mg once daily for 4-8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drugs: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent dosing should be adjusted based on the patient's condition, and treatment should be continued as long as clinical symptoms are present. According to clinical data, most patients can be controlled on doses ranging from 80 to 160 mg per day. Doses exceeding 80 mg per day should be divided into two doses. 6) Maintenance therapy after preventing rebleeding from gastric or duodenal ulcers through intravenous administration After inducing the prevention of rebleeding through intravenous administration, administer 40 mg once daily for 4 weeks. 2. Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, an additional 4 weeks of treatment is necessary. - Treatment of symptoms of 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, ongoing symptoms should be managed with 20 mg once daily. In adults, it may be taken as needed, up to 20 mg once daily. For patients at high risk for developing gastric and duodenal ulcers due to the use of non-steroidal anti-inflammatory drugs, it is not recommended to take it continuously for symptom control. 3. Children under 12 years of age There is no experience administering this medication to children under 12 years of age. 4. Renal impairment No dosage adjustment is necessary. There is little experience administering to patients with severe renal failure, so it should be administered cautiously. 5. Hepatic impairment No dosage adjustment is necessary for patients with mild to moderate liver dysfunction. In patients with severe liver dysfunction, doses greater than 20 mg of this medication should not be employed. 6. Elderly patients No dosage adjustment is necessary.

Children's dosage

Adolescents aged 12 years and older - Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - If symptoms persist or are not resolved, an additional 4 weeks of treatment is necessary. -

Precautions

This medication should not be administered to certain patients. For example, patients who have hypersensitivity to this medication or its ingredients, or who have previously experienced such reactions, should not take this medication. Additionally, patients allergic to amoxicillin or clarithromycin, when used in combination for the eradication of Helicobacter pylori, should not use this medication. It is also safer for women who have a history of specific heart diseases or who are nursing to avoid this medication. Various adverse reactions may occur while taking this medication. Common symptoms include headaches, abdominal pain, diarrhea, nausea, and dizziness, while serious side effects may include blood disorders, liver dysfunction, and severe skin rashes, so caution is required. In particular, if symptoms of muscle pain or weakness appear, rhabdomyolysis should be suspected, and immediate consultation with a healthcare provider is necessary. Long-term use of this medication requires regular check-ups, and if symptoms worsen or new symptoms appear, immediate consultation with a physician is necessary. This medication may reduce gastric acid, promoting bacterial growth in the stomach, which can increase the risk of infections such as diarrhea. The risk of fractures may also increase with long-term use, so caution is necessary for patients with osteoporosis. This medication has many interactions with other drugs, and dosage adjustments or caution may be required depending on the medication taken. In particular, when used in combination with antiviral drugs, anticoagulants, or anticonvulsants, it should be taken according to a doctor's instructions. The safety of this medication during pregnancy has not been fully established, so it should be used cautiously only when necessary, and nursing mothers should avoid taking it. In the case of overdose, there is no specific antidote, so appropriate treatment should be administered based on symptoms, and this medication is not removed by dialysis, so follow the healthcare provider's instructions. Finally, this medication should be kept out of the reach of children, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction, shock, severe skin reactions associated with fever, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), microscopic colitis, hepatitis, liver failure, encephalopathy, renal interstitial nephritis, jaundice, severe swelling, systemic lupus erythematosus, Stevens-Johnson syndrome, toxicity.

Mild side effects

  • Headache
  • dizziness
  • abnormal sensation
  • drowsiness
  • insomnia
  • anxiety
  • mental confusion
  • depression
  • aggression
  • hallucinations
Show 28 more
  • taste disorder
  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal distension
  • nausea and vomiting
  • dry mouth
  • stomatitis
  • increased liver enzymes
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fractures
  • joint pain
  • muscle pain
  • weakness
  • increased sweating
  • weakness
  • allergic reactions
  • back pain
  • chest pain
  • substernal pain
  • facial swelling
  • facial flushing.

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is best kept at room temperature between 1 and 30 degrees Celsius. By storing it this way, the efficacy of the medication can be maintained for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu 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.