Medication info
Esomeprazole Magnesium Trihydrate 40 mg (Esomeprazole Magnesium)

Esomeprazole Magnesium Trihydrate 40 mg (Esomeprazole Magnesium)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
화일약품(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP X 2)
Approval status
Active

MFDS item code 201907480 · Approved 2019.10.28 · Insurance code 684501810

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of relapse of Helicobacter pylori positive peptic ulcers, alleviation of gastrointestinal symptoms related to nonsteroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with water or other liquids and should not be chewed or crushed. 1. Gastroesophageal Reflux Disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - If esophagitis remains untreated or symptoms persist, take for an additional 4 weeks - Long-term maintenance therapy for preventing relapse in patients with esophagitis: 20 mg once daily - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is needed. · Once symptoms are alleviated, subsequent symptoms should be controlled with 20 mg once daily. · For adults, 20 mg once daily may be taken as needed. In patients at high risk for gastric or duodenal ulcer due to nonsteroidal anti-inflammatory drug usage, it is not recommended to use this medication as needed for continuous symptom control. 2) Combination therapy with antibiotics for the eradication of Helicobacter pylori 20 mg of this medication should be administered in combination with 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) associated with nonsteroidal anti-inflammatory drug (both non-selective and selective COX-2) administration - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is needed. Clinical trials have not been conducted for over 4 weeks. 4) Patients requiring continuous administration of nonsteroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with nonsteroidal anti-inflammatory drug usage: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg administered twice daily. The dosage should be adjusted according to the individual patient, and treatment should continue while clinical symptoms are present. According to clinical data, the majority of patients can be controlled at doses ranging from 80 to 160 mg per day. Doses above 80 mg per day should be taken divided into two doses. 6) Maintenance therapy after intravenous induction of bleeding prevention due to gastric or duodenal ulcers After intravenous induction of bleeding prevention due to gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents over 12 years 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If symptoms persist or esophagitis remains untreated, take for an additional 4 weeks. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is needed. · Once symptoms are alleviated, subsequent symptoms should be controlled with 20 mg once daily. · For adults, 20 mg once daily may be taken as needed. It is not recommended to use this medication as needed for continuous symptom control in patients at high risk of developing gastric or duodenal ulcers associated with nonsteroidal anti-inflammatory drugs. 3. Children under 12 years: There is no experience in administering this medication to children under 12 years. 4. Renal dysfunction: No dosage adjustment is required. There is limited experience administering to patients with severe renal failure, so caution is warranted. 5. Hepatic dysfunction: No dosage adjustment is needed for patients with mild to moderate hepatic impairment. For patients with severe hepatic impairment, the dosage should not exceed 20 mg. 6. Elderly: No dosage adjustment is needed.
Children's dosage
Adolescents over 12 years - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily - Symptoms

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of relapse of Helicobacter pylori positive peptic ulcers, alleviation of gastrointestinal symptoms related to nonsteroidal anti-inflammatory drugs.

  • 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 the long-term maintenance therapy of gastroesophageal reflux disease, particularly erosive esophagitis. It is also included in combination therapy with antibiotics for the eradication of Helicobacter pylori, aiding in the treatment and prevention of relapse of duodenal ulcers and peptic ulcers. It is effective for treating upper gastrointestinal symptoms or gastric ulcers caused by nonsteroidal anti-inflammatory drugs and is also used for the prevention of related ulcers. It is applied in the treatment of Zollinger-Ellison syndrome, and is effective for preventing rebleeding and maintenance therapy due to gastric ulcers or duodenal ulcers. Overall, it is widely used for the treatment and prevention of various gastrointestinal diseases.

Dosage and Administration

Adult dosage

This medication should be swallowed with water or other liquids and should not be chewed or crushed. 1. Gastroesophageal Reflux Disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - If esophagitis remains untreated or symptoms persist, take for an additional 4 weeks - Long-term maintenance therapy for preventing relapse in patients with esophagitis: 20 mg once daily - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is needed. · Once symptoms are alleviated, subsequent symptoms should be controlled with 20 mg once daily. · For adults, 20 mg once daily may be taken as needed. In patients at high risk for gastric or duodenal ulcer due to nonsteroidal anti-inflammatory drug usage, it is not recommended to use this medication as needed for continuous symptom control. 2) Combination therapy with antibiotics for the eradication of Helicobacter pylori 20 mg of this medication should be administered in combination with 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) associated with nonsteroidal anti-inflammatory drug (both non-selective and selective COX-2) administration - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is needed. Clinical trials have not been conducted for over 4 weeks. 4) Patients requiring continuous administration of nonsteroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with nonsteroidal anti-inflammatory drug usage: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg administered twice daily. The dosage should be adjusted according to the individual patient, and treatment should continue while clinical symptoms are present. According to clinical data, the majority of patients can be controlled at doses ranging from 80 to 160 mg per day. Doses above 80 mg per day should be taken divided into two doses. 6) Maintenance therapy after intravenous induction of bleeding prevention due to gastric or duodenal ulcers After intravenous induction of bleeding prevention due to gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents over 12 years 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If symptoms persist or esophagitis remains untreated, take for an additional 4 weeks. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is needed. · Once symptoms are alleviated, subsequent symptoms should be controlled with 20 mg once daily. · For adults, 20 mg once daily may be taken as needed. It is not recommended to use this medication as needed for continuous symptom control in patients at high risk of developing gastric or duodenal ulcers associated with nonsteroidal anti-inflammatory drugs. 3. Children under 12 years: There is no experience in administering this medication to children under 12 years. 4. Renal dysfunction: No dosage adjustment is required. There is limited experience administering to patients with severe renal failure, so caution is warranted. 5. Hepatic dysfunction: No dosage adjustment is needed for patients with mild to moderate hepatic impairment. For patients with severe hepatic impairment, the dosage should not exceed 20 mg. 6. Elderly: No dosage adjustment is needed.

Children's dosage

Adolescents over 12 years - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily - Symptoms

Precautions

This medication should not be administered to certain patients. For example, individuals who are allergic to this drug or any of its components, or those with hypersensitivity to certain antibiotics should not take it. Additionally, individuals with certain heart conditions or nursing mothers should not use this medication. Various side effects may occur, so if unusual symptoms such as headaches, dizziness, dyspepsia, skin rash, or muscle pain occur while taking this drug, consult a doctor immediately. Long-term use requires regular blood tests or magnesium level checks, and caution is needed as the risk of fractures may increase. This drug can interact with other medications; therefore, inform a doctor or pharmacist of any other medications currently being taken. Pregnant or nursing individuals must consult healthcare professionals before use and it is safer to avoid this drug while nursing. In case of overdose, as there is no specific antidote, appropriate treatment should be administered according to symptoms, and it is essential to store this medication out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reactions, shock, hypomagnesemia, severe skin adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms), hepatitis, liver failure, encephalopathy, interstitial nephritis, sudden and severe headaches, seizures, confusion, visual disturbances, paralysis, rhabdomyolysis, severe edema, hypertension, significantly reduced urine output.

Mild side effects

Insomnia, anxiety, mental confusion, depression, aggression, hallucinations, headache, dizziness, sensory disturbances, drowsiness, taste disorders, blurred vision, dizziness, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea and vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, dermatitis, itching, rash, hair loss, photosensitivity, arthralgia, myalgia, muscle weakness, asthenia, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, facial edema.

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture and should be kept at room temperature, between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness over a long period.

Appearance and packaging

Appearance

Pink round film-coated tablet

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.

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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.