Medication info
Esomeprazole Magnesium 40 mg Tablet

Esomeprazole Magnesium 40 mg Tablet

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›43.38mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
Pink oblong film-coated tablet
Packaging
28 tablets (14 tablets/PTP × 2)
Approval status
Active

MFDS item code 201701081 · Approved 2017.02.28 · Insurance code 657203020

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori associated benign peptic ulcers, relief of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, prevention and maintenance therapy for gastric and duodenal ulcer rebleeding.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid such as water and must not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. - If esophagitis is not treated or symptoms continue, take for another 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. · Once symptoms are alleviated, any subsequent symptoms should be managed with 20 mg once daily. · In adults, 20 mg can be dosed as needed once daily. For patients at high risk of developing gastric or duodenal ulcers due to non-steroidal anti-inflammatory drug use, it is not recommended to administer continuously as needed for symptomatic control. 2) Antibiotic combination therapy for Helicobacter pylori eradication Administer this drug at 20 mg with amoxicillin 1 g and clarithromycin 500 mg twice daily for 7 days. 3) Short-term therapy for symptoms (pain, discomfort, burning) related to non-steroidal anti-inflammatory drug (non-selective COX-2, selective) administration - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is necessary. No clinical trials have been conducted exceeding 4 weeks. 4) For patients requiring continuous non-steroidal anti-inflammatory drug administration - Treatment of gastric ulcers related to non-steroidal anti-inflammatory drug administration: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drug administration: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome A recommended initial dose is 40 mg administered twice daily. Subsequent doses should be adjusted based on the individual patient, and treatment should continue for as long as clinical symptoms are present. According to clinical data, most patients can be controlled at doses of 80 to 160 mg daily. Doses exceeding 80 mg daily should be divided into two doses. 6) Maintenance therapy after intravenous administration to prevent rebleeding due to gastric or duodenal ulcers Following intravenous administration to prevent rebleeding due to gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents aged 12 and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. If esophagitis is not treated or symptoms persist, continue for another 4 weeks. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. · Once symptoms are alleviated, any subsequent symptoms should be managed with 20 mg once daily. · In adults, 20 mg can be dosed as needed once daily. For patients at high risk of developing gastric or duodenal ulcers due to non-steroidal anti-inflammatory drug use, it is not recommended to administer continuously as needed for symptomatic control. 3. Children under 12 There is no experience administering this drug to children under the age of 12. 4. Renal impairment No dosage adjustment is necessary. Due to limited cases in severe renal failure patients, caution is advised during administration. 5. Hepatic impairment No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. For patients with severe hepatic impairment, this medication should not exceed 20 mg per dose. 6. Elderly patients No dosage adjustment is necessary.
Children's dosage
Adolescents aged 12 and above 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. - If esophagitis is not treated or symptoms persist, continue for another 4 weeks.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

