Medication info
Esomeprazole Magnesium Hydrate 40mg

Esomeprazole Magnesium Hydrate 40mg

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
Pink round film-coated tablet
Packaging
Box - 28 tablets/box [14 tablets/PTP x 2], Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle
Approval status
Active

MFDS item code 201506636 · Approved 2015.09.18 · Insurance code 653805110

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcer, and alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid 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 esophagitis is not resolved or symptoms persist, continue for another 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. · Once symptoms have improved, subsequent symptoms should be controlled with 20 mg once daily. · In adults, 20 mg can be administered once daily as needed. Continuous administration is not recommended for patients at high risk of developing gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug use. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer this medication 20 mg 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) related to the use of non-steroidal anti-inflammatory drugs (non-selective and selective COX-2). - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. Clinical trials have not been conducted beyond 4 weeks. 4) Patients requiring continuous non-steroidal anti-inflammatory drug administration - Treatment of gastric ulcers related to non-steroidal anti-inflammatory drug use: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drug use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent dosing should be adjusted according to the patient, and treatment should continue during symptomatic periods. According to clinical data, most patients can be managed on doses of 80 to 160 mg daily. Doses above 80 mg should be divided into two doses. 6) Maintenance therapy following intravenous induction for the prevention of rebleeding due to gastric or duodenal ulcers After intravenous induction for the prevention of rebleeding from gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents over 12 years old 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, continue for another 4 weeks. - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. · Once symptoms have improved, subsequent symptoms should be controlled with 20 mg once daily. · In adults, 20 mg can be administered once daily as needed. Continuous administration is not recommended for patients at high risk of developing gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug use. 3. Children under 12 years old There is no experience with administering this medication to children under 12 years old. 4. Renal impairment There is no need to adjust the dose. There are not many examples of administration in patients with severe renal failure, so caution is required. 5. Hepatic impairment There is no need to adjust the dose in patients with mild to moderate liver impairment. In patients with severe liver impairment, the dose should not exceed 20 mg. 6. Elderly patients There is no need to adjust the dose.
Children's dosage
Adolescents over 12 years old: - Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - If symptoms persist or are not resolved, continue for another 4 weeks.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

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

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

This medication is used to treat gastroesophageal reflux disease and erosive esophagitis, and is effective for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It also helps alleviate symptoms in patients with gastroesophageal reflux disease without esophagitis. It is used in combination with antibiotics for the prevention of recurrence in patients with Helicobacter pylori infection and duodenal or peptic ulcers. It is effective for the treatment and prevention of upper gastrointestinal symptoms or gastric ulcers and duodenal ulcers related to non-steroidal anti-inflammatory drug use. It is also applied for the treatment of Zollinger-Ellison syndrome and for maintenance therapy after prevention of rebleeding of gastric or duodenal ulcers following intravenous administration. Overall, it is used for the treatment and prevention of various digestive diseases.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid 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 esophagitis is not resolved or symptoms persist, continue for another 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. · Once symptoms have improved, subsequent symptoms should be controlled with 20 mg once daily. · In adults, 20 mg can be administered once daily as needed. Continuous administration is not recommended for patients at high risk of developing gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug use. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer this medication 20 mg 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) related to the use of non-steroidal anti-inflammatory drugs (non-selective and selective COX-2). - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. Clinical trials have not been conducted beyond 4 weeks. 4) Patients requiring continuous non-steroidal anti-inflammatory drug administration - Treatment of gastric ulcers related to non-steroidal anti-inflammatory drug use: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drug use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent dosing should be adjusted according to the patient, and treatment should continue during symptomatic periods. According to clinical data, most patients can be managed on doses of 80 to 160 mg daily. Doses above 80 mg should be divided into two doses. 6) Maintenance therapy following intravenous induction for the prevention of rebleeding due to gastric or duodenal ulcers After intravenous induction for the prevention of rebleeding from gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents over 12 years old 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, continue for another 4 weeks. - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. · Once symptoms have improved, subsequent symptoms should be controlled with 20 mg once daily. · In adults, 20 mg can be administered once daily as needed. Continuous administration is not recommended for patients at high risk of developing gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug use. 3. Children under 12 years old There is no experience with administering this medication to children under 12 years old. 4. Renal impairment There is no need to adjust the dose. There are not many examples of administration in patients with severe renal failure, so caution is required. 5. Hepatic impairment There is no need to adjust the dose in patients with mild to moderate liver impairment. In patients with severe liver impairment, the dose should not exceed 20 mg. 6. Elderly patients There is no need to adjust the dose.

Children's dosage

Adolescents over 12 years old: - Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - If symptoms persist or are not resolved, continue for another 4 weeks.

Precautions

This medication should not be used in patients who are allergic to specific components or have had hypersensitivity reactions. Caution is also warranted in patients allergic to penicillin antibiotics or macrolide antibiotics. Patients taking certain cardiac medications or antivirals, as well as women with a history of myocardial infarction or those who are nursing, should avoid taking this medication. This medication can cause various side effects, so if symptoms like headache, abdominal pain, diarrhea, skin rash, muscle pain, or blood abnormalities occur, medical consultation should be sought immediately. Regular examinations are needed for long-term use, particularly to periodically check magnesium levels and liver function. This medication may increase bacterial growth in the stomach by reducing gastric acid, so if symptoms of diarrhea or infection persist, medical attention should be sought. Additionally, there may be an increased risk of fractures, so caution is needed in patients with osteoporosis or a high risk of fractures. This medication can interact with other drugs, so it is essential to inform healthcare professionals of any ongoing medications. Care should be particularly taken when used with medications affecting blood coagulation, antibiotics, antivirals, and immunosuppressants. The safety of this medication has not been fully established during pregnancy, so pregnant patients should discuss use with their physician. It is recommended that nursing women do not take this medication. In cases of overdose, as there is no specific antidote, immediate medical attention should be sought for appropriate treatment. This medication should be kept out of reach of children and transferring it to another container should be avoided.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, shock, severe allergic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome, acute generalized exanthematous pustulosis, drug reactions with eosinophilia and systemic symptoms, DRESS syndrome, hepatitis, liver failure, jaundice, encephalopathy, liver abnormality, bronchospasm, pancreatitis, severe skin adverse reactions, rhabdomyolysis, severe edema, severe neurological symptoms.

Mild side effects

  • Headache
  • dizziness
  • sensory disturbance
  • drowsiness
  • taste disorder
  • blurred vision
  • anxiety
  • mental confusion
  • depression
  • aggression
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  • hallucination
  • fever
  • peripheral edema
  • hyponatremia
  • hypomagnesemia
  • insomnia
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • elevated liver enzymes
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fracture
  • arthralgia
  • myalgia
  • muscle weakness
  • asthenia
  • increased sweating.

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. To maintain effectiveness, it is important to store it at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Box - 28 tablets/box [14 tablets/PTP x 2], Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle

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.