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

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

This medication is used for the treatment of gastroesophageal reflux disease and erosive esophagitis, and it is also effective for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It is additionally utilized for the treatment of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection, as well as for their prevention of recurrence. It aids in alleviating symptoms such as pain, discomfort, and burning sensation in the upper gastrointestinal tract that can occur when taking non-steroidal anti-inflammatory drugs, and is used for the treatment and prevention of gastric and duodenal ulcers. It is also applied in the treatment of Zollinger-Ellison syndrome and for maintenance therapy following intravenous administration, thus assisting in the management of various gastrointestinal diseases. Overall, this drug is used to improve and treat symptoms related to various diseases of the stomach and esophagus.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid such as water and must not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. - If esophagitis is not treated or symptoms continue, take for another 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. · Once symptoms are alleviated, any subsequent symptoms should be managed with 20 mg once daily. · In adults, 20 mg can be dosed as needed once daily. For patients at high risk of developing gastric or duodenal ulcers due to non-steroidal anti-inflammatory drug use, it is not recommended to administer continuously as needed for symptomatic control. 2) Antibiotic combination therapy for Helicobacter pylori eradication Administer this drug at 20 mg with amoxicillin 1 g and clarithromycin 500 mg twice daily for 7 days. 3) Short-term therapy for symptoms (pain, discomfort, burning) related to non-steroidal anti-inflammatory drug (non-selective COX-2, selective) administration - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is necessary. No clinical trials have been conducted exceeding 4 weeks. 4) For patients requiring continuous non-steroidal anti-inflammatory drug administration - Treatment of gastric ulcers related to non-steroidal anti-inflammatory drug administration: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drug administration: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome A recommended initial dose is 40 mg administered twice daily. Subsequent doses should be adjusted based on the individual patient, and treatment should continue for as long as clinical symptoms are present. According to clinical data, most patients can be controlled at doses of 80 to 160 mg daily. Doses exceeding 80 mg daily should be divided into two doses. 6) Maintenance therapy after intravenous administration to prevent rebleeding due to gastric or duodenal ulcers Following intravenous administration to prevent rebleeding due to gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents aged 12 and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. If esophagitis is not treated or symptoms persist, continue for another 4 weeks. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. · Once symptoms are alleviated, any subsequent symptoms should be managed with 20 mg once daily. · In adults, 20 mg can be dosed as needed once daily. For patients at high risk of developing gastric or duodenal ulcers due to non-steroidal anti-inflammatory drug use, it is not recommended to administer continuously as needed for symptomatic control. 3. Children under 12 There is no experience administering this drug to children under the age of 12. 4. Renal impairment No dosage adjustment is necessary. Due to limited cases in severe renal failure patients, caution is advised during administration. 5. Hepatic impairment No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. For patients with severe hepatic impairment, this medication should not exceed 20 mg per dose. 6. Elderly patients No dosage adjustment is necessary.

Children's dosage

Adolescents aged 12 and above 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. - If esophagitis is not treated or symptoms persist, continue for another 4 weeks.

Precautions

This medication should not be administered to certain patients. For example, individuals allergic to this medication or its components, or those who have previously experienced hypersensitivity reactions to similar drugs, should avoid taking it. Caution is also required for those with allergies to penicillin or macrolide antibiotics when used in combination. Patients currently on specific heart-related medications or with a history of myocardial infarction, as well as nursing women, are also advised against using this drug. This medication may cause various side effects, so any symptoms occurring should be immediately discussed with healthcare professionals. Gastrointestinal symptoms such as headache, abdominal pain, diarrhea, and vomiting may commonly occur, while rarer serious reactions like blood abnormalities, skin rashes, and difficulty in breathing have also been reported. Long-term use may lead to decreased levels of magnesium, calcium, and potassium, requiring regular testing. This drug inhibits gastric acid secretion and may increase the risk of bacterial growth in the stomach, so if diarrhea persists, infection should be checked. Additionally, long-term use may increase the risk of fractures, and caution is warranted for those at risk of osteoporosis. This medication may interact with several other drugs, so patients taking other medications must inform their physician or pharmacist. In particular, dosage adjustments or monitoring may be necessary when used with anticoagulants, antiviral agents, certain antibiotics, and anticonvulsants. Due to limited safety data during pregnancy, those who are pregnant or planning to become pregnant should consult with their doctor before use. If nursing, it is recommended to avoid this medication as it may be transmitted through breast milk. In the case of overdose, there is no specific antidote; symptomatic treatment is required, and the medication should be kept out of the reach of children to prevent accidents.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, severe allergic reactions, angioedema, urticaria, skin rashes, dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, DRESS syndrome, jaundice, hepatitis, liver failure, encephalopathy, rhabdomyolysis, severe skin reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, respiratory distress, bronchospasm, exacerbation of asthma, difficulty in breathing.

Mild side effects

  • Fever
  • angioedema
  • peripheral edema
  • insomnia
  • anxiety
  • confusion
  • depression
  • aggression
  • hallucinations
  • headache
Show 28 more
  • dizziness
  • paresthesia
  • drowsiness
  • taste disturbances
  • blurred vision
  • dizziness
  • bronchospasm
  • pancreatitis
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • microscopic colitis
  • elevated liver enzymes
  • hepatitis
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fractures
  • arthralgia
  • myalgia.

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. The storage temperature should ideally be maintained between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink oblong film-coated tablet

Package unit

28 tablets (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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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